Medical Device Reporting Training Program
April 30, 2020 | Healthcare Risk, Quality, & Safety Guidance
Medical device reporting (MDR) is intended to help the U.S. Food and Drug Administration (FDA) identify medical device problems that pose a threat to public health and safety. Under the Safe Medical Devices Act of 1990 (SMDA) and the FDA Modernization Act of 1997 (FDAMA), user facilities, including healthcare facilities, are required to report to FDA and/or a device manufacturer certain adverse events involving medical devices. Three types of device-related incidents must be reported: deaths, serious injuries, and serious illnesses. Risk managers must be familiar with the nuances of the regulations, FDA's approach to enforcement, and their healthcare facilities' procedures for reporting.
Successful implementation of an MDR program depends on effective communication and education of staff responsible for patient care. This includes educating all appropriate staff—including physicians, nurses, allied health professionals, and support staff—on the facility's reporting program and the specifics of FDA's MDR requirements. Off-site services (e.g., ambulance, home health, long-term care, outpatient treatment and diagnosis) also need to be incorporated into the MDR program; however, physician practices are excluded from MDR reporting requirements.
This training package...