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FDA Faults Hospitals for Failing to Disclose Injuries, Deaths Linked to Medical Devices
The FDA has reported that 12 U.S. hospitals, including well-known medical centers in Los Angeles, Boston, and New York, failed to promptly report patient deaths or injuries linked to medical devices. The agency publicly disclosed the violations amid growing scrutiny of its ability to identify device-related dangers and to protect patients from harm, according to an article on the Kaiser Health News website.
Some of the reporting lapses were found at Massachusetts General Hospital in Boston, at New York–Presbyterian Hospital, and at two hospitals in Los Angeles—the Ronald Reagan UCLA Medical Center and the 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 associated with medical devices.
“We believe that these hospitals are not unique in that there is limited to no reporting to the FDA or to the manufacturers at some hospitals,” Shuren wrote in an agency blog report. “Hospital staff often were not aware of, nor trained to comply with, all of the FDA’s medical device reporting requirements.”
Under federal rules, hospitals have 10 days to report serious device-related injuries to the device’s manufacturer and to notify both the manufacturer and the FDA about any deaths that may have resulted. Manufacturers are required to file reports to the FDA within 30 days of learning about an injury or death that may have been caused by a device.
Among the 17 hospitals reviewed, the FDA said six didn’t properly report both patient deaths and injuries linked to medical devices within 10 days, as required. Five other hospitals didn’t report serious injuries in a timely manner, according to the agency.
The FDA’s findings underscore concerns raised by a U.S. Senate report in January, which exposed reporting failures by hospitals as well as mistakes by device makers that contributed to multiple “superbug” outbreaks in the U.S. from contaminated duodenoscopes. The FDA’s oversight of medical devices was also faulted in the report.
The agency initiated its investigation of hospitals’ reporting in December 2015, a month before the Senate report was released. But the agency was already under fire for lax oversight of manufacturers of duodenoscopes and other devices.
Shuren said in his blog post that the FDA focused on hospitals where safety issues involved either a duodenoscope or a power morcellator (a surgical tool used in hysterectomies). The FDA has warned that morcellators may spread cancerous tissue in the abdomen and pelvis.
Other than publicly announcing the violations, Shuren said the agency didn’t plan on taking further action against the hospitals. Instead, he said he wants to work with the hospital industry to improve the monitoring of devices.
Lawmakers, health policy experts, and the FDA have proposed various reforms aimed at strengthening device surveillance, including tracking insurance-claims data to supplement the injury reports and automating adverse-event reports through electronic health records.
The issue may take on more urgency after federal authorities this month highlighted the infection risk from heater-cooler units used in open-heart surgery.
On December 5, the FDA will hold a public meeting on improving hospital-based device surveillance.
Source: Kaiser Health News; October 28, 2016.