The FDA released the documents of its May 14-15 meeting about the duodenoscope safety scare, which has been implicated in a few recent deaths of patients who picked up the drug-resistant bacteria CRE due to improper sterilization.
The incident has been an embarrassing one for the agency after it was revealed that the issue had been known about for some time. In addition, the Olympus duodenoscope responsible for the recent patient deaths and injuries made it onto the market without FDA clearance.
The panelists will be provided with information regarding the methodology and criteria for acceptance of duodenoscope cleaning, high‐level disinfection, and sterilization validation testing, for both manual and automated processes.
The panelists will be asked if duodenoscopes that meet the criteria provide a reasonable assurance of safety and effectiveness, how the cleaning process should be evaluated in premarket testing, the responsibility of various stakeholders like the FDA and professional societies in ensuring the devices perform as intended, Centers for Disease Control and Prevention guidelines about bacterial contamination of the devices after reprocessing, patient safety during the procedure, and how to communicate the issue to the public.
The FDA says that more than 500,000 endoscopic procedures are performed annually. It has resisted calls to recall or withdraw the devices from the market because that would harm patients who benefit from the surgeries that it enables.
As such, the chances of infection from CRE bacteria are quite small, though the consequences could be fatal.
- read the documents