15261_Technical Specifications Neonatal Report For Web.pdf

WHO Technical
specifications of Neonatal


Resuscitation Devices






WHO Technical
specifications of Neonatal


Resuscitation Devices




WHO Library Cataloguing-in-Publication Data


WHO technical specifications of neonatal resuscitation devices.


1.Resuscitation – instrumentation. 2.Infant, Newborn. 3.Asphyxia Neonatorum – prevention and control.


4.Infant Mortality – prevention and control. I.World Health Organization.


ISBN 978 92 4 151026 4 (NLM classification: WQ 450)


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Contents


Acknowledgements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3


Abbreviations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4


Executive summary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5


Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
How to read this document . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Who is this document intended for? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Purpose of the document . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Scope of the document . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9


Chapter 1: Technical specifications for a self-inflating neonatal resuscitation
bag with mask . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10


1.1 Scope . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
1.2 Background for a neonatal resuscitation bag with mask . . . . . . . . . . . . . . 10


1.2.1 Self-inflating bag . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
1.2.2 Valve. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
1.2.3 Mask . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12


1.3 Standards and regulations compliance . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
1.4 Other considerations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13


1.4.1 How to use a resuscitation bag with mask . . . . . . . . . . . . . . . . . . . . . . . 13
1.4.2 Reprocessing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
1.4.3 Storage and packaging . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
1.4.4 Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
1.4.5 Capacity-building and quality assurance related to the neonatal


resuscitator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
1.5 Key tender/request for quotation specifications for a neonatal


resuscitation bag with masks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
1.5.1 Neonatal resuscitation bag with mask specifications . . . . . . . . . . . . . . . . 16


Chapter 2: Technical specifications for a suction machine . . . . . . . . . . . . . . . . . 18
2.1 Scope . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
2.2 Background for a suction machine . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
2.3 Equipment requirement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19


2.3.1 Electrical suction machine . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
2.4 How to use an electrical suction machine . . . . . . . . . . . . . . . . . . . . . . . . . . 20


2.4.1 Manual/foot-operated suction machines . . . . . . . . . . . . . . . . . . . . . . . . . 21
2.5 Standards and regulations compliance . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
2.6 Other considerations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22


2.6.1 Reprocessing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
2.6.2 Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
2.6.3 Suction catheter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23


2.7 Key tender/request for quotation specifications for a suction machine,
electrically operated . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
2.7.1 Suction machine specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23


1Technical specifications of Neonatal Resuscitation Devices




Chapter 3: Technical specifications for a suction device . . . . . . . . . . . . . . . . . . . 25
Brief description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
3.1 Scope . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
3.2 Background . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
3.3 Standards and regulations compliance . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
3.4 Reprocessing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
3.5 Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
3.6 Capacity-building and quality assurance related to the suction devices . . 26
3.7 Key tender/request for quotation specifications for a suction bulb . . . . . . 27


3.7.1 Single-use suction bulb specifications . . . . . . . . . . . . . . . . . . . . . . . . . . 27
3.7.2 Suction device specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28


Chapter 4: Procurement guidance for neonatal resuscitation devices . . . . . . . . 29


Chapter 5: For further research . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30


Annex 1. Glossary of terms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31


Annex 2. Facemask size discussion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34


Annex 3. Bag size review – resuscitation bag with mask . . . . . . . . . . . . . . . . . . . 35


Annex 4. 2012 WHO Guidelines on basic newborn resuscitation . . . . . . . . . . . . 37


Annex 5. Technical specifications for a self-inflating neonatal resuscitation
bag with masks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39


Annex 6. Technical specifications for a suction machine, electrically operated . . 43


Annex 7. Technical specifications for a single-use suction device . . . . . . . . . . 47


Annex 8. Technical specifications for a suction device . . . . . . . . . . . . . . . . . . . . 50


Annex 9. Meeting Report - Consultation for technical specifications for
procurement and regulatory pathway of medical devices determined by the
United Nations Commission on Life Saving Commodities (June 10-12, 2013) . . 53


Annex 10. Sixty-Sixth World Health Assembly Implementation of the
recommendations of the United Nations Commission on Life-Saving
Commodities for Women and Children (WHA66.4) . . . . . . . . . . . . . . . . . . . . . . . . . 68


Annex 11. UNCLSC Poster – Second Global Forum on Medical Devices . . . . . . 71


References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 72


Technical specifications of Neonatal Resuscitation Devices2




Acknowledgements


The WHO technical specifications of Neonatal Resuscitation Devices was developed
under the framework of the World Health Assembly Resolution WHA66.7,(5) which
is at the foundation of the United Nations Commission on Life-Saving Commodities
(UNCLSC) for Women and Children (Annex 10). The mandate of the UNCLSC is to
promote and assure the availability of 13 safe, quality commodities, which include
resuscitation devices.


These specifications are the result of a collaboration of experts from different backgrounds
and organizations, including WHO, UNICEF, CHAI, PATH and Save the Children, with
funding support from the Reproductive, Maternal, Newborn, Child and Adolescent
Health (RMNCH) Trust Fund, derived from the UNCLSC.


Cai Long and Didier Mukama drafted this document under the supervision of Adriana
Velazquez Berumen, Senior Advisor of Medical Devices at the Policy and Access Unit
of the Essential Medicines and Health Products at WHO.


It is noted that in June 2013, an expert group from the Neonatal Resuscitation Group
along with representatives from six African countries, gathered at WHO headquarters to
discuss for the first time the technical specifications of neonatal resuscitation devices;
WHO is grateful to every participant (Annex 9 includes the report of this meeting).


WHO addresses its sincere gratitude to the following people for their knowledgeable
contribution during the development of these technical specifications and for their
primary review of this document:


Severin Ritter Von Xylander (WHO); Donna Vivio (USAID); Manjari Quintanar Solares
(PATH); Jillian Zemanek (PATH); Fay Venegas (PATH); Kellen Thomas (CHAI); Linda
Wright (NIH); Keith Neroutsos (PATH); Indira Narayanan (Global Newborn Health);
Stella Abwao (Save the Children); Susan Niermeyer (University of Colorado); Shauna
Mullally (UNICEF); Monique Supiot (UNICEF); Yukiko Nakatani (WHO); Annie Clark
(University Research Co. LLC); William Keenan (Saint Louis University); Sherri Bucher
(Indiana University); Mohammed Ameel (NHSRC India); Tomomichi Nakazaki (Tokyo
Women’s Medical University-Waseda University); Lloyd Jensen (University of Utah).


Funding of this project was granted to WHO by the RMNCH Trust Fund to support
the implementation of the actions of the UNCLSC.


Technical editor AvisAnne Julien; drawings designer, Cristina Ortiz; and overall
design L’IV Com Sàrl.


3Technical specifications of Neonatal Resuscitation Devices




Abbreviations


CE Conformité Européenne/European Conformity
CFR Code of Federal Regulations – FDA (United States)
CHAI Clinton Health Access Initiative
Cm centimetre
cmH2O centimetre of water
EEC European Economic Commission
EU European Union
FDA Food and Drug Administration (United States)
g gram
GHTF Global Harmonization Task Force
GMDN© Global Medical Devices Nomenclature
HLD high-level disinfection
IEC International Electrotechnical Commission
IMDRF International Medical Device Regulators Forum
IMDRF founding
member country


Australia, Canada, European Union, Japan, United States


ISO International Organization for Standardization
JIS Japanese Industrial Standards
Kg kilogram
kPa kilopascal
L litre
M metre
MHLW Ministry of Health, Labour and Welfare - Japan
mL millilitre
mm millimetre
mmHg millimetre of mercury
N Newton
N/A not applicable
NIH National Institutes of Health (United States)
O2 oxygen
PIP peak inspiratory pressure
ROHS Restriction of Hazardous Substances
SoPs standard operating procedures
UMDNS© Universal Medical Device Nomenclature System
UN United Nations
UNCLSC United Nations Commission on Life-Saving Commodities for


Women and Children
UNFPA United Nations Population Fund
UNICEF United Nations Children's Fund
UNSPSC United Nations Standard Products and Services Code
USAID United States Agency for International Development
WHA World Health Assembly
WHO World Health Organization


Technical specifications of Neonatal Resuscitation Devices4




Executive summary


The United Nations Commission on Life-Saving Commodities (UNCLSC), launched
in 2012, defined 13 health products to be available and used appropriately to end
preventable deaths of woman and children. One of those 13 products is the neonatal
resuscitator, an indispensable medical device to save newborns from asphyxia at birth.
This document is part of the work led by WHO to ensure availability of good quality,
affordable neonatal resuscitators in every place where a child is born, along with trained
health-care workers, in order to help babies breathe and save their lives. This document
is a guide for the selection and procurement of neonatal resuscitators, describing the
technical specifications as well as providing guidance for correct use.


Neonatal mortality represents approximately 44% of under-5 child deaths, of which
one quarter of overall neonatal deaths (around 700 000) is attributed to birth asphyxia,
defined as the failure to initiate and sustain breathing at birth. Effective neonatal
resuscitation; immediate care, including thorough drying, suction and stimulation after
assessment; and positive-pressure ventilation, if needed, can prevent a high number
of neonatal deaths (1).


Based on the World Health Organization (WHO) Guidelines on basic newborn
resuscitation (2012) and the technical meeting on medical devices of the UNCLSC
in June 2013, the WHO medical devices team worked in collaboration with neonatal
resuscitation experts from PATH, the Clinton Health Access Initiative (CHAI) and the
United Nations Children’s Fund (UNICEF) to develop technical specifications for
neonatal resuscitation devices, which are described in each chapter:


• Chapter 1, neonatal resuscitation self-inflating bag with mask
• Chapter 2, suction machine
• Chapter 3, single and suction device
• Chapter 4, procurement guidance
• Chapter 5, research agenda


The WHO technical specifications for neonatal resuscitation devices were developed
based on existing international standards, evidence-based publications from reliable
sources and field expert experience. For equipment without prior technical specifications,
recommendations were made based on a literature research, depending on quality and
significance of evidence.


The purpose of the WHO technical specifications of Neonatal Resuscitation Devices
is to provide a minimum standard baseline to meet the increasing demand to procure
good quality, affordable, accessible and appropriate neonatal resuscitation devices. The
specifications are intended to support policy-makers, managers, procurement officers,
manufacturers, regulators and nongovernmental agencies, especially in low- and middle-
income countries to select, procure, use, reprocess and decommission appropriate
neonatal resuscitation equipment. The end goal is to save the children, particularly in
low-resource settings.


5Technical specifications of Neonatal Resuscitation Devices




Introduction


Neonatal mortality represents approximately 44% of under 5 year old child deaths, of
which one quarter of overall neonatal deaths (around 700 000) is attributed to birth
asphyxia, defined as the failure to initiate and sustain breathing at birth. About 3–6% of
all newborns (about 6 million) require basic neonatal resuscitation (2). A high number of
neonatal deaths can be prevented through effective neonatal resuscitation, immediate
care including thorough drying, suction, stimulation as needed after assessment, and
positive-pressure ventilation if the newborn has not established spontaneous respirations
(1). However, lack of commodities is one of the main bottlenecks found in health systems
in low-resource settings (3).


To address the above-mentioned health challenges faced in low-resource countries,
the World Health Organization (WHO), in conjunction with other United Nations (UN)
agencies, has been working on Millennium Development Goals (MDGs) 4, 5 and 6,
specifically the under-5 mortality rate and the maternal mortality ratio. In that regard, the
UNCLSC was created in 2012 with the goal to increase access to life-saving medicines
and health supplies for the world’s most vulnerable people by championing efforts to
reduce barriers that block access to essential health commodities.


Over 6 million women and children could be saved by 2017 if access to simple,
essential and affordable medicines, medical devices and health supplies is provided.
The UNCLSC has made 10 recommendations (Table 1) to increase access to 13
essential, overlooked commodities in four categories: reproductive health; maternal
health; newborn health; and child health (4). Neonatal resuscitation devices are one of
the 13 commodities for newborn.


Table 1. The UNCLSC recommendations on essential, overlooked commodities




1. Shaping global market
2. Shaping delivery markets
3. Innovative Financing
4. Quality strengthening
5. Regulation efficiency
6. Supply and awareness
7. Demand and awareness
8. Reaching women and children
9. Performance & accountability
10. Product innovation


Source: UNCoLSC- brochure. September 2015 (http://www.lifesavingcommodities.org/).


Accelerate
achievement of


MDGs 4 & 5


Reproductive health Female Condoms
Implants
Emergency
Contraception


Maternal Health Oxytocin
Misoprostol
Magnesium sulfate


Newborn Health Injectable antibiotics
Antenatal Corticosteroid
(ANCS)
Chlorohexidine
Resuscitation Equipment


Child Health Amoxicillin
Oral Rehydration
Salts
Zinc


Technical specifications of Neonatal Resuscitation Devices6




In May 2013, resolution WHA66.7 Implementation of the recommendations of the
United Nations Commission on Life-Saving Commodities for Women and Children
(Annex 10) was approved and requests WHO:


1. to work with UNICEF, UNFPA, the World Bank, UNAIDS, UN Women, national,
regional and international regulators, private sector actors and other partners, in
order to promote and assure the availability of safe, quality commodities;


2. to work with and support Member States, as appropriate, in improving regulatory
efficiency, standardizing and harmonizing registration requirement and streamlining
assessment processes, including granting priority to review of the life-saving
commodities (5).


The 13 commodities included three related to medical devices that were analysed and
discussed at the June 2013 meeting (Annex 9). However, each of these commodities
imply other related medical devices, as can be seen in Table 2.


Table 2. List of the 13 recommended life-saving commodities



Reproductive health commodities
• Female condom


Injectable antibiotics for newborn sepsis
• Syringe 2mL with needle 23 G 25 mm (with re-use prevention feature)


• Syringe 2mL with needle 23 G 25 mm (without re-use prevention feature)


• Safety box, for used syringes/needles


• Infant scale less than 20 kg


• Clinical thermometer, non-mercury


Resuscitation devices for newborn asphyxia
• Self-inflating neonatal resuscitation bag with masks for pre-term (size 0) and term (size 1) babies


• Electric or foot operated suction machine/pump, negative pressure less than 100mm Hg, with 1 bottle


• Suction catheter, length 50 cm, single use, conical tip, Fr #8


• Single use suction bulb


• Multi-use suction bulb that can be opened, cleaned and sterilized


• Training mannequin/simulator for neonatal resuscitation


• Infant stethoscope


In order to contribute to the access of quality, appropriate life-saving commodities, the
medical devices team at WHO, in collaboration with other international organizations,
called for technical advisors to support the development of the present publication on
technical specifications of neonatal resuscitation devices, specifically: resuscitation
bag with masks; suction machine; and single- and suction device. Therefore, these
specifications are meant to assist health facilities managers and staffs in low- and
middle-income countries in the selection, acquisition and use of appropriate and good
quality neonatal resuscitation devices.


With regard to the practice of neonatal resuscitation, WHO published the Guidelines
on basic newborn resuscitation in 2012, particularly for resource-limited settings
countries requiring effective resuscitation. The recommendations (please see details in


7Technical specifications of Neonatal Resuscitation Devices




Annex 4) in the above-mentioned publication were made based on benefits and harms,
quality of evidence, etc. These guidelines, listed in Annex 4, are used as a baseline for
neonatal resuscitation recommendations. The WHO technical specifications of Neonatal
Resuscitation Devices is a complementary support manual on acquisition of the correct
and appropriate neonatal resuscitation equipment.


A successful resuscitation programme requires both adequate training and necessary
equipment. Moreover, good quality, accessible, acceptable and affordable medical
devices play a vital role in efficient neonatal resuscitation. It is, therefore, the role of
policy- and decision-makers responsible for health-care delivery to make the essential
equipment and supplies as well as training available.


Unique challenges noticed during the development of these technical specifications were:
• discrepancies among existing standards and professional association guidelines;
• lack of evidence-based research for devices in low resource settings.


Strategies, including collaboration with international nongovernmental organizations
and associations, internal and external experts advisory, market review and systematic
literature review, were used in order to address these challenges and, therefore, provide
the most beneficial guide that supports health facility managers in low- and middle-
income countries to make the best informative decisions during purchase and selection
of neonatal resuscitation devices.


How to read this document


Each chapter provides information on each specific type of neonatal resuscitation
medical device, preceded by a summary of specifications. The detailed WHO standard
template technical specifications tables are presented in the annexes. Detailed
clarifications are provided for certain technical characteristics when needed.


Technical specifications for the following devices are available in separate chapters:
• neonatal resuscitation bag with mask (reusable)
• suction machine
• single and multi-use suction device.


This is followed by a section on procurement guidance and the final chapter addresses
the research agenda.


The annexes include the complete WHO template of technical specifications as well as
a report from a consultation to discuss technical specifications and the World Health
Assembly resolution related to the implementation of the United Nations Commission
on Life-Saving Commodities (UNCLSC).


Who is this document intended for?


This document is intended primarily for any policy-maker, manager, procurement officer
or professional health worker who has responsibility for procuring, supplying and using
neonatal resuscitation devices for all health settings, but particularly in low-resource
settings.


Technical specifications of Neonatal Resuscitation Devices8




Manufacturers would benefit from the specifications from this document to produce
quality products. Nongovernmental agencies will also be able to find useful information
in this document to support the access, whether by in-kind donation or procurement,
to quality products that comply with the present specifications.


Purpose of the document


The purpose of this document is to facilitate availability of resuscitation through the
introduction of appropriate neonatal resuscitation devices to all levels of health facilities
in low-resource setting countries and regions, from health centres to district hospitals,
outpatient clinics, ambulances, emergency services and specialized hospitals, wherever
neonatal resuscitation is required.


The document provides a technical baseline to meet the increasing demand of
procuring affordable, good quality and appropriate neonatal resuscitation devices. These
specifications can also be used to assist in the selection, procurement, distribution of
medical devices and training of health-care professionals on the safe use of neonatal
resuscitation devices to reduce newborn deaths.


Scope of the document


This document includes available evidence and advice for procurement officers to
help them make informed decisions when choosing products that meet performance
and design standards; it also includes scientific evidence for manufacturers so that
they may better understand the needs in low-resource settings, and may be beneficial
for local manufacturers to make local
supply products.


The neonatal resuscitation devices
are basic priority medical devices that
have been named in guidelines and
WHO documents, e.g. the Interagency
list of priority medical devices for
essential interventions for reproductive,
maternal, newborn and child health,
published in July 2015.


Interagency list of priority medical
devices for essential interventions
for reproductive, maternal,
newborn and child health


http://www.who.int/medical_devices/md_maternal_v12_web.pdf


9Technical specifications of Neonatal Resuscitation Devices




Chapter 1: Technical specifications for a self-
inflating neonatal resuscitation bag with mask


Brief description
A neonatal self-inflating resuscitator is used to ventilate a neonate with a body weight
less than 5 kg. Ventilation can be done with ambient air or with oxygen; the device can
be totally disassembled and is easy to clean and disinfect. All parts are manufactured
with durable and high-quality materials that can withstand a variety of cleaning methods
and a range of storage conditions. It is supplied as a complete set with:


• Non-rebreathing patient valve with a pressure limiting valve so that airway pressure
does not exceed 4.5 kPa (45 cmH2O) and can generate an airway pressure of at
least 3 kPa (30 cmH2O).


• Masks: translucent, in two different sizes: Size 0 (preterm and low–birth-weight
baby), round type, outer diameter 35–50 mm; Size 1 (term baby), round type,
outer diameter 50–65 mm. Silicone rubber or any material fulfilling at least the
standards ISO 10993-1; ISO 10993-5; ISO 10993-10 or equivalent; or classified
as USP Class V.


• Compressible self-refilling ventilation bag: silicone rubber or any other material
fulfilling the standards. Bag size: 200–320 mL. Intake valve with optional nipple for
O2 tubing: polycarbonate/ polysulfone or other material fulfilling the ISO 10651-4
or equivalent.


1.1 Scope


This chapter specifies technical requirements for a reusable neonatal self-inflating
resuscitation bag with mask, which uses a self-inflating bag to provide positive pressure
to open the neonatal airway as described below. The specifications are mainly based
on WHO neonatal resuscitation guidelines (1), international standards and evidence-
based research publications. For issues not addressed in standards or reliable sources,
recommendations are based on a series of meetings, surveys and reviews with experts
and studies by WHO and several nongovernmental organizations and scientific
institutions.


1.2 Background for a neonatal resuscitation bag with mask


Every year, 2.9 million newborn babies worldwide die within their first month of life, and
more than 1 million die on their first day of life. Almost one quarter of the newborn deaths
results from intrapartum hypoxia, also known as birth asphyxia (6). Birth asphyxia is defined
as the failure to initiate and sustain breathing at birth. Asphyxia can result from a variety
of causes, for example: maternal asphyxia; interruption of blood flow in the cord; fetal
anaemia; heart failure, etc. (7). In the WHO Guidelines on basic newborn resuscitation,
positive-pressure ventilation is recommended to be initiated within 1 minute after birth if
the baby has not started breathing after initial steps of resuscitation (1).


Technical specifications of Neonatal Resuscitation Devices10




A neonatal resuscitation bag with mask is the most standard basic neonatal ventilation
device to ventilate a neonate with a body weight less than 5 kg, due to its automatic re-
expansion feature and simplicity of use. It can be used without an additional continuous
power source or pressurized gas, which is particularly important in low-resource settings.
For babies who do not start breathing despite thorough drying and additional stimulation,
positive-pressure ventilation using a self-inflating bag and mask should be initiated
within 1 minute after birth. WHO recommends starting ventilation with ambient air; if
that is not successful, then ventilation should be started with 30% oxygen (1). There
should be a source of 100% oxygen and capability to blend the oxygen with air to yield
a concentration that produces the desired saturation as measured by pulse oximetry.


The neonatal resuscitator with bag technology in itself is not new, but materials and
features have improved over time. The device usually consists of three main parts: a
bag; a pressure relief valve; and a facemask (Figures 1 and 2).


Figure 1. Sample neonatal resuscitation
bag with mask


Figure 2. How to use a neonatal resuscitation
bag with mask


A neonatal resuscitation bag with mask is recommended to be operated by health-care
professionals who have received adequate relevant resuscitation training.


1.2.1 Self-inflating bag
A compressible, self-inflating bag, usually made of silicone rubber or equivalent
regulatory approved materials provides positive air pressure required to ventilate an
asphyxiated baby.


The immediate spontaneous tidal volume of preterm and term infants after birth ranges
from 6.5–7 mL/kg. For babies suffering from asphyxia, it is recommended to maintain
a tidal volume from 4–8 mL/kg during resuscitation, at a rate of 40–60 breaths per
minute (8–12). A low ventilated volume (tidal volume) might be insufficient to achieve
an adequate gas exchange and might cause hypercapnia or atelectotrauma (please


11Technical specifications of Neonatal Resuscitation Devices




refer to Annex 1 for definition). Animal studies show that excessive ventilation might
cause volutrauma (13,14), hence small tidal volumes at the start of ventilation is more
adequate than higher volumes (15). According to human factor experiments, “smaller
self-inflating bags are more likely to reduce the incidence of excessive tidal volumes
and produce better guideline-consistent ventilation for patients” (16).


For the majority of babies weighing less than 5 kg at birth, a bag with a 200–320 mL
(Annex 3) size should be adequate to provide ventilation for neonatal resuscitation.


1.2.2 Valve
To prevent administering excessive pressure, which can cause lung damage, a pressure
relief valve is recommended.


During resuscitation, a 30–40 cmH2O initial peak inspiratory pressure (PIP) may be
necessary to open term infants’ airways. For preterm infants, 20–25 cmH2O may be
effective and in some instances, such as the commencement of resuscitation, a positive
pressure of more than 40 cmH2O may be required to initiate resuscitation (8).


To ensure optimum protection and adequate ventilation, the valve should be able to
transmit an airway pressure of at least 30 cmH2O, and the maximum pressure for the
pressure relief valve is recommended to be 45 cmH2O.


The lung compliance is low especially in the initial stages of birth asphyxia and in
preterm babies with fluid filled lungs and low surfactant; at times in the early stages,
higher pressures or prolonged inflations are required. It is necessary to have the ability
to occlude or override the pressure relief valve in these specific circumstances. The
user training on the self-inflating neonatal resuscitator should include training on how
and when to override the pressure relief valve.


1.2.3 Mask
The mask or facemask is connected to the bag and covers the mouth and nose of the
newborn who is being resuscitated. A correctly sized mask should cover the mouth and
nose, but not the eyes, and should not extend beyond the chin. Using an appropriately
sized mask will reduce leakage and is vital for successful effective resuscitation
(Figure 3).


Figure 3. Correct use of a neonatal mask


a. Correct position and size b. Wrong: the facemask covers the eyes c. Wrong: the facemask covers the eyes
and beyond the chin


Technical specifications of Neonatal Resuscitation Devices12




As stipulated by ISO 10651-4:2002, the facemask should have a connecting port that
has either a 22 mm female connector or a 15 mm male connector.


For preterm babies, 35 mm or 42 mm diameter facemasks are suitable (17). Based on
market review and scientific evidence presented in Annex 2, the proposed ranges for
the dimensions of facemasks are:


• Size 0: outer diameter 35–50 mm
• Size 1: outer diameter 50–65 mm.


Ideally, a Size 1 mask is used for term babies and a Size 0 mask for preterm and low-
birth-weight babies. However, standards for size are not clearly defined; users should
make a note that the mask selected for use in a particular baby should be such that
it covers the mouth and nose without covering the eyes or extending over the chin.
Manufacturers and users should note that the mask design should provide a good seal
and limit air leakage as much as possible. A reusable mask should be able to withstand
appropriate reprocessing – pre-clean, disassemble, cleaning and high-level disinfection
(HLD)/sterilization, reassemble – and preserve its shape and material properties. Please
see Section 1.4.2 for more details on reprocessing.


1.3 Standards and regulations compliance


A newborn resuscitation bag with mask should comply with ISO 10651-4:2002 Lung
Ventilators – Particular requirements for operator-powered resuscitators or equivalent
national or regional standard compliance. For more details with regard to other regional
regulations and standards, see the specifications table at the end of the chapter.


1.4 Other considerations


1.4.1 How to use a resuscitation bag with mask
The steps below serve as a general guide to trained personnel. The protocol can be
customized according to health facilities standards and requirements, but neonatal
resuscitator should be prepared and tested for proper functionality before delivery (18).
It should be noted that when the resuscitator is used on a newborn, it is important to
watch for chest rise, listen to air movement and check for improvement of the newborn’s
heart rate and colour.


1. Check equipment and select the correct mask.
2. Apply the mask to make a firm seal. Extend the head, place the mask on the chin,


then over the mouth and nose. A firm seal permits chest movement when the
bag is squeezed.


3. Begin ventilation, practice should follow the WHO Guidelines on basic newborn
resuscitation.


4. Pre-clean, disassemble, clean, subject equipment to HLD or sterilization, reassemble
and assure proper storage before the next use. Please see Section 1.4.2 for more
details on reprocessing.


13Technical specifications of Neonatal Resuscitation Devices




1.4.2 Reprocessing
Reusable neonatal resuscitation devices (bag, mask, manual suction device) must be
properly reprocessed between patients to avoid infection and the continued functioning
of your equipment. Single-use resuscitation devices must be discarded after use as
they are not manufactured with materials that are intended to withstand repeated
reprocessing and may not be designed to resist to HLD or to sterilization.


The determination of the appropriate reprocessing method for a reusable medical device
takes into account the level of infection risk posed by the object. For this, the Spaulding
Classification System (19) outlines the risk of infection transmission posed by medical
devices and equipment. This risk classification divides equipment and devices into three
categories: critical; semi-critical; and noncritical items. Neonatal resuscitation devices
fall into the semi-critical class, given that they are objects that come into contact with
mucous membranes or non-intact skin, and thus pose a medium level of risk. Before
reusing, such objects must be free from all microorganisms, but a small number of
bacterial spores are permissible.


Instructions to reprocess neonatal resuscitation devices vary by source and context.
Guidelines designed for low-resource settings include selected components of the
following process: immediate pre-cleaning; disassembly; cleaning; HLD/sterilization;
reassembly; and storage.


Ideally, the manufacturer’s instructions, where available, should be followed. Immediate
pre-cleaning should be the first step in reprocessing soiled instruments to protect
cleaning staff before handling. This step inactivates hepatitis B virus (HBV) and HIV and
reduces, but does not eliminate, a number of other microorganisms (21). Pre-cleaning
can be done by wiping the outside of the devices with gauze soaked in a 0.5% chlorine
solution (19). This first step protects the health worker, but does not achieve a high level
disinfection thus the instruments are not ready for reuse yet.


Resuscitation devices should then be disassembled to allow for proper contact of
the cleaning and disinfecting agents/methods to reach all surfaces. The next step is
cleaning, a process in which visible organic and inorganic material is removed from the
devices by washing with soap and water. All the surfaces of the device must be free from
any material (such as blood or vernix) and thoroughly rinsed to allow the subsequent
disinfecting agent/method to act effectively. Then, resuscitation devices ideally should
be sterilized, but otherwise they should be dried and then undergo HLD. HLD can be
done by boiling for 20 minutes or by soaking the devices in activated glutaraldehyde
or in the 0.5% chlorine solution described above (19). It is important to follow the
instructions of the chemical manufacturer regarding exposure time, concentration and
solution temperature. After rinsing with clean boiled water, devices should be dried,
and then visually inspected for cracks and tears before reassembly. In order to extend
the lifetime of your device, it is important to prevent it from overexposure to chemicals
and to reprocess it according to the manufacturer’s recommendations.


After reassembly, the bag should be checked for correct assembly and proper
functioning as recommended by the manufacturer. If the instructions are not available:


• Put the mask on the ventilation bag. Squeeze the bag and look for the valve in the
patient outlet to open as you squeeze. This confirms that the device is ready to
deliver air to a patient.


Technical specifications of Neonatal Resuscitation Devices14




• Seal the mask tightly with the palm of the hand and squeeze hard enough to open
the pressure release valve. Listen for the sound of air escaping. This demonstrates
that air that cannot be delivered safely to the baby will escape through the pressure
release valve.


• Maintain the tight seal and check that the bag reinflates after each squeeze. This
shows that fresh air will enter the bag through the inlet valve.


If the resuscitator does not function properly, it should either be repaired before use
or replaced. The device should then be appropriately packaged and stored to avoid
recontamination.


1.4.3 Storage and packaging
ISO 15223-1:2012 Medical devices – Symbols to be used with medical device labels,
labelling and information to be supplied – Part 1: General requirements should be
followed to ensure safe, easy-to-use packaging. Labelling on the primary packaging
should include the name and/or trademark of the manufacturer.


The device should always be stored in a clean condition in a clean container on a shelf
or on the resuscitation table with the appropriate temperature and humidity to avoid
dust and exposure to insects.


1.4.4 Maintenance
Besides the use and care of the device, proper reprocessing and assembly, no other
maintenance is required. If a device appears damaged or does not pass the functionality
requirements test, it should immediately be taken out of service and replaced.


1.4.5 Capacity-building and quality assurance related to the neonatal
resuscitator


Availability of equipment for resuscitation is, on its own, not sufficient; the performance of
the user is equally critical. Therefore, competency-based capacity-building of the skilled
attendant using the self- inflating bag and mask, based on the standard guidelines,
is required not only for use on the baby, but also for reprocessing and maintenance
of equipment to prevent infection. Courses on basic resuscitation for low-resource
countries are available and cover the required set of skills (18). Moreover, the availability
of a training manikin can greatly help in acquiring skills before the attendant actually
needs to resuscitate a baby who is not breathing. Ideally, health facilities should have
at least one training manikin for training purposes.


It should also be noted that reprocessing of the equipment may or may not be done by
the same skilled birth attendant who carries out the resuscitation and who received the
training. It is, therefore, essential that the competency is passed onto the appropriate
person responsible for the full reprocessing.


Once the resuscitator reaches the facility, it is very important to train the health
professionals who will use the resuscitator, making sure supervision of correct and
appropriate use is in place, in order to guarantee patient safety and quality of care.
Should the device become damaged, or not function properly, then it is indispensable
to have good maintenance with qualified professionals who can replace the parts with
original manufacturer’s parts as needed or have them sent to the manufacturer for repair.


15Technical specifications of Neonatal Resuscitation Devices




The presences of a training manikin in the facility and motivation to practice frequently
have also been shown to help maintain skills (22). The above-mentioned processes
should be part of policy support and quality assessment and an improvement framework
that should encompass timely procurement of required accessories to avoid out-of-
stocks.


1.5 Key tender/request for quotation specifications for a neonatal
resuscitation bag with masks


Following are the key features that may be noted in a tender or request for quotation;
see Annex 5 for detailed standardized WHO technical specifications.


1.5.1 Neonatal resuscitation bag with mask specifications


Product Neonatal resuscitation bag with masks
Key resuscitation bag features • size: 200–320 mL


• for full-term babies, preterm and low-weight infants less than 5 kg
• reusable
• self inflating
• hand operated
• portable
• made of silicone or other materials specified in ISO10651-4 or equivalent
• ventilation can be done with ambient air or with oxygen
• intake valve with optional nipple for O2 tubing, material made of polycarbonate/


polysulfone or any other material fulfilling ISO 10651-4 or equivalent.


