FDA to Close Its Controversial Medical Device Reporting Program

In what is being called a victory for patients and consumers, the U.S. Food and Drug Administration (FDA) said that it is ending its “alternative summary reporting” program, which allowed medical device manufacturers to conceal reports of harm and malfunctions from the general public.

FDA Principal Deputy Commissioner Amy Abernethy, MD, PhD, and Director of the Center for Devices and Radiological Health Jeff Shuren, MD, announced the decision in a statement on increasing transparency about the safety of breast implants.

The alternative summary reporting was intended “to more efficiently review adverse events [AEs] for well-established risks but was not allowed for patient deaths and unusual, unique, or uncommon AEs,” they explained. In the case of breast implants, those unique events included an increased risk for breast implant–associated anaplastic large cell lymphoma. The program, however, meant that those events were not made available in the FDA’s public database for medical device reports, Manufacturer and User Facility Device Experience (MAUDE).

The alternative summary reporting program, which was established in 1997, was relatively obscure; the general public, forensic medical device experts, “and even a recent FDA commissioner were unaware of its existence,” according to a Kaiser Health News investigation.

An FDA spokesperson told Kaiser Health News that this recent action is a culmination of efforts to improve transparency that began in mid-2017, when the agency revoked reporting exemptions for saline breast implants and intra-aortic balloon pumps. The FDA also announced it is ending alternative summary reporting exemptions for manufacturers of implantable cardiac defibrillators, pacemakers, and tooth implants.

Going forward, medical device manufacturers will be required to file individual reports, describing each case of patient harm related to a medical device, in MAUDE.

Sources: FDA press release, May 2, 2019; Kaiser Health News, May 3, 2019.