Costs involved in compliance with new endoscope reprocessing guidelines

Area of Science:

• Medical device reprocessing
• Healthcare standards
• Infection control

Background:

• The Association for the Advancement of Medical Instrumentation (AAMI) released updated guidelines in March 2022: American National Standards Institute (ANSI)/AAMI ST91:2021.
• These standards cover comprehensive reprocessing for flexible and semirigid endoscopes.
• Key updates include recommendations for sterilization of high-risk endoscopes and detailed procedures for precleaning, leak testing, manual cleaning, inspection, automated reprocessing, drying, storage, and transport.

Purpose of the Study:

• To compare the latest ANSI/AAMI ST91:2021 standards with the previous 2015 version.
• To identify major reprocessing differences that may increase time and/or costs.
• To estimate the financial and temporal impact of implementing the new AAMI endoscope reprocessing standards.

Main Methods:

• Comparative analysis of ANSI/AAMI ST91:2021 and ANSI/AAMI ST91:2015.
• Estimation of reprocessing time based on explicit recommendations and literature review.
• Calculation of costs using publicly available resources.

Main Results:

• The updated AAMI standards may increase reprocessing time by approximately 24.3 minutes per procedure.
• Estimated cost increases range from $52.35 to $67.57 per procedure, excluding capital investments.
• Capital costs per procedure are significantly influenced by facility procedure volume.

Conclusions:

• New AAMI standards mandate significant changes in endoscope reprocessing, including sterilization.
• Implementation of these updated standards incurs additional costs and time delays for facilities.
• Healthcare facilities should assess the true costs of compliance and explore alternative solutions, such as single-use endoscopes.