FDA Ending Program that Let Companies Hide Injury Reports

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Secure Medical Records

The U.S. Food and Drug Administration is shutting down a program that allowed medical device manufacturers to hide millions of reported patient injuries or device malfunctions. The agency did not give an exact date for a complete shutdown but said, in a May 2, 2019 statement, it would apply immediately to breast implant manufacturers.

“This is part of a larger effort to end the alternative summary reporting program for all medical devices, which we intend to complete in the coming weeks,” the agency said.

The FDA called the move “an effort to promote greater public transparency.”

Manufacturers are usually required to notify the FDA of each individual malfunction or injury related to a specific device in a separate report to the agency. These are called adverse event reports and are searchable by the general public in the agency’s MAUDE database.

But the alternative summary program let companies bundle dozens or even hundreds of similar adverse events into a single quarterly report. Once those reports were sent to the FDA, only certain people at the agency could access them. The reports were effectively hidden from doctors, patients and other members of the general public who might benefit from knowing about recurring problems with a particular medical device.

Millions of Medical Device Failures Hidden from Public

Roughly 1 million device malfunctions and 994,000 patient injuries reported between 2014 and the first nine months of 2018 were part of the hidden database, according to a March 2019 investigation by Kaiser Health News. But the database also contains other reports filed since the program began in 1997.

In the searchable MAUDE database, people are able to find 84 reports of injuries or malfunctions involving Covidien surgical staplers in 2016. But according to Kaiser, nearly 10,000 additional cases were reported to the hidden database that same year.

The FDA allowed roughly 100 medical devices an exemption under the program.

The agency says that all reports within the program since 2017 are now available to the public through the MAUDE database. But 20 years of information before then may remain hidden until the program is shut down.

FDA Allowed Other Ways to Hide Problem Reports

Other U.S. Food and Drug Administration exemptions allow medical device makers to compile long lists of patient deaths into a spreadsheet as part of the agency’s “registry exemption.” These apply to deaths reported in private registries set up by medical societies to track patients. Though companies are supposed to file individual reports of patient deaths related to their devices, this exemption may allow manufacturers to get by with turning in less information than if they file individual reports.

One registry report to the FDA for a heart valve summarized 297 deaths related to the device, but provided no information on the specifics of each death.

Litigation Complaint Summary Reporting

Another exemption the FDA gives to device makers is called “litigation complaint summary reporting.” It applies to patient injuries cited in lawsuits. The exemption allows companies to combine several reports of patient injuries into a single spreadsheet.

Kaiser Health News reported in March 2019, that as many as 1,175 injuries have been summed up in a single report using this system. To someone without knowledge of the program, it can look like those were just a single injury associated with the device.

In 2017 alone, eight companies reportedly used the exemption to report 12,000 injuries identified in transvaginal mesh lawsuits to the FDA, according to Kaiser.

The maker of the robotic da Vinci Surgical System also used the exemption to turn in a single report of 1,406 patient injuries related to the device between 2004 and 2014.

Retrospective Summary Reporting

Companies are required to file adverse event reports within 30 days of receiving word of a problem with their devices. But retrospective summary reporting allows manufacturers to again bundle similar reports if they become aware of them after the 30-day deadline.

The Minneapolis Star Tribune reported that the FDA had received 300,000 of these overdue reports from at least 24 medical device makers as of late 2016. These records are not simply hidden, but require a Freedom of Information Act request to access.

The FDA has considered some of the problems reported under this exemption to be company secrets that it shouldn’t share with the public.

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Terry Turner
Written By Terry Turner Writer

Terry Turner has been writing articles and producing news broadcasts for more than 25 years. He covers FDA policy, proton pump inhibitors, and medical devices such as hernia mesh, IVC filters, and hip and knee implants. An Emmy-winning journalist, he has reported on health and medical policy issues before Congress, the FDA and other federal agencies. Some of his qualifications include:

  • American Medical Writers Association (AMWA) and The Alliance of Professional Health Advocates member
  • Centers for Disease Control and Prevention Health Literacy certificates
  • Original works published or cited in Washington Examiner, MedPage Today and The New York Times
  • Appeared as an expert panelist on hernia mesh lawsuits on the BBC
Edited By

7 Cited Research Articles

  1. Jewett, C. (2019, May 3). FDA to End Program that Hid Millions of Reports on Faulty Medical Devices. Kaiser Health News. Retrieved from https://khn.org/news/fda-to-end-program-that-hid-millions-of-reports-on-faulty-medical-devices/
  2. Brennan, Z. (2019, May 3). FDA to End Alternative Summary Reporting for Devices. Regulatory Focus. Retrieved from https://www.raps.org/news-and-articles/news-articles/2019/5/fda-to-end-alternative-summary-reporting-for-devic
  3. Carlson, J. and Spencer, J. (2016, October 16). FDA Rules Allow Medical Device Makers to Keep Injuries Under Wraps. Minneapolis Star Tribune. Retrieved from http://www.startribune.com/fda-protocols-allow-medical-device-makers-to-keep-adverse-events-out-of-view/397256291/
  4. Jewett, C. (2019, March 27). Device-Safety Experts to FDA: Make Data Public. Kaiser Health News and Tampa Bay Times. Retrieved from https://khn.org/news/device-safety-experts-to-fda-make-data-public/
  5. Jewett, C. (2019, March 7). Hidden FDA Reports Detail Harm Caused by Scores of Medical Devices. Kaiser Health News. Retrieved from https://khn.org/news/hidden-fda-database-medical-device-injuries-malfunctions/
  6. U.S. Food and Drug Administration. (2014, February 27). MAUDE Adverse Event Report: Intuitive Surgical, Inc. da Vinci Surgical System Endoscopic Instrument Control System. Retrieved from https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/Detail.cfm?MDRFOI__ID=3651923
  7. U.S. Food and Drug Administration. (2019, May 2). Statement from FDA Principal Deputy Commissioner Amy Abernethy, M.D., Ph.D., and Jeff Shuren, M.D., J.D., Director of the FDA’s Center for Devices and Radiological Health on FDA’s New Efforts to Protect Women’s Health and Help to Ensure the Safety of Breast Implants. Retrieved from https://www.fda.gov/news-events/press-announcements/statement-fda-principal-deputy-commissioner-amy-abernethy-md-phd-and-jeff-shuren-md-jd-director-fdas
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