The first installments of a recently released biweekly public health podcast zero in on infection prevention in endoscopy.
Transmission Control is meant to be an “injection of insight” on hot-button public health topics and issues of the day. The first three episodes discuss device-related infections traced back to flexible endoscopes, reprocessing challenges, and the potential for patient cross-contamination.
“Will we see a world where the GI endoscopy unit can be using solely disposable duodenoscopes such that all these [infection prevention] problems seem to control themselves?” Lawrence Muscarella, an infectious disease specialist and president of LFM Healthcare Solutions LLC, asks in the second episode of the new podcast.
Muscarella, an interviewer on the podcast, has done extensive research on the cleaning of semi-critical devices and best practices for disinfection. Semi-critical devices, such as flexible endoscopes, require a minimum of high-level disinfection between uses.
Endoscopes are delicate and complex instruments and reprocessing can take up to two hours and 100 steps to complete. Endoscope-associated infections, while rare, do happen, and some experts believe the number of cases is underreported due to poor surveillance and tracking.
In fact, the very first Transmission Control episode takes a deep dive into what they are calling the “hidden harm” — evidence of device-related damage seen in the U.S. Food and Drug Administration database of device malfunction and injury reports.
In this episode, Christina Jewett, a senior correspondent at Kaiser Health News, shares her experiences reporting on the FDA’s Manufacturer and User Facility Device (MAUDE) database and the exposure of millions of medical device reports (not just endoscopes) in 2019.
Much of the research and attention to device-related infection in endoscopy has been centered around duodenoscopes. These are arguably the most difficult endoscopes to disinfect because of their multiple working channels and the elevator mechanism on the distal end.
The FDA issued safety guidance in August 2019 calling for an industry switch to partially disposable or fully single-use duodenoscopes to address infection concerns in endoscopic retrograde cholangiopancreatography (ERCP).
Just this spring, the FDA announced new investigations into infection outbreaks and three deaths related to urological endoscopes.
Dr. Raman Muthusamy, an advanced therapeutic endoscopist and a professor at UCLA, said said single-use duodenoscope technology has been given a lift thanks to FDA safety communications as well as the granting of breakthrough device designation. He was the featured guest on the podcast’s second episode about reprocessing guidelines.
“I would argue that since 2015, there’s been more published research on the issue of endoscope device reprocessing than there has been in the history of endoscopes prior to that,” Muthusamy said.
There may be a future for single-use duodenoscopes, he added, if the devices can accomplish three things: perform as well as legacy duodenoscopes, be cost-effective, and have minimal environmental impact.
Transmission Control episodes run approximately 45 minutes.