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.

The Importance of Medical Device Reporting by Health Technology Managers Before and After Recalls Are Posted

“…The FDA uses MDRs to inform on potential regulatory decisions, to make more informed decisions when working with medical device manufacturers on recalls or other actions, and to communicate safety communications to the public at large. 5 Whether through MedWatch or MedSun, the FDA uses MDRs to obtain data on device trends and potential areas of concern with devices used in the clinical setting. Although reporting medical device events as soon as possible is paramount, it is critical for hospitals to continue to report incidents when they are directly related to ongoing device recalls.…”

“…Healthcare technology managers offer a unique perspective and expertise on medical device events, ideally conveying their device experience through reporting medical device events. The FDA uses MDRs to inform on potential regulatory decisions, to make more informed decisions when working with medical device manufacturers on recalls or other actions, and to communicate safety communications to the public at large 5 . Whether through MedWatch or MedSun, the FDA uses MDRs to obtain data on device trends and potential areas of concern with devices used in the clinical setting.…”

“…The submission of MDRs can lead to a variety of actions by the FDA and the device manufacturer including issuing public safety communications, making a change to the manufacturing process, and initiating a device recall. 4,5 Most recalls are voluntarily initiated by manufacturers to protect the public health from products that present a risk of injury or are otherwise defective. Timely submission of MDRs to device manufacturers and the FDA is a critical component to manufacturers' ability to quickly respond to postmarket device issues and initiate medical device recalls when appropriate.…”

“…Healthcare technology managers may be the first to identify and report underlying issues to the FDA, and these early-stage reports may also be the first time device manufacturers are made aware of those concerns or potential safety risks. The submission of MDRs can lead to a variety of actions by the FDA and the device manufacturer including issuing public safety communications, making a change to the manufacturing process, and initiating a device recall 4,5 . Most recalls are voluntarily initiated by manufacturers to protect the public health from products that present a risk of injury or are otherwise defective.…”