Kochman said those rules also are beneficial because it often takes time to determine what sickened patients, and immediate public scrutiny could do more harm than good.
“Confidentiality encourages reporting,” said Kochman, chairman of the American Gastroenterological Association’s Center for GI Innovation and Technology. “There are early warning signals but one has to be careful not to scare the public. Within 30 days of an event, it may not be known if an infection was truly related to a device.”
The medical detective work involved in these cases can be complicated. Some hospital officials told Senate investigators they didn’t see a need to report their superbug infections to manufacturers until they were conclusively linked to the scopes.
But the Senate report said hospitals were applying too high a standard and waiting too long to share important details.
The investigation, launched by Sen. Patty Murray, D-Wash., after superbug outbreaks in Seattle, Pittsburgh and Los Angeles, also faulted manufacturers for failing to fully comply with federal reporting requirements.
Asked about the Fox Chase incident, a spokeswoman for Fujifilm declined to comment on the hospital or the company’s report to the FDA.
“We are committed to working together with all stakeholders, including hospitals, regulators and lawmakers, to ensure the long-term sustainable use of duodenoscopes,” the company said in a statement.
Tokar and Fox Chase have worked closely with Fujifilm for years.
In October, 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.
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. The company hailed its partnership with “one of the most prominent cancer prevention and treatment facilities in the United States.”
Academic medical centers say patients benefit from these industry ties because they can lead to medical breakthroughs. But critics say it can create conflicts of interest and make hospitals hesitant to share information that reflects poorly on an industry partner.
Consumer advocate Helen Haskell, founder of Mothers Against Medical Error in Columbia, South Carolina, said patients deserve to know all the available facts so they can make an informed decision on where to seek care.
Haskell also said outside pressure is necessary to force hospitals to tackle problems more urgently.
“Patients could be walking into a potentially fatal situation,” she said. “It’s time for everything to be on the table.”
By Chad Terhune, Kaiser Health News