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AAMI ST108 Water Standards – Prepare your Sterile Processing Department

Start Planning Now to Update Water Systems for Medical Device Sterilization

AAMI ST108 Water Standards: Water for the Processing of Reusable Medical Devices advances will finalize the guidance contained in AAMI TIR34.  Patient health doesn’t solely rely on the outcome of a surgical procedure, but also upon the sterile water treatment, cleanliness of the operating room and instruments used. Water quality could be the single most important factor for proper sterilization of surgical instruments. New guidelines issued by the Association for the Advancement of Medical Instrumentation (AAMI) reemphasize the importance of high purity water for sterilization purposes. 

One possible change is that the new standard may eliminate direct feed systems, and instead requires a recirculation loop that passes through a final filter to purify the water from bacteria and endotoxins. The water quality standards could also include testing requirements found in AAMI TIR34. This single change could require significant overhaul of current sterile water treatment systems in existing medical facilities and surgical centers. The question is, are you ready? And what do you need to do to prepare for the new AAMI ST108 water standards? 

Facilities Impacted By New AAMI ST108 Standard

The new standard, anticipated to come into effect in the summer of 2023, details steps and requirements related to water system design, monitoring, testing and system maintenance. The standard will impact any medical facility conducting surgical procedures with instrumentation that requires sterilization. This includes major medical facilities, hospitals, ambulatory surgical centers (ASCs) and doctors’ offices that perform outpatient or same-day surgeries.   

In total, potential surgical centers impacted by this standard number in the thousands. The number of surgical procedures conducted within these facilities in 2021 equaled more than 23 million, for a market size that totaled 36.96 billion in 2021—with the Covid-19 pandemic blamed for substandard growth over an 18-month period.  What these settings cannot afford is substandard water treatment systems that could shut them down, based on this updated guidance for instrument sterilization.   

Sterile Water Treatment System Goals For Sterilization Processes

The sterilization processes involve moist heat, a prime environment for proliferation of gram-negative bacteria. Proper treatment yields high purity water with low levels of endotoxins and appropriate chemical and microbiological levels.   

Water can vary from one geographic location to another and even can exhibit variances due to changing seasons.  High purity water begins with distilled, reverse osmosis (RO) or deionization, but gram-negative bacteria and mycobacteria can grow in any type of water, including deionized, distilled and RO treated water. Beyond human health risks and concerns, the surgical instruments themselves can suffer damage from water’s mineral content—all conditions that can be mitigated and controlled through proper water treatment systems and maintenance. 

What Changes Under The New Standard 

AAMI Standard 108 or ST108 is designed to replace the technical information report AAMI TIR34. It is anticipated to clarify minimum requirements for the appropriate grades of water used at different points in the reusable medical device processing sequence. These minimum requirements will help ensure successful cleaning, disinfection, and sterilization of devices to minimize the chance of surgical site infections.   

Some facilities use service steam from ordinary boilers to sterilize instruments. Technical documentation indicate that this type of steam will most likely not be of sufficient quality for equipment sterilization. Instead, a closed loop high purity water system will centralize the sterile water supply.   

ChemREADY can design a system compliant with AAMI ST108 that provides the most advanced system available in the marketplace when selecting the optional facilities management communications package. The stainless steel GRUNDFOS multi-stage reverse osmosis (RO) pump with an integrated SS recirculation pump handles up to 30 GPM@40 PSI for recirculation at 3 feet per second (velocity recommended by the Copper Tubing Institute). Some features:  

  • Pretreats water using reverse osmosis  
  • Recovers 40-75% of water for less waste  
  • Occupies minimal floor space 
  • Runs on dedicated 115 Volt 20-amp circuit  
  • Requires less maintenance (chlorine destruct/antiscalent related to the Optional Integrated Pretreatment Injection) 
  • Easy hose connection setup in minutes 

AAMI representatives themselves said that of all the factors involved in instrument sterilization, the water quality is probably the most underestimated. Representatives stated that the best trained staff in the world cannot overcome poor water quality. They pointed out that technological advances for surgical procedures have created increasingly complex devices leading to instrumentation that presents an even greater challenge to clean and sterilize.   

The standards establish sampling and sterilization requirements for the system. The closed system will need monthly monitoring to look for traces of bacteria and endotoxins. A system that does not fall within acceptable limits for contamination will need to recalibrate and test again, until water quality meets acceptable standards.

What Can Happen If These Systems Aren’t Implemented Properly Or On Time?  

When a pack of surgical instruments is sterilized, the team tests it for cleanliness. If it fails to pass the test, the facility is not allowed to perform surgeries that day. In fact, surgery is shut down until the water quality within the sterilization system can meet minimum standards.   

Working with a reputable, experienced chemical service provider is one of the best safeguards against failed test results. ChemREADY water technicians have assisted surgical centers when poor water treatment quality led to shutdowns that have lasted as long as six weeks. That time period represents hundreds of thousands in lost revenue, not to mention the incalculable long-term damage to a facility’s reputation.  

The Joint Commission measures the impact of compliance with standards and specifically, sterilization issues. In one of its Quick Safety bulletins, the commission called improper sterilization a growing problem and pointed to ambulatory care sites, such as office-based surgical facilities and decentralized hospital locations as particularly noteworthy in terms of non-compliance.   

Risks range from adverse impact on patient health, otherwise termed an immediate threat to life (ITL), to lost business, potential loss of Joint Commission accreditation and litigation, among other concerns.

The Clock Is Ticking 

Medical facilities that perform surgical procedures will need to coordinate new system installation with a water treatment specialist and a mechanical contractor. ChemREADY can provide the equipment, water management plants, testing services and remediation if necessary for both the central sterile system and potable drinking water if tests return out of range of acceptable specifications.   

It can take time to plan and budget the necessary funds for a project of this magnitude. However, the initial system installation will require additional piping to create a closed system via a return loop for the water, requiring installation by a mechanical contractor.   

The amount of additional piping required will vary depending on the hospital design and the distance between the water source and the sterilization area. While lead times vary, mechanical contractors might not have availability for several months.  

Extensive project planning will need to work around the interruption to surgical services necessary during system installation. Complete system installation including testing could take a week or more.

Legionella And Other Waterborne Pathogens 

Centers supplying Medicaid and Medicare services are required to have a water management plan in place for Legionella and other waterborne pathogens. The water management plan includes verification and validation steps and the only way to validate a plan is through Legionella testing.  

A provider like ChemREADY has years’ worth of experience providing comprehensive services for Legionella detection and water system treatment, including assessment, testing, management and disinfection. This enables medical facilities to work with a single provider for existing testing and treatment as well as compliance with the new AAMI ST108 water standards for bacteria and endotoxins.   

Trust A Company With Medical Industry Experience 

ChemREADY is an experienced provider of sterile water treatment solutions for medical facilities of all types, and able to provide a complete system evaluation, recommendations and the equipment and treatment necessary to help prepare for the upcoming AAMI ST108 water standards. Sample detailed drawings and design specifications for Central Sterile Water Systems can be found here. ChemREADY technicians will work with your staff to design and monitor a central sterile water system that fits within the facility’s space and serves the needs for sterilization. 

Don’t get caught in a last-minute rush to meet new standards for surgical instrument sterilization. Protect patients, preserve the quality of surgical instruments, and maintain standards for accreditation with early compliance. Call ChemREADY today to schedule your site assessment and begin planning your strategy to meet the latest hygienic standards for surgical instrument sterilization.   

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