Dr. Mark Gromski is a gastroenterologist, advanced endoscopist, and assistant professor of
medicine at IUHealth/Indiana University School of Medicine in Indianapolis, Indiana, where he
personally performs about 400 endoscopic retrograde cholangiopancreatography procedures per year. He’s also an expert on the patient safety issues surrounding ERCP.
More than 500,000 ERCP procedures are performed in the U.S. annually. ERCP combines
upper gastrointestinal (GI) endoscopy with fluoroscopic imaging to evaluate – as well as to treat – conditions involving the biliary tree and pancreas.
Gromski and his team have done extensive research into ERCP technology, and he has a
personal interest in the duodenoscope reprocessing issue as well. The unique and complex design of duodenoscopes is what makes ERCP effective, but their difficult-to-clean components can put patients at risk if the instrument is not reprocessed properly – a risk that is perhaps overstated in media coverage.
In this Q&A, he weighs in on the ERCP cross-contamination issue that has become prevalent in the press, and on the steps that practitioners and manufacturers can take to ensure patient safety.
He also discusses the recent guidance from the Food and Drug Administration that hospitals and endoscopy facilities transition away from fixed endcap duodenoscopes to those with newer design features that facilitate or eliminate the need for reprocessing. While noting that a full transition will take time, the FDA is pushing for new and innovative designs that will minimize the risks from hard-to-clean components.
“I think the FDA’s right to call for a re-assessment of our approach to infection prevention for ERCP,” Gromski says. “But, I think all developments need to be measured very carefully, and we should not have any mandatory decrees from the FDA until we know data on the developing technologies.”