WASHINGTON — Aggressive efforts by the FDA and manufacturers of duodenoscopes in recent years have not succeeded in eliminating bacterial contamination problems with the devices after reprocessing, the agency said in a Safety Communication issued late Monday.
Following revelations in 2015 that scores of patients had developed abdominal infections following endoscopic retrograde cholangiopancreatography (ERCP) procedures using reprocessed duodenoscopes, the FDA ordered manufacturers including Olympus, Fuji, and Pentax to upgrade their recommendations for post-procedural cleaning and to conduct regular testing to determine how well the procedures are working.
“Interim results from these studies indicate higher-than-expected contamination rates after reprocessing, with up to 3% of properly collected samples testing positive for enough low concern organisms to indicate a reprocessing failure and up to 3% of properly collected samples testing positive for high concern organisms,” the agency said in the Monday statement. “High concern organisms” include E. coli, Pseudomonas aeruginosa, and others associated with disease, the FDA explained.
An FDA advisory committee meeting in 2015 agreed that duodenoscopes for ERCP procedures cannot be completely sterilized in every case — they contain hinged parts such as elevators at the working tip where organisms may lodge and evade removal or killing. Small cracks and other forms of damage can also occur with repeated use, which can also complicate thorough cleaning.
Yet while calling the reusable devices inherently unsafe, panel members also reluctantly concluded that clinicians and patients can’t do without them. ERCP procedures are irreplaceable for patients with pancreatic disease. Manufacturers had not then, and still have not, developed single-use instruments that are sufficiently economical for clinicians and payers.
In the new statement, the FDA advised endoscopy clinics that automated reprocessing is not sufficient. The agency said staff should “[m]eticulously clean the elevator mechanism and the recesses surrounding the elevator mechanism by hand, even when using automated endoscope reprocessors” (emphasis added). It also emphasized visual inspection for remaining debris or damage after reprocessing and again prior to use.
Clinics should also develop “a comprehensive quality control program [that] should include written procedures for monitoring training and adherence to the program, and documentation of equipment tests, processes, and quality monitors used during the reprocessing procedure.”
Separately on Monday, federal prosecutors obtained a guilty plea from an Olympus subsidiary to settle criminal charges that the company failed to report infections it knew about that were related to use of its duodenoscopes. The firm agreed to pay an $80-million fine as part of a plea deal.