Medical device reporting ended by FDA

WASHINGTON, D.C. — The United States Food and Drug Administration (FDA) finally put an end to summary medical device reporting. According to U.S. Recall News, FDA rules allowed medical device manufacturers to summarily report medical device malfunctions and defects that caused injuries or deaths to patients. The practice known as Alternative Summary Reporting allowed companies to hide defective medical device reports from public view and scrutiny. The FDA approved the practice to continue for decades but will now come to an end.

The FDA receives innumerable complaints every year concerning adverse effects and outcomes from medical devices that are defective or have malfunctioned. Companies must submit a medical device report to the FDA when the company becomes aware of a malfunction that could be related to serious injury or death of a patient using the device, or, if a failure occurred, would lead to the serious injury or death of a patient. Alternative Summary Reporting allowed medical device manufacturers to avoid this seemingly onerous requirement. Additionally, the FDA benefitted from Alternative Summary Reporting because summary reporting reduced the agency’s workload.

Reporting adverse events in a summary fashion to the FDA gave the device makers a lawful method of concealing potentially dangerous defects. The practice kept an unwitting public at bay. The numbers are not trifling. According to U.S. Recall News, the FDA received 1.1 million reports of medical device malfunction or reports of defective medical devices that caused the death or serious injury of a patient since 2016.

Hiding defects allowed medical device makers to avoid litigation to a certain extent. Notwithstanding, medical device manufacturers face numerous lawsuits alleging personal injuries or wrongful death each year. The FDA receives complaints concerning faulty medical devices such as transvaginal surgical mesh, hip implants, knee implants, breast implants, defective defibrillators, surgical robot malfunctions, flawed stents, and blood clot filters, among others.