FDA beefs up testing for duodenoscope cleaning devices

CDRH's William Maisel

Amid growing scrutiny over the FDA's regulation of duodenoscope devices, the agency is calling for more stringent review of machines used to clean the products and companies that make the tools.

As USA Today reports, regulators are asking manufacturers of Automated Endoscope Reprocessors (AERs) to beef up testing for the products to make sure that they thoroughly sanitize scopes between uses. The FDA is also inspecting some companies' manufacturing facilities to make sure production and quality control is up to snuff.

The inspections have already led the agency to cite one AER manufacturer for not meeting its new cleaning standards, according to FDA documents obtained by USA Today. But the agency isn't revealing which companies are taking part in the inspections or what was found at facilities.

"We did ask each of the AER firms to conduct additional testing … (and) to make the testing more challenging," William Maisel, deputy director at the FDA's Center for Devices and Radiological Health, told the news outlet. "The agency considers this an urgent public health matter of great importance, so it is our expectation that all (AER) firms … will respond quickly to our inquiries."

But even as the FDA pushes for more thorough testing of AERs, some medical experts are questioning the agency's response to the recent controversy surrounding the devices. Regulators began probing duodenoscope's contamination last year after superbug outbreaks linked to the devices started surfacing at U.S. hospitals, warning the public that the scope's complex design may impede proper cleaning.

Still, the FDA waited until this past spring to ask AER manufacturers for data showing that their products could clean duodenoscopes effectively, USA Today points out, raising a few eyebrows among those in the industry.

"If the manufacturers (of AERs) didn't have acceptable validation data to prove that these scopes could be reprocessed safely, then it's fair to ask why the FDA hadn't determined this well before these (infection) problems became an issue," Lawrence Muscarella, a Pennsylvania-based healthcare consultant, told the news outlet.

Meanwhile, the FDA continues to crack down on companies producing duodenoscope devices and step up its oversight of the products. Last month, the agency revealed its first set of detailed recommendations for cleaning duodenoscopes. A couple of weeks later, the agency sent warning letters to three companies manufacturing the devices for not reporting problems with the scopes as they turned up or making sure that the devices could be properly cleaned.

But the agency has stopped short of pulling duodenoscopes from the market altogether, maintaining that the devices' benefits "continue to outweigh the risks" in certain patients and that the risk of getting an infection from an improperly cleaned device is low given the amount in use.

- here's the USA Today story