Too much ‘noise’ in system at root of device recall delays

Postmarket surveillance of medical devices, which includes device manufacturers’ investigations of complaints about their devices, are generally not logged in the FDA’s adverse event report system. In a study sponsored by the University of Minnesota and published in the journal Production and Operations Management, the researchers found that the more adverse event reports there are for a ­particular device, the more likely it was a company would have “under-reaction” bias in deciding whether a recall was appropriate.  In other words, device manufacturers, when presented with multiple adverse event reports for a specific device, actually took longer to react on the recall decision.

Each year, the FDA receives several hundred thousand medical device reports (MDRs) of suspected device-associated deaths, serious injuries, and malfunctions. The FDA uses MDRs to monitor device performance, detect potential device-related safety issues, and contribute to benefit-risk assessments of these products. A Manufacturer and User Facility Device Experience (MAUDE) database houses these MDRs submitted to the FDA by mandatory reporters (manufacturers, importers, and device user facilities) and voluntary reporters, such as health care professionals, patients and consumers.

Although MDRs are a valuable source of information, they provide only a passive surveillance system. Limitations include the potential submission of incomplete, inaccurate, untimely, unverified, or biased data. In addition, the incidence or prevalence of an event cannot be determined from this reporting system alone due to potential under-reporting of events and lack of information about frequency of device use. Because of this, MDRs comprise only one of the FDA’s several important postmarket surveillance data sources. As the researchers applied digital analytics to millions of medical device product reports and recall records for their study, they found a high “signal to noise” ratio correlated with the delays. Not only did these indicators create detection issues, older and widely used devices tended to have multiple adverse event reports in MAUDE, making safety-signal detection difficult.

In 2012, the FDA announced plans to develop a National Evaluation System for Health Technology (NEST) to generate better evidence for regulation and agency decisions throughout the lifespan of a device. Whether the system will provide a better way for both the agency and industry to monitor postmarket safety of medical devices is indeterminate, but the FDA is counting on the system providing more collaboration than the current one.