The U.S. Food and Drug Administration (FDA) recommends manufacturers and healthcare facilities adopt the use of duodenoscopes that have disposable components, claiming they may pose less risk compared to traditional reprocessed devices. The disposable accessories should be gradually transitioned into healthcare facilities to avoid shortage, according to Medscape.
"We recognize that a full transition away from conventional duodenoscopes to innovative models will take time and immediate transition is not possible for all healthcare facilities due to cost and market availability," Jeff Shuren, MD, director of the FDA's Center for Devices and Radiological Health, said in a press announcement.
Inside the Duodenscope
A duodenoscope is a thin, flexible tube equipped with a camera to take photos of the patient's insides. The scopes perform endoscopic retrograde cholangiopancreatography procedures (ERCPs), which require the tool to be threaded through the throat, stomach and small intestines to identify cancers, gallstones and other digestive illnesses. The devices can also assist doctors with removal and biopsies. More than 660,000 ERCPs were performed in 2014.
Closed-channel duodenoscopes are designed with elevator mechanisms to allow healthcare professionals to control the machine, move the camera and gather necessary health information. Bacteria can crawl inside the channel, meant to be sealed by an O-ring mechanism, during the procedure and remain there. The crevices of the channel are too small to be sanitized with a brush, which is exacerbated by poor-quality sealing mechanisms.
Scopes contaminated with deadly superbug bacteria have been reused time and again, infecting hundreds of patients across the country. This issue has resulted in the spread of antibiotic-resistant bacteria in more than 25 U.S. hospitals. Many endoscopy infection strains have become multi-drug resistant. One particular scope model, which wasn’t approved by the FDA, caused two deaths and hundreds of infections.
In April, the FDA released adverse event data that showed three deaths, 45 patient infections and 159 cases of device contamination related to inadequate reprocessing of the devices between October 15, 2018, and March 31, 2019. Results of postmarket "human factors" studies, as outlined in the FDA's executive summary, suggest that users "frequently" have trouble understanding and following manufacturers' reprocessing instructions and are not able to successfully complete reprocessing, which may leave the duodenoscopes contaminated.
FDA Warns Against Illegal Test Strips
The FDA is also warning against certain test strips illegally marketed to assess duodenoscope cleanliness. Some healthcare facilities are using adenosine triphosphate (ATP) test strips that claim to indicate the presence of live microbes inside of duodenoscopes. However, there are no legally marketed ATP test strips cleared by the FDA for this use, the agency said.
ATP test strips assess duodenoscope cleaning by indicating the presence of live microbes inside of duodenoscopes. However, to date, the FDA is not aware of any legally marketed ATP test strips cleared by the agency, which means the FDA has not reviewed them for effectiveness in assessing reprocessing, they said.
'Reducing the Risk of Infection from Reprocessed Duodenoscopes.' FDA Executive Summary. November 6-7, 2019. Prepared for General Hospital and Personal Use Devices Panel of the Medical Devices Advisory Committee.