Key mask features • Size 0 for preterm and low-weight baby, round type, outer diameter 35–50 mm
• Size 1 for term baby, round type, outer diameter 50–65 mm
• translucent
• fulfilling ISO 10993-1:2009; ISO 10993-5:2009; ISO 10993-10:2010 or USP Class V (or


equivalents)


Bundling instructions Resuscitator bag and masks supplied as a complete set along with the following:
• non-rebreathing patient valve with a pressure limiting valve so that the airway pressure


does not exceed 4.5 kPa (45 cmH2O) and can generate an airway pressure of at least 3 kPa
(30 cmH2O)


Materials • all parts manufactured from high-strength, long-life materials that require no special
maintenance or storage conditions and comply to with national standards


• the mask is made of silicone rubber or any material fulfilling ISO 10993-1:2009; ISO
10993-5:2009; ISO 10993-10:2010 or equivalent or USP Class V


• the bag is made of silicone and valve of polycarbonate/polysulfone or any materials
fulfilling ISO10651-4 or equivalent.


Technical specifications of Neonatal Resuscitation Devices16




Packaging • primary packaging: unit of use; one resuscitator set in a plastic bag + box with
manufacturer’s instruction for use


• labelling on the primary packaging: name and/or trademark of the manufacturer;
manufacturer product reference; type of product and main characteristics


• if the packaging is not transparent, it must bear a diagram (preferably actual size)
showing the essential parts of the product and indicating the position of the product in the
packaging


• lot number prefixed by the word “LOT” (or equivalent harmonized symbol)
• information for particular storage conditions (temperature, pressure, light, humidity, etc.)


as appropriate (or equivalent harmonized symbol)
• information for handling, if applicable (or equivalent harmonized symbol)


Language • English and/or any language preferred by users


Assembly and reassembly
instructions


• resuscitator can be totally disassembled
• clear instructions/diagrams for assembly and reassembly instructions must be included in


and/or on the packaging


Cleaning instructions • easy to clean, disinfect and sterilize
• clear instructions/diagrams for cleaning instructions must be included in and/or on the


packaging


Warranty • minimum 1 year


Reference to International
standards


• ISO 13485:2012 Medical devices – Quality management systems – Requirements for
regulatory purposes
ISO 10651-4:2002* Lung ventilators – Part 4: Particular requirements for operator-
powered resuscitators (*EN 13544-2 implied), oxygen related clauses are optional


• For facemask (if not made of silicone).
ISO 10993-1:2009 Biological evaluation of medical devices – Part 1: Evaluation and
testing for mask
ISO 10993-5:2009 Biological evaluation of medical devices – Part 5: Tests for in vitro
cytotoxicity
ISO 10993-10:2009 Biological evaluation of medical devices – Part 10: Tests for irritation
and delayed-type hypersensitivity (or classified as USP class V):


• Optional:
ISO 14971:2012 Medical devices – Application of risk management to medical devices


• ISO 5356-1:2004 Anaesthetic and respiratory equipment – Conical connectors – Part 1:
Cones and sockets
BS EN 980:2008 Graphical symbols for use in the labelling of medical devices
ISO 15223-1:2012 Medical devices - Symbols to be used with medical device labels,
labelling and information to be supplies – Part 1: General requirements
BS EN 1041:2008 Information supplied by the manufacturer with medical devices


Regulatory approvals • To comply with the regulatory requirements of the National Regulatory Agency; or
• registered in country of import, if applicable; or
• approval from the National Regulatory Agency of the manufacturer’s country; or
• FDA registration (United States); or
• CE Mark (EU) for class IIa, with notified body number, or


approval from other regulatory body in an IMDRF founding member country


17Technical specifications of Neonatal Resuscitation Devices




Chapter 2: Technical specifications for a
suction machine


Brief description
A portable, hand-held, battery-powered/hand- or foot-operated suction equipment
designed to enable an adult to gently suction and clear excessive mucus from the airway
(nasal or oral) passages of an newborn or an infant to facilitate easier breathing, with
following technical requirements:


• AC line or battery-powered with rechargeable battery;
• maximum vacuum: 100 mmHg (20 kPa);
• collection bottle (one or two): 1L (disposable bag or collection jar);
• bottle(s) with an automatic cut off when full, to prevent ingress of fluid to the


pump; filter and overflow valve incorporated to prevent cross-contamination (e.g.
shatterproof material; overflow protection system); should be either disposable or
autoclavable;


• tubing to the patient is a minimum of 0.5 m long, noncollapsible type.


2.1 Scope


This chapter defines technical specifications for a suction machine, also known as an
airway/nasal aspirator. Suction machines are used to gently suction and clear excessive
mucus from the airway passages of a newborn or an infant, in order to facilitate easier
breathing. They can be electrical, manual or foot operated. Suction machines used
for newborns are classified as low-flow suction machines (with airflow less than 20 L/
minute).


2.2 Background for a suction machine


When a newborn is unable to breathe enough in the first few minutes of life, birth
asphyxia may occur. One way that this occurs is when the infant still has fluid in the
airway. Suction can, therefore, in this case assist in removing the fluid and clear the
airway to allow the newborn to breathe easily or to decrease respiratory resistance.
However, as suction can cause bradycardia in certain circumstances, it is recommended
to carry it out only in cases where the newborn has obvious airway obstruction that
prevents spontaneous breathing. WHO recommends suctioning only if the newborn
has meconium-stained amniotic liquid or when either the mouth or nose is blocked
with secretions (23).


Moreover, it also has been evidenced that a few inexpensive practices can save newborn
lives. One of these practices is immediate drying and stimulation at birth (24). In
addition, clearing of the newborn’s airways, where indicated, may also help in improving


Technical specifications of Neonatal Resuscitation Devices18




breathing. The suction machine is used to clear the airways, allowing the newborn to
breathe properly and prevent asphyxia.


However, high vacuum pressures can be harmful to the newborn airway tissues.
Therefore, the most important characteristic of the aspirator is its regulated negative
pressure that sucks the obstructing fluids from the buccal cavity and the nasal airways.
Negative pressure regulates the vacuum created in the airways. Published airway suction
guidelines recommend a negative pressure level of 80-100 mmHg for newborns (25,26)
Negative pressure recommended in these specifications for a newborn nasal aspirator
is a maximum of 100 mmHg. Moreover, ISO recommends that a low-flow device should
have a vacuum less than 20 kPa (150 mmHg).


2.3 Equipment requirement


2.3.1 Electrical suction machine
The equipment is electrically powered and portable, thus there must be an electric
power source (220V or 120V, according to different national standards) in the room
to allow battery charging. The user should be trained on how to operate the machine
and how to clean and maintain the equipment. The user should wear protective gear
such as gloves, as a self-protection measure during the use and care of the equipment
(Figure 4). More details on the equipment requirements are available in the technical
specifications tables in Annex 6.


An electrical suction machine consists of the following.


2.3.1.1 POWER SOURCE/MAINS
In this case, a rechargeable battery-operated electric circuit powers the pump. The line
power cord allows connection to the battery and recharging of the battery. The device
should be able to run intermittently for a minimum duration of 30 minutes on the battery,
under maximum free airflow of not less than 20 L/minute and a vacuum of not less than
20 kPa below atmospheric pressure. The device should have audible and visible alarms
indicating a low battery. This part should fulfil Clause 7 of IEC6061-1:1998 or equivalent.


2.3.1.2 VACUUM SOURCE
The vacuum source is the pump. It should be durable and require limited maintenance,
produce a maximum vacuum of 100 mmHg and a flow of 20 L/minute, and be able to
produce 20 kPa below atmospheric pressure in 10 seconds. The pump should cease
to operate when the collection container is full; or, if it continues to operate, the device
should have an overfill means. The device should stop working when a maximum of
5 mL of liquid passes downstream of the overfill device. The suction machine should
have the means to prevent the pump from contamination.


2.3.1.3 COLLECTION BOTTLE
The collection container can be either a disposable bag or collection jar, with a capacity
of 1 L and should be transparent in order to see the level of the contents. The usable
volume should be marked in millilitres, by no less than 50 mL and no more than 250
mL graduations. The container should have inlet and outlet ports clearly indicated (26).


19Technical specifications of Neonatal Resuscitation Devices




2.3.1.4 SUCTION TUBING
The inner diameter of the suction tubing should be no less than 6 mm. The degree
of collapse is indicated in ISO 10079-2:2014. The minimum length of the tubing to
the patient should be not less than 0.5 m. The airline to the pump must incorporate a
bacterial filter (hydrophobic). Both tubings should be a noncollapsible type, reusable
and made of silicone (26).


2.3.1.5 CONNECTORS
The inlet port and the outlet port of the suction device are to have different inner
diameters and it must not be possible to connect the suction tubing to the outlet port.
The inner diameter of the inlet port should be 6–12 mm, while the minimum inner
diameter of the outlet port is 14 mm, to avoid the risk of incorrect connections (26).


2.3.1.6 VACUUM GAUGE AND VACUUM REGULATOR
The vacuum gauge indicates the level of the vacuum pressure and should have an
accuracy of +/- 0%. The vacuum regulator should adjust the suction from 0–100 mmHg.


Figure 4. Electrical suction machine with a canister


2.4 How to use an electrical suction machine


It should be noted that the device must be available in the room and ready to be used
before the baby is born.


1. Wash hands thoroughly with water and soap, dry thoroughly and put on gloves.
2. Place the suction machine on a sturdy surface.
3. Position the baby in a comfortable position with his/her head supported.
4. Connect the catheter with the connecting tubing to the suction tubing.
5. Turn on the suction machine (refer to the device user manual).
6. Set the suction unit to the appropriate suction pressure, a range 50–100 mmHg,


or according to the health facility’s standard operating procedures (SoPs).
7. Insert the suction catheter according to the SoPs. If not available, mouth should


be suctioned first.


Technical specifications of Neonatal Resuscitation Devices20




8. Start suctioning. Proceed as required by the SoPs. It is advised to not use more
than 10 seconds for every suction and to provide some time between suction
passes (approximately 30 seconds or as required by the SoPs guideline) to allow
for the infant to catch its breath.


9. Clean (clear by suctioning some sterile water) the catheter after each pass
(according to the SoPs).


10. Repeat steps 7, 8 and 9 until the mucus is cleared in the mouth or nose.
11. Disconnect the tubings and catheter. Discard the catheter appropriately after use or


if reusable, then clean and sterilize before using on another baby. Discard patient
tubing or catheter if not reusable or damaged.


12. Dismantle and clean (remove body fluids, wash with detergent, rinse and dry),
disinfect and reassemble as described in user manual.


13. Use disinfectant solutions such as 0.5% chlorine and avoid exposing the electric
parts to this solution to clean the suction machine.


2.4.1 Manual/foot-operated suction machines
A manual/foot-operated machine, in contrast with the electrical suction machine,
generates a vacuum by direct human effort, the foot in this case (Figures 5 and 6).
The specifications in the previous paragraph on a vacuum source, collection bottle,
vacuum gauges and regulators also apply to manual/foot-operated suction machines.
Foot-operated devices have the special advantage in that they free up the hands for
other aspects of care of the baby.


Figure 5. Sample foot-operated suction
machine


Figure 6. Sample manual-operated suction machine


2.4.1.1 POWER SOURCE
The device is actuated by hand or feet. A foot-operated suction machine should require
less than 350 N (approximately 35 kg) to activate the device. Hand-operated suction
equipment should not require more than 45 N (approximately 4.5 kg).


21Technical specifications of Neonatal Resuscitation Devices




2.5 Standards and regulations compliance


The electrical suction machine must comply with the product standards as mentioned in
the technical specifications sheet: ISO 10079-1:1999 Medical suction equipment – Part
1: Electrically powered suction equipment – Safety requirements as a minimum standard
or equivalent; as well as ISO 5359: 2014 or equivalent. Details of other regulations and
standards, regional or international, can be found in the technical specifications table
at the end of the chapter.


2.6 Other considerations


2.6.1 Reprocessing
Table 3 provides an overview of different parts of a suction machine and its cleaning
methods in case no SOPs are available. It is advised to follow the health facility’s SOPs.
The suction catheter is a single-use item and must be discarded after use, as noted
above.


Table 3. Suction pump user maintenance chart


No. Part Clean Disinfect Sterilize
1 Pump X X


2 Collection bottle X X


3 Suction tubing (patient) X X X


4 Vacuum regulators and vacuum gauges X X


5 Connectors X X


2.6.2 Maintenance
The electrical suction pump should require the least maintenance possible except for
the user care: cleaning; disinfection; and sterilization. Where maintenance is required,
it should be as minimal as possible and the internal parts of the device should be easily
reachable. Before performing maintenance tasks, it is advised to prevent the likelihood
of infection by ensuring sterilization of the machine before any maintenance task. Care
should be taken to wear gloves and clean hands after maintenance tasks or use of the
machine. Generic regular checks on suction devices include:


1. On a daily basis, clean, wipe dust off the exterior and cover the equipment after
each use.


2. Wash the bottle and patient tubing as previously indicated.
3. Check if all fittings and accessories are mounted correctly.
4. Check if the filter is clean; and check for leaks and crack.
5. Check for the level of suction. A lower level indicates that there are leakages.


Check that parts are fitted tightly (the lid on the bottle, the sealing washer and
tube connections on the bottle or on the pump) and replace any broken tubes
or damaged bottle or washer. If after these two procedures suction is still weak,


Technical specifications of Neonatal Resuscitation Devices22




it might be caused by an internal fault. To check for an internal fault, remove the
tubing from the pump outlet; block the outlet while the device is on. The suction
gauge indicator should reach the maximum level. If it does not, then the problem
is internal (assuming all other checks mentioned earlier have been done and are
satisfactory). A qualified biomedical technician must then open the pump to check
if the pump’s diaphragm (if it is a diaphragm pump) does not have a hole or is
broken or has any other fault.


6. Always check if the device functions well after maintenance and repair before
returning it to service.


2.6.3 Suction catheter
Single-use, Fr #8 catheters with a length of 50 cm should be used during neonatal
resuscitation. They are single-use or reusable and should have a soft conical tip to
reduce damaging mucus membranes.


2.7 Key tender/request for quotation specifications for a suction
machine, electrically operated


Following are the key features that may be noted in a tender or request for quotation;
detailed standardized WHO technical specifications can be found in Annex 6.


2.7.1 Suction machine specifications


Product Suction machine, electrically operated
Key features • low vacuum, low flow, oil-free vacuum pump


• electrically powered or battery-powered with rechargeable battery
• maximum vacuum: 100 mmHg
• collection bottle (one or two): 1 L (disposable bag or collection jar); with an automatic


cut off when full to prevent ingress of fluid to the pump; a filter and overflow valve
incorporated to prevent cross-contamination (e.g. shatterproof material, overflow
protection system); either disposable or autoclavable


• airline to the pump incorporating a bacterial filter
• tubing to the patient a minimum of 0.5 m long, a noncollapsible type; all parts


manufactured from high-strength, durable material that does not require specific
maintenance or storage conditions and are approved by national regulatory agencies


• pump that can be disassembled entirely, is easy to disinfect and clean
• pressure gauge that displays the level of suction generated
• adjustment of suction delivered to the patient
• unit surface that is hard and corrosion resistant; pump handle/pedal that is spring loaded


to return to the “up” position after each stroke
• mounted on a robust board with a carrying handle
• supplied with: spare filters: 10 sets; spare suction bottle: one unit; seals: two pairs for


each storage jar
• additional documents from supplier:


› a list of other spare parts anticipated during one year’s operation, with costs
› user and maintenance manuals


Language • English and/or any language preferred by final users
• packaging of the set depends on the shipment type; at a minimum, per Annex C: Clause


12.1 of Part 1 of ISO 15500:2004 or equivalent
• symbols used according to ISO 15223 or equivalent


23Technical specifications of Neonatal Resuscitation Devices




Warranty • duration of warranty clearly stated
• minimum 1 year, with specific inclusions and exclusions listed and contact details of the


manufacturer, supplier and local service agent provided


Reference to International
standards


• ISO 10079-1:1999 Medical suction equipment – Part 1: Electrically powered suction
equipment – Safety requirements or equivalent


• ISO 13485:2003 Medical devices – Quality management systems – Requirements for
regulatory purposes (Australia, Canada, EU) or equivalent


• IEC 60601-1-2 Ed. 3.0:2014 Medical electrical equipment – Part 1-2: General
requirements for basic safety and essential performance – Collateral standard:
Electromagnetic compatibility – Requirements and tests or equivalent


• ISO 14971:2012 Medical devices – Application of risk management to medical device


Regulation requirement To comply with the regulatory requirements of the national regulatory agency


Optional:
• registered in country of import, if applicable; or
• approval from the national regulatory agency of the manufacturer’s country; or
• FDA registration (United States); or
• CE Mark (EU) for class IIa, with notified body number,


or approval from other regulatory body in an IMDRF founding member country


Technical specifications of Neonatal Resuscitation Devices24




Chapter 3: Technical specifications for a
suction device


Brief description
A suction device is a portable, hand-held, manual suction device designed to suck gently
and clear excessive mucus from the airway of a newborn to facilitate easier breathing
(Figures 7 and 8). Both single-use and multi-use suction devices are used in clinical
settings. Single-use bulbs must be discarded after use and reusable suction devices
need to be opened and subjected to pre-cleaning, cleaning, HLD/sterilization and proper
storage until subsequent use.


