We all have certain expectations when visiting our doctors.

“We all feel that when we go in for a procedure — whether it’s a colonoscopy or we go in and get our teeth cleaned — our expectation is that we have the safest possible care and our instrumentation will be clean and ready to use for our procedure,” said Dr. Hudson Garrett Jr. “That’s unfortunately not always the case, as we’re certainly aware.”

In a new AORN webinar — “A Journey to Safer Endoscopy: Making Sense of the New FDA Safety Alert and Implications to Clinical Practice in the Perioperative Setting” — Garrett reviews three recent communications issued by the U.S. Food and Drug Administration.

The alerts were triggered by suspected infections or device contamination issues, reprocessing instructions in the device labeling, or flaws in reprocessing methods and endoscope design. Garrett, an expert in infection prevention and training, details:

• The FDA's 522 postmarket surveillance studies of reprocessing duodenoscopes used in endoscopic retrograde cholangiopancreatography procedures (ERCP). The study came as the result of a congressional order and identified several challenges in endoscope reprocessing. It also led to the eventual FDA recommendation that providers transition to duodenoscopes with innovative designs that better protect patients, including disposable components.
• The April 2021 FDA letter to healthcare providers describing multiple medical device reports involving reprocessed urological endoscopes. One issue with urologic endoscopies is that many are performed outside of the hospital without an infection preventionist. This may mean a lack of oversight or reporting when issues occur.
• The June 2021 communication involving reprocessing flexible bronchoscopes.

Garrett, who is an Ambu consultant, outlines his “3 P’s” approach to safety and proactively preventing an outbreak rather than reacting to one — people, process, and products — and compares the risks of reusable devices with the benefits of single-use alternatives.

For this information and much more, watch the entire webinar here.