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Sterile Processing Water Management Program for AAMI ST108 Compliance

Be ready to show control of sterile processing water

Acute care hospitals are increasingly expected to demonstrate how sterile processing water is defined, monitored and managed. With AAMI ST108 and evolving Joint Commission expectations, teams need a clear, documented and defensible approach.

When gaps in visibility, ownership or documentation exist, Nalco Water helps move teams from uncertainty to a defined, visible program that supports consistency and survey readiness.

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AAMI ST108 is raising expectations

ANSI/AAMI ST108:2023 establishes a new framework for how water in medical device processing is managed, monitored and documented.

Facilities are expected to:

  • Define water categories and use points
  • Routinely monitor water quality
  • Maintain documentation to demonstrate control
  • Take consistent action when results fall outside expectations

At the same time, Joint Commission surveys can occur within unannounced windows, with ongoing preparation and real impact to operations and accreditation.

Bottom line: teams must be ready to prove control at any time.

 

Where the Gap Shows

Across Infection Prevention, SPD and Facilities teams, gaps in visibility, ownership and documentation make it difficult to consistently monitor water quality, respond to issues and demonstrate control during audits.

 

Presenting a Defined Program for Sterile Processing Water 

Nalco Water provides a structured water management program that helps bring clarity and consistency to sterile processing. With defined protocols for testing, monitoring, documentation and response, teams gain the visibility and alignment needed to support AAMI ST108 expectations and survey readiness.


Featured Program Offerings for Sterile Processing

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Water Management Program for Sterile Processing 

  • Risk assessment and program design
  • Verification and validation protocols
  • Ongoing program review and optimization
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Analytical Testing Services 

  • Follows sampling protocol of water management plan
  • pH, conductivity, hardness, TOC and metals
  • Microbiological testing including HPC and endotoxin
  • Routine and performance qualification testing
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Water Purification Equipment and Services

  • Systems designed to meet AAMI ST108 specifications
  • Preventive maintenance and 24/7/365 support
  • Service for existing equipment
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How the Program Supports Compliance and Operations

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Compliance, risk and documentation

  • Supports alignment with AAMI ST108 expectations
  • Helps strengthen documentation for survey readiness
  • Helps reduce risk tied to water-related variability
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Operations, visibility and alignment

  • Enables more consistent water quality management
  • Supports operational efficiency in sterile processing
  • Provides visibility into water used in instrument reprocessing
  • Aligns Sterile Processing, Infection Prevention and Facilities teams 

FAQs

What Do Surveyors Look for in Sterile Processing Water Programs?

A. Surveyors generally look for traceability and consistency. They often look for a clear line from water system design to point-of-use in the processing of reusable medical devices, with defined sampling, limits and repeatable response actions. The focus is on whether the process is understood and consistently followed.

A. Gaps often show up at the point of use. Water treated upstream may not be verified consistently where it’s used in instrument reprocessing. Other breakdowns include inconsistent sampling, unclear ownership across teams and limited visibility into performance over time.

A. ST108 outlines a more structured, risk-based approach. It includes defining water types (utility, critical, steam), establishing baseline data and moving to routine chemical and microbiological testing. It also drives closer coordination across SPD, Facilities and Infection Prevention.

A. Water should be fit-for-purpose at the point of application (final rinse, ultrasonic cleaning or steam). This typically includes defined sampling locations, consistent testing protocols and visibility into water quality where devices are processed.

A. Teams may be asked to produce a clear, end-to-end record of their program, including water management plan, sampling schedule, test results, excursions and documented response actions. Surveyors are looking for continuity over time and evidence the system remains in a state of control.

A. Many teams know they need to prove control, but don’t yet have a clear, connected way to do it. The pressure comes from survey readiness, unannounced reviews and the need to align a multidisciplinary water management team around a single, defensible approach.

A. Critical water is used in final rinse and other high-risk steps in medical device reprocessing. It is generally held to tighter quality specifications and should be monitored consistently for fitness for use at the point of application.

Move from reactive to ready

Sterile processing water is under increased scrutiny—and expectations are rising.

Nalco Water helps you implement a defined program with the testing, documentation and visibility needed to support consistent outcomes and demonstrate control when it matters most.

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