Benefits of Healthcare Technology Management Input in Medical Product Safety Network Reports

Abstract

Healthcare technology management professionals play an important role in reporting medical device adverse events to the Food and Drug Administration by helping to identify and report device concerns, providing critical context to medical device reports, and mitigating safety concerns. The expert opinions and insights shared by healthcare technology management professionals are beneficial to the Food and Drug Administration and help the agency mitigate device-related problems and improve patient safety. This article is a case study that discusses how a medical device report involving infusion pump controllers was submitted to the Food and Drug Administration's Medical Product Safety Network reporting program and contributed to a voluntary class I recall affecting more than 800,000 devices nationwide. The details and context provided in the medical device report by the reporting team helped inform the investigation into, and resolution of, a device safety concern.