FDA Updates Recommendations on Reprocessing of Flexible Bronchoscopes

By A.J. Plunkett

Be aware that the FDA has issued new guidance on reprocessing flexible bronchoscopes that recommends using disposable versions of the device if there is increased risk of spreading infection or when reusable versions cannot be reprocessed.

Most of the recommendations, issued in 2015, remain the same.

However, in the June 25 update, the FDA notes it is providing the following new recommendations:

  • Consider “using a single-use bronchoscope in situations where there is increased risk of spreading infection (for example, multidrug resistant microorganisms, immunocompromised patients, or patients with prion disease) or when there is no support for immediate reprocessing of the bronchoscope.”
  • And “when treating patients with the 2019 coronavirus (COVID-19), refer to recent recommendations from the American Association for Bronchology & Interventional Pulmonology (AABIP).”

Remember that instruments used on patients with infectious prion diseases like Creutzfeldt-Jakob Disease (CJD) require special cleaning and handling, so dispose of those single-use bronchoscopes carefully.

Under recommendations from the CDC on infection control related to CJD, the agency recommends that “all disposable instruments, materials, and wastes that come in contact with high infectivity tissues (brain, spinal cord, and eyes) and low infectivity tissues (cerebrospinal fluid, kidneys, liver, lungs, lymph nodes, spleen, and placenta) of suspected or confirmed TSE patients should be disposed of by incineration.”

Meanwhile, the CDC notes that “surfaces and heat-sensitive re-usable instruments that come in contact with high infectivity and low infectivity tissues should be decontaminated by flooding with or soaking in 2N NaOH or undiluted sodium hypochlorite for 1 hour and rinsed with water.” CDC also adds the caution that “sodium hypochlorite may be corrosive to some instruments.”

A.J. Plunkett is editor of Inside Accreditation & Quality, an HCPro publication.