Physician negligence may cause a surgical or other fatal medical error. Malfunctioning medical devices can also play a large role in medical malpractice. However, a recent report shows that the US Food and Drug Administration grants exemptions allowing them to file reports on faulty equipment in a database that is hidden from doctors and researchers.
Kaiser Health News found that at least 1.1 million incidents over defective medical equipment went into an internal FDA alternative summary reporting repository instead of being individually listed in a widely-scrutinized MAUDE public database. Medical experts relied on this database to identify issues that may place patients into danger.
Deaths must be reported to the MAUDE system. However, the undisclosed database has included reports of serious injury and malfunctions for approximately 100 devices. The included surgical staplers, balloon pumps inserted into vessels for improving circulation and mechanical breathing machines.
During this information blackout, patients have been injured. Injuries occurred hundreds of times in some cases.
The FDA also began another obscure process for device manufacturers to report thousands of injuries that were disclosed in lawsuits or deaths appearing in private registries that medical societies use to follow patients. These exemptions have involved pelvic mesh devices implanted into the heart and other risky and controversial devices. In 2017, over 480,000 injuries or malfunctions were reported through this program.
The FDA has recently pushed for more transparency. Most exemptions for public reporting were revoked and single placeholder reports listing numerous injuries must be filed publicly.
Over a million reports of malfunctions or injuries for about 15 years are still in a database that is accessible only to the FDA. The public may locate a public report and file a Freedom of Information request to obtain information about incidents. Responses may take up to two years.
Lack of disclosure has kept important information from surgeons and researchers. For example, there were 84 reports of stapler injuries or malfunctions that were openly submitted. But almost 10,000 malfunction reports were contained in the FDA’s hidden database.
Victims of malpractice or defective equipment may be entitled to compensation. An attorney can help locate evidence and pursue a lawsuit.