FDA Expands Warnings about Infection Risk from Medical Scopes

Federal regulators have expanded warnings about medical scopes that can spread infections among patients. Contaminated bronchoscopes pose a risk to patients.

The Food and Drug Administration (FDA) said it was investigating reports that bronchoscopes are causing infections in patients even after the reusable devices were cleaned, the Los Angeles Times reports. Duodenoscopes—devices to diagnose and treat gastrointestinal conditions have been linked to recent superbug outbreaks that have caused illnesses and deaths in facilities nationwide.

The FDA said thus far no deaths have been reported from bronchoscopes, scopes used to diagnose and treat problems in the lungs or airway. But the bronchoscope advisory confirms infection experts’ fears that the infection risk in not confined to one type of scope, according to the Times.

Patients in Los Angeles, Seattle, Pittsburgh and other cities have developed antibiotic-resistant infections after duodenoscope procedures. Three patients at UCLA’s Ronald Reagan Medical Center died from these infections. The Justice Department is investigating the outbreaks and issued subpoenas to scope makers this year. The FDA said the risk of infection from bronchoscopes “appears to be lower” than the risk posed by duodenoscopes. The FDA is “proactively investigating [bronchoscopes] to determine if additional steps should be taken,” the Times reports. The FDA did not pull the device from the market or limit its use because the agency feels that for most patients the benefits outweigh the risks.

The bronchoscope—a thin, lighted tube threaded through the nose or mouth—allows a doctor to examine a patient’s throat, larynx, trachea and lungs. About 500,000 bronchoscopy procedures are performed annually in the U.S.

The FDA analyzed 109 reports received from January 2010 to June 2015 involving infections or device contamination related to bronchoscopes. Fifty of the reports came last year, prompting the extra scrutiny, the agency said.

In December, scope maker Olympus Corp. notified the FDA in a medical-device report that one of its bronchoscopes had potentially infected 14 patients with the deadly carbapenem-resistant Enterobacteriaceae. Olympus told the FDA that the bronchoscope involved in that incident had been sent to an outside company for repair. according to the Times.

Lawrence Muscarella, a hospital-safety consultant in Montgomeryville, Pennsylvania, said the FDA alert raises questions about the design of the bronchoscopes and how they can be effectively cleaned. Bronchoscopes have a simpler design than duodenoscopes, and are easier to clean. “If we are transmitting CRE from bronchoscopes, it means hospitals are not doing an adequate job of manually cleaning and it could also mean the manufacturers’ design of bronchoscopes should be enhanced,” Muscarella said. Infection experts have warned for years that many types of scopes could remain dirty after cleaning.

Researcher Michelle Alfa, of the University of Manitoba, tested scopes at a Canadian hospital and found that 9 percent of gastroscopes, 7 percent of colonoscopes and 4 percent of bronchoscopes had traces of potentially infectious material after cleaning.

The FDA said its bronchoscope investigation has pointed to a variety of factors so far. A small number of incident reports indicate “persistent device contamination despite following the manufacturer’s reprocessing instructions, according to the Times. ”Regulators said a contributing factor could be using bronchoscopes with scratches, holes or cracks — all areas where debris could hide. The FDA urged hospitals to strictly adhere to manufacturers’ instructions and immediately remove from use bronchoscopes that show signs of damage.



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