The FDA Grand Rounds is an educational presentation that is webcast monthly to highlight cutting-edge research underway across the Agency and its impact on protecting and advancing public health. Each session features an FDA scientist presenting on a key public health challenge and how FDA is applying science to its regulatory activities. The 45-minute educational presentation is followed by questions from the audience. You can also view the presentation under Past Grand Rounds following the live webcast. #FDAGrandRounds.
The next FDA Grand Rounds is scheduled for January 9, 2020.
Thursday, January 9, 2020
12:00 p.m. - 1:00 p.m. EST
WO Building 2, Room 2047 (or via webcast)
About the Presentation:
Every year there are over 75 million endoscopic procedures in the US 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, we will introduce FDA QC-ER and review results from testing in three hospitals and what we learned about factors contribute to scope cleanliness. Quality control of endoscope reprocessing can help hospitals to prevent future infection outbreaks.
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