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Doc Urges Openness About “Superbug” Infections, Fails to Report Cases in Own Hospital

FDA rules encourage secrecy

As “superbug” outbreaks caused alarm across the country last year, Dr. Jeffrey Tokar, director of gastrointestinal endoscopy at Fox Chase Cancer Center in Philadelphia, pointed to recent outbreaks from contaminated medical scopes and discussed steps doctors and hospitals should take to ensure patient safety in a September 2015 article in the Annals of Internal Medicine. What Tokar didn’t mention was that a tainted device at his own cancer center may have infected three patients with drug-resistant bacteria, according to a new report posted on the Kaiser Health News (KHN) website.

In accordance with federal rules, the hospital reported the possibility to the manufacturer, Fujifilm, in May 2015, and the manufacturer filed the information with U.S. regulators. But the public never found out. The information only came to light last month when a U.S. Senate committee unveiled the results of a year-long investigation into scope-related infections that affected nearly 200 patients across the country from 2012 to 2015, including those potential cases at Fox Chase in Philadelphia.

The incident in Philadelphia illustrates a larger problem: a lack of public disclosure when medical devices are suspected of posing a risk to patients, according to KHN.

“This culture of secrecy is not in patients’ best interest,” said Lawrence Muscarella, a hospital-safety consultant in Montgomeryville, Pennsylvania. “Hospitals don’t realize the more transparent they are, the more infection risks would decrease. It looks like important information was missing from this paper” by the Fox Chase doctor.

Tokar, who has identified himself as a paid consultant to the scope manufacturer, didn’t respond to KHN’s requests for comment. A spokeswoman for Fox Chase also declined to answer questions.

Under current federal rules, hospitals must report serious injuries potentially caused by devices to the manufacturer within 10 business days and notify both the manufacturer and the FDA about any suspected device-related deaths. 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.

Fox Chase followed federal rules and notified the scope manufacturer. In response, Fujifilm sent employees to the medical center to learn more, and ultimately the company quarantined the scope.

But the cancer center—and its gastrointestinal endoscopy chief—made no public disclosure of the incident, nor were they legally required to, KHN says. It’s not known whether the three unidentified Fox Chase patients mentioned in the federal injury report were told that a bacteria-laden scope may have caused their antibiotic-resistant infection. The infections can kill up to half of affected patients, although the fate of the three at Fox Chase could not be determined.

The FDA redacts the names of hospitals and other medical facilities from its public database of adverse-event reports. Fox Chase was identified only because the Senate report published additional documents that named the hospitals involved.

Across the country, there is no easy way for the public to learn about where such infections are occurring. In fact, the FDA says it is bound to keep the names of hospitals and other medical providers who report them confidential.

“The Food, Drug, and Cosmetic Act prohibits the public release of the identity of the user facility that submits a medical-device adverse event,” agency spokeswoman Deborah Kotz told KHN.

In October 2015, a month after his article on the scopes, Fujifilm touted Tokar as an industry expert in a company press release and said he was leading a hands-on workshop for doctors at a medical conference in Honolulu where the company also pitched its products, KHN notes.

In 2014, Tokar received $6,366 from Fujifilm for travel and lodging in Tokyo, where the company is based, according to a federal database on industry payments to doctors and teaching hospitals. Temple University Hospital, which is affiliated with Fox Chase, also received $134,697 from Fujifilm that same year for consulting work.

In 2010, Fujifilm announced a five-year research and development deal with Fox Chase for endoscopy products.

Source: Kaiser Health News; February 22, 2016.

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