Accreditation

Medical devices enter the realm of partisan politics

Accreditation Insider, February 9, 2016

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Duodenoscopes received a lot of publicity in 2015, most of it bad. The final straw was when a Senate committee report linked defective scope designs to 25 infection outbreaks since 2012, 19 of which involved drug-resistant superbugs.

The Food and Drug Administration (FDA) took the brunt of the blame in the Senate report for its handling of the issue. The reports show that while the FDA was aware of the potential risks of dirty scopes, it didn’t warn the public until after a 17-month investigation. By the time the FDA warning was released, there were seven more scope-caused outbreaks, with 68 patients contracting antibiotic-resistant infections.

The report dragged the issue into the public eye and now Democrats and Republicans are both condemning the FDA’s handling of the situation. The Washington Post reports that while both sides agree changes need to be made, they disagree over what needs to be done.

Democrats argue that implementing a bar code system for medical devices would allow hospitals to track what devices are linked to infections or other issues. A similar system is already in place for prescription medications and would be faster and more reliable than the current injury reports system. The Washington Post reports that the bar code program is already being phased in and will cost around $250 million along with new laws requiring hospitals and physicians to include barcode data on insurance claim forms.

Republicans argue that instead of a new system the FDA should simply use the power it already has, noting that the agency already has the (often unused) power to impose civil and criminal penalties against manufacturers for not reporting injuries or deaths.

Robert Califf, the current FDA commissioner nominee, endorsed the idea of a new device tracking system during his confirmation hearing this November. 

“We have plans to do that, but we are going to have to work with you on how to fund it,” Califf told senators during the confirmation. “Imagine with these duodenoscopes, if there had been such a system, we would have seen the problem very early. We could see it independently of industry and act on it much more rapidly.”

You can read the full Senate committee report here, along with some of our previous coverage on duodenoscopes.



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