Within the healthcare setting, an endoscope is used multiple times each day. As a result, paying careful attention to every part of the cleaning process is important. And although reprocessing issues have been a concern for years, the more recent and deadly superbug infections (Carbapenem-resistant Enterobacteriaceae) involving duodenoscopes have put a spotlight on effective device cleaning and protecting patients. “The duodenoscope is considered one of the most challenging scopes to clean,” said Chris Lavanchy, engineering director of ECRI Institute’s Health Devices Group. “When a technician is doing the reprocessing, they’re typically using a brush that’s threaded through each of the channels to clean out crud that is left behind.” He adds that the manual nature of the process introduces quite a bit of variability, including how much pressure the technician is under to get the cleaning done—and how fast.
During a recent visit to ECRI (Plymouth Meeting, PA), Lavanchy explained the complex design of the devices and why they can be so difficult to clean. “We’re not doing a great job in reprocessing the scopes,” he said, adding that the elevator feature of the device has been implicated as a proximate cause of the deadly infections. Accessing the area with a brush to get rid of blood and bacteria is a difficult task. More troubling is the fact that patients could be in danger of contracting other infections from duodenoscopes. Watch the video to find out why.
The UK MHRA has published “Software and Artificial Intelligence as a Medical Device.” The guidance document assembles previous guidances and regulatory requirements for SaMD and AIaMD devices seeking commercialization in the UK market.
“Addressing unmet needs across pediatric populations is critical to advancing children’s health, and we are delighted to once again work with pioneering companies that seek to bridge this care gap."
More and more, the quality of real-world evidence (RWE)—gathered from remote patient monitoring data, product and disease registry data, and patient feedback—determines whether a medical device is approved and, in some instances, for how long. Yet some medical device manufacturers…
The MDDT program was developed in collaboration with the National Institutes of Health’s (NIH’s) National Institute of Drug Abuse (NIDA), National Institute of Dental Craniofacial Research (NIDCR) and National Cancer Institute (NCI) as a way for the FDA to qualify…
Maria Fontanazza has more than 15 years of experience in journalism, marketing and communications. She was previously marketing communications manager and market research manager at Secant Medical, Inc., a manufacturer of biomedical textiles and advanced biomaterials. Fontanazza also served as an editor at MD+DI and has authored articles that have appeared in domestic and international industry publications. Fontanazza has a B.A. in Journalism and Mass Communications with a concentration in New Media and Visual Design, and a Minor in Fine Arts, from St. Michael’s College in Colchester, VT. Follow her industry insights on Twitter at @MariaFontanazza. Contact Maria