New FDA Warning Indicates Infection Risk from Another Type of Medical ScopeSep 21, 2015
Medical scopes, devices used to examine and treat conditions in the lungs, the colon, the bladder and the stomach, have been linked to superbug outbreaks. The Food and Drug Administrations (FDA) has just issued a warning that the bronchoscope can spread infection from patient to patient.
The FDA is investigating reports that bronchoscopes are transmitting infections even after the reusable devices have been cleaned according to manufacturer’s instructions, the Los Angeles Times reports. Patients have been exposed to bacteria, human tissue, and dried blood left inside bronchoscopes.
The FDA said thus far no deaths have been linked to bronchoscopes, which are used to diagnose and treat problems in the lungs or airway. About half a million bronchoscopies are performed annually in the U.S. But the new advisory confirms the fears infection experts have expressed that the infection risk in not confined to one type of scope, according to the Times. The duodenoscope, which is used to diagnose and treat gastrointestinal conditions, has been linked to superbug outbreaks across the country in the last three years.
After duodenoscope procedures, patients in Los Angeles, Seattle, Pittsburgh and other cities have developed antibiotic-resistant infections and three patients at UCLA's Ronald Reagan Medical Center died. Major scope makers are under Justice Department investigation for not properly reporting outbreaks. The FDA said that while infection risk from bronchoscopes "appears to be lower" than the risk posed by duodenoscopes, it is investigating to determine if additional steps should be taken. Bronchoscopes have not been removed from the market and their use has not been limited because the FDA feels the benefits outweigh the risks for most patients.
From January 2010 to June 2015 the FDA received 109 reports involving infections or device contamination related to bronchoscopes. Olympus Corp., a major scope manufacturer, notified the FDA in December that one of its bronchoscopes had potentially infected 14 patients with the deadly carbapenem-resistant Enterobacteriaceae. Olympus said the bronchoscope involved had been sent to an unregulated company for repair, the Times reports.
Hospital-safety consultant Lawrence Muscarella, of Montgomeryville, Pennsylvania, said the FDA alert raises questions about effective cleaning of bronchoscopes. Bronchoscopes have a simpler design than duodenoscopes, and are easier to clean, but if CRE is being transmitted by bronchoscopes, Muscarella said hospitals may not be doing an adequate job of cleaning. Infection experts have long been concerned that medical scopes could remain contaminated after cleaning.
Researcher Michelle Alfa, of the University of Manitoba, found that 9 percent of gastroscopes, 7 percent of colonoscopes and 4 percent of bronchoscopes tested at a Canadian hospital had traces of potentially infectious material after cleaning. The FDA says various factors could contribute to infection risk, including a hospital not properly following the manufacturer's reprocessing instructions. But regulators said there is a risk if a hospital is using bronchoscopes with scratches, holes, or cracks where debris could hide. To ensure patient safety, the FDA urges strict adherence to manufacturers' cleaning instructions and says hospitals should immediately stop using bronchoscopes that show signs of damage.