Automated Washer/Disinfector Cycles for Validation of Processing/Reprocessing of Medical Devices

Automated washer/disinfector cycles are performed to validate that reusable medical devices are effectively cleaned and disinfected before reuse. This process confirms that automated systems meet regulatory expectations for removing contaminants and reducing bioburden. Validation includes simulating worst-case conditions and verifying that the device remains safe and functional after repeated processing. It supports manufacturers in providing scientifically backed instructions for reprocessing, which are essential for regulatory approval and clinical safety.

Why This Test is Performed

Validation of automated cleaning and disinfection cycles is critical to ensure that reusable medical devices are safe for patient use after reprocessing. It verifies that the washer/disinfector can consistently remove soil and microorganisms, preventing infection and maintaining device integrity. Regulatory bodies require validated instructions to protect healthcare personnel and patients from residual contamination and to ensure device performance over its intended life cycle.

Have you tried our Test Navigator Tool? Try it now

Steps in Conducting This Test

1. Define Product and Process: Identify device design, materials, and contamination sources.
2. Simulate Soiling: Apply test soils to mimic clinical contamination.
3. Run Automated Cycle: Use washer/disinfector under worst-case conditions (e.g., low detergent concentration, high load).
4. Measure Cleaning Efficacy: Analyze residual soil markers and bioburden reduction.
5. Verify Disinfection: Confirm microbial log reduction meets required levels.
6. Assess Device Integrity: Ensure device remains functional and undamaged after multiple cycles.

Standards, Guidance, and Regulations

• AAMI TIR12: Technical information reports on medical device processing and validation.
• ANSI/AAMI ST58: Chemical sterilization and high-level disinfection guidelines.
• ANSI/AAMI ST98: Requirements for development and validation of a cleaning process for medica devices.
• ISO 17664-1 and ISO 17664-2: Information to be provided by the medical device manufacturer for the processing of medical devices.
• FDA Guidance (2011, amended 2017): Outlines expectations for validating reprocessing instructions, including worst-case testing, soil removal, and microbial reduction. It also emphasizes the need for clear labeling and instructions for healthcare providers to ensure safe and effective reuse of medical devices.