infection prevention
infection prevention
By Hillary Hei , MPH , CIC , LSSGB , FAPIC
Going with the Flow : AAMI ST108:2023 and What to Know
The transition from AAMI TIR34:2024 to AAMI ST108:2023 is an evolution in water quality standards for the processing of medical devices , shifting from advisory best practices to enforceable standards . This new standard is a comprehensive approach to ensure water quality and steam purity with proper design , monitoring , testing , and maintenance . Here is a summary of the key changes and requirements in AAMI ST108 for healthcare :
Multidisciplinary Water Management Team
One of the most significant changes is the requirement for healthcare facilities to establish a multidisciplinary team responsible for water quality and the water management program . The team can be comprised of internal or external partners and should have representatives of the following disciplines , including but not limited to senior organizational leadership , facilities engineering , infection prevention and control , medical device processing , clinical engineering , surgical suite / procedure room personnel , and water treatment . This team is responsible for developing , implementing , and documenting all parts of the water management program . This multidisciplinary team of diverse roles ensures a comprehensive approach to water management and ultimately ensuring patient safety .
Categories of Water Quality and Criteria AAMI ST108 expanded the categories of water quality for medical device processing to include :
● Utility Water : This is water from the tap that may require further treatment . It ’ s used for flushing , washing , and initial rinsing of medical devices .
● Critical Water : Extensively treated water to ensure the removal of microorganisms , inorganic , and organic materials . It ’ s used for final rinse or steam generation .
● Steam : Water heated to vapor phase , used for sterilization of medical devices .
The standard also lists water quality parameters for all three categories , including pH , alkalinity , bacteria , endotoxin , and ionic contaminants .
Water System Design
AAMI ST108 places strong emphasis on proper water system design . The system should be appropriate for the specific needs of the facility , with proper installation , operation , and performance evaluations as necessary components . An expert in water treatment and knowledge of local feedwater conditions is essential for planning the configuration of the water system . Facilities may need to further treat municipal feed water to produce utility water , including particulate filtration and some form of softening . The goal of treating utility water is to prevent scale formation and ensure adequate pH levels for compatibility with cleaning agents . To produce critical water , required water systems can include reverse osmosis ( RO ), deionization ( DI ), electrodeionization ( EDI ), and distillation . These systems are used to extensively treat the water to remove all microorganisms , inorganic , and organic contaminants . Lastly , the standard emphasizes a validation plan of the installed water system , including creating and conducting operational protocols .
Ongoing Water Monitoring and Maintenance
AAM ST108 introduces more stringent testing and monitoring requirements to maintain the integrity of the water treatment system . Table 4 in ST108 is a guideline for monitoring requirements , while Table 5 provides a minimum frequency of testing . The primary accountable party for monitoring water quality is the facility ’ s engineering / water maintenance personnel , but sterile processing staff should be aware of water quality monitoring and its implications when testing does not meet certain thresholds . Contaminated water used in processing instruments can contribute to corrosion , staining , and elevated risk of microbial transmission . To prevent these adverse effects , frequent monitoring and continuous quality improvement ensures that water quality is maintained and does not deteriorate over time . Lastly , this standard emphasizes the need for maintenance protocols during emergency circumstances , such as extended service interruptions or boil water advisories .
Considerations for Healthcare Facilities The adoption and implementation of AAMI ST108 is a vital step toward improving efficacy and efficiency of water used in medical device processing and ultimately ensuring patient safety . Considerations for Infection Preventionists include partnering with facilities to understand current water treatment systems and the maintenance of these systems . Laboratory testing can assess the current quality of water used for processing , and regular audits and monitoring can assist in continuous improvement . Existing water management plans will need to be amended to incorporate new or revised policies and procedures , and all relevant personnel will need to be educated . Lastly , facilities may need to invest in infrastructure , such as upgrading or installing new water treatment systems . Failure to implement proper water systems may result in risk of non-compliance with Joint Commission standards , inability to perform surgery dues to failed sterilization tests , or patient health risks due to improperly sterilized or malfunctioning equipment .
In conclusion , AAMI ST108:2023 provides a significant advancement in water quality standards for medical device processing . Infection preventionists and other key stakeholders must familiarize themselves with these new standards and take proactive steps to ensure compliance , which may involve significant updates to existing water treatment systems and processes .
Hillary Hei , MPH , CIC , LSSG , B FAPIC , is a senior infection preventionist with ECRI , an independent , nonprofit organization improving the safety , quality , and cost-effectiveness of care across all health care settings worldwide . ECRI infection preventionists provide insights on topics of interest in infection prevention and control , environmental services , and sterile processing services to help advance worker and patient safety .
Reference :
ANSI / AAMI ST108:2023 . Water for the processing of medical devices . AAMI , Arlington , VA . 2023 .
10 • www . healthcarehygienemagazine . com • october 2024