Hospitals, CMS rail against update to FDA device safety reports amid duodenoscope pushback

Olympus TJF-Q180V Duodenoscope--Courtesy of Olympus Australia

Last month, senators pointed to problems with duodenoscopes linked to superbug outbreaks and partly blamed an outdated FDA reporting system for not adequately monitoring the devices' safety. The lawmakers want to give the system a facelift, but they could face obstacles from hospitals and Medicare officials who are railing against some of the proposed changes.

An updated FDA device safety reporting system would require certain products to have a number to make them easier to track. But a trade group of U.S. hospitals and Medicare directors are speaking out against a part of the plan that would add a line to a standard insurance claim so the numbers can be recorded by insurers, The Los Angeles Times reports.

The groups and officials are pointing to potential problems with cost and infrastructure. "Hospital internal billing systems do not currently exist to accommodate" the device number, senior director of the American Hospital Association George Arges said, as quoted by the LA Times. "Who will pay providers for undertaking such changes?"

Medicare directors are singing a similar tune. Last year, Marilyn Tavenner, the administrator of the Centers for Medicare and Medicaid Services (CMS), wrote a letter to two senators saying that including the device number on the claims "would entail significant technological challenges, costs and risks to normal claims processing for Medicare and other payers," Tavenner said, as quoted by the LA Times.

But supporters of the new system, including health insurer Aetna and the AARP, are countering those claims. Including a device number on insurance claims would eventually save the healthcare system money by helping weed out devices that cause injuries, the groups argue. Sen. Patty Murray (D-WA), who led the Senate probe into superbug outbreaks, is also pushing for an updated system, calling on Congress last month to require that device numbers be included in insurance claims.

Sen. Patty Murray (D-WA)

In January, Democratic staff of the Senate Committee on Health, Education, Labor and Pensions released a report showing that 25 superbug outbreaks, including two widely publicized ones in Los Angeles, were associated with duodenoscope devices. Senators came down on Olympus, the largest maker of the devices, for sweeping early reports of problems with the devices under the rug and for blaming hospitals for the issues instead.

The group also chastised the FDA for wasting "valuable time" in dealing with the situation. At least 141 patients across the U.S. were infected between the time the FDA first said that it would investigate the scopes and its warning to the public last year.

"Patients should be able to trust that the devices they need for treatment are safe and effective," Sen. Patty Murray (D-WA), said last month. "Unfortunately this investigation makes clear that current policies for monitoring medical device safety put patients at risk, and in this case, allowed tragedies to occur that could have, and should have, been prevented."

Still, the FDA is standing by its response to recent outbreaks. Regulators are working on recommendations laid out in the recent Senate report, FDA spokeswoman Deborah Kotz told the LA Times. And the agency "is committed to establishing a national medical device evaluation system that leverages real-world evidence to help us more quickly identify safety signals," Kotz said.

- read the LA Times story

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