Advisory committee offers guidance on FDA duodenoscope regulation

An advisory committee assembled by the FDA viewed current criteria for the design and cleaning of reusable duodenoscopic devices as unsatisfactory and provided suggestions for potential regulatory action by the agency concerning these issues.

The gathering was held after a number of carbapenem-resistant Enterobacteriaceae outbreaks occurred at institutions around the country in the past 8 months. One outbreak at the University of California, Los Angeles Health System resulted in at least seven patients with confirmed infections and two deaths after endoscopic retrograde cholangiopancreatography (ERCP) procedures at Ronald Reagan UCLA Medical Center.

During the 2-day meeting, recent reports and epidemiologic investigations regarding infections from duodenoscopes used for ERCP were presented by attendees for consideration. Committee members discussed pressing concerns highlighted by the data for consideration by FDA policymakers.

“My point today is that we are not ensuring patient safety,” William A. Rutala, PhD, MPH, director of hospital epidemiology at the University of North Carolina School of Medicine, said during a presentation. “[Compared with other devices,] there have been more outbreaks and infections associated with endoscopes by far.”

Committee members unanimously agreed that existing standards concerning device design, cleaning and reuse did not provide an appropriate assurance of safety, but were not severe enough to halt all ERCP procedures. Other major issues identified included:

proper training and competency tests for those manually cleaning the devices;
changes in disinfection practices and a move toward full sterilization;
reclassification of duodenoscopes as Class 3 medical device;
provision of validity results from manufacturers or outside groups;
difficulties in identifying structural defects after multiple uses and routine maintenance;
regulation and development of automated endoscope reprocessors;
assays to evaluate pathogen presence after cleaning procedures;
regulation of secondary cleaning agents such as endoscope brushes;
adoption of standardized contamination surveillance procedures in health care facilities;
patient risk awareness and informed consent; and
dissemination of relevant medical information preceding a definitive resolution by the agency.

Recommendations were primarily made concerning duodenoscopic devices such as those associated with recent reports of ERCP transmission events, as many committee members said they lacked the appropriate data to endorse practices with other reusable invasive scopes.

Stephen Ostroff

“At the end of the day, our goal is clear: Make sure doctors and their patients will be confident in the safety of the duodenoscopes used in the procedures,” Stephen Ostroff, MD, acting commissioner of the FDA, said during the meeting. – by Dave Muoio and Adam Leitenberger