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
AAMI Responds to GI Societies’ ST91 Rebuttal
Gastrointestinal Endoscopy Applications
A group of GI societies voiced concerns over the updated reprocessing guidelines, particularly their length, redundancies, disparate definitions, and conflicting recommendations.
Reviewing the Efficacy of Duodenoscope Reprocessing Techniques
Prevention Challenges
A literature review finds current duodenoscope reprocessing measures to be inadequate and explores several promising novel developments.
More From Single-Use Endoscopy
SARS-CoV-2 has played viral muse when it comes to publication of otolaryngology articles.

Public Health

The global pandemic has boosted the volume, citations and attention for both COVID-19 and non-COVID-19-related otolaryngology journal articles.

Experts: ‘How Do We Prove Clean is Clean?’

Prevention Strategies

The only agreed-upon endoscope reprocessing standard, experts note, is to follow the manufacturers’ instructions for use — but those IFUs can contain hundreds of steps and can be impossible for staffers to follow down to the letter.

High stress and poor work-life balance top the concerns of critical care doctors responding to a recent survey.

Public Health

Although critical care doctors largely are satisfied with their jobs, they also report high job stress and low satisfaction when it comes to work-life balance, according to a new survey.