FDA Issues New Recommendations For Reprocessing Bronchoscopes to Reduce Infection Risk

Federal regulators have issued an update for healthcare providers about the steps that should be taken to reprocess bronchoscopes, as well as accessories that are used on multiple patients, which may pose a serious infection risk if not properly cleaned.

A safety communication was issued by the FDA on June 25, providing new information about hundreds of adverse event reports involving infections or contamination associated with reprocessed flexible bronchoscopes, which have been received since the agency last warned about the problems in September 2015.

Bronchoscopes are long, thin, flexible lighted tubes that are inserted through the mouth or nose and used to examined the larynx, throat, trachea and lower airways. The FDA estimates that about 500,000 procedures per year in the U.S. involve bronchoscope examinations, and most procedures involve the same instruments that are used on different patients.

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In 2015, the FDA issued a series of recommendations to avoid the risk of bronchoscope infections, indicating at that time that the agency had received at least 109 Medical Device Reports (MDRs) involving infections or device contamination linked to bronchoscopes between January 2010 and June 2015.

According to the latest update, the FDA has received at least 867 new reports involving problems between July 2015 and January 2021, including at least seven deaths.

“Similar to what was reported in 2015, factors contributing to infection included failure to follow manufacturer instructions, or continued use of devices despite integrity, maintenance and mechanical issues,” according to the FDA safety communication.

Among reported brochoscope infections that identified a specific microorganism, the most frequently reported were Mycobacterium, Pseudomonas, Serratia and Klebsiella.

Bronchoscope Infection Risks

Concerns about the risk of infections from contaminated bronchoscopes emerged after drug-resistant superbug emerged at UCLA Medical Center in early 2015, involving problems with duodenoscopes, which are a different type of scope used in endoscopic retrograde cholangiopancreatography (ERCP) procedures.

The FDA began investigating all medical devices requiring extensive sterilization between procedures between patients, known as reprocessing, after determining several infection outbreaks were linked to contaminated scopes, even after hospitals followed the cleaning instructions provided by the device manufacturers.

Poorly reprocessed devices can cause the spread of infections and blood borne diseases from one patient to the next. Following a series of recalls and cleaning instruction updates provided by various manufacturers, there has also been a push toward single-use designs, which can be disposed of, instead of being reprocessed between patients.

In this new FDA safety communication, the agency reiterates a lot of the recommendations made in 2015 about cleaning bronchoscopes. However, much like with duodenoscopes, the FDA now appears to be encouraging the industry to move toward single-use, disposable bronchoscopes to ensure bloodborne diseases are not being transmitted from one patient to another.

Healthcare providers are now encouraged to consider single-use bronchoscope in scenarios where there could be an increased risk of spreading infection to patients, such as when patients have a compromised immune system or prion disease, or when multi-drug resistant microorganisms may be present. The FDA also recommends using single-use devices “when there is no support for immediate reprocessing of the bronchoscope.”

The agency indicates it is continuing to evaluate the situation and urges anyone who believes they have had an infection after a bronchoscopy procedure to file a report with the FDA’s MedWatch reporting program.

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