FDA faults 12 hospitals for failing to disclose injuries, deaths linked to medical devices

Some of the reporting lapses were found at Massachusetts General Hospital in Boston, NewYork-Presbyterian Hospital and two hospitals in Los Angeles — the Ronald Reagan UCLA Medical Center and Cedars-Sinai Medical Center. Dr. Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health, said the violations pointed to a larger problem among hospitals nationwide in reporting patient harm tied to medical devices.