Medical Device Reporting Requirements
For adverse events and product problems, the Food and Drug Administration (FDA) Medical Device Reporting (MDR) regulation (21 CFR Part 803) contains mandatory requirements for manufacturers, importers, and device user facilities to report certain device-related adverse events and product problems to the FDA. Manufacturers are required to report to the FDA when they learn that any of their devices may have caused or contributed to a death or serious injury. Caused or contributed means that a death or serious injury was or may have been attributed to a medical device, or that a medical device was or may have been a factor in a death or serious injury, including events occurring as a result of: failure; malfunction; improper or inadequate design; manufacture; labeling; or, user error.
The FDA’s responsibilities include post-market surveillance monitoring of products after their clearance to market so as to maintain traceability of certain devices to the user level. The FDA utilizes an online publicly accessible database for voluntary and mandatory reporting, which is called Med Watch, The FDA Safety Information and Adverse Event Reporting Program. The FDA monitors reports of adverse events and other problems with medical devices, as reported to MedWatch and, when needed, alerts health professionals and the public to ensure proper use of devices and the health and safety of patients in the form of Guidance Documents.
The Joint Commission 2013 Hospital Accreditation Standard EC.02.01.01 EP 11 requires hospitals to respond to product notices and recalls and requires hospitals to have an effective system in place to manage the safety risks associated with medical equipment. Standard EC.02.04.01 EP 5 requires hospitals to monitor and report all incidents in which medical equipment is suspected in or attributed to the death, serious injury, or serious illness of any individual, as required by the Safe Medical Devices Act of 1990.
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