September 17, 2015 — The FDA has issued a Safety Warning about the risk of disease-transmission on bronchoscopes that are not adequately cleaned between uses.
Bronchoscopes are a type of endoscope — a long, flexible tube with a light and a camera on the end — that doctors use to look into a patient’s throat or lungs.
Between January 2010 and June 2015, the FDA received 109 reports of contamination associated with bronchoscopes. The number of reports is low compared to how many procedures are performed every year. However, the FDA is concerned because 50 of those reports were submitted last year.
Some of those reports described bronchoscopes that remained contaminated even after following the manufacturer’s cleaning instructions.
After analyzing the reports, the FDA emphasized the importance of meticulous manual cleaning before it is disinfected or sterilized. The agency also warned against using worn-out scopes with cracks, scratches, persistent kinks, and other issues. The agency also made recommendations for patients:
“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.”
The FDA has been on high-alert about hard-to-clean medical scopes after several deadly outbreaks of antibiotic-resistant infections were transmitted on dirty duodenoscopes.
Most of those infections were traced to scopes that were on the market with little proof the cleaning instructions or tools were adequate. One scope made by Olympus Corp. had been on the market since 2010 without clearance from the FDA.