FDA Ending Controversial ‘Alternative Summary Reporting’ Program for Faulty Medical Devices

For decades, the Food and Drug Administration (FDA) has allowed certain medical device manufacturers including Covidien (now a division of Medtronic) to conceal reports of harm and malfunction from the public eye through what was called an “alternative summary reporting program.” Under this program, certain manufacturers were exempt from filing device-related injury reports through the FDA’s public Manufacturer and User Facility Device Experience (MAUDE) database. Instead, millions of reports on devices that have caused serious harm to patients, including surgical staplers, breast implants, and breathing machines, were filtered through an alternative summary reporting repository and hidden from the public eye.

The 20-year-old program was first revealed to the public in a March 2019 Kaiser Health News investigation, much to the surprise of medical professionals, industry watchdogs, and even former FDA employees. According to the report, deaths must still be reported in the MAUDE database, but exemptions were granted for around 100 medical devices linked to serious injury and malfunction. Over 1.1 million device reports have been collected since 2016.

Following the public outcry of the “secret” reporting database, the FDA announced it would be shuttering the alternative summary reporting program in the coming months. The FDA also stated that it began “winding down” the program in 2017, revoking many of the reporting exemptions it had granted for breast implants and balloon pumps. Still, Kaiser Health News reports that the FDA still accepted hundreds of thousands of injury reports during the period the FDA was shuttering the program.

In addition to ending the program, the FDA has committed to publicly releasing data from the alternative summary reports filed before mid-2017.  The FDA will still allow exemptions for devices that are the subject of mass litigation, or when a company submits reports from independent device-tracking registries.

While it’s certainly a victory for patients and consumers, one can’t help but wonder how many lives were lost or permanently harmed due to faulty medical devices that could have been avoided if only doctors had full access to the reporting data.

I suppose we’ll have a better idea once the FDA releases the reports.