Kaiser Health News issued an alarming report this week that revealed a FDA program and set of policies that allow dozens of device manufacturers to avoid public scrutiny of serious injury risks from their products. This covert program includes Davinci surgical robot incidents, pelvic mesh problems, heart device issues, and surgical staplers, and it encompasses both serious injury and death “summary” reports filed quietly with the FDA, and not reported in its public MAUDE (Manufacturer And User Device Experience) database.
Doctors, patient safety advocates, and public policy researchers rely on the transparency provided by the FDA public safety reports MAUDE database to do their jobs and to help determine the risks of particular devices and procedures, and there was no indication for nearly any of those devices that there were other problems with these health devices, leading to further injuries and deaths for many patients. Those device makers’ representatives would then misrepresent the effectiveness and safety of their products to doctors to induce more sales of products with hidden safety problems.
Within a day of the report, the FDA announced that it would review the issue surrounding surgical staplers, but not overhaul the entire secret program, which is necessary to allow doctors and patients to make informed decisions about what is best for each patient in their circumstances.
The relevant articles are below: