In 2015, prompted by outbreaks of antibiotic-resistant infections linked to duodenoscopes, the FDA issued a Safety Communication, indicating that the complex design of duodenoscopes may impede effective reprocessing. From January 2013 through December 2014, the FDA received 75 Medical Device Reports (MDRs) involving approximately 135 patients relating to possible microbial transmission from reprocessed duodenoscopes. Duodenoscopes are used to visualize the duodenum and upper digestive tract, for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenum. Reprocessing involves a detailed, multistep process to clean and disinfect or sterilize the reusable devices.
The FDA reports that more than 500,000 Endoscopic Retrograde Cholangiopancreatography (ERCP) procedures using duodenoscopes are performed in the United States each year. The procedure is the least invasive way of draining fluids from pancreatic and biliary ducts blocked by cancerous tumors, gallstones, or other conditions. The complex design of duodenoscopes improves the efficiency and effectiveness of ERCP. However, that design creates challenges for cleaning and disinfection because some parts of the scopes may be difficult to access. Residual body fluids and organic debris may remain in crevices after cleaning and disinfection. If these fluids contain microbial contamination, subsequent patients may be exposed to serious infections.
Shortly after the FDA issued its Safety Communication, the Economic Cycle Research Institute ranked the duodenoscope issue at the top of its list of health technology hazards that hospitals and clinicians should tackle in 2016, as reported by Medscape Medical News.
In an effort to improve safety, the FDA has been closely monitoring the association between reprocessed endoscopes and the transmission of infectious agents, and has been working with duodenoscope manufacturers to modify and validate their reprocessing instructions.
Fujifilm Medical Systems U.S.A., Inc., Endoscopy Division (FMSU) recently issued a voluntary recall involving its duodenoscope model ED-530XT. This action includes replacement of the ED-530XT forceps elevator mechanism and O-ring seal, replacement of the distal end cap, and new operation manuals. The “Urgent Medical Device Correction And Removal” notice was sent to endoscopy departments and infection control and reprocessing units at health care facilities, including gastroenterologists, gastrointestinal surgeons, endoscopy nurses, staff working in endoscopy reprocessing units in health care facilities, infection control practitioners, and facility risk managers.
The FDA cleared the updated design and labeling for the ED-530XT on July 21, 2017. The updated design and labeling were implemented to reduce the potential risk associated with inadequate reprocessing of the device. Pursuant to this clearance, FMSU provided healthcare providers with updated manuals and directed them to discard previous versions.
FMSU will contact all customers that have the duodenoscope by October 2017, with details for returning the ED-530XT for replacement parts.