3.1 Scope


This chapter specifies technical requirements for suction devices for neonatal
resuscitation. Both single-use and multi-use suction devices are approved to be clinically
efficient to clear excessive mucus to facilitate breathing. The specifications are based on
WHO neonatal resuscitation guidelines and international standards (see Section 3.3).


3.2 Background


Neonates who do not start breathing after thorough drying and stimulation require
suctioning before ventilation, if the mouth or nose is blocked with secretions. When
mechanical equipment to perform suction is not available, a suction device (single-use
or reusable) is recommended (1). A suction device is a portable, hand-held, manual
suction device designed to suck gently and clear excessive mucus from the airway of
the newborn to facilitate easier breathing.


A suction device should be able to withstand appropriate reprocessing (pre-cleaning,
cleaning and HLD/sterilization).


Figure 7. Sample suction devices Figure 8. Suction device being used on a baby


25Technical specifications of Neonatal Resuscitation Devices




3.3 Standards and regulations compliance


Although no specific industry reference standards are available for newborn suction
devices, the standards noted in the following resources (or other equivalent standards)
are suggested to ensure quality:


ISO 13485:2003 Medical devices – Quality management systems – Requirements
for regulatory purposes


ISO 14971:2007 Medical devices – Application of risk management to medical
devices


ISO 11135-1:2007 Sterilization of health-care products – Ethylene oxide – Part
1: Requirements for development, validation and routine control of a sterilization
process for medical devices


ISO 11135:2014 Sterilization of health-care products – Ethylene oxide –
Requirements for the development, validation and routine control of a sterilization
process for medical devices


ISO 8836:2007 or ISO 8836:2014 Suction catheters for use in the respiratory tract


3.4 Reprocessing


It is essential to be able to easily dispose of single-use suction bulbs without causing
harm to the environment.


Reusable Suction devices must be able to be easily opened, pre-cleaned, cleaned
and subjected to HLD/sterilization after each use. Although suction devices can be
difficult to clean sometimes, note that they can become a source of cross-infection if
not cleaned properly.
Manufacturer’s instructions and international guidelines should be followed to ensure
appropriate HLD/sterilization.


3.5 Maintenance


Besides pre-cleaning, cleaning, HLD/sterilization and proper storage after each use no
other maintenance is required.


3.6 Capacity-building and quality assurance related to the suction
devices


Health workers involved in resuscitation need to have the competence to use the suction
device and suction bulb.


Technical specifications of Neonatal Resuscitation Devices26




Training, supervision and motivation are needed to use the suction device in a safe
and effective manner, and to avoid infection. Single-use bulbs must be discarded after
use and reusable suction devices need to be opened and subjected to pre-cleaning,
cleaning, HLD/sterilization, and proper storage until subsequent use.
Follow-up supervision and mentoring for quality of care should be carried out as
described for the bag and mask.


3.7 Key tender/request for quotation specifications for a suction bulb


Following are the key features that may be noted in a tender or request for quotation;
detailed standardized WHO technical specifications can be found in Annex 7 and
Annex 8.


3.7.1 Single-use suction bulb specifications


Product Suction machine, electrically operated
Key features • oral, nasal


• manual or handheld
• compressible bulb with a tip that can be inserted into the nares


Clinical purpose • evacuate secretions and liquids from the nasal cavity or from high infant airways


Materials • non-latex


Packaging • ensure the device is clean and in a sealed package
• note any special markings/information required on the packaging


Colour • any


Reference to International
standards


• ISO 13485:2003 Medical devices – Quality management systems – Requirements for
regulatory purposes or equivalent


Regulation requirement Approval to comply with the regulatory requirements from the national regulatory agency


Optional:
• registered in country of import, if applicable
• approval by regulatory body of the country of the manufacturer
• FDA registration (United States), CE Mark (EU)


27Technical specifications of Neonatal Resuscitation Devices




3.7.2 Suction device specifications


Product Suction machine, electrically operated
Key features • oral, nasal


• manual or handheld
• compressible bulb with a tip that can be inserted into the nares


Clinical purpose • evacuate secretions and liquids from the nasal cavity or from high infant airways


Materials • silicone or any material fulfilling ISO 10993-4:2002 and USP Class V or equivalent
• latex free


Packaging • insert any relevant information regarding packaging and labelling of packaging


Colour • any


Cleaning • can be subjected to boiling HLD and sterilization, including autoclaving
• clear instructions/diagrams for cleaning instructions must be included in and/or on the


packaging


Reference to International
standards


• ISO 13485:2003 Medical devices – Quality management systems – Requirements for
regulatory purposes (Australia, Canada, EU) or equivalent.


• ISO 10079-2:1999 Medical suction equipment – Part 2: Manually powered suction
equipment or ISO 10079-2:2014 or equivalent


Regulation requirement Approval to comply with the regulatory requirements from the national regulatory agency


Optional:
• registered in country of import, if applicable
• approval by regulatory body of the country of the manufacturer
• FDA registration (United States), CE Mark (EU)


Technical specifications of Neonatal Resuscitation Devices28




Chapter 4: Procurement guidance for neonatal
resuscitation devices


There are a number of neonatal resuscitation devices on the market, but not all of them
adhere to a high standard of quality. Although specifications should be selected to suit
the needs of the end users, the key specifications that can be included in a tender in
order to help managers and procurement personnel to purchase the correct product
are described in each corresponding chapter.


A request for information that is also useful to include in a tender/request for quotation
may include the following:


• lead-time from receipt of contract/purchase order;
• delivery date;
• method of shipment;
• shipping route;
• INCOTERMS (ensure it is clear who is paying customs clearance charges, import


duties and taxes, final delivery costs, etc.);
• shipment/delivery costs, if applicable;
• weight and dimension of shipment;
• validity of quotation;
• payment terms;
• general and any special terms and conditions that will appear on the contract and/


or the purchase order;
• copy of ISO certificates;
• copy of quality assurance certificates such as those from the United States Food


and Drug Administration (FDA), CE certificate or other regulatory body approval
certificates;


• copy of the certificate of conformity, where applicable;
• copy of proof of registration in the country of import, where applicable.


It is also important to mention that medical devices are regulated in some countries and
there both the device and manufacturer must be registered in order for the medical
devices to be imported into the country. In the absence of a registered product/
manufacturer, an importer can often work with the Ministry of Health to apply for an
import waiver. An import waiver, however, is only issued on a per shipment basis thus it
is important to work with manufacturers to ensure that they apply to the local regulatory
authority in order to become registered for future procurements. In some countries, the
registration process can take from one to three years so the earlier the manufacturer
applies, the better.


More procurement information for neonatal resuscitation devices can be found in the
Neonatal Resuscitation Commodities Procurement Toolkit (27). A detailed key tender/
request for quotation specification for each device type can be found at the end of
each chapter.


29Technical specifications of Neonatal Resuscitation Devices




Chapter 5: For further research


Technical specifications play a vital role in procuring good quality, appropriate, affordable
neonatal resuscitation devices. In collaboration with the United Nations Children’s Fund
(UNICEF), the United States Agency for International Development (USAID), PATH and
the Clinton Health Access Initiative (CHAI), WHO has gathered internal and external
experts to determine and develop technical specifications. The challenges faced during
this process are:


• discrepancies among existing standards and professional association guidelines;
• lack of international standards for certain technical specifications for life-saving


essential health technologies, specifically for mask sizes and bag sizes;
• lack of information and research for life-saving essential health technologies;
• making unbiased optimal recommendations in a smaller market with limited


vendors.


For example, there is a gap between physiology and available equipment specifications:
although the goal is to ventilate with an adequate tidal volume, current devices are
calibrated in terms of pressure. Active research and development is required in this area.


Also, as stated in Chapter 2, the mask size has not been standardized in international
standards, which leads manufacturers to use different dimensions. From users and
procurers’ perspective, this greatly increases the barrier to supply appropriate products
for health facilities and creates confusion.


Some manufacturers from low-income countries find it difficult to comply with ISO, the
prevalent international standards, as they are not publically available. It is difficult for
these countries to make affordable devices for health facilities in low-resource settings,
while following those standards. It is, therefore, recommended to conduct further
research on standards for appropriate technology for low-resource settings or availability
of international standards to improve compliance


There is a lack of evidence and data on the safe use of life-saving devices in low-income
settings. Further actions on this can help manufacturers make more efficient devices.
Attention should be raised towards life-saving essential health technologies, including
encouraging scientific research and evidence-based clinical reports.


Technical specifications of Neonatal Resuscitation Devices30




Annex 1. Glossary of terms


-A-
Amniotic fluid: A clear, slightly yellowish liquid that surrounds the unborn baby (fetus)
during pregnancy. It is contained in the amniotic sac. While in the womb, the baby
floats in the amniotic fluid. The amount of amniotic fluid is greatest at about 34 weeks
(gestation) into the pregnancy, when it averages around 800 mL.


Apnoea: Temporary cessation of breathing.


Atelectotrauma: Occurs when there is ventilation that causes atelectasis. Atelectasis is
a complete or partial collapse of a lung or lobe of a lung that occurs when the tiny air
sacs (alveoli) within the lung deflate.


-B-
Birth asphyxia: Failure to establish breathing at birth.


Blender: An oxygen blender is a device used to control the oxygen-air mix according
to patients’ needs.


-C-
CE: From the French “Conformité Européenne” or “European Conformity”. It is a mark
on products. It indicates that the product complies with the essential requirements of
the relevant European health, safety and environmental protection legislation.


-H-
HLD: High-level disinfectant. It is a type of germicide that inactivates all microbial
pathogens in (or on) a container for a short contact time.


Hypercapnia: Presence of too much carbon dioxide in the blood.


-I-
Inner diameter: The length from one interior edge to the other of a round shape facemask.


Intrapartum hypoxia: Lack of oxygen in the fetus during labour, due pinching of the
umbilical cord. It is also called fetal hypoxia.


-L-
Lung compliance: Change in lung volume for a given change in pressure.


-M-
Meconium: Earliest stool of a newborn. It is viscous, sticky-like tar; its colour is usually
a very dark olive green or can appear in various shades of green, brown or yellow. It is
completely passed by the end of the first few days after birth.


31Technical specifications of Neonatal Resuscitation Devices




-N-
Negative pressure: Pressure that is less than ambient atmospheric pressure. It is also
called vacuum.


Newborn: An infant less than 28 days of age.


-O-
Oral intercommissural distance: Mouth width at rest, measured from one corner of the
mouth to the other.


Oxygen concentrator: A device used to produce and provide oxygen to patients.


Oxygen saturation: A measurement that derives the amount of oxygen in the blood.


-P-
Peak inspiratory pressure (PIP): Highest proximal airway pressure reached during
inspiration.


Philtrum length: The distance from under the nose to the lowest point of the mid-Cupid’s
bow (tip of mouth).


Positive-pressure ventilation: Pressure that is higher than ambient atmospheric pressure.


Preterm: Newborn who is born alive before week 37 of pregnancy.


Pulse oximetry: Non-invasive method for monitoring a person’s O2 saturation. A pulse
oximeter is a sensor device placed usually on the fingertip or earlobe or, in the case of
an infant, across a foot.


-R-
Resuscitator: A hand-operated device using positive pressure to assist breathing.


-S-
Self-inflating bag: Stiff plastic bag, squeezed to deliver its gas contents into the patient’s
airway; when the pressure is released, it is reinflated from the atmosphere or an attached
oxygen supply.


Silicone: Class of synthetic materials based on chains of alternate silicon and oxygen
atoms used to make rubber and plastics.


Single-use 50 cm length, Fr #8 catheter: Accessory used for the removal of secretions
from the trachea and bronchial tubes to keep the airway clear. Fr #8 refers to French
size 8.


Suction machine: Device used to clear the airways, to allow proper breathing and prevent
asphyxia.


Suction regulator: Component of a suction machine that is used to control the negative
pressure or suction pressure.


Technical specifications of Neonatal Resuscitation Devices32




-T-
Term: Infant born alive after week 37 of pregnancy.


Tidal volume: Normal lung volume of air displaced between normal inhalation and
exhalation without extra effort.


Tracheal: From “trachea”. The main trunk of respiratory system tubes that connects
the mouth and nose to the lungs.


-U-
UNSPSC: United Nations Standard Products and Services Code. It is an open, global,
multi-sector standard for efficient, accurate classification of products and services.


-V-
Vacuum/suction: See negative pressure.


Valve: Component of a facemask that controls inlet or outlet airflow and protects against
too much pressure in the airways.


Vernix: Also called vernix caseosa; the waxy, white substance found covering the skin
of newborns.


Volutrauma: Damage to the lung caused by excessive high tidal volume.


33Technical specifications of Neonatal Resuscitation Devices




Annex 2. Facemask size discussion


As seen in Table A2.1, the manufacturer example does not classify the facemask sizes
as Size 0, Size 1, etc., as is the case with most manufacturers, though many other details
are provided. Size M (outer diameter 50 mm) corresponds to masks for newborns less
than 2.5 kg, which compares to Size S (outer diameter 42 mm) masks for preterm
newborns, and Size L (outer diameter 60 mm) masks for term newborns. It was also
found that, based on studies on the oral inter-commissural distance, the mentioned
distances range from 17 mm to 33 mm (28).


Table A2.1 Sample facemask sizes in terms of inner diameter from one manufacturer


Micro-
premature (XS) Premature (S) Neonatal (M) Infant (L) Paediatric (XL)


Diameter (inner) 35 mm
(1.38 inches)


42 mm
(1.65 inches)


50 mm
(1.97 inches)


60 mm
(2.36 inches)


72 mm
(2.83 inches)


Suggested weight
range


400 g–1 kg
(2.3 pounds)


<1.5 kg
(3.3 pounds)


<2.5 kg
(5.5 pounds)


<5 kg
(11 pounds)


<10 kg
(22 pounds)


Extremely low-
birth-weight
(ELBW)


Very low-birth-
weight (VLBW)


Low-birth-
weight (LBW)


Term


Technical specifications of Neonatal Resuscitation Devices34




Annex 3. Bag size review – resuscitation bag
with mask


A3.1 Overview
A literature review has been completed by searching “neonatal resuscitation”, “neonatal
ventilator”, “neonatal resuscitator” and other related or referenced articles. The outcome
of the literature review is listed in the section below as evidences.


A3.2 Summary of evidences
Two kinds of scientific evidences are listed below for further discussion, including
physiological facts that scientists have found about infants, especially their breathing
pattern; and human factor considerations for the bag size and mask ventilation process.


A3.2.1 Physiological evidence
Recommended beginning pressure is 30 cmH2O for term infants; for preterm infants it
is 20–25 cmH2O, at a rate of 40–60 breaths per minute (1,2).


The immediate spontaneous tidal volumes of preterm and term infants after birth are
found to be 6.5–7 mL/kg (3).


It is recommended to maintain a tidal volume of 4–8 mL/kg during resuscitation (1,6).
Animal studies show that a low ventilated volume (tidal volume) might be insufficient
to achieve adequate gas exchange and might cause hypercapnia or atelectotrauma,
while excessive ventilation might cause volutrauma (7,8). The Australia Resuscitation
Association recommends starting resuscitation with a smaller tidal volume (6).


A3.2.2 Human factor evidence
Studies show that mask leak usually has a range of 45±20% (1).


It has been found that smaller self-inflating bags reduce the incidence of overzealous tidal
volumes and produce greater guideline-consistent results for cardiac arrest patients (8).


Table A3.1 Discussion on required bag size


Maximum Majority (97%)
Infant weight Less than 7 kg 2.4–4.5 kg


Optimum tidal volume 28–56 mL 10–36 mL


Average 42 mL 23 mL


Stroke volume needed with 45% leakage 63–126 mL 22–80 mL


Average 95 mL 51 mL


From the table it is shown that for the majority infant size, up to 80 mL of air is needed
to compress into the lung, which only takes less than one third of the total volume of
250 mL.


35Technical specifications of Neonatal Resuscitation Devices




Researchers have agreed that a self-inflating neonatal resuscitation bag with about
250 mL will be more than adequate to inflate a baby’s lungs. If inadequate, then it must
be due to a very large leakage (greater than 90%) between the mask and the face.


A3.3 Market review
WHO conducted a web search of bag sizes available on market based on a field guide
of practical selection of neonatal resuscitators by PATH (29). The results showed that
almost all of the manufacturers are using bag sizes between 240 mL and 320 mL for
infants and 500 mL for children (Table A3.1) and two had a maximum stroke volume
of 150 mL.


