Endoscopes are complex devices that are difficult to clean and disinfect. Because endoscope reprocessing procedures are complex, missed steps and variations in infection prevention practices are common. Defective equipment, failure to follow established cleaning and disinfection guidelines, and difficult-to-clean scopes and associated equipment may introduce infection risks during endoscopic procedures.​

For more than 50 years, ECRI has worked to improve the safety, quality, and cost-effectiveness of care across all healthcare settings. The combination of evidence-based research, medical device testing specific to brocoscopes, duodenoscopes, and colonoscopes, and expertise in patient and medication safety makes ECRI uniquely respected by healthcare leaders and agencies worldwide. ECRI’s health device experts and infection preventionists have worked with a number of agencies, members, and subject matter experts to understand endoscope technologies and endoscope reprocessing challenges.

Cleaning and disinfection of flexible endoscopes between uses proves to be a challenging process. ECRI has identified this as a Top 10 Technology Health Hazard for the past several years.  Failure to precisely follow a manufacturer’s instructions for use (IFU) and reprocessing can lead to debilitating or even fatal infections. Improper handling and storage practices can recontaminate already disinfected scopes, further increasing infection risk.

As of July 24, 2020, the U.S. Food and Drug Administration recommends that endoscopy facilities transition to innovative duodenoscope designs to improve cleaning and reduce contamination between patients, including designs with disposable components such as end caps. ECRI’s health device engineers have evaluated duodenoscopes with disposable end caps and performed cost comparison studies of reusable versus single-use duodenoscopes and bronchoscopes. ECRI suggests that ambulatory care centers perform a thorough evaluation to determine whether single-use scopes would provide a cost or process benefit for their facility.

Ambulatory surgery centers that perform endoscopy procedures should establish reprocessing policies and procedures that staff must follow based on professional association guidelines and manufacturers' IFUs. The facility’s policies and procedures should detail the safe cleaning and reprocessing of soiled endoscopes and associated equipment to reduce the risk of infection for both patients and providers.

ECRI evaluations reveal that most endoscope reprocessing problems are categorized in three areas: