In sterile processing departments (SPDs) around the world, there are countless tools, instruments, and machines that keep the standard of patient safety at its highest level. These implements are a valuable part of a hospital’s inventory, and taking care of them is paramount to long-term safety and success as technology and patient needs evolve. But there’s one resource that often goes unnoticed, as it seemingly flows freely in the background of daily tasks while being crucial to operations.
Water: inexpensive, readily available, and magical in its ability to change states and serve a powerful purpose. There’s a case to be made that water is, in fact, one of the most important resources SPDs have in their arsenal against infection. In the context of ST108, water quality isn’t just about general facility operations – it’s directly tied to medical device reprocessing, where consistent purity is critical for preventing contamination and ensuring compliance. With the implementation of ANSI/AAMI ST108:2023, water (and water quality as it relates to sterilization and infection prevention) is finally getting its time in the spotlight.
With SPDs facing increasing regulatory scrutiny on multiple fronts, the release of ST108 marks a pivotal shift in how healthcare facilities must manage water quality. As research and evidence coalesce, ST108 introduces binding standards that warrant proactive processes, calculated infrastructure, and strategic investment. For SPD professionals navigating this transition, understanding the risks of outdated systems and the benefits of future-ready solutions will ensure long-term success.
Why ST108 Compliance Is Non-Negotiable
Through peer-reviewed collaboration and wisdom from the frontlines of sterile processing in the U.S., ST108 burst on the scene to replace the advisory standards of TIR34. Welcome to the age of enforceable requirements for water quality in medical device reprocessing, and though it might not seem as exciting or impactful as shiny new washer technology or scope science, the stakes are higher than many might think. Quality water is critical in the fight against biofilm buildup, thorough instrument sterilization, and departmental efficiency.
With that in mind, compliance on ST108 isn’t just about adopting new standards. It’s about safeguarding patient safety, ensuring operational continuity for healthcare facilities of all shapes and sizes. Downtime from water-related failures can also carry huge financial risks, with published research showing facilities can lose millions of dollars in lost revenue if sterile processing is forced offline. Beyond the financial impact, cancelled operations and increased patient waiting times can create significant disruption for both staff and patients, further underlining the importance of proactive compliance.
The Hidden Costs of Legacy Systems
There are still many facilities that rely on low-temp, chemical-dependent water purification systems. These outdated plants often require manual intervention by techs, vendors, or repair services and come with increasing sustainability concerns over time. Most importantly, they fail to meet ST108’s water purity benchmarks.
While many healthcare facilities choose incremental upgrades to save on costs in the short term, these ‘upgrades’ can act as bandages on much larger vulnerabilities, leading to costly repairs, decreased efficiency, and exposure to regulatory risk. Short-term fixes also fail to address redundancy, leaving facilities exposed if critical components lack duty/standby backup (e.g., pumps, RO modules, distribution heaters, UV, and final endotoxin barrier filters).
Thinking Through the Investment Cycle: CAPEX, OPEX, and TOTEX
When evaluating facility needs and water purification solutions, focusing solely on upfront cost (CAPEX or Capital Expense) can be misleading. True value lies in understanding these key lifecycle concepts:
- CAPEX: Initial investment in equipment and installation
- OPEX or Operating Expense: Ongoing costs like