Medical Device Makers Could Just “Summarize” Malfunction Reports Under Proposed FDA Rule

Federal regulators are considering a plan that would let many medical device manufacturers avoid requirements that they provide detailed reports about adverse events associated with their products, allowing the companies to only provide brief, quarterly summaries instead for the most commonly known problems. 

Public comment closed this week on a proposed rule put forward by the FDA, which would create a program for manufacturer to provide summary reports of some medical device malfunctions. The proposed program is raising concerns that the public would lose transparency into some medical device problems amid complaints that manufacturers already often fail to file fully fleshed out medical device reports (MDRs) and often do so well after the legally required time limit.

The proposed rule, known as the Voluntary Malfunction Summary Reporting Program, was announced in a federal register notice in late December. It follows a pilot initiative the FDA launched in 2015 to test the possibility of quarterly summary reporting for low risk medical devices.

The FDA indicates that the pilot program reduced the volume of reports by more than 87%, but preserved essential information regarding the malfunction event. The FDA says that the summary reports could also be more easily shared publicly and in fact would increase transparency.

“This proposed voluntary program reflects goals for streamlining malfunction reporting outlined in the commitment letter agreed to by FDA and industry and submitted to Congress,” the proposed rule states. “These goals include permitting manufacturers of devices in certain product codes to report malfunctions on a quarterly basis and in a summary format.”

The proposed program has raised concerns by some patient advocates, who say that the program would weaken post-market surveillance of medical devices.

An investigation by the Star Tribune published on February 24 found, for example, that Medtronic was allowed to summarize a study that included more than 1,000 malfunctions linked to its Infuse bone grafting system in just three sentences. The investigation found that Medtronic did not report the study until five years after the legal requirement. When Medtronic, a major medical device manufacturer, was asked why it had not revealed the results of the study in a timely fashion, the company’s officials indicated they had lost the study and only found it again five years later.

FDA officials indicate that the new program will be limited to only those malfunctions that are already known and that do not result in severe injury or death. Full reporting would still be required in cases of new, undocumented malfunctions, as well as those that are likely to cause or contribute to severe injury or death. Those reports would still be required within 30 days of the manufacturer learning of the incident.