The Importance of Reporting Recurring Medical Device Issues

Abstract

Medical device reporting provides critical safety information that assists the US Food and Drug Administration in its mission to protect and promote the public health. Reporting device–associated events each time they happen can give insight to the severity of device-related issues and help ensure that medical devices are safe and effective. This case study examines how detailed and frequent medical device reports submitted to the Food and Drug Administration can provide key context regarding device malfunctions. The frequency of reported events from the hospital in the case study described in this article helped initiate an investigation that ultimately contributed to a class II recall for the medical device.