FDA’s stance on the importance of properly cleaning duodenoscopes in order to prevent contamination and the continued spread of bacterial infections has been ongoing for several years. The agency has issued voluntary protocols for duodenoscope surveillance sampling and culturing, which aided in alleviating patient infections. It also required U.S. duodenoscope manufacturers to conduct postmarket surveillance studies to help understand how the bacterial infections are transmitted as well as any contributing factors. Some results of these studies, which are still ongoing, were released on Friday.
Three years ago, MedTech Intelligence went behind the scenes at ECRI: Watch the video to find out why duodenoscopes are so tough to clean.Last week CDRH Director Jeff Shuren, M.D. released a statement emphasizing the fact that the contamination risk among duodenoscopes continues to be a problem. “We’d like to see strong evidence that proper cleaning and reprocessing can virtually eliminate any bacteria residue that can spread infections,” said Shuren. “Currently, that evidence is lacking, and we’re considering what additional regulatory actions may be necessary.”
According to the above-mentioned report released by FDA on Friday, 5.4% of properly collected samples tested positive for “high-concern” organisms. This was a higher-than-expected contamination rate, according to FDA. “Let me be clear, the percent of contaminated samples based on these interim results shows that improvements are necessary and we are committed to taking additional steps to reduce infections and contamination even further,” stated Shuren. He added that FDA is looking into more ways that contamination rates can be reduced, including collaborating with CDC to get feedback about infection control and participating in the Healthcare Infection Control Practices Advisory Committee meeting in May to obtain more information on how to improve the safety of reprocessing these devices.
Although he sounded the alarm on the higher-than-expected contamination rates, Shuren did point out that the patient risk of getting an infection from a poorly reprocessed medical device is still “relatively low given the large number of such devices in use.”
The agency also continues to work with duodenoscope manufacturers on product designs that could help lower the contamination risk, along with disposable duodenoscopes that would not be reprocessed.