The FDA is raising red flags about bronchoscope devices used in throat or airway procedures, pointing to infections linked to products that are not cleaned properly.
The agency said in a safety notice that it has been looking into the issue, sifting through 109 Medical Device Reports (MDRs) received between January 2010 and June 2015 about infections or contamination associated with flexible bronchoscopes. That number is still small compared with the number of procedures performed with the devices each year in the U.S., the FDA said in its notice.
But in 2014, regulators received 50 MDRs that mentioned infections or device contamination associated with flexible bronchoscopes that were already cleaned, prompting an "additional investigation on this issue," the agency noted. And a small number of reports show "persistent device contamination" even after the facility followed the manufacturer's instructions for cleaning the device, the FDA said in its notice, raising a few eyebrows as to whether or not the products are safe for patients.
The problem boils down to two issues: Failing to "meticulously follow" the manufacturer's instructions for cleaning the bronchoscopes and continuing to use them even as problems arise, according to the FDA notice. The agency recommends that facilities "strictly adhere" to manufacturers' reprocessing instructions and make sure that staff members are properly trained to clean the devices, it said in its notice. Regulators are also urging facilities to throw out any damaged scopes to make sure they don't spread infection.
The news echoes an ongoing saga for the FDA, as it continues to deal with the fallout over duodenoscope devices implicated in superbug outbreaks at U.S. hospitals. Last month, the agency revealed its first set of detailed recommendations for cleaning duodenoscopes. Regulators also sent warning letters to three companies manufacturing the devices for not making sure that the devices were clean.
Still, the agency maintains that duodenoscopes' benefits "continue to outweigh the risks" in certain patients, it said in a statement. And the risk of getting an infection from an improperly cleaned device is "relatively low" given the number in use, FDA spokeswoman Jennifer Dooren told The Los Angeles Times last month.
- read the FDA safety notice