WHO Technical Specifications of Neonatal Resuscitation Devices
(2016; 80 pages) [French]

Abstract

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.

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.

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.

 
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