Collaborative Partnership Among Hospital Healthcare Technology Management Community, Medical Device Manufacturers, and the FDA’s MedSun Program

Abstract

The collaboration of hospitals, medical device manufacturers, and the US Food and Drug Administration serves to promote patient safety and device performance in the clinical setting. Each entity brings its own set of expertise, perspective, and resources that can be used to perform in-depth investigations into medical device–related safety concerns with the common goal of patient safety and device performance. This article describes the ways in which healthcare technology management professionals, medical device manufacturers, and Food and Drug Administration’s MedSun program work together to resolve medical device–related safety concerns, with a focus on case reports of exemplary communication and resolution of such concerns.

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

“…8 MedSun reports detailing the work of HTMs have directly contributed to recall classifications as well as other regulatory actions in the past. 4,8 One of FDA's key levers in working with manufacturers on addressing medical device concerns is to encourage and rely upon diligent medical device reporting from user facilities. The invaluable knowledge of HTMs is vital to achieving that aim.…”

“…When problems do occur with medical devices that HTMs set up, maintain, update, and/or repair, they can initiate internal investigations into what went wrong. 4 When HTMs encourage staff to retain devices or equipment, device evaluation and testing can be completed. Healthcare technology managers conduct visual inspections of devices, consult with clinical staff, and conduct in-house maintenance whenever possible.…”

“…Offering to sequester certain equipment is especially helpful during these investigations. 4 Manufacturers can validate the testing and any findings from the hospital when devices are retained and made available to the manufacturer for evaluation. The root cause of device malfunctions for medical devices can be difficult or nearly impossible to determine whether the device is not available for evaluation.…”

“…The root cause of device malfunctions for medical devices can be difficult or nearly impossible to determine whether the device is not available for evaluation. 4 When necessary, HTMs may also use bench testing to recreate problems, determine the potential failure modes, and develop initial analyses and theories of the device problem to better inform the MDRs submitted to the FDA and the device manufacturer. By working to determine root causes of malfunctions, examining data logs, and conducting other tests on medical devices, HTMs can provide the FDA with supplemental information, which greatly enhances FDA's ability to understand the full scope of device issues impacting user facilities.…”

“…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.…”