Endoscopy is a procedure to visually examine the inside of the body using an endoscope. Duodenoscope is an example of a flexible endoscope used in endoscopic retrograde cholangiopancreatography (ERCP) procedures and have received attention due to the infections associated with the improper reprocessing in recently years.1

Joint Commission provides services designed to improve patient safety as well as to maintain compliance with the accreditation standards of TJC (Sterile Processing in HealthCare Facilities, Rose Seavey, AMMI 3rd Edition 2017, page 5-14) Endoscope Reprocessing is under scrutiny and has been identified as one of health care’s most dangerous health technology hazards.

Reprocessing flexible endoscopes in today’s fast-paced clinical environment demands consistent, effective high-level disinfection (HLD) using automated endoscope reprocessors (AERs). Yet, despite advancements in technology over the last decade, AER operators are still required to manually test biocide minimum recommended concentration (MRC) levels during every cycle using a test strip. With the introduction of the ASP AEROFLEX™ AER with AUTOSURE™ MRC Monitor, automatic MRC testing for every cycle is a standard feature, designed to increase compliance and patient safety and reduce the risk of healthcare-acquired infections during endoscopy procedures. The AUTOSURE™ MRC Monitor is a novel automated concentration measurement system grounded in mature chemistry and colorimetry; a summary technical explanation is presented in this document.

On April 1, 2021, the US Food and Drug Administration (FDA) issued a safety alert in the form of a letter to health care providers regarding infections linked to reprocessed urological endoscopes. In this announcement, the FDA notes they have received numerous Medical Device Reports (MDRs) that describe patient infections post procedure or other possible contamination issues associated with reprocessing these devices.

Infection control thought leaders Dr. William Rutala and Cori Ofstead discuss evidence-based factors that contribute to reprocessing failures in real-world settings and offer potential solutions to mitigate the problems.