Endoscope Reprocessing and Disinfection Audit Checklist [FREE PDF]

Endoscope reprocessing failures represent one of the most significant infection control risks in healthcare, with outbreaks traced to inadequate cleaning, high-level disinfection, and storage practices. The FDA, CDC, AAMI ST91, and Joint Commission IC standards establish specific requirements for each step of the reprocessing cycle to prevent patient-to-patient transmission of pathogens. This audit checklist enables Sterile Processing Managers and Biomedical Engineers to systematically verify th

  • Industry: Sterile Processing
  • Frequency: Monthly
  • Estimated Time: 45-60 minutes
  • Role: Sterile Processing Manager
  • Total Items: 38
  • Compliance: AAMI ST91:2021 - Flexible and Semi-rigid Endoscope Processing in Health Care Facilities, OSHA 29 CFR 1910.1030 - Bloodborne Pathogens Standard, Joint Commission IC.02.02.01 - Infection Prevention and Control, FDA 21 CFR 820 - Quality System Regulation for Medical Devices, CDC Guidelines for Disinfection and Sterilization in Healthcare Facilities (2008, Updated 2019)

Pre-Cleaning and Point-of-Use Treatment

Verify that initial point-of-use pre-cleaning steps are performed immediately after each procedure before organic material can dry.

  • Is point-of-use pre-cleaning performed immediately at the procedure table before the endoscope is transported?
  • Are staff performing point-of-use pre-cleaning wearing appropriate PPE (gloves, mask, eye protection, gown)?
  • Are all accessible endoscope channels flushed with enzymatic detergent solution at the point of use?
  • Is the endoscope transported to the reprocessing area in a closed, leak-proof transport container?
  • Is the time elapsed between procedure completion and beginning of full reprocessing recorded and within the facility policy limit?

Manual Cleaning Process

Observe and verify that manual cleaning steps are performed according to the manufacturer's IFU and AAMI ST91 requirements.

  • Are staff using the enzymatic detergent at the correct dilution ratio as specified by the manufacturer's IFU?
  • Is the water temperature for manual cleaning within the manufacturer-specified range?
  • Are all channels brushed with the correct size and type of brush per the endoscope manufacturer's IFU?
  • Are cleaning brushes single-use or, if reusable, cleaned and high-level disinfected after each use?
  • Is leak testing performed before manual cleaning and documented for each scope?
  • Are cleaning sink basins cleaned and disinfected between uses to prevent cross-contamination?

High-Level Disinfection (HLD) Process

Verify that high-level disinfection is performed correctly using approved disinfectants at required concentrations and contact times.

  • Is the HLD agent (e.g., glutaraldehyde, OPA, peracetic acid) currently cleared by FDA for use with flexible endoscopes?
  • Is the minimum effective concentration (MEC) of the HLD agent tested and documented before each use with a chemical indicator?
  • Is the HLD soak time meeting the manufacturer's minimum contact time for high-level disinfection at the measured temperature?
  • What is the measured temperature of the HLD solution during disinfection?
  • Are all endoscope channels completely filled with HLD solution during the soak period?
  • Is HLD solution replaced within the manufacturer's maximum reuse period or when MEC test fails (whichever comes first)?

Rinsing and Drying Procedures

Verify that post-HLD rinsing and drying processes prevent residual chemical exposure and moisture-related microbial growth.

  • Is rinse water quality (sterile, filtered, or critical-use water) appropriate per AAMI ST91 and facility policy?
  • Are all channels thoroughly rinsed with the appropriate water to remove all HLD chemical residue?
  • Are all channels purged with instrument-grade compressed air or alcohol to remove residual moisture after rinsing?
  • Is the exterior of the endoscope dried with a clean, soft lint-free cloth after rinsing?
  • Is the drying process and final quality check documented in the reprocessing log for each scope?

Endoscope Storage and Handling

Assess storage conditions to ensure processed endoscopes are maintained in a manner that prevents recontamination.

  • Are processed endoscopes stored in a ventilated, vertical hanging position in a dedicated storage cabinet?
  • Is the storage cabinet designed to protect endoscopes from recontamination (filtered air, positive pressure or enclosed design)?
  • Are endoscopes labeled or tracked with their reprocessing date to enforce maximum storage duration before re-reprocessing?
  • Are all accessories (biopsy valves, caps, water bottles) stored separately and in a clean, dry condition?
  • Is the storage area restricted to authorized personnel and maintained at appropriate temperature and humidity?

Automated Endoscope Reprocessor (AER) Verification

If AERs are used, verify that automated reprocessors are properly qualified, maintained, and producing validated cycles.

  • Is the AER currently validated for use with the specific endoscope models being reprocessed?
  • Does the AER complete each cycle successfully with printed or electronic cycle documentation for each reprocessed scope?
  • Is the AER maintained per the manufacturer's schedule and are maintenance records current?
  • Is manual cleaning always performed before placing endoscopes in the AER?
  • Is the AER water filtration system (if applicable) changed at the manufacturer-required interval?

Staff Competency and Program Documentation

Verify that all reprocessing staff are trained, competency-assessed, and that program documentation is complete and current.

  • Have all reprocessing staff completed initial competency-based training on endoscope reprocessing within the past 12 months?
  • Are written standard operating procedures (SOPs) for each endoscope model and reprocessing step available in the work area?
  • Is a reprocessing log maintained that allows full traceability from patient procedure to specific scope and reprocessing cycle?
  • Are blood and body fluid exposure incidents related to reprocessing documented and reported per OSHA requirements?
  • Are microbiological surveillance cultures of processed endoscopes performed per facility policy?
  • Please document any reprocessing failures, non-conformances, or corrective actions identified during this audit.

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Why Use This Endoscope Reprocessing and Disinfection Audit Checklist [FREE PDF]?

This endoscope reprocessing and disinfection audit checklist [free pdf] helps sterile processing teams maintain compliance and operational excellence. Designed for sterile processing manager professionals, this checklist covers 38 critical inspection points across 7 sections. Recommended frequency: monthly.

Ensures compliance with AAMI ST91:2021 - Flexible and Semi-rigid Endoscope Processing in Health Care Facilities, OSHA 29 CFR 1910.1030 - Bloodborne Pathogens Standard, Joint Commission IC.02.02.01 - Infection Prevention and Control, FDA 21 CFR 820 - Quality System Regulation for Medical Devices, CDC Guidelines for Disinfection and Sterilization in Healthcare Facilities (2008, Updated 2019). Regulatory-aligned for audit readiness and inspection documentation.

Frequently Asked Questions

What does the Endoscope Reprocessing and Disinfection Audit Checklist [FREE PDF] cover?

This checklist covers 38 inspection items across 7 sections: Pre-Cleaning and Point-of-Use Treatment, Manual Cleaning Process, High-Level Disinfection (HLD) Process, Rinsing and Drying Procedures, Endoscope Storage and Handling, Automated Endoscope Reprocessor (AER) Verification, Staff Competency and Program Documentation. It is designed for sterile processing operations and compliance.

How often should this checklist be completed?

This checklist should be completed monthly. Each completion takes approximately 45-60 minutes.

Who should use this Endoscope Reprocessing and Disinfection Audit Checklist [FREE PDF]?

This checklist is designed for Sterile Processing Manager professionals in the sterile processing industry. It can be used for self-assessments, team audits, and regulatory compliance documentation.

Can I download this checklist as a PDF?

Yes, this checklist is available as a free PDF download. You can also use it digitally in the POPProbe mobile app for real-time data capture, photo documentation, and automatic reporting.

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