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FDA Faults Hospitals For Failing To Report Safety Problems With Medical Devices

After several prominent safety problems with medical devices in hospitals emerged, the Food and Drug Administration inspected 17 hospitals across the country in late 2015 to assess their compliance with reporting regulations.
Congressional Quarterly
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After several prominent safety problems with medical devices in hospitals emerged, the Food and Drug Administration inspected 17 hospitals across the country in late 2015 to assess their compliance with reporting regulations.

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 — 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 Monday in an agency blog post. "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 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. For the most serious problems that would require immediate action to prevent major public health harm, companies have five days to report them to FDA.

It's hard to discern from the FDA inspections which devices were involved or other details in many cases because the reports released publicly are brief and partly redacted by the FDA. The reports indicate that in some cases hospitals reported events late and in others not at all.

At Massachusetts General, FDA investigators found reporting delays of 10 months and 18 months in two separate patient deaths related to devices.

In a statement, hospital spokeswoman Terri Ogan said the FDA's findings all have been addressed. "Massachusetts General Hospital takes its reporting obligations very seriously and strives to comply with all requirements in a comprehensive and timely manner," she said.

At Huntington Memorial Hospital in Pasadena, Calif., an FDA investigator found that a patient died from complications related to a multidrug-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. "However, this death was not reported to the FDA and the manufacturer by your facility," the FDA inspector wrote in a December 2015 report.

A spokeswoman for Huntington Hospital, Eileen Neuwirth, said, "We have taken steps to ensure rigorous compliance going forward."

Many of the hospitals involved — such as Cedars-Sinai — said they welcomed the agency's feedback and supported efforts to improve device oversight, but some disputed them or offered explanations.

New York-Presbyterian said in a statement that it filed medical device reports "in accordance with FDA regulations" and none of the agency's findings related to the quality or safety of patient care. Also in a statement, UCLA said it promptly reported scope-related cases to the FDA but that the agency asked for duplicate reports through a separate system.

The findings underscore concerns raised by a 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.

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 by then for spotty oversight of duodenoscope manufacturers and other devices.

Shuren said in his blog post that the agency focused on 17 hospitals where safety issues had occurred involving either duodenoscopes or power morcellators, a surgical tool used in hysterectomies. Morcellators are used to cut up benign growths called fibroids, but the FDA has warned about the device spreading cancerous tissue in the abdomen and pelvis. The investigators examined incidents involving other devices as well.

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.

"We feel certain there is a better way to work with hospitals to get the real-world information we need, and we should work with the hospital community to find that right path," Shuren wrote.

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 so-called 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.

Kaiser Health News is a national health policy news service that is part of the nonpartisan Henry J. Kaiser Family Foundation. You can follow Chad Terhune on Twitter: @chadterhune.

Copyright 2023 Kaiser Health News. To see more, visit Kaiser Health News.

Chad Terhune