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Bronchoscope Infection Warning Issued by FDA

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September 17, 2015 — After receiving 109 reports of dirty bronchoscopes, the FDA has issued a Safety Communication to raise awareness about the risk of disease transmission.

A bronchoscope is a long, flexible tube with a light and a camera on the tip. It is used by doctors to look down a patient’s throat and diagnose diseases in the airway, lungs, or lymph nodes.

After each procedure, bronchoscopes must be meticulously cleaned before they can be used on another patient. As medical technology has advanced, cleaning has become more complex.

The FDA is concerned about bronchoscopes because they have received 109 reports of contamination since 2005, with 50 of those reports received in 2014. Some reports describe scopes that remained contaminated even after they were cleaned following the manufacturer’s instructions.

According to the FDA, bronchoscopes must be physically scrubbed clean before they are disinfected and sterilized. Scopes that have cracks or scratches where bacteria can hide should not be used.

For patients, the FDA recommended:

“For most patients, the benefits of undergoing bronchoscopy outweigh the risk of infection. … You should call your doctor if, following your procedure, you have symptoms such as fever, pain, nausea and vomiting, that may be a sign of a more serious problem.”

This year, the FDA has issued several warnings about endoscopes after deadly outbreaks of antibiotic-resistant infections. Many of those infections were transmitted on scopes that lacked clearance from the FDA and had remained on the market despite little proof that the manufacturer’s cleaning instructions actually worked.

 

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