Reporting Medical Device Events

Abstract

The Food and Drug Administration (FDA) is responsible for protecting public health by regulating medical devices, radiation-emitting electronic devices, drugs, biologics, food, tobacco, and cosmetics. After a product reaches the market, the Agency continues to evaluate a product's safety by monitoring adverse events. FDA's Center for Devices and Radiological Health facilitates reporting of medical device events and complaints by manufacturers, importers, healthcare facilities, and the general public to help FDA identify potential safety signals and/or improve medical device performance. FDA has established 2 reporting mechanisms (1) reporting through the public MedWatch system and (2) direct user facility collaboration via the MedSun program.Does this scenario sound familiar to you? You are meeting your responsibilities to keep a fleet of medical devices properly maintained and functioning well to be used on the hospital floor, but despite your best efforts, the devices seem to keep failing, all in a similar way. How do you report the malfunctions and stop this problem from continuing, or worse-from impacting delivery of safe and timely patient care?Reporting of adverse events helps to ensure the continued safety of medical devices and other products regulated by the Food and Drug Administration (FDA) once they are introduced into the US market. When problems with FDAregulated products occur, FDA wants to know about them because timely reporting by consumers, health professionals, and manufacturers allows the Agency and manufacturers to take prompt action to mitigate the problem. Because of their responsibilities with setting up, maintaining, and repairing a range of medical devices used throughout hospital departments, healthcare technology management (HTM) professionals are in a distinct position to first observe and, subsequently, report device-related adverse events and concerns, which can be critical in notifying FDA of new safety signals or an increase in known risks. 1 Only after the details surrounding the device event or concern have been identified and reported can FDA use the information to inform solutions through follow-up with the device manufacturer or identify other mechanisms (eg, safety communications or recalls) to resolve problems resulting in risk mitigation to both patients and healthcare providers. However, in order to improve patient safety through reporting medical device events and concerns to FDA, you must first understand what to report and where to report. So far, we have covered the "Why?" of reporting medical device events. This article aims to help HTM professionals get from observation to action by explaining regulatory reporting requirements at a high level, as well as the who, what, when, where, and how to report medical device events and concerns related to device safety, efficacy, or reliability, to FDA. What Events Should Be Reported?An adverse event is any undesirable experience associated with the use of a medical product in a patient. 2 FDA is interested in receiving repor...

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

“…All user facilities are required by law to report all deaths and serious injuries that a device has or may have caused or contributed to, and non-MedSun user facilities must also submit summary annual reports to the FDA. 1,2 MedWatch also receives reports about drugs, biologics, cosmetics, and food, in addition to medical devices. The FDA's MedSun program is another medical device reporting mechanism available to participating hospitals.…”

“…MedWatch, FDA's public facing medical product safety reporting program, is also available to health professionals, patients, and consumers. All user facilities are required by law to report all deaths and serious injuries that a device has or may have caused or contributed to, and non-MedSun user facilities must also submit summary annual reports to the FDA 1,2 . MedWatch also receives reports about drugs, biologics, cosmetics, and food, in addition to medical devices.…”