FDA Guidance Looks to Single-Use Bronchoscopes

Patient Safety

Webinar: FDA Safety Communication Explained

“In many instances the reprocessing personnel are following the exact steps they were told to by the manufacturer,. The system has innately set them up for failure."

For the first time, the U.S. Food and Drug Administration (FDA) has recommended providers use single-use bronchoscopes in select cases.

This was in addition to a recommendation that sterilization replace high-level disinfection during flexible bronchoscope reprocessing, given its greater safety margin.

“Our end game is to get to a completely safe device for that patient so that there’s no risk that’s not necessary, in the equation,” said Dr. Hudson Garrett Jr., an expert in infection prevention, in a recent webinar sponsored by Ambu.

Garrett’s webinar outlined the latest safety communication on reusable bronchoscopes from the FDA — released on June 25, 2021 — and explored how facilities could implement new recommendations in practice.

Garrett, who has long advocated incorporating lessons learned from infections related to other endoscopes into the study of bronchoscopes, is an adjunct assistant professor of medicine in the Division of Infectious Diseases at the University of Louisville School of Medicine. He also is co-founder of the nonprofit Infection Prevention Institute which disseminates best practices of infection prevention and control across healthcare globally.

In those cases of increased risk of infection, along with COVID patients, the FDA is recommending that healthcare providers consider single-use bronchoscopes. Single-use is also recommended when there is no immediate support for reprocessing.

While the risk of device-related infection is considered to be rare, the latest FDA safety communication updated years of investigation into medical device reports (MDRs) related to bronchoscope-associated infection. The agency collected 867 MDRs between July 2015 and January 2021, an almost eightfold increase compared with the 109 bronchoscope-related MDRs from January 2010 to June 2015.

A full transition to single-use bronchoscopes avoids the need for an expensive upgrade to sterilization from high-level disinfection. But, he noted, any disinfecting process is only as good as the initial cleaning.

“Reprocessing is sort of a flawed process in general, whether that’s due to personnel issues, the device itself, the equipment that’s used within that process — there’s lots of different ways that this process can sort of go off the tracks,” Garrett said.

Failures in reprocessing are not an attack on the personnel involved, he added.

“In many instances the reprocessing personnel are following the exact steps they were told to by the manufacturer,” Garrett said. “The system has innately set them up for failure. The more that we can do to eliminate human variability in this equation, the better off we’ll be at reducing overall risk of infection and cross-contamination.”

The FDA also recently announced new investigations into numerous MDRs related to urological endoscopes. In a letter to healthcare providers on April 1, the agency disclosed the reports being investigated include patient infections and three device-related patient deaths outside of the U.S.

In August 2019, the FDA recommended duodenoscope manufacturers and healthcare facilities transition to partially or fully disposable duodenoscopes. Investigations into device-related infection in endoscopic retrograde cholangiopancreatography (ERCP), the procedure duodenoscopes are used for, began in 2015.

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