Many eyebrows were raised following 2016’s recall of duodenoscope model TJF-Q180V by Olympus. The voluntary recall was intended to replace the problematic elevator channel sealing mechanisms in the 4,400 Olympus duodenoscopes that were issued prior to 510k clearance for the device. Olympus planned to complete the recall by August 2016 and also planned to conduct annual inspections of each scope in use by facilities to identify any wear and tear on the elevator channel sealing mechanism.
The Olympus recall led many to wonder if Pentax would follow suit with their duodenscopes. While Pentax issued updated cleaning instructions in February 2016, they did not match Olympus and recall their ED-3490TK duodenoscopes. Then in January 2017, the FDA came out with a new warning about the patient infection risks of Pentax duodenoscopes. As this article by Kendra Goldhirsch at the Legal Examiner explains:
“On January 17, 2017, the FDA announced that the Pentax ED-3490TK has a “design issue” that could increase the risk of patient infections. According to the FDA, “[c]racks and gaps in the adhesive that seals the device’s distal cap to its distal tip may occur, which can lead to microbial and fluid ingress. These areas can be challenging to clean and high-level disinfect and may increase the risk of infection transmission among patients.”
To address these safety issues, the FDA recommends that hospitals, medical centers, and their staff members be sure they’re using Pentax’s updated cleaning instructions for the device. They were also told to repair or replace any duodenoscopes that show visible signs of damage, including kinks or bends in tubing, loose parts, cracks and gaps in the adhesive, or other signs of wear and tear.
So far, however, Pentax has chosen not to issue a recall of these devices. Olympus, which recalled their devices last year to update the design, created a tighter seal to reduce the potential for leakage of patient fluids and tissue. The FDA approved this new design last year. Prior to that, at least 16 hospitals in the U.S. had reported antibiotic-resistant infections related to the Olympus and other brands of duodenoscopes.
Olympus is currently defending several duodenoscope infection lawsuits. Pentax may soon face its own liability issues.”
Read the entire article here: FDA Warning: Pentax Duodenoscope May Lead to Infection
While duodenoscopes continue to be a focal point of legal issues for both Olympus and Pentax, both manufacturers and the FDA believe that the scopes currently in market are usable as long as hospitals follow exactly the manufacturer reprocessing instructions. Hospitals that worry about staff adherence to instructions for use can turn to automation systems such as iRIScope to get better control of high-risk processes such as endoscope reprocessing. These systems improve staff compliance by standardizing processes and automating many of the data collection workflows. As duodenoscopes continue to be evaluated for their safety and risks of infection, hospitals must be diligent in their ability to consistently follow manufacturer cleaning instructions every single time to avoid potential litigation.