Case Series

Abstract

Health technology managers play a vital role in medical device safety for pediatric patients in the neonatal intensive care unit and the pediatric intensive care unit. Medical device malfunctions and failures can contribute to potential for harm and adverse events. These patients are especially vulnerable to harm when these incidents occur. When health technology managers provide their expertise on medical device malfunction reports, their valuable input can provide a more complete view of the safety concerns to the US Food and Drug Administration and the device manufacturer. The examples in this article are from medical device reports submitted to the US Food and Drug Administration's MedSun program and illustrate how health technology managers' input has advanced US Food and Drug Administration's understanding of medical device safety concerns and contributed to subsequent recalls and other safety actions for devices used in the neonatal intensive care unit and pediatric intensive care unit.