FDA Grand Rounds

Quality Control: Stopping infections before they happen through safer endoscope reprocessing.

Thursday, January 9, 2020

WO Bldg 2: 2047 (Or Via Webcast)

12:00 p.m. - 1:00 p.m. EST

Register here for webcast (public attendees and FDA staff)

CE Credit Available

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

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.

What you’ll learn from these FDA Scientists:

Reasons why the endoscope is associated with antibiotic resistant bacterial infection outbreaks.
The FDA QC-ER approach and why it is a promising new solution to quality control of endoscope reprocessing.
The next steps needed to expand testing of FDA QC-ER and its potential use to help prevent outbreaks nationwide