Errors associated with medical devices can be costly to health institutions and manufacturers, with some patients paying the ultimate price with their lives. Some of these medical device errors could be prevented. The U.S. Food and Drug Administration (FDA) obtains accounts of errors or adverse events for medical devices that encompasses a spectrum of reporters. Some reporting is required, such as adverse events from the manufacturer, while the FDA relies on consumers to report their issues on a voluntary basis.

After 510k approval, a medical device company has the obligation to report any errors to the FDA through Medical Device Reporting, known as MDR. Medical device consulting firms advise clients to have a plan in place on how and what to report to the FDA. Medical device consulting firms will implement flow charts which make it easy for personnel to follow and easily access federal code regulations which will cite the specific requirements.

The FDA offers consumers and health professionals the ability to report medical device issues online utilizing their MedWatch system. There are different forms for reporting depending upon who is making the submission. Health professionals will report on form 3500 and consumers will report on form 3500B. Both of these types are voluntary.

The FDA requires manufacturers, importers, and device user facilities to report certain device-related adverse events and product problems utilizing form 3500A. For example, if a medical device causes serious injury or death or has a potential to do so through a malfunction the manufacturer is aware of, it must be reported to the FDA.

The importer is required to report any malfunctions to the manufacturer, but if there was serious injury or death, the importer must file a report to the FDA. A device user facility must report a serious injury to the manufacturer. If the manufacturer is not known, then they must report it to the FDA. Medical device consulting firms will generally advise filing a report with both the FDA and manufacturer. However, if the death was suspected due to the medical device, it must be reported to the FDA via Form 3500A.

Source: https://biotechresearchgroup.com/medical-device-consulting-adverse-events/