Analysis of Medical Device Reports Involving Ventilator-Related Incidents in a Clinical Setting

Abstract

Continuous ventilators are a critical resource for the treatment and management of respiratory diseases, particularly in the midst of the COVID-19 pandemic. Healthcare technology management professionals (HTMs) are instrumental toward protecting the safety of patients by ensuring that ventilators and ventilator accessories (ventilator-related medical devices) remain functional during their lifetime. This article discusses a retrospective analysis on the failure modes described in ventilator-related medical device reports that were submitted to the US Food and Drug Administration Medical Product Safety Network (MedSun). In addition, the article also examines MedSun case studies, obtained from medical device reports, to provide HTMs with a comprehensive analysis of the lifecycle of a safety signal and how their input is essential to improve the safety and effectiveness of medical devices. Postmarket medical device surveillance in a constantly changing medical device ecosystem benefits from the first-hand knowledge that HTMs contribute to the cross-functional collaboration between the clinical community, medical device manufacturers, and the US Food and Drug Administration.