FDA Panel Acknowledges Safety Risk with Duodenoscope Reprocessing


Posted May 20, 2015

A Food and Drug Administration (FDA) advisory panel has determined that current methods for cleaning and disinfecting a complex type of endoscope do not provide a reasonable assurance of safety and effectiveness.

To tackle the problem, experts on the panel suggested a variety of potential solutions, including a redesign of some devices and the establishment of new maintenance and inspection practices. And they made it clear that they believed the benefits of medical procedures involving the endoscopes in question far outweighed the risks.

Members of the Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee met May 14 and 15 to discuss the problem of multidrug-resistant infections associated with the use of duodenoscopes in endoscopic retrograde cholangiopancreatography (ERCP) procedures. Between January 2013 and December 2014, the FDA received 75 reports—involving approximately 135 patients—of carbapenem-resistant Enterobacteriaceae (CRE) infections linked to reprocessed duodenoscopes. The agency has noted that that number of such infections linked to the device could be larger. Panel members said more could and should be done to tackle the problem.

"Although the incidence of infection appears to be very low relative to the 500,000 to 600,000 ECRP procedures performed a year, there certainly have been infections traced to the scopes despite apparent compliance with recommended guidelines for cleaning and disinfection," said Kenneth McQuaid, MD, of the Veterans Affairs Medical Center in San Francisco. "It would appear to me that the scopes and AERs [automated endoscope reprocessors] don’t provide the assurance of safety and effectiveness we would like."

He added that there is agreement that duodenoscopes should be redesigned, but that would be a long process. In the meantime, he recommended that scope manufacturers create cost-effective maintenance programs to allow the devices to be inspected on a periodic basis.

Over the course of the meeting, the panel heard from representatives from the FDA, Centers for Disease Control and Prevention, healthcare facilities, and patient advocates. Carla Warner, whose husband Bill died after undergoing an ECRP procedure, took both the FDA and industry to task over the infections, saying they had failed patients.

"Bill fought the infection courageously for over eight months, enduring excruciating pain," she said, adding that even after reports of CRE infections were broadcast to the media, healthcare professionals were still unaware of the link.

Her testimony had an impact on at least one panel member. Craig Donatucci, MD, of Eli Lilly, said Warner’s powerful story made him reconsider what is acceptable in terms of risk. "It reinforced in my mind, that as a healthcare provider, what I think is reasonable may not be reasonable to a patient," he said.

The majority of the panel agreed that the devices should be reclassified as critical, a designation intended for instruments that come into contact with blood or normally sterile tissue and therefore must be sterilized. Endoscopes are classified as semi-critical, as they come into contact with mucus membranes. Semi-critical items at a minimum must undergo high-level disinfection. 

Although many on the panel thought sterilization was preferable, Karen Woods, MD, of the Baylor College of Medicine in Houston, TX, backed high-level disinfection as acceptable. "I firmly believe, that done properly, high-level disinfection works." She added that the breakdown occurs at the manual cleaning phase. "Sterilization won’t work either if you don’t do step one properly."

Despite the infections risk, the panel stopped short of calling for the discontinuation of the ERCP procedure. "The risk of stopping this would be catastrophic," said Col. Bryce Mays, MD, of the Fort Belvoir Community Hospital in Fort Belvoir, VA.

AAMI has a host of resources on reprocessing on a  Hot Topics page. Among these resources is a new standard, ST91, which deals with the the processing of flexible and semi-rigid endoscopes, as well as the report that resulted from the 2011 AAMI/FDA Medical Device Reprocessing Summit. During the May panel meeting, Suzanne Schwartz, MD, director of emergency preparedness and operations and medical countermeasures within the FDA's Center for Devices and Radiological Health called the summit, “a call to action to address issues and challenges in following complex reprocessing instructions.”