FDA disclosed the violations this week amid growing criticism of its ability to identify such problems and protect patients from device-related harm.
Lapses were found at Massachusetts General Hospital in Boston, NewYork-Presbyterian in New York City, as well as the Ronald Reagan UCLA Medical Center and Cedars-Sinai in Los Angeles.
“We believe that these hospitals are not unique in that there is limited to no reporting to FDA or to the manufacturers at some hospitals,” said Jeffrey Shuren, MD, director of the FDA’s Center for Devices and Radiological Health. “Hospital staff often were not aware of, nor trained to comply with, all of the FDA’s medical device reporting requirements.”
Federal law requires hospitals to report serious injuries associated with medical devices to the manufacturer within 10 days, and notify both the device maker and the FDA about any deaths that occur as a result. Manufacturers must submit reports to the agency within 30 days of learning about an injury or death linked to a device.
Of the 17 medical facilities reviewed, FDA said six failed to report both patient deaths and injuries linked to devices within the 10 day deadline. Five other hospitals didn’t report serious injuries within the specified timeframe, according the FDA.
An inspection at NewYork-Presbyterian focused on a patient death. The hospital said it filed medical device reports “in accordance with FDA regulations,” and that the agency found no violations related to the quality or safety of patient care.
It’s unclear which devices were involved in many cases because inspection reports are brief and have been partially redacted by the FDA. Inspectors found that in some cases hospitals reported adverse events late, and in others they were not reported at all.
At Massachusetts General, the investigation found reporting delays of 10 months and 18 months in two separate patient deaths associated with medical devices. A hospital spokesperson said that all the FDA’s findings have been addressed since the report.
At Huntington Memorial Hospital in Pasadena, Calif., FDA found that a patient died from complications linked to an antibiotic-resistant superbug infection involving a contaminated duodenoscope. The hospital later determined that the patient’s infection was likely related to 14 other infections caused by duodenoscopes. However, the death was never reported to the FDA or the manufacturer, according to the inspector.
Lawmakers and health policy experts have proposed new reforms aimed at increasing medical device surveillance, including monitoring insurance claims data and automating adverse event reporting through electronic health records.
The issue may take on more urgency after federal authorities found an infection risk with yet another medical device — heater cooler units used during open-heart surgeries. FDA is holding a public meeting Dec. 5 to discuss how to improve hospital-based surveillance of the devices.