During the period in which the database was hidden from consumers, device manufacturers were able to report defects and injuries to the FDA without releasing the information publicly. The FDA does have a public database (the Manufacturer and User Facility Device Experience, or MAUDE) that patients and doctors are able to view, but manufacturers were allowed exemptions to avoid the public database, instead reporting incidents to the confidential system.
The secrecy of the confidential database — known as “alternative summary reporting” — left countless patients and medical professionals without crucial information. Unknowingly, doctors provided dangerous devices to patients and contributed to injuries. Fatalities, allegedly, were required to be reported to the public database, but Kaiser Health News stated that 176 deaths were included in the alternative summary reporting system.
The Voluntary Summary Reporting Program — A New System?
The FDA established the “voluntary summary reporting program” in 2017 to as a reformed version of the alternative summary reporting system. However, this “change” in processes does not appear to solve the issue of confidential incident reporting. Approximately 87% of medical devices will qualify for the use of the voluntary summary reporting program. “Patient advocates say they fear that these will be just as difficult to tally and track,” says Kaiser.
The newly-released database uncovers a culture of secrecy that exists within regulatory agencies. Organizations that are supposed to protect consumers are endangering patients by hiding crucial information on dangerous medical devices. If you or a loved one suffered from an injury that was caused by a defective device or hazardous drug, contact Brown & Barron, LLC.