Newborn self-inflating manual resuscitators: precision robotic testing of safety and reliability.

A new interesting article has been published in Arch Dis Child Fetal Neonatal Ed. 2019 Jul;104(4):F403-F408. doi: 10.1136/archdischild-2018-315391. Epub 2018 Oct 18. Evaluation Studies and titled:

Newborn self-inflating manual resuscitators: precision robotic testing of safety and reliability.

Authors of this article are:

Tracy MB, Halliday R, Tracy SK, Hinder MK.

A summary of the article is shown below:

AIM: A controlled bench test was undertaken to determine the performance variability among a range of neonatal self-inflating bags (SIB) compliant with current International Standards Organisation (ISO).INTRODUCTION: Use of SIB to provide positive pressure ventilation during newborn resuscitation is a common emergency procedure. The United Nations programmes advocate increasing availability of SIB in low-income and middle-income nations and recommend devices compliant with ISO. No systematic study has evaluated variance in different models of neonatal SIB.METHODS: 20 models of SIB were incrementally compressed by an automated robotic device simulating the geometry and force of a human hand across a range of precise distances in a newborn lung model. Significance was calculated using analysis of variance repeated measures to determine the relationship between distance of SIB compression and delivered ventilation. A pass/fail was derived from a composite score comprising: minimum tidal volume; coefficient of variation (across all compression distances); peak pressures generated and functional compression distance.RESULTS: Ten out of the 20 models of SIB failed our testing methodology. Two models could not provide safe minimum tidal volumes (2.5-5 mL); six models exceeded safety inflation pressure limit >45 cm H2O, representing 6% of their inflations; five models had excessive coefficient of variation (>30% averaged across compression distances) and three models did not deliver inflation volumes >2.5 mL until approximately 50% of maximum bag compression distance was reached. The study also found significant intrabatch variability and forward leakage.CONCLUSION: Compliance of SIBs with ISO standards may not guarantee acceptable or safe performance to resuscitate newborn infants.© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Check out the article’s website on Pubmed for more information:

This article is a good source of information and a good way to become familiar with topics such as: Cardiopulmonary Resuscitation;Equipment Design;Equipment Safety;Humans;Infant Care;Infant, Newborn;Insufflation;Positive-Pressure Respiration;Respiration, Artificial;Robotics.

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