FDA faulty devices

The U.S. Food and Drug Administration is ending its decades-long practice of allowing medical device makers to conceal millions of reports of harm and malfunctions from public review. — Andrew Harnik, Associated Press

The U.S. Food and Drug Administration is shutting down its controversial “alternative summary reporting” program and ending its decades-long practice of allowing medical device makers to conceal millions of reports of harm and malfunctions from the general public.

The agency said recently it would open past records to the public within weeks.

A Kaiser Health News investigation in March revealed that the obscure program was vast, collecting 1.1 million reports since 2016. The nearly 20-year-old program was so little-known that forensic medical device experts and even a recent FDA commissioner were unaware of its existence.

Former FDA official Dr. S. Lori Brown said ending the program now is a “victory for patients and consumers.”

“The No. 1 job of the FDA — it shouldn’t be ‘buyer beware’ — is to have the information available to people so they can have information about the devices they are going to put in their body,” Brown said.

Dr. Amy Abernethy, the agency’s principal deputy commissioner, and Dr. Jeff Shuren, the device center director, announced the decision to terminate the program in a statement on increasing transparency about the safety of breast implants.

The agency has for years allowed makers of breast implants to report hundreds of thousands of injuries and malfunctions out of the public eye, federal records show.

“We believe these steps for more transparent medical device reports will contribute to greater public awareness of breast implant adverse events,” Abernethy and Shuren said the statement. “This is part of a larger effort to end the alternative summary reporting program for all medical devices.”

FDA spokeswoman Angela Stark said the agency would also end “alternative summary reporting” exemptions still in place for makers of implantable cardiac defibrillators, pacemakers and tooth implants. The agency had began winding down the program in mid-2017, revoking many reporting exemptions, including those for saline breast implants and for balloon pumps used inside patients’ blood vessels.

At that point, the agency required device makers with ongoing exemptions to file quarterly reports in its public device-harm database known as MAUDE, short for the Manufacturer and User Facility Device Experience.

Still, FDA data provided to KHN show that during the first nine months of 2018 the FDA continued to accept more than 190,000 injury reports and 45,000 malfunction reports under the hidden “alternative summary reporting” program.

Ronni Solomon, vice president and chief policy officer of the ECRI Institute, which studies device safety, says the staff uses the FDA’s open data on a daily basis to look for signals that may show heightened risks with a particular device.

“We think it’s really vital for the sake of transparency, for the sake of policy, for sake of science,” she said. “We’re really glad to see this, the sooner the better.”

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

The FDA has not said it will stop allowing device makers to file other types of device-harm exemption reports that are withheld from the public, such as when there is mass litigation over a device or when a company is submitting reports from an independent device-tracking registry. Nor has a plan been announced to open those records, which contain reports of harm related to pelvic mesh and surgical robots and reports of deaths related to several cardiac devices.

The FDA will leave in place a newer summary-reporting program that allows makers of more than 5,500 types of devices to send the agency spreadsheets logging device malfunctions. Unlike the “alternative summary reporting” program, device makers will not be allowed to report serious injuries using that approach.

— Black Voice News

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