The U.S. Food and Drug Administration (FDA) will host an FDA Grand Rounds webcast, “Quality Control: Stopping infections before they happen through safer endoscope reprocessing” today from 12:00 p.m. to 1:00 p.m. EST. The webcast will be presented by CDR Kenneth Phillips, PhD, Biofilms Research Group Leader, Division of Biology, Chemistry and Materials Science Office of Science and Engineering Laboratories, CDRH and Anant Agrawal, PhD, Research Electrical Engineer, Division of Biomedical Physics Office of Science and Engineering Laboratories, CDRH.
Every year there are over 75 million endoscopic procedures in the U.S. that allow healthcare providers to perform hundreds of essential procedures, ranging from colonoscopies to treatment of pancreatic cancer. FDA facilitates patient access to the world’s best endoscopic technologies and ensures that endoscopes can be safely used. An ongoing challenge related to endoscope use has been antibiotic-resistant bacterial infection outbreaks. Research has shown that biofilm can build up inside endoscopes over time, making current cleaning and disinfection procedures (called "reprocessing") less effective. To address this problem, the FDA has proactively taken measures with several warnings to manufacturers and healthcare facilities.
The FDA required manufacturers to study endoscopes being used in the clinic, and the results showed that about 2-5% of endoscopes do in fact have bacterial contamination. Recently, the Biofilms Research Group in the Center for Devices and Radiological Health’s Office of Science and Engineering Laboratories has developed tools that can tell hospitals how clean an endoscope is after reprocessing. These tools can detect and quantify miniscule amounts of contamination, much lower than anything currently commercially available. The tools are quick and inexpensive for hospitals to use. We call this approach FDA QC-ER, or "FDA Quicker" for short, because the device helps hospitals maintain the quality (quality control) of their endoscope reprocessing.
In this talk, they will introduce FDA QC-ER and review results from testing in three hospitals and what they learned about factors contribute to scope cleanliness. Quality control of endoscope reprocessing can help hospitals to prevent future infection outbreaks.
About the speakers:
CDR Phillips is leader of the Biofilms Research Group in the Division of Biology, Chemistry and Materials Science (DBCMS) in FDA’s Center for Devices and Radiological Health (CDRH). He earned his PhD in Bioanalytical Chemistry from UC Riverside and did postdoctoral research at UNC Chapel Hill in Biomedical Engineering. CDR Phillips has worked at FDA to develop science-based solutions for medical device associated infections (MD-HAIs). He has over 38 publications, 3 book chapters and 1 patent, has mentored 5 postdoctoral fellows, 8 graduate students, and 16 undergraduates at the FDA, and has been on the dissertation committee for students at several Universities. As a Commissioned Officer of the USPHS, he was honored to be on the rapid deployment force that helped set up a Federal Medical Shelter in High Point, NC for displaced residents with special medical needs from coastal towns during hurricane Florence.
Dr. Agrawal is a Research Electrical Engineer in the Division of Biomedical Physics (DBP), of the Office of Science and Engineering Laboratories at CDRH. He has been with DBP for over 16 years, leading a variety of regulatory science research projects applying optical imaging and spectroscopy techniques to evaluate medical devices. His work has been funded by a number of intramural research grants from the FDA Critical Path Initiative and Medical Countermeasures Initiative. Anant currently serves on the Ophthalmic Specialty Task Group of the CDRH Standards Program and on the Regulatory Science Subcommittee of the CDRH Center Science Council. He is also a CDRH representative on the Committee for the Advancement of Clinical and Scientific Education (CACSE). Prior to his time in CDRH, he spent 5 years at a medical device company developing new optical spectroscopy methods for early cancer detection. He has co-authored over 25 peer-reviewed journal articles, 1 book chapter, and 3 US patents. Dr. Agrawal received his Bachelor’s, Master’s and PhD degrees in Electrical Engineering from the University of Virginia, the University of Texas at Austin, and the Catholic University of America, respectively.
