Water quality is an important consideration in all stages of medical device reprocessing with the primary objective of ensuring that surgical instruments and medical equipment are properly cleaned, disinfected and sterilized. Various minerals and contaminants commonly found in tap water can adversely affect this process. This can lead to the following consequences occurring during the central sterilization process:
- Instrument pitting/corrosion/staining
- Mineral scale build-up
- Reduced detergent performance
- Biofilm formation/increased microbial & endotoxin load
Contaminant related issues can negatively effect the performance of sterile processing equipment. This translates to costly rework, replacement costs, and increased risk such as:
- Repeat loads/cycles
- Reduced longevity of instruments and medical devices
- Reduced performance and longevity of reprocessing equipment
- Potential patient risk due to biofilm formation/microorganism entrapment in damaged instruments
Water Purity Requirements for Medical Device Reprocessing
The Association for the Advancement of Medical Instrumentation (AAMI) publishes a comprehensive Standard called ST108 - Water for the processing of medical devices, to provide education and guidance to healthcare personnel. This document provides requirements for the quality of water that should be used in each stage of medical device reprocessing, for each category of medical device. Specifically, AAMI ST108:2023 includes the following information:
- Quality of water needed to appropriately clean, rinse, disinfect and sterilize medical devices
- Definition of water types based on hardness, pH, microorganism levels, endotoxin levels and other characteristics
- Annexes with technical details pertaining to water treatment and monitoring
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