Many physicians rely on publicly available reports to assess the safety of the devices they use on patients, but in some cases, these reports aren’t painting the full picture. A recent Kaiser Health News (“KHN”) article raises serious questions about FDA’s practice of allowing a significant number of medical device injury and malfunction reports to stay out of the public eye.
Under FDA’s Medical Device Reporting (“MDR”) regulation (21 CFR part 803), device manufacturers, importers, and device user facilities (which include hospitals, ambulatory surgery centers, nursing homes, and outpatient diagnostic and treatment facilities (but not physician offices)) are required to submit reports of adverse events and product problems to the Agency. Outside of this mandatory reporting structure, FDA also encourages health professionals and patients to submit voluntary reports of significant device adverse events and product problems through MedWatch.
Both mandatory and voluntary adverse event reports dating back to the 1990s are housed in FDA’s publicly-accessible Manufacturer and User Facility Device Experience Database (“MAUDE”), which is updated by the Agency monthly. However, according to FDA’s website, MAUDE may not include reports made according to “exemptions, variances, or alternative reporting requirements granted under 21 CFR 803.19.”
The KHN article examined the scope of such “hidden” reporting channels, which keep certain device injury and malfunction reports from ever seeing the light of day. In fact, according to KHN’s investigation, since 2016, more than one million device incidents have been able to bypass inclusion in the MAUDE database as a result of FDA’s “alternative summary reporting program.”
Under this program, which launched in 2000, device manufacturers have been able to seek an “alternative summary” reporting exemption, permitting them to send FDA an accounting of device injuries and malfunctions on a periodic basis (e.g., quarterly or annually) in lieu of fulfilling their standard public reporting obligations. Initially, only a few devices had been granted reporting exemptions, but today, about 100 devices, from surgical staplers to balloon pumps to mechanical breathing machines, are subject to exemptions. The internal Agency database tied to this program is not open to the public.
FDA has also granted other types of reporting exemptions. For example, pelvic mesh manufacturers have been granted a special “litigation complaint summary reporting” exemption. This allows them to submit a single “injury” report to FDA, but attached to that summary report may be a listing of hundreds of patient injury reports (based on lawsuit allegations). For someone reviewing pelvic mesh injuries in MAUDE, this would look like a single injury, with the underlying detail (and sometimes voluminous) patient injury reports tied to the summary report only being accessible through a Freedom of Information Act request.
According to FDA, for certain devices, alternative summary reporting helps eliminate redundant paperwork for the Agency. But for physicians and patients, many of whom have no awareness of FDA’s “alternative” reporting mechanisms (and thus perceive the publicly available reports as the full universe of available safety information), the lack of transparency is troubling. Where patient care decisions are in the balance, administrative efficiency should not trump the need for full public access to device injury and malfunction information. At the very least, FDA should be completely transparent about the types of reporting exemptions that have been granted, and the specific devices that are subject to exemptions.