Senior male patient

Gastrointestinal Endoscopy Procedure

Q&A: Why ERCP Is So Critical to Effective GI Care

The FDA is pushing for new and innovative designs that will minimize the risks from hard-to-clean components.

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."

Click here to download our Q & A with Dr. Mark Gromski on "Why ERCP Is So Critical to Effective GI Care."

More Gastroenterology Articles
How Often Should IBD Patients Undergo Colonoscopy?
Gastrointestinal Endoscopy Applications
Colorectal cancer patients who had undergone the surveillance procedure within a year of diagnosis had lower mortality rates than those who did not.
Endoscopists Detail Multifaceted Approach to Infection Prevention
Gastrointestinal Endoscopy Applications
Two advanced endoscopists outline the challenges in infection prevention in ERCP and discuss the potential for single-use endoscopy as part of a comprehensive solution.
More From Single-Use Endoscopy

Emerging Technologies

Physicians, researchers, and other industry professionals will gather in San Diego for Digestive Disease Week 2022 after the COVID-19 pandemic forced the event to go virtual each of the past two years.

5 Things Urologists Were Talking About at AUA 2022

Endoscopy Tech

Patient engagement and advancing diversity in urologic oncology were among the topics probed over three days in New Orleans as the American Urology Association held its annual meeting.

A Matter of Time: Shifting the Healthcare Paradigm With Single-Use

Emerging Technologies

At DeviceTalks Boston, med-tech executives talk of a day when single-use endoscopy is the standard of care and reusable endoscopes are “hanging in a museum.”