Table A3.2 Self-inflating neonatal and child resuscitator bag sizes


Manufacturer Bag size (mL) Note
Zeal Medical 250 Infant


500 Child


Shinmed 280 Infant


BlS system 320 Infant


900 Child


Laerdal 220/240 Infant (up to 5 kg)


320 Infant (up to 10 kg)


500 Child


Besmed 280 Infant


500 Child


Kaycoindia 240 Infant


500 Child


Ambu 220 Infant (up to 10 kg)


Table A3.3 Estimated percentage of neonatal resuscitation bag sizes (mL) on the market
(research conducted by PATH)


30


0


20


15


10


5


25


|
500


|
220


|
240


|
250


|
260


|
280


|
300


|
320


|
360


|
370


|
450


Technical specifications of Neonatal Resuscitation Devices36




Annex 4. 2012 WHO Guidelines on basic
newborn resuscitation


No. Recommendation
Strength of


recommendation Quality of evidence
Immediate care after birth


1. In newly born term or preterm babies who do not
require positive-pressure ventilation, the cord should
not be clamped earlier than 1 minute after birth.


When newly born term or preterm babies require
positive-pressure ventilation, the cord should be
clamped and cut to allow effective ventilation to be
performed.


Strong


Weak


High to moderate


Guidelines Development Group
consensus in absence of published
evidence


2. Newborn babies who do not breathe spontaneously
after thorough drying should be stimulated by
rubbing the back two to three times before clamping
the cord and initiating positive-pressure ventilation.


Weak Guidelines Development Group
consensus in absence of published
evidence


3. In neonates born through clear amniotic fluid who
start breathing on their own after birth, suctioning of
the mouth and nose should not be performed.


In neonates born through clear amniotic fluid who
do not start breathing after thorough drying and
rubbing the back two to three times, suctioning of the
mouth and nose should not be done routinely before
initiating positive-pressure ventilation. Suctioning
should be done only if the mouth or nose is full of
secretions.


Strong


Weak


High


Guidelines Development Group
consensus in absence of published
evidence


4. In the presence of meconium-stained amniotic fluid,
intrapartum suctioning of the mouth and nose at the
delivery of the head is not recommended.


Strong Low


5. In neonates born through meconium-stained
amniotic fluid who start breathing on their own,
tracheal suctioning should not be performed.


In neonates born through meconium-stained
amniotic fluid who start breathing on their own,
suctioning of the mouth or nose is not recommended.


In neonates born through meconium-stained
amniotic fluid who do not start breathing on their
own, tracheal suctioning should be done before
initiating positive-pressure ventilation.


In neonates born through meconium-stained
amniotic fluid who do not start breathing on their
own, suctioning of the mouth and nose should be
done before initiating positive-pressure ventilation.


Strong


Weak


Weak
(in situations where
endotracheal
intubation is possible)


Weak


Moderate to low


Guidelines Development Group
consensus in absence of published
evidence


Very low


Guidelines Development Group
consensus in absence of published
evidence


37Technical specifications of Neonatal Resuscitation Devices




6. In settings where mechanical equipment to generate
negative pressure for suctioning is not available
and a newly born baby requires suctioning, a bulb
syringe (single-use or easy-to-clean) is preferable to
a mucous extractor with a trap in which the provider
generates suction by aspiration.


Weak Very low


Positive-pressure ventilation


7. In newborn babies who do not start breathing
despite thorough drying and additional stimulation,
positive-pressure ventilation should be initiated
within 1 minute after birth.


Strong Very low


8. In newborn term or preterm (>32 weeks gestation)
babies requiring positive-pressure ventilation,
ventilation should be initiated with air.


Strong Moderate


9. In newborn babies requiring positive-pressure
ventilation, ventilation should be provided using a
self- inflating bag and mask.


Weak Very low


10. In newborn babies requiring positive-pressure
ventilation, ventilation should be initiated using a
facemask interface.


Strong Based on limited availability and
lack of experience with nasal
cannulae, despite low-quality
evidence for benefits


11. In newborn babies requiring positive-pressure
ventilation, adequacy of ventilation should be
assessed by measurement of the heart rate after 60
seconds of ventilation with visible chest movements.


Strong Very low


12. In newly born babies who do not start breathing
within 1 minute after birth, priority should be given
to providing adequate ventilation rather than to
chest compressions.


Strong Very low


Stopping resuscitation


13. In newly born babies with no detectable heart rate
after 10 minutes of effective ventilation, resuscitation
should be stopped.


In newly born babies who continue to have a heart
rate less than 60/minute and no spontaneous
breathing after 20 minutes of resuscitation,
resuscitation should be stopped.


Strong



Weak
(relevant to resource-
1imited settings)


Low


Very low


Technical specifications of Neonatal Resuscitation Devices38




Annex 5. Technical specifications for a self-
inflating neonatal resuscitation bag with
masks


Medical device specifications
I Version No. 1


II Date of initial version 25 June 2013


III Date of last modification 11 December 2015


IV Date of publication 30 December 2015


V Completed/submitted by Working group (WHO/UNFPA/UNICEF)


Name, category and coding
1 WHO Category/code (under development)


2 Generic name Resuscitator, hand operated neonatal, reusable.


3 Specific type or variation (optional) Multi-use self-inflating neonatal resuscitation bag with masks for preterm and
full-term babies and low-birth-weight infants (less than 5 kg).


4 GMDN© name Manual pulmonary resuscitator, reusable and resuscitator facemask, reusable.


5 GMDN© code 17591and 17170


6 GMDN© category 02 Anaesthetic and respiratory devices, 09 Reusable devices


7 UMDNS© name Resuscitators, pulmonary, manual [13-367]; resuscitators, pulmonary, manual,
reusable [17-591].


8 UMDNS© code 13-367
17-591


9 UNSPS code 42272303


10 Alternative name/s Resuscitation kit, resuscitation cabinets; CPR emergency kit; emergency kit,
cardiopulmonary resuscitation, resuscitation bag and masks.


11 Alternative code/s S 37507; S 16161


12 Keywords resuscitation bag, mask, resuscitator, reusable devices, valves


13 GMDN©/UMDNS© definition “Manual pulmonary resuscitator, reusable [17591] A hand-operated device
designed to provide or assist ventilation in patients who are apnoeic or exhibit
inadequate respiration. It typically employs entrained ambient air and includes
a large flexible chamber that is hand ventilated, a gas reservoir, tubing, and a
connector for attachment to a mask or endotracheal (ET) tube; oxygen (O2) from
an O2 source may also be connected when necessary. It is used by emergency
medical services (EMS) in ambulances, intensive care units (ICU), during internal
patient transfer, accident and emergency (A&E), mass casualty incidents (MCI), and
is generally placed strategically throughout a hospital. This is a reusable device.”


“Resuscitator facemask, reusable [17170] A flexible, form-shaped device that is
placed over a patient’s nose and mouth to direct ambient air, or medical oxygen
(O2) and air, from a resuscitator to the upper airway and lungs. It is typically made
of non-conductive sterilisable materials (e.g. silicone) that will create a gas-tight
seal against the face. It will typically include a 15 mm and/or 22 mm connector
and is available in a range of sizes (baby to adult). It will be directly attached to
the resuscitator and held in place on the patient’s face by the operator. This device
is intended for use with a breathing resuscitator but may be used for the delivery
of anaesthesia gases. This is a reusable device.”


39Technical specifications of Neonatal Resuscitation Devices




Purpose of use
14 Clinical or other purpose Provide positive air pressure ventilation to newborn babies with asphyxia, babies


who experience respiratory arrest, apnoea or respiratory distress requiring assisted
ventilation, and babies who require assisted ventilation during procedures.


15 Level of use (if relevant) Health centre/district hospital/provincial hospital/specialized hospital/other health
facilities that include maternity services.


16 Clinical department/ward (if
relevant)


Nursing services, surgery, paediatrics, emergency medicine, obstetrics, intensive
care unit, labour and delivery room.


17 Overview of functional
requirements


The resuscitator is used to ventilate newborns with a body weight less than 5 kg.
The resuscitator can be used to efficiently maintain ventilation, or as resuscitation
in other critical situations.


Technical characteristics
18 Detailed requirements A resuscitator is used to ventilate a neonate with a body weight of less than 5 kg. It


is operated by hand and ventilation can be done with ambient air or with oxygen.
A resuscitator can be totally disassembled, and is easy to clean and disinfect. All
parts are manufactured from high-strength, long-life materials that require no
special maintenance or storage conditions. A resuscitator is supplied as a complete
set with:
• non-rebreathing patient valve with a pressure limiting valve so that airway


pressure does not exceed 4.5 kPa (45 cmH2O) and can transmit an airway
pressure of at least 3 kPa (=30 cmH2O);


• masks, translucent, in two different sizes: Size 0 (preterm and low-birth-weight
baby), round type, outer diameter 35–50 mm; Size 1 (term baby), round type,
outer diameter 50–65 mm silicone rubber or any material fulfilling at least
the standards ISO 10993-1:2009; ISO 10993-5:2009; ISO 10993-10:2010, or
equivalent; or classified as USP Class V;


• compressible self-refilling ventilation bag: silicone rubber or any other
material fulfilling ISO 10651-4;


• bag size: 200–320 mL; intake valve with an optional nipple for O2 tubing:
polycarbonate/polysulfone or any other material fulfilling the ISO 10651-4 or
any other equivalent;


• bag made of silicone and valve made of polycarbonate or polysulfone or any
other sterilizable material complying with ISO10651-4 or equivalent


• material: polycarbonate/polysulfone or any other sterilizable material
fulfilling at least ISO 10651-4.


19 Displayed parameters N/A


20 User adjustable settings


Physical/chemical characteristics
21 Components (if relevant) Self-inflating neonatal resuscitation bag with masks for preterm and term babies.


Patient valves with pressure relief valves o 45 cmH2O.


22 Mobility, portability (if relevant) Portable and mobile.


23 Raw materials (if relevant) Recommended material is silicone rubber for the bag and mask and
polycarbonate/polysulfone for the valves. Any material fulfilling ISO 10993-
1:2009; ISO 10993-5:2009; ISO 10993-10:2010 or equivalent or USP Class V is
also recommended.


Utility requirements
24 Electrical, water and/or gas supply


(if relevant)
N/A


Accessories, consumables, spare parts and other components
25 Accessories (if relevant) Masks for preterm, low-birth-weight babies (Size 0) and term babies (Size 1) (see


Section 18 of this table for details).


26 Sterilization process for accessories
(if relevant


The resuscitator and mask must be cleaned and disinfected after each use;
following the manufacturer's instruction is recommended.


27 Consumables/reagents (if relevant) N/A


Technical specifications of Neonatal Resuscitation Devices40




28 Spare parts (if relevant) N/A


29 Other components (if relevant) N/A


Packaging
30 Sterility status on delivery (if


relevant)
Cleaned and disinfected before use.


31 Shelf life (if relevant) N/A


32 Transportation and storage (if
relevant)


Primary packaging: unit of use. One resuscitator set in a plastic bag + box with
the manufacturer's instruction for use. Labelling on the primary packaging: name
and/or trademark of the manufacturer. Manufacturer's product reference. Type of
product and main characteristics. If the packaging is not transparent, it must bear
a diagram (preferably actual size) showing the essential parts of the product and
indicating the position of the product in the packaging. Lot number prefixed by
the word "LOT" (or equivalent harmonized symbol) (if applicable). Information
for particular storage conditions (temperature, pressure, light, humidity, etc.)
as appropriate (or equivalent harmonized symbol). Information for handling, if
applicable (or equivalent harmonized symbol).


33 Labelling (if relevant) Symbols used according to ISO 15223 standards.


Environmental requirements
34 Context-dependent requirements N/A


Training, installation and utilization
35 Pre-installation requirements (if


relevant)
N/A


36 Requirements for commissioning
(if relevant)


N/A


37 Training of user/s (if relevant) The resuscitator should only be operated someone who has received adequate
basic training in resuscitation technique.


38 User care (if relevant) After each dismantling and cleaning, the resuscitator must be reassembled
and tested to make sure that it works correctly. In view of its use, the item is
considered an "emergency resuscitation item", which means that it must always be
readily available and in a good working condition. Following the manufacturer's
instructions manual is recommended.


Warranty and maintenance
39 Warranty Minimum 1 year.


40 Maintenance tasks N/A


41 Type of service contract N/A


42 Spare parts availability post-
warranty


N/A


43 Software/hardware upgrade
availability


N/A


Documentation
44 Documentation requirements The resuscitator is supplied in a box as a complete set, with clear instructions/


diagrams for use and assembly in the language of the user and a list of
accessories/parts. The resuscitator is supplied with instructions and diagrams
covering its functionality, how to use it, how to dismantle and assemble it, and how
to clean, disinfect and sterilize it. It is supplied with an instruction manual covering
item descriptions and functionality, including usage, maintenance and a list of
spare parts.


41Technical specifications of Neonatal Resuscitation Devices




Decommissioning
45 Estimated lifespan 5 years.


Safety and standards
46 Risk classification Class B (GHTF Rule 6), Class II a (EU, Australia), Class II (Canada, Japan).


47 Regulatory approval/certification Optional:
• registered in country of import, if applicable;
• approval from the national regulatory agency of the manufacturer’s country;
• FDA registration (United States); or
• CE Mark (EU) for class IIa, with notified body number, or approval from other


regulatory body in an IMDRF founding member country.


48 International standards (for
reference)


ISO 13485:2012 Medical devices - Quality management systems – Requirements
for regulatory purposes:
ISO 10651-4:2002 Lung ventilators -- Part 4: Particular requirements for
operator-powered resuscitators (EN 13544-2 implied). For devices not intended to
be used with oxygen, oxygen related clauses are optional


For facemask (if not made of silicone):
ISO 10993-1:2009 Biological evaluation of medical devices – Part 1: Evaluation
and testing for mask
ISO 10993-5:2009 Biological evaluation of medical devices – Part 5: Tests for in
vitro cytotoxicity
ISO 10993-10:2009 Biological evaluation of medical devices – Part 10: Tests for
irritation and delayed-type hypersensitivity
or classified as USP class V


Optional:
ISO 14971:2012 Medical devices – Application of risk management to medical
devices
ISO 5356-1:2004 Anaesthetic and respiratory equipment – Conical connectors -
Part 1: Cones and sockets
BS EN 980:2008 Graphical symbols for use in the labelling of medical devices
ISO 15223-1:2012 Medical devices – Symbols to be used with medical device
labels, labelling and information to be supplies – Part 1: General requirements
BS EN 1041:2008 Information supplied by the manufacturer with medical devices


49 Regional/local standards Any national standards equivalent/harmonized to International standards.


50 Regulations Directive 93/68/EEC (CE Mark)
Directive 2001/104/EC
Directive 2007/47/EC


Japan regulations:
MHLW Ministerial Ordinance No. 169
17591000 Reusable manually operated pulmonary resuscitator
Or any other national or regional regulation equivalent/harmonized to the above
mentioned


Technical specifications of Neonatal Resuscitation Devices42




Annex 6. Technical specifications for a
suction machine, electrically operated


Medical device specification
(including information on the following where relevant/appropriate, but not limited to)
I Version No. 1


II Date of initial version 25 June 2013


III Date of last modification 11 December 2015


IV Date of publication December 2015


V Completed/submitted by WHO and revision of neonatal resuscitation of the UNCLSC group (UNICEF, CHAI,
and PATH).


Name, category and coding
1 WHO Category/code (under development)


2 Generic name Electrical or hand/foot-operated portable suction machine/pump.


3 Specific type or variation (optional) Infant suction system with negative pressure less than 100 mmHg, with one bottle.


4 GMDN© name Nasal aspirator, electric.


5 GMDN© code 56647


6 GMDN© category 09 Reusable devices.


7 UMDNS© name Aspirators; aspirators, infant; aspirators, nasal; aspirators, thoracic; aspirators,
tracheal.


8 UMDNS© code 10208; 10214; 10216; 10218; 10219


9 UNSPS code (optional) 42142400


10 Alternative name/s (optional) Aspirator for medical use; compressors; aspirator; evacuators; pumps, aspirator;
pumps, suction; suction pumps; suction units; sump pumps; vacuum pumps.


11 Alternative code/s (optional) MS 43699, 120400001


12 Keywords (optional) compressors, aspirator, evacuators pumps, suction pumps, vacuum pumps


13 GMDN©/UMDNS© definition
(optional)


A portable hand-held, either electrical, battery-powered or hand- or foot-operated
suction device designed to enable an adult to gently suction and clear excessive
mucus from the nasal passages of an infant or child to facilitate easier breathing. It
consists of a handgrip that contains the batteries, a small electric pump that creates
the suction, and typically a silicone nozzle attached to a detachable, washable,
collection cup at the distal end. It is designed for domestic use and is typically
applied superficially to the nasal opening (i.e. not inserted into the nasal cavity).
This is a reusable device.


Purpose of use
14 Clinical or other purpose Devices designed to evacuate gas, fluid, tissue or foreign materials from the high


airways by means of vacuum suction.


15 Level of use (if relevant) District hospital, provincial hospital, specialized hospital.


16 Clinical department/ward (if
relevant)


Emergency medicine, gynecology, intensive care unit, nursing services, obstetrics,
paediatrics.


17 Overview of functional
requirements


Electrically operated, biohazard disposal and negative pressure less than 100
mmHg.


43Technical specifications of Neonatal Resuscitation Devices




Technical characteristics
18 Detailed requirements • low vacuum, low flow, oil-free vacuum pump;


• battery powered with rechargeable battery;
• maximum vacuum: 100 mmHg;
• collection bottle (one or two): 1 L (disposable bag or collection jar);


bottle(s) with an automatic cut off when full to prevent ingress of fluid to
pump, a filter and overflow valve incorporated to prevent cross-contamination
(e.g. shatterproof material, overflow protection system), and either disposable
or autoclavable;


• airline to the pump to incorporate a bacterial filter;
• tubing to the patient a minimum of 0.5 m long, noncollapsible type;
• all parts manufactured from high-strength, durable material that does not


require specific maintenance or storage conditions;
• pump can be disassembled entirely and is easy to clean, disinfect and sterilize;
• any necessary greasing/oiling is simple, accessible and possible by normal


clinical operator.


19 Displayed parameters Pressure gauge displays the suction generated.


20 User adjustable settings User settable adjustment of suction delivered to the patient.


Physical/chemical characteristics
21 Components (if relevant) Unit surface is hard and corrosion resistant.


Pump handle/pedal is spring loaded to return to the “up” position after each
stroke.
Supplied mounted on robust board with carrying handle.


22 Mobility, portability (if relevant) Portable.


23 Raw materials (if relevant) N/A


Utility requirements
24 Electrical, water and/or gas supply


(if relevant)
Line power AC and/or rechargeable battery (optional).


Accessories, consumables, spare parts and other components
25 Accessories (if relevant) Suction tubes and soft conical tip.


26 Sterilization process for accessories
(if relevant


The collection canister and the aspirating tube must be cleaned and disinfected
after each use.
All parts can be sterilized in a steam sterilizer. All parts can be autoclaved at
121 °C.


27 Consumables/reagents (if relevant) Tubing, collection canisters.
Supplier to describe detailing shelf life and number of uses.


28 Spare parts (if relevant) Spare filters: 10 sets.
Spare suction bottle: one unit.
Seals: two pairs for each storage jar.
To provide list of other spare parts anticipated during one year’s operation, with
costs.


29 Other components (if relevant) N/A


Packaging
30 Sterility status on delivery (if


relevant)
N/A


31 Shelf life (if relevant) N/A


32 Transportation and storage (if
relevant)


Unit supplied protectively packed for safe onward shipping.
Labelling on the primary packaging under local regulations.


33 Labelling (if relevant) Symbols used according to ISO 15223 standards.


Technical specifications of Neonatal Resuscitation Devices44




Environmental requirements
34 Context-dependent requirements Capable of being stored continuously in ambient temperature of 0–50 °C and


relative humidity of 15–90%.
Capable of operating continuously in ambient temperature of 10–40 °C and
relative humidity of 15–90%.


Training, installation and utilization
35 Pre-installation requirements (if


relevant)
Supplier to perform installation, safety and operation checks before handover.
Local clinical staff to confirm completion of installation and training if necessary.


36 Requirements for commissioning
(if relevant)


N/A


37 Training of user/s (if relevant) Training of users in operation and basic maintenance is provided. Local clinical
users need to be trained in neonatal resuscitation.


38 User care (if relevant) Collection canisters should be monitored and emptied if they come close to
capacity. Suction regulators must be accurate; suction levels that are too high
can cause tissue damage. A pump containing aspirated fluid can be a source of
contamination; changing or cleaning the suction tip during surgeries or other
use can help reduce infection risk. Operators should follow universal precautions,
including wearing gloves, face shields or masks and gowns. After dismantling and
cleaning, the pump must be reassembled and tested to make sure that it works
correctly.


Warranty and maintenance
39 Warranty Duration of warranty clearly stated, minimum 1 year.


Specific inclusions and exclusions listed.
Contact details of manufacturer, supplier and local service agent provided.


40 Maintenance tasks List of equipment and procedures required for local routine user maintenance is
provided.
Advanced maintenance tasks required are documented.


41 Type of service contract Costs and types of post-warranty service contract available are described.


42 Spare parts availability post-
warranty


Guaranteed time period of availability of spare parts post-warranty is described.


43 Software/hardware upgrade
availability


Guaranteed time period of support availability post-warranty is described.


Documentation
44 Documentation requirements User and maintenance manuals are supplied in English or local language specified


by the purchaser.
Supplier to describe any materials contained in the device that are classified as
hazardous under local regulations.


Decommissioning
45 Estimated lifespan Supplier to describe estimated lifetime of fully maintained device.


Safety and standards
46 Risk classification Class B (GHTF Rule 11); Class II a (EU, Australia), Class II (Canada, Japan).


47 Regulatory approval/certification To comply with the regulatory requirements of the national regulatory agency.


Optional:
• registered in country of import, if applicable;
• approval from the national regulatory agency f the manufacturer’s country;
• FDA registration (United States); or
• CE Mark (EU) for class IIa, with notified body number, or approval from other


regulatory body in an IMDRF founding member country.


45Technical specifications of Neonatal Resuscitation Devices




48 International standards (for
reference)


ISO 10079-1:1999 Medical suction equipment – Part 1: Electrically powered
suction equipment – Safety requirements. or equivalent
ISO 13485:2003 Medical devices – Quality management systems – Requirements
for regulatory purposes (Australia, Canada, EU); or equivalent
ISO 14971:2007 Medical devices – Application of risk management to medical
devices
IEC 60601-1-2 Ed. 3.0:2007 (or later version) Medical electrical equipment – Part
1–2: General requirements for basic safety and essential performance – Collateral
standard: Electromagnetic compatibility – Requirements and tests


The set packaging depends on the shipment type.
At a minimum, as per Annex C: Clause 12.1 of Part 1 of IS 15500:2004.
ROHS compliant.


49 Regional/local standards JIS T 7111:2006 Hose assemblies for use with medical gas systems (Japan).


Any national standards equivalent/harmonized to international standards.


50 Regulations United States regulations:
21 CFR part 820; 21CFR Section 878.4780 pump, portable, aspiration (manual or
powered) (United States)


EU regulations:
Council Directive 93/42/EEC
Directive 93/68/EEC (CE Mark)
Directive 2007/47/EC


Japan regulations:
MHLW Ministerial Ordinance No. 169
34860010 Low pressure suction unit; 34860020 Electrically powered low pressure
suction unit 36616030 Electrically powered transportable suction unit (Japan)


Any national regulation equivalent/harmonized to those above.


Technical specifications of Neonatal Resuscitation Devices46




Annex 7. Technical specifications for a
single-use suction device


Medical device specification
(including information on the following where relevant/appropriate, but not limited to)
I Version No. 1


II Date of initial version 25 June 2013


III Date of last modification 11 December 2015


IV Date of publication 30 December 2015


V Completed/submitted by Working group (WHO/UNFPA/UNICEF)


Name, category and coding
1 WHO Category/code (under development)


2 Generic name Suction bulb.


3 Specific type or variation (optional) Single-use suction bulb.


4 GMDN© name Nasal aspirator, manual.


5 GMDN© code 41826


6 GMDN© category 09 Reusable devices (GMDN© has no single-use term).


7 UMDNS© name Suction kits.


8 UMDNS© code 13846


9 UNSPS code (optional) 42142400


10 Alternative name/s (optional) Aspirators infant, infant nasal aspirators, paediatric nasal aspirators, toddler nasal
aspirators.


11 Alternative code/s (optional) N/A


12 Keywords (optional) suction, aspirator


13 GMDN© generic definition
(optional)


A collection of items intended for suctioning secretions from a patient; this is a
single-use device.


Purpose of use
14 Clinical or other purpose Evacuate secretions and liquids from the nasal cavity or from high infant airways.


15 Level of use (if relevant) Health centre, district hospital, province hospital, specialized hospital ambulances.


16 Clinical department/ward (if
relevant)


Obstetrics, paediatrics, surgery.


17 Overview of functional
requirements


Device that provides the suction in a manually operated bulb that draw mucus out
of the child's nose.


Technical characteristics
18 Detailed requirements • Ensure the device is clean and in a sealed package.


19 Displayed parameters N/A


20 User adjustable settings N/A


Physical/chemical characteristics
21 Components (if relevant) N/A


22 Mobility, portability (if relevant) Portable and mobile.


23 Raw materials (if relevant) N/A


47Technical specifications of Neonatal Resuscitation Devices




Utility requirements
24 Electrical, water and/or gas supply


(if relevant)
N/A


Accessories, consumables, spare parts and other components
25 Accessories (if relevant) N/A


26 Sterilization process for accessories
(if relevant)


N/A


27 Consumables/reagents (if relevant) N/A


28 Spare parts (if relevant) N/A


29 Other components (if relevant) N/A


Packaging
30 Sterility status on delivery (if


relevant)
N/A


31 Shelf life (if relevant) N/A


32 Transportation and storage (if
relevant)


Required to keep the product clean and in a sealed package.


33 Labelling (if relevant) N/A


Environmental requirements
34 Context-dependent requirements As per manufacturer recommendations.


Training, installation and utilization
35 Pre-installation requirements (if


relevant)
N/A


36 Requirements for commissioning
(if relevant)


N/A


37 Training of user/s (if relevant) N/A


38 User care (if relevant) Ensure the pressure is not too high when working with the device, avoid trauma
from deep or aggressive suctioning or stimulation of vagal reflexes, which produce
bradycardia.


Warranty and maintenance
39 Warranty N/A


40 Maintenance tasks N/A


41 Type of service contract N/A


42 Spare parts availability post-
warranty


N/A


43 Software/hardware upgrade
availability


N/A


Technical specifications of Neonatal Resuscitation Devices48




Documentation
44 Documentation requirements N/A


Decommissioning
45 Estimated lifespan N/A


Safety and standards
46 Risk classification Class B (GHTF Rule 5-6); Class II a (EU, Australia); Class II (Canada, Japan), Class


I (United States).


47 Regulatory approval/certification FDA approval (United States) or CE Mark (EU).


48 International standards (for
reference)


ISO 13485:2003 Medical devices – Quality management systems – Requirements
for regulatory purposes (Australia, Canada, EU); or equivalent


49 Regional/local standards To comply with the regulatory requirements of the national regulatory agency.


Optional:
• registered in country of import, if applicable;
• approval from the national regulatory agency of the manufacturer’s country;
• FDA registration (United States); or
• CE Mark (EU) for class IIa, with notified body number, or approval from other


regulatory body in an IMDRF founding member country.


Any national standards equivalent/harmonized to international standards.


50 Regulations United States regulations:
21 CFR part 820
21CFR Section 868.68106 tracheal suction set (kit) (United States)


EU regulations:
Council Directive 93/42/EEC, Directive 2007/47/EC

Japan regulations:
MHLW Ministerial Ordinance No. 169:
• 34860010 Low pressure suction unit
• 36616010 Manually operated transportable suction unit


Or any other national or regional regulation equivalent/harmonized to the above
mentioned.


49Technical specifications of Neonatal Resuscitation Devices




Annex 8. Technical specifications for a
reusable suction device


Medical device specification
(including information on the following where relevant/appropriate, but not limited to)
I Version No. 1


II Date of initial version 25 June 2013


III Date of last modification 11 December 2015


IV Date of publication 30 December 2015


V Completed/submitted by Working group (WHO/UNFPA/UNICEF)


Name, category and coding
1 WHO Category/code (under development)


2 Generic name Suction bulb.


3 Specific type or variation
(optional)


Multi-use suction bulb that can be opened cleaned and sterilized.


4 GMDN© name Nasal aspirator, manual.


5 GMDN© code 41826


6 GMDN© category Categories: 09 Reusable devices.


7 UMDNS© name Aspirators, airway, nasal, infant.


8 UMDNS© code 10214


9 UNSPS code (optional) 42142400


10 Alternative name/s (optional) Aspirators infant, infant nasal aspirators, paediatric nasal aspirators, toddler nasal
aspirators.


11 Alternative code/s (optional)


12 Keywords (optional) suction, aspirator


13 GMDN© generic definition
(optional)


A portable, hand-held, manual suction device designed to enable an adult to
gently suction and clear excessive mucus from the nasal passages of an infant or
child to facilitate easier breathing. It is available in a variety of forms, including a
compressible bulb with a tube that is inserted into the nares, or a syringe with a
small bulb at its distal end that is applied to the nasal opening. It is designed for
domestic use. This is a reusable device.


Purpose of use
14 Clinical or other purpose Evacuate secretions and liquids from the nasal cavity or from high infant airways.


15 Level of use (if relevant) Health centre, district hospital, province hospital, specialized hospital.


16 Clinical department/ward (if
relevant)


Obstetrics, paediatrics, surgery. Delivery room.


17 Overview of functional
requirements


Device that provides the suction in a manually operated bulb that draw mucus out
of the newborn’s mouth and nose.


Technical characteristics
18 Detailed requirements The top part can be opened to permit easier cleaning, can be subjected to boiling


(HLD) and sterilization, including autoclaving, and can be translucent.
It does not contain latex.


Technical specifications of Neonatal Resuscitation Devices50




19 Displayed parameters N/A


20 User adjustable settings N/A


Physical/chemical characteristics
21 Components (if relevant) N/A


22 Mobility, portability (if relevant) Mobile and portable


23 Raw materials (if relevant) N/A


Utility requirements
24 Electrical, water and/or gas supply


(if relevant)
N/A


Accessories, consumables, spare parts and other components
25 Accessories (if relevant) N/A


26 Sterilization process for accessories
(if relevant)


Subjected to boiling (HLD) and sterilization, including autoclaving.


27 Consumables/reagents (if
relevant)


N/A


28 Spare parts (if relevant) N/A


29 Other components (if relevant) N/A


Packaging
30 Sterility status on delivery (if


relevant)
Following the sterilization process.


31 Shelf life (if relevant) N/A


32 Transportation and storage (if
relevant)


Required to keep the product clean.


33 Labelling (if relevant) N/A


Environmental requirements
34 Context-dependent requirements N/A


Training, installation and utilization
35 Pre-installation requirements (if


relevant)
N/A


36 Requirements for commissioning
(if relevant)


N/A


37 Training of user/s (if relevant) N/A


38 User care (if relevant) Clean and sterilize before use according to the stability process.


Warranty and maintenance
39 Warranty N/A


40 Maintenance tasks N/A


41 Type of service contract N/A


42 Spare parts availability post-
warranty


N/A


43 Software/hardware upgrade
availability


N/A


Documentation
44 Documentation requirements N/A


51Technical specifications of Neonatal Resuscitation Devices




Decommissioning
45 Estimated lifespan N/A


Safety and standards
46 Risk classification Class B (GHTF Rule 11); Class II a (EU, Australia); Class II (Canada, Japan, United


States).


47 Regulatory Approval/certification To comply with the regulatory requirements of the national regulatory agency.
Optional:
• registered in country of import, if applicable;
• approval from the national regulatory agency of the manufacturer’s country;
• FDA registration (United States); or
• CE Mark (EU) for class IIa, with notified body number, or,
• approval from other regulatory body in an IMDRF founding member country.


48 International standards (for
reference)


ISO 13485:2003 Medical devices – Quality management systems – Requirements
for regulatory purposes (Australia, Canada, EU)
ISO 10079-2:1999 Medical suction equipment – Part 2: Manually powered suction
equipment or equivalent


49 Regional/local standards To comply with the regulatory requirements of the national regulatory agency.
Optional:
• registered in country of import, if applicable;
• approval from the national regulatory agency of the manufacturer’s country;
• FDA registration (United States); or
• CE Mark (EU) for class IIa, with notified body number, or approval from other


regulatory body in an IMDRF founding member country.


Any other national standards equivalent/harmonized to international standards.


50 Regulations United States regulations:
21 CFR part 820
21CFR Section 878.4780 pump, portable, aspiration (manual or powered) (United
States)


EU regulations:
Council Directive 93/42/EEC
Directive 93/68/EEC (CE Mark)
Directive 98/79/EC
Directive 2001/104/EC
Directive 2007/47/EC


Japan regulations:
MHLW Ministerial Ordinance No. 169; 36616010 Manually operated transportable
suction unit (Japan)


Or any other national or regional regulation equivalent/harmonized to the above
mentioned.


Technical specifications of Neonatal Resuscitation Devices52




Annex 9. Meeting Report - Consultation for
technical specifications for procurement
and regulatory pathway of medical
devices determined by the United Nations
Commission on Life Saving Commodities
(June 10-12, 2013)


DRAFT V1
MEETING REPORT


Consultation for technical specifications for procurement and regulatory pathway
of medical devices determined by the United Nations Commission on Life Saving


Commodities


WORLD HEALTH ORGANIZATION – HEADQUARTERS
GENEVA, SWITZERLAND



June 10-12, 2013


Diagnostic Imaging and Medical Device Unit
Essential Medicines and Health Products Department


Health Systems and Innovation Cluster


53Technical specifications of Neonatal Resuscitation Devices




BACKGROUND


As a way to increase the actions towards reaching the Millennium Development
Goals 4, 5 and 6, the UN Commission on Life Saving commodities was launched in
March 2012 (http://www.everywomaneverychild.org/resources/un-commission-on-life-
savingcommodities/about) and developed 10 recommendations in order to increase the
access to 13 essential commodities.


The 10 recommendations are the following:


I. Improved markets for life-saving commodities:
1. Shaping global markets;
2. Shaping local delivery markets;
3. Innovative financing;
4. Quality strengthening: By 2015, at least three manufacturers per commodity are
manufacturing and marketing quality-certified and affordable products;
5. Regulatory efficiency: By 2015, all EWEC countries have standardized and


streamlined their registration requirements and assessment processes for the 13
live-saving commodities with support from stringent regulatory authorities, the
World Health Organization and regional collaboration.


II. Improved national delivery of life-saving commodities:
6. Supply and awareness;
7. Demand and utilization;
8. Reaching women and children;
9. Performance and accountability.


III Improved integration of private sector and consumer needs.
10. Product innovation.


Note that WHO is fully responsible of recommendations 4 and 5, and participates in
others as Needed.


The 13 commodities involve 3 specific types of medical devices: female condom,
neonatal resuscitation (mask, valve and bag, suction bulb or aspirator) and supportive
medical devices for injectable antibiotics (syringes, needle,) that are part of the
commodities defined by the UNCoLSC.


Further references:
http://www.everywomaneverychild.org/resources/un-commission-on-lifesaving-
commodities/life-saving-commodities and


http://www.everywomaneverychild.org/resources/un-commission-on-life-saving-
commodities.


World Health Organization
Considering the resolution WHA66.7 approved in May 2013, named “Implementation
of the recommendations of the United Nations Commission on Life Saving Commodities
for Women and Children.”


Technical specifications of Neonatal Resuscitation Devices54




Requests WHO:
“(1) to work with UNICEF, UNFPA, the World Bank, UNAIDS, UN Women, national,
regional and international regulators, private sector actors and other partners in order
to promoten and assure the availability of safe, quality commodities;


(2) to work with and support Member States, as appropriate, in improving regulatory
efficiency, standardizing and harmonizing registration requirements and streamlining
assessment processes, including granting priority to review of the life-saving commodities”


(See annex 1 on WHA66.7)


CONSULTATION


Will specifically focus on: recommendations 4 and 5 which are responsibility of WHO:
4. Quality strengthening: By 2015, at least three manufacturers per commodity are


manufacturing and marketing quality-certified and affordable products;
5. Regulatory efficiency: By 2015, all EWEC countries have standardized and


streamlined their registration requirements and assessment processes for the 13
live-saving commodities with support from stringent regulatory authorities, the
World Health Organization and regional collaboration.


The three essential commodities that involve medical devices:
1. For Reproductive Health: Female Condoms
2. For Newborn Health: Neonatal Resuscitation Equipment
3. For New born and child: Injectable antibiotics (syringes and other medical


devices)


MEETING OBJECTIVES


1. To develop the three essential commodities technical specifications of in order
to have quality affordable and developed products in the market, as stated in
recommendation 4 on quality strengthening.


2. To establish a regulatory pathway of those commodities including a harmonized
registration requirements and the assessment process, as indicated in the
recommendation 5 on regulatory efficiency.


3. To disseminate these requirements to the regulatory authorities and to the
procurement agencies that belong to the Member States, NGOs and UN agencies,
in furtherance to increase the access to the commodities mentioned before.


PARTICIPANTS


a. The lead conveners for each of this commodities group.
b. The health technology focal points, (for medical devices management, selection,


procurement or regulation) or the person designated by the Ministry of Health of
the countries where the actions are being implemented in the first phase. (Path
finder countries).


c. WHO Advisors in technical specifications.


55Technical specifications of Neonatal Resuscitation Devices




d. WHO Advisors in medical devices regulations.
e. NGOs and UN agencies involved with procurement of these products.
f. The WHO staff related to recommendations: 4 on quality of product and 5 on


regulatory process. (For specific details, please see list of participants at the end
section of this document)


APPOINTMENTS


Co-Chairs: June 10, 2013: Mr Sam S.B. Wanda
June 11, 2013: Dr Jean Bosco Ndihokubwayo and Ms Bidia Deperthes
June 12, 2013: Ms Adriana Velazquez and Mr Keith Neroutsos


Rapporteurs: Ms Alejandra Velez, Dr Yukiko Nakatani. Support from interns : Mr
Nathan Lo, Ms Jacintha Leyden, Ms Samantha Mendoza and Ms Daria Istrate.


MEETING MINUTES


Following is an overview of discussions and inputs generated on each day of the meeting.
(All presentations are in annex 3)


Day 1: June 10, 2013


Day 1 program was aimed to discuss objectives and background of the meeting and
WHO’s Medical Devices Unit and during the afternoon focused on discussion of the
Female Condom’s commodity.


Introduction and background
• Participants were greeted and the meeting objectives were presented by Ms.


Velazquez.
• The UN Commision on Life Saving Commodities was presented by Dr. Kristensen.
• Presentation of the on-going projects within WHO’s Medical Devices Unit:


› Available publications.
› Global challenges on medical devices.
› Results on the country survey of medical devices.
› Local production and technology transfer to increase access to medical device
› Compendium of innovative health technologies for low-resource settings.
› H4+ Interagency list of essential medical devices for reproductive maternal and


newborn health.


Country Assessments Tools for Procurement and Regulatory Agency and Commodity Status
Survey
For the purpose of collecting country information for the recommendation 4 and 5, on
regulatory and procurement process of the 13 commodities described in the UNCoLSC,
an automated version using a WHO tool named datacol was discussed. This Country
Assessments Tools for Procurement and Regulatory Agency and Commodity Status
Survey, Sections 7a, 7b, 8a and 8b were presented by Ms. Barragan.


Technical specifications of Neonatal Resuscitation Devices56




• General discussion on the Country Assessment Tools:
• As the first concern: countries usually do not have information about specific


devices, instead of this information they normally know how much do they invest
by group of devices for each specialty, in this case maternal/newborn.


• Mr. Wanda suggested that even the survey information could be provided by different
departments inside the country, which would be useful for filter and standardize it.


• Dr. Nagesh suggested the establishment of a specific period of time for answering
the survey.


• Important to get information of the final user
• Source of funding: that can come different sources, for each commodity for


instance: UN agencies, NGO’s, donations, world bank, etc.
• Furthermore depending on the origin of the founding, the process of procurement


and regulating would be.

Generic specifications on the Commodity: Female Condom
Dr. Festin presented a current situation of policies that are related to Family Planning
at WHO. Also, specific characteristics, use and provision of the female condoms. The
need of training people in the correct use of the female condom was emphasized.


Ms Deperthes and Ms Traeger, from UNFPA, presented the generic specifications,
pre-qualification process and guidelines for procurement of female condom. Aditionally
estatistics, and efforts for marketing and distribution. They presented how pre-
qualification process analyses if the manufacturing site and the product is developed
with acceptable standards and if they have the ability to produce according with the
specifications. The list of prequalified products are publicly available on the UNFPA
and WHO website data. It was also mentioned that the ISO qualification is different for
male and female condoms.


• General discussion on prequalification of female condoms:
› Standards are not available online, it is needed to increase the access to them.
› The high price of female condom compare with the male condom’s price.
› Not enough promotion, training and funds guided for female condom


programming.
› Low availability: 1 female condom for 8 women in Sub Saharan Africa.
› Not enough knowledge and information for women and men in reproductive age


regarding the use and benefit of the female condom for safer sex.
› It was mentioned by Mr Neroutsos that if manufacturers are required to get a


re-qualification every two years, the product could be continually tested.
› It was recommended by Mr Nado that once the product is pre-qualified, into a


country level they register the product on a fast track.
› Ms Deperthes recommended a review of the essential medicines list, then


countries can easily include female condoms in its essential medicines list, the
distribution is still insufficient.


Country considerations:


Malawi:
• Ms Departhes commented that Malawi is one of the success stories; they went from


150 thousand to 1.5 million female condoms.


57Technical specifications of Neonatal Resuscitation Devices




• The Government was delegated to decide whether they want to register the condom
or not, and also to define the minimum criteria that the local government authorities
should have.


Sierra Leone by Mr Kabia:
• Female condoms are not very popular.
• Procurement of medical devices in general:


› Biomedical engineers are not involved in procurement developed by the Ministry
of Health.


› There is no regulation authority for Medical Equipment.


Tanzania by Mr Mvanga and Ms Mariki:
• Different NGO’s are working on condoms promotion, mostly about the FC2.
• Female condoms usability is low, because the purpose of usability is not well


understood.
• Great need of training, motivation and promotion.
• The Ministry of Health through the Tanzanian FDA regulates medicine, cosmetics,


medical devices and food.
• Female condoms are registered as single use devices and follow ISO standards.
• Two procedures: screening phase for 60 days and payment of fees for different


classes of products (B-USD 500, C-USD 750, D-USD 1,000) and 270 working days
for class C products to be released in Tanzania, almost one year, samples need
to be submitted also and they usually contract out the testing of these samples to
South Africa or other countries.


• Tanzanian FDA has types of evaluation: full and abridged. If the applicant is pre-
qualified by WHO or is released in other developed countries, it could be evaluated
in the abridged form, otherwise it needs to be evaluated fully.


• Tanzania’s regulatory model could be used in the region.
• Ms Deperthes proposed to first see how the condoms would be accepted in the


specific countries, then define what is needed and then register a product as soon
as possible.


Uganda by Mr Wanda:
• NDA – regulators since 1983, added food and medical devices as a small


department.
• NACME – since 1989, the Ministry of Health said they needed a committee of


experts with advisory role that are sitting on NDA and UNBS.
• Currently no national specifications for female condoms, but both FC2 and Cupid


are available in the country; but are much more expensive than the male condoms.
There is a high need to promote its use.


• Ms Deperthes addressed that sometime ago there was a request to provide Uganda
with 1 million Cupid condoms, however UNFPA rejected this idea because it
is important to have an overview to make sure that people could accept these
condoms, to receive some samples to show them to the population. She also
commented that when providing a country of a high quantity of condoms is useless
if this action is just done for 2-3 years and then discontinue the product. The use
of this commodity is based on education.


• South Africa and Uganda are countries where Cupid is already distributed; it is
needed to create competition between Cupid and FC2.


Technical specifications of Neonatal Resuscitation Devices58




H4+ Interagency List of Essential Medical Devices for Maternal and Newborn Health


Ms Velez presented the section on Family Planning and Reproductive Health of the
draft book H4+ Interagency List of Essential Medical Devices for Maternal and Newborn
Health, and the challenges confronted during the whole project.


Day 2: June 11, 2013

Day 2 program was aimed to discuss injectable antibiotics for newborn and thus the
medical devices required for the delivery of these antibiotics.


Injectable antibiotics for neonatal sepsis:


Dr Wall from Save the Children, who leads the injectable antibiotics group of the
UNCoLSC, presented a current situation and key activities for priority injectable
antibiotics. Also, critical points which we should consider: the difficulties to select
antibiotics, neonatal formulations, promoting appropriate use, and the lack of distribution
and local production. In terms of medical devices, he suggested to develop technical
specifications of all related products.


Dr Weerasuriya, from WHO, presented the background and current work concerning
the WHO Essential Medicines List (EMLc) for children, and the difficulties in supply
due to small maker size.


Dr Qazi presented WHO documents on dosage of antibiotics for neonatal sepsis,
diagnostic, treatment and management for neonatal infections and sepsis. At the view of
clinical use for neonatal treatment, 2 ml syringes with 23G needle are required medical
devices to delivery antibiotics to neonates.


• General discussion on Injectable antibiotics for neonatal sepsis
› As dosage of antibiotics determined by weight of babies, infant scale is also


required as essential medical device.
› Alcohol and swabs are also suggested to be available always for injections.
› Consider to innovation products (e.g. autodisable injection, re-use prevention,


single dose(UnijectTM), micro-needle patches).


Patient safety and Injection safety on injectable antibiotics for neonatal sepsis:


Ms Allegranzi presented WHO considerations on patient safety and recommendations
on avoidance, prevention and amelioration of adverse events in healthcare system.
In terms of injection, injuries, infection were some of typical adverse events due to
incorrect use of medical devices on injection. Unnecessary injection was also problem
considering the risk for patients. She mentioned it was quite important the training for
health workers at each level of facility in each country.


Dr Khamassi presented Injection safety topics. Reuse, overuse, unsafe disposal,
unsafe collection are major problems. As intended in survey on year 2000, up to 70%
of injections were done by reused syringes. Transmission of blood borne pathogens,
abscess and nerve damage were associated risks with injections. The WHO injection


59Technical specifications of Neonatal Resuscitation Devices




safety program includes patients, health workers, and community safety (seven steps of
safe injection) A big problem is the training of service providers, given the high turnover.
Waste management such as sharps management is very important and broader health
system approach is needed. For example, high temperature incineration or other options
are selected by the country.


• General discussion on Patient safety and Injection safety
› Important for WHO to promote safety issues related to the use of medical devices


(e.g. the right dose, the right management of adverse events).
› The system causes adverse events primarily, not the individual and medical


devices as part of this system (e.g. health care workers are not sufficiently trained
to manage those medical devices).


› Checklists can be a solution to delivery antibiotics. Nevertheless the correct use
requires quite a lot of effort for the education of the health care workers, but it
is very effective.


› Tools for training individuals to sustain their learned skills:
› Training given by highly respected and constant leader
› Do training the trainer.
› Standard Operating Procedures posted on the wall.
› Advocacy to manufacturers to change vial labels to distinguish between


medications.
› Denmark has specific systems to manage invisible waste (as medicines that go


throw the pipes).


General specifications on injection medical devices:


Dr Maire presented WHO PQS Prequalification System including background, databases,
methods of qualification and prequalified injection devices. The WHO databases of
prequalified medical products covers laboratory, company, eight categories of medical
devices. Over 30 syringes and 10 safety boxes are prequalified by WHO. The type of
syringes are 2 piece, 3 piece, auto-disable (AD) syringes, re-use prevention (RUP)
syringes. The mechanism of syringes are Serrated plunger, Piston with hook, Ring on
barrel and Claw on plunger. Risk classification of single use syringe is medical devices
Class IIa. For the prequalification of syringes, dossier requirements contain information
on manufacturing, product, material, mechanism, label, volume, laboratory test report,
compliance with ISO, 20 samples, and other regulatory requirements.


Dr Moller form Supply division of UNICEF presented the UNICEF Supply Catalogue
which provides technical specifications on needles, syringes including RUP, safety box,
etc. UNICEF also procures AD syringes only prequalified by WHO. UNICEF procurement
has to consider supply chain, clearance through the ports, and distribution campaign,
etc. Sometimes UNICEF has to delivery medical devices different from medicines.


Dr Nakatani presented the draft book of the H4+ Interagency List of Essential Medical
Devices for Reproductive, Maternal and Newborn Health, a section on Newborn Health.
The draft tables of medical devices related to diagnostics and interventions for neonatal
sepsis, which was containing normal syringes, syringes with RUP, needles, cannula,
safety box, etc. In the draft book, the management and treatment for neonatal sepsis
is available in District hospital and Referral Hospital.


Technical specifications of Neonatal Resuscitation Devices60




• General discussion on specifications of injectable antibiotics
› Suggest linking the UN Commission on Life Saving Commodities with the H4+


Interagency List of Essential Medical Devices for Maternal and Newborn Health.
› Debates on what antibiotics should be accessible at what level of care. Agreement


is to define procedures conducted at each level, then to define necessary devices.


Country presentations:


Each of the invited countries presented their current status, needs and challenges
regarding injectable antibiotics, patient safety, prequalification, procurement of medical
devices on the country level. These presentations were followed by an open discussion.


Malawi by Mr Mkukuma:
• Chemical engineer, works for MoH, management and procurement of medical


equipment.
• Hospitals responsible for procurement.
• Cites four types of needles for procurement.
• Syringes and needles are procured by the hospital themselves, they are also


responsible for the specifications.
• The Government recently procured 4 types of needles and three sizes of syringes.


Sierra Leone by Mr Kabia:
• All procurement is done by UNICEF.
• District Health Facilities program – procurement was done by UNFPA.
• Believes children are forgotten in medical device procurement (e.g. lack of scale,


incubator).
• Cites major problem with donation of equipment on lack of training or on lack of


maintenance.


Senegal by Mr Nado:
• All procurement is done by UN agencies. Syringes and vaccines are coming from


UNICEF.


India by Dr Nagesh:
• Public-private partnerships to improve health.
• A lot of coordination and centralization from the Ministry of Health, but different


states have different budgets and policies.
• Procurement funding available through the government, but still a long way to go,


as opposed to the private sector that is moving much faster.
• Single use syringes available for immunization in public and private sector.
• Newborn is the biggest challenges: lack of equipment and personnel


Tanzania by Mr Mvanga and Ms Mariki:
• Syringes, AD one the only ones used.
• UNICEF, Jhapiego, and others support procurement.
• Cash program to train community health worker to help with procedures.
• Private facility may gain funding from public since it has capacity not available in


public hospitals.
• Western medical products may be present, but not operational.


61Technical specifications of Neonatal Resuscitation Devices




• Got contract with Netherlands to build incinerators for waste management of
syringes.


• Regulatory pathway: syringes are Class II device.
• Post-market surveillance, started with sterile syringes and gloves.
• Permit system, medical devices should not be procured without permit.
• Guideline for disposal of waste.


Uganda by Mr Wanda:
• The responsibility of the Ministry of Health to make sure that the requirements and


needs of their country are met.
• Newborns need specific sizes for needles, the right dilution and calculations of


medicines.
• Collect waste with funding from USAID.


• General Discussion on country presentation
› For babies, size of needle must be adjusted.
› Weighing scale, calibrated weekly is needed to calculate the dose.
› Incubators also needed for neonatal care in hospitals.
› Use technical specification if qualification from PQS system.
› Large proportion of those giving injections are not trained.
› How to deal with RUP advocacy against drug users who are allowed to reuse


on themselves.
› Waste both visible and invisible (health waste put into water source, cannot


be captured at purification point)


Day 3: June 12, 2013

Day 3 program was aimed to discuss neonatal resuscitation devices


Dr Bahl presented the WHO Neonatal Resuscitation Guidelines:
• Differences between adult and baby resuscitation. In babies is more important to


recover breathing than circulation.
• Procedures for ventilation, suction, etc.
• Recommendation, not to use 100% oxygen for resuscitation. If available, blender


to provide maximum 30%.
• There is no WHO guideline for minimum resuscitation conditions in terms of number


of weeks of pregnancy for newborn. It depends on too many factors/ context and
legal issues – decided to go with national level decision.


Dr Narayanan presented an overview of Neonatal Resuscitation of the UNCLSC:
• Core package for the basic facility/peripheral centers – give priorities to centers that


have deliveries above a certain threshold.
• In Tanzania it is compulsory to practice the steps of resuscitation, with checklist on


the wall with steps that need to be undertaken.
• Specifications for manufacturers – how many of them could produce the models,


by closely defining what we need.
• Presented advantages and disadvantages of different types of neonatal resuscitators.


Technical specifications of Neonatal Resuscitation Devices62




• Provide the basic requirements for suction device should have: easy to be cleaned,
translucent, not hard/plastic edge, etc. Training also in the sterilization/cleaning
method for these devices.


• Mannequins are very expensive but she proposed that they should be available for
training purposes.


• Temperature control during neonatal resuscitation is an important issue.
• Market and regulatory perspective must be considered.
• For high level medical devices, we should try to prioritize between different items,


based on evidence guidelines.


Ms Velazquez presented background and the current status of H4+ Interagency List
for reproductive, maternal and newborn health (RMNH), and current WHO activities
on medical devices. WHO already has provided the list of medical devices by health
care facilities, e.g. health post, health centre, district hospital, specialized hospital, but
the list is not linked to interventions. H4+ Interagency List for RMNH is integrated with
cross-matching tables by interventions, level of healthcare facility, and medical devices.
The basic list of medical devices includes over 500 medical devices.


Country presentations


Each of the invited countries presented their current status, needs and challenges
regarding resuscitation for newborn, procurement of related medical devices on the
country level. These presentations were followed by an open discussion.


Malawi by Mr Mkukuma:
• Only four biomedical engineers in charge of all the medical devices at ministry of


health.
• As donated medical equipment come from different brands, engineers are not


usually prepared in the maintenance skills neither with enough consumables to
operate the equipment.


Sierra Leone by Mr Kabia:
• Big challenge: scarce of medical equipment and skills,
• It is needed to bring trainers from other Western African countries to train them.
• Statistics presented are based on empirical evidence, no database.
• Experienced in many events against safety patient.


Tanzania by Mr Mvanga and Ms Mariki:
• Country receives donations of medical equipment and they just distribute in the


health facilities without previous strategic planning.
• Oxygen concentrators can only adjust volume and pressure and alarms when


oxygen is less than 72%.
• For example, in health facilities usually do not receive breathing circuits for children,


just for adults.
• Most of the patient deaths are inside the health centers or during the transportation


to referral level.


63Technical specifications of Neonatal Resuscitation Devices




Uganda by Mr Wanda:
• Using Masks, Valves and Bags for the newborn asphyxia in Uganda.
• Bags as Ambu, masks were size 0 for prenatal and size 1 for full-natal babies.
• Masks had upright or horizontal bag, but preferred upright type because of better


seal, fewer parts to clean and assemble, and lower cost.
• Resuscitation set contained a transparent ”penguin” suction bulb which was


openable for cleaning, boilable for disinfection, easily checked for readiness, highly
durable and affordable.


• Resuscitation set contained stethoscope, warm clothes and cord ties.


Other general discussions:


• Due to procurement that is not standardized, there are not only several brands for
the same medical device but also not enough training, spare parts, manuals, etc.


• There is no way to track down the equipment at the hospital because there is no
an asset registry.


• Safe use of medical devices – not a very specific initiative on addressing the high
mortality due to unsafe use of medical devices and high risk ones in particular,


• Participants interested in the safe use of medical devices book that will be prepared
by WHO as part of the medical devices technical series.


DELIVERABLES and WAY FORWARD


Based on the meeting objectives and the expected outcomes, following are the list of
deliverables:


1. In Table 1. is the list of the precise medical devices associated to the commodities
discussed.


Table 2. List of the 13 recommended life-saving commodities



Reproductive health commodities


• Female condom


Injectable antibiotics for newborn sepsis
• Syringe 2 mL with needle 23 G 25 mm (with re-use prevention feature)


• Syringe 2 mL with needle 23 G 25 mm (without re-use prevention feature)


• Safety box, for used syringes/needles


• Infant scale less than 20 kg


• Clinical thermometer, non-mercury


Resuscitation devices for newborn asphyxia
• Self-inflating neonatal resuscitation bag with masks for pre-term(size 0) and term(size 1) babies


• Electric or foot operated suction machine/pump, negative pressure less than 100mm Hg, with 1 bottle


Technical specifications of Neonatal Resuscitation Devices64




• Suction catheter, length 50 cm, single use, conical tip, Fr# 8


• Single use suction bulb


• Multi-use suction bulb that can be opened, cleaned and sterilized


• Training mannequin/simulator for neonatal resuscitation


• Infant stethoscope


2. In Annex A, are the thirteen technical specifications in WHO Template for the
medical devices listed on Table 1. For review by the participants of the consultation.
Response due 31 July, 2013.


3. The survey launched by WHO to assess the status of the 13 life –saving commodities
in country level, in sections 7a, 7b, 8a and 8b has been updated according to the
comments received during this meeting and to the list of devices in Table 1. The
link to this survey will be provided to all participants. And will be distributed in
Senegal meeting and also to other EWEC countries. Results will be expected end
of August, 2013.


4. The definition of Harmonized Registration technical requirements and Assessment
tool to improve the quality assurance in countries and the national delivery on
those devices, is being developed with the assistance of other regulators and will
be shared with the members of this consultation before the end of August.


5. In Annex B, Provisional Programme of Work.


6. Attached all PowerPoint presentation in the meeting, to be used as reference of
this report.


LIST OF PARTICIPANTS


HEALTH TECHNOLOGY FOCAL POINTS FROM PATH FINDER COUNTRIES FOR
UNCoLSC:


Mr Alusine B. KABIA
Bio Medical Consultant, Ministry of Health and Sanitation, SIERRA LEONE
Email: alusinebk@yahoo.com


Ms Rehema MARIKI
Tanzania Food & Drugs Authorities, UNITED REPUBLIC OF TANZANIA
Email: remariki@yahoo.com


Mr Lovemore MKUKUMA
Ministry of Health, MALAWI
Email: mkukuma@yahoo.co.uk


65Technical specifications of Neonatal Resuscitation Devices




Mr Valentino MVANGA
Ministry of Health, UNITED REPUBLIC OF TANZANIA
Email: vmvanga@yahoo.com


Dr Youssou NDAO
Pharmacien Inspecteur de sante publique, Ministry of Health, SENEGAL
Email: youisn @yahoo.fr


Mr Sam. S.B. WANDA
Ministry of Health, UGANDA
Email: ssbwanda@gmail.com


NGOs


Ms Indira NARAYANAN
Neonatal resuscitator main consultant from USAID (lead convener), UNITED STATES
Email: inarayanan6@gmail.com


Dr Nagarajan Kartik NAGESH
Consultant in Neonatology, INDIA
Email: karthiknagesh@yahoo.co.in


Mr Keith NEROUTSOS
Director of Procurement at PATH, UNITED STATES
Email: kneroutsos@path.org


Mr Steve WALL
Save the Children (lead convener for injectable antibiotics)
Email: swall@savechildren.org


OTHER UN ORGANIZATIONS


Ms Bidia Deperthes
UNFPA (lead convener for female condoms), UNITED STATES
Email: deperthes@unfpa.org


Dr Helene MOLLER
UNICEF Supply division, DENMARK
Email: hmoller@unicef.org


Ms Hayley TRAEGER
UNFPA Procurement Services Branch, DENMARK
Email: traeger@unfpa.org


Technical specifications of Neonatal Resuscitation Devices66




OBSERVERS


Ms Tatjana R. SACHSE
Sidley Austin LLP, SWITZERLAND
Email: tsachse@sidley.com


WHO REGIONAL OFFICE FOR AFRICA


Dr Jean Bosco NDIHOKUBAYO
Regional Advisor for Health Technologies
Email: ndihokubwayoj@who.int


WHO HEADQUARTERS


Dr Benedetta ALLEGRANZI
Technical Officer, Patient Safety Programme, PSP
Email: allegranzib@who.int


Dr Rajiv BAHL
Medical officer, Research and development, MCA/FWC
Email: bahlr@who.int


Dr Mario FESTIN
Lead specialist Family Planning, FWC
Email: festinma@who.int


Dr Selma KHAMASSI
Technical officer, Injection safety, PSP
Email: KhamassiS@who.int


Dr Frederik KRISTENSEN
Office of the Assistant DG for Family, Women´s and Children´s Health (FWC)
Email: kristensenf@who.int


Dr Denis MAIRE
Scientist, Vaccines, EMP
Email: maired@who.int


Dr Shamim Ahmad QAZI
Research and Development, MCA/FWC
Email: qazis@who.int


Dr Krisantha WEERASURIYA
Medicines Access and Rational Use, EMP
Email: weerasuriyak@who.int


67Technical specifications of Neonatal Resuscitation Devices




ESSENTIAL MEDICINES AND HEALTH PRODUCTS DEPARTMENT (EMP)/MEDICAL
DEVICES UNIT


Ms Jennifer BARRAGAN
Consultant
Email: j.barragan.biz@gmail.com


Dr Yukiko NAKATANI
Technical Officer, Diagnostic Imaging and Medical Devices
Email: nakataniy@who.int


Mr Amir SABET SARVESTANI
Technical Officer, Diagnostic Imaging and Medical Devices
Email: sabetsarvestania@who.int


Ms Laura Alejandra VELEZ RUIZ GAITAN
Consultant
Email: la.velezrg@gmail.com


Ms Adriana VELAZQUEZ BERUMEN
Coordinator, Diagnostic Imaging and Medical Devices
Email: velazquezberumena@who.int


Technical specifications of Neonatal Resuscitation Devices68




Annex 10. Sixty-Sixth World Health Assembly
Implementation of the recommendations
of the United Nations Commission on Life-
Saving Commodities for Women and Children
(WHA66.4)


The Sixty-sixth World Health Assembly,


Having considered the report on follow-up actions to recommendations of the high-level
commissions convened to advance women’s and children’s health;


Recalling resolution WHA63.15 on monitoring of the achievement of the health-related
Millennium Development Goals and resolution WHA65.7 on implementation of the
recommendations of the United Nations Commission on Information and Accountability
for Women’s and Children’s Health;


Recalling also that the United Nations Secretary-General called upon the global
community through the Global Strategy for Women’s and Children’s Health to work
together to save 16 million lives by 2015;


Acknowledging the pledges and commitments made by a large number of Member
States and partners to the United Nations Secretary-General’s Global Strategy for
Women’s and Children’s Health;


Recognizing that millions of women and children die needlessly every year from
conditions that are easily prevented by the use of existing, inexpensive medical
commodities;


Recognizing also the need urgently to address and overcome the barriers that prevent
women and children from accessing and using appropriate commodities;


Welcoming the report of the United Nations Commission on Life-Saving Commodities
for Women and Children, which estimates that six million lives can be saved within five
years by improving access to 13 specific, overlooked commodities and related products
(see Annex);


Welcoming also the actions recommended by the United Nations Commission on Life-
Saving Commodities for Women and Children and the implementation plan to deliver
the actions;


Acknowledging that the actions recommended by the United Nations Commission on
Life-Saving Commodities for Women and Children’s Health will also increase access to
a broader set of commodities;


69Technical specifications of Neonatal Resuscitation Devices




Acknowledging also the need to promote, establish or support and strengthen the health
services needed by women and children from before pregnancy to delivery, during the
immediate post-delivery period, and childhood;


Reaffirming the importance of facilitating technology transfer on mutually agreed terms
between developed and developing countries as well as among developing countries,
as appropriate;


Acknowledging the role of the independent Expert Review Group in reviewing the
progress made in implementing the recommended actions,


1. URGES Member States to put into practice, as appropriate, the implementation plan
on lifesaving commodities for women and children, including:


1. improving the quality, supply and use of the 13 life-saving commodities and other
essential commodities for reproductive, maternal, newborn and child health,
under the supervision and guidance of health care professionals, where needed,
and building upon information and communication technology best practices for
making these improvements;


2. developing plans to implement at scale appropriate interventions in order to
increase demand for and utilization of health services, particularly among
underserved populations;


3. facilitating universal access for all members of society, in particular the poorest,
to the 13 life-saving commodities as well as to other essential commodities for
reproductive, maternal, newborn and child health;


4. improving regulatory efficiency by harmonizing registration requirements and
streamlining assessment processes, including granting priority to review of the
life-saving commodities;


5. implementing proven mechanisms and interventions to ensure that health care
providers are knowledgeable about the latest national guidelines for maternal and
child health;


2. REQUESTS the Director-General:


1. to work with UNICEF, UNFPA, the World Bank, UNAIDS, UN Women, national,
regional and international regulators, private sector actors and other partners in
order to promote and assure the availability of safe, quality commodities;


2. to work with and support Member States, as appropriate, in improving regulatory
efficiency, standardizing and harmonizing registration requirements and
streamlining assessment processes, including granting priority to review of the
life-saving commodities;


Technical specifications of Neonatal Resuscitation Devices70




3. to provide support to the independent Expert Review Group on Information
and Accountability for Women’s and Children’s Health in its work on assessing
the progress made in the implementation of the United Nations Secretary-
General’s Global Strategy for Women’s and Children’s Health, as well as in the
implementation of the recommendations of the United Nations Commission on
Life-Saving Commodities for Women and Children;


4. to report annually until 2015, through the Executive Board, to the World Health
Assembly on progress achieved in the follow-up of the recommendations of the
Commission on Life-Saving Commodities for Women and Children, in connection
with the agenda item concerning promoting health through the life course.


ANNEX


Commodities by life stage


Maternal health commodities
Oxytocin – post partum haemorrhage (PPH)


Misoprostol – post-partum haemorrhage


Magnesium sulfate – eclampsia and severe pre-eclampsia


Newborn health commodities
Injectable antibiotics – newborn sepsis


Antenatal corticosteroids (ANCs) – preterm respiratory distress syndrome


Chlorhexidine – newborn cord care


Resuscitation devices – newborn asphyxia


Child health commodities
Amoxicillin – pneumonia


Oral rehydration salts – diarrhoea


Zinc – diarrhea


Reproductive health commodities
Female condoms


Contraceptive implants – family planning/contraception


Emergency contraception – family planning/contraception


71Technical specifications of Neonatal Resuscitation Devices




Annex 11. UNCLSC Poster – Second Global
Forum on Medical Devices


Technical specifications of Neonatal Resuscitation Devices72




References


1. Guidelines on basic newborn resuscitation. Geneva: World Health Organization;
2012.


2. Wall SN, Lee AC, Niermeyer S, English M, Keenan W, Carlo W et al. Neonatal
resuscitation in low-resource settings: What, who, and how to overcome challenges
to scale up? Int J Gynaecol Obstet. 2009;107:S47–S64.


3. Knippenberg R, Lawn J, Darmstadt G, Begkoyian G, Fogstad H, Walelign N et al.
Systematic scaling up of neonatal care in countries. Lancet. 2005;365(9464):1087–
98.


4. UNCLSC (http://www.everywomaneverychild.org/networks/life-saving-
commodities).


5. WHA66/2013/REC/1 (http://apps.who.int/gb/ebwha/pdf_files/WHA66-REC1/
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Technical specifications of Neonatal Resuscitation Devices74






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