Throughout this week, the FDA released inspection reports that claimed 12 U.S. hospitals did not promptly report patient deaths or injuries associated with medical devices, according to Kaiser Health News.
Here are six things to know:
1. Jeffrey Shaun, MD, JD, director of the FDA's Center for Devices and Radiological Health, said the report speaks to a larger, nationwide problem of hospitals failing to report patient harm incidents linked to medical devices. Dr. Shaun said the cited hospitals "are not unique" and that many of the hospitals' staff members were not equipped with the necessary training or were not aware of all the FDA's reporting requirements for medical devices.
2. Federal requirements mandate hospitals report serious injuries that medical devices possibly caused to the manufacturers within 10 days. The requirements also require hospitals to report such incidents to both the manufacturer and the FDA about any fatalities resulting from the devices. Manufacturers then have to file reports to the FDA within 30 days of being made aware of the injury or death.
3. Of the 17 hospitals the agency reviewed, the FDA found six hospitals failed to properly report patient deaths linked to devices within 10 days, and five other hospitals did not promptly report serious injuries.
4. The agency listed the following hospitals in the report for failing to report patient deaths as required:
• Advocate Lutheran General in Park Ridge, Ill.
• Huntington Memorial Hospital in Pasadena, Calif.
• Reading Hospital and Medical Center in West Reading, Pa.
• Allegheny General Hospital in Pittsburgh
• NewYork-Presbyterian in New York City
• Brigham and Women's Hospital in Boston
• Massachusetts General in Boston
5. The agency said those that failed to report serious injuries in time were:
• UCLA
• Cedars-Sinai in Los Angeles
• Virginia Mason Medical Center in Seattle
• UMass Memorial Medical Center in Worcester
• Dartmouth-Hitchcock Medical Center in Lebanon, N.H.
6. KHN reported many of the hospitals cited in the report supported the FDA's feedback and were receptive to efforts to improve device oversight.
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