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.Continuous ventilators are intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. 1 These medical devices are used to treat conditions such as respiratory failure, chronic respiratory insufficiency, and other conditions in which a patient requires breathing assistance. Some situations where ventilators are used are as follows: providing respiratory support for an unconscious patient with a severe infection, assisting a patient by decreasing the amount of energy used by the lungs during the recovery process, and aiding a patient who is not breathing due to a traumatic injury to the brain or spinal cord. Ventilators, as well as their accompanying tubing, connectors, and other accessories ("ventilator-related"), are also critical for the treatment of some severe COVID-19 patients.Monitoring and understanding medical device safety signals are critical to the collaborative relationship among the US Food and Drug Administration (FDA), device manufacturers, and the clinical community. A better understanding of ventilator malfunctions will provide healthcare technology management professionals (HTMs) with valuable information that may help mitigate similar incidents in the future. One valuable way HTMs and other hospital staff can continue to promote patient safety is to report medical device adverse events or close calls to the FDA's MedSun. An analysis of MedSun's ventilator-related medical device reports (MDRs) from January 2019 through November 2021 was conducted with a goal of determining the most prevalent device failures and reported adverse events for these device types. This article also discusses case studies involving several MedSun reports to help HTMs and clinical engineers enhance their knowledge of potential ventilator-related issues. If your hospital is not part...

Surplus Value Quantification of Overdue Medical Devices Based on Kohonen Network Algorithm

“…His research incorporated factors such as equipment technical performance, maintenance costs, and environmental risks into the evaluation model. By comprehensively evaluating the maintenance needs and risks of equipment, a comprehensive quantitative assessment of the surplus value of equipment in overdue service was realized [4]. The quantitative method of surplus value of overdue medical device used by these scholars has some shortcomings, such as subjective limitations, lack of quantitative indicators, di culties in data collection, and lack of exibility and adaptability.…”