FDA faults 12 hospitals for failing to disclose injuries, deaths linked to medical devices
Nauss,Karen A (Mount Auburn)
FDA faults 12 hospitals for failing to disclose injuries, deaths linked to medical devices
Federal regulators said 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 Food and Drug Administration publicly disclosed the violations in inspection reports this week amid growing scrutiny of its ability to identify device-related dangers and protect patients from harm.
Some of the reporting lapses were found at Massachusetts General Hospital in Boston, New York-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.
"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," Shuren wrote in an agency blog post this week. "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 must within 10 days report serious injuries potentially caused by devices to the manufacturer and 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 devices within 10 days as required. Five other hospitals didn't report serious injuries in a timely manner, according to the FDA. The inspection at one hospital, New York-Presbyterian, focused only on a death.
It's hard to discern what devices were involved or other details in many of these cases because the inspection reports are brief and partly redacted by the FDA. The inspection reports indicate that in some cases hospitals reported events late and in others not at all.
At Massachusetts General, an FDA investigator found reporting delays of 10 months and 18 months in two separate patient deaths related to devices.
At Huntington Memorial Hospital in Pasadena, CA, an FDA investigator found that a patient died from complications related to a multi-drug resistant infection and cardiac arrest following a procedure involving a duodenoscope, a long and flexible instrument put down a patient's throat.
According to FDA records, the hospital learned through test results that the patient's infection was likely related to 14 other confirmed infections caused by contaminated duodenoscopes.
The FDA 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 across the U.S. from contaminated duodenoscopes. The FDA's oversight of medical devices was also faulted in the report.
As many as 350 patients at 41 medical centers worldwide have been infected or exposed to contaminated duodenoscopes from 2010 to 2015, according to the FDA.
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 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 yet another commonly used device - heater-cooler units used in open-heart surgeries. The FDA is holding a public meeting Dec. 5 on improving hospital-based surveillance of devices.
According to the FDA, the hospitals that didn't report deaths as required were Advocate Lutheran General in Park Ridge, IL; Huntington Memorial Hospital; Reading Hospital and Medical Center in West Reading, PA; Allegheny General Hospital in Pittsburgh; NewYork-Presbyterian; and two in Boston - Brigham and Women's Hospital and Massachusetts General.
The agency said those that failed to report serious injuries in time were UCLA; Cedars-Sinai; Virginia Mason Medical Center in Seattle; UMass Memorial Medical Center in Worcester, MA; and Dartmouth-Hitchcock Medical Center in Lebanon, NH.
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