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

Abstract

The Food and Drug Administration (FDA) performs postmarket surveillance of medical devices as part of its mission to ensure that devices remain safe and effective while they are on the market. Medical device reporting by manufacturers, user facilities, and the public plays an important role in the agency identifying and resolving medical device safety signals. User facilities are defined as a hospital, ambulatory surgical facility, nursing home, outpatient diagnostic facility, or outpatient treatment facility and do not include physician's offices. The Safe Medical Devices Act requires user facilities to report medical-device–related deaths to the FDA and the device manufacturer, to report device-related serious injuries to the manufacturer, and to submit an annual summary of all device reports to the FDA. If the manufacturer is unknown for a serious injury report, the user facility then submits the report to the FDA. Healthcare technology managers in user facilities use their expertise to recognize, communicate, and evaluate medical device concerns. This article highlights the importance of identifying and reporting medical device issues to the FDA to ensure continued safety and effectiveness of devices on the market.

The Importance of Reporting Recurring Medical Device Issues

“…Reports containing HTM perspectives are beneficial to FDA as they provide information about actions taken, timelines of problematic devices, and interactions with manufacturers. In addition to providing descriptions of device failure modes, CEs and other HTM professionals can provide critical information to FDA through sharing photos of events, data logs, and through retaining devices for manufacturer evaluation 3 . HTM professionals play a crucial role in ensuring the safety and effectiveness of medical devices.…”

“…In addition to providing descriptions of device failure modes, CEs and other HTM professionals can provide critical information to FDA through sharing photos of events, data logs, and through retaining devices for manufacturer evaluation. 3 HTM professionals play a crucial role in ensuring the safety and effectiveness of medical devices. HTM professionals work with devices throughout their entire useful life, such as through performing preventive maintenance, inspections, repairs, and assisting with training and troubleshooting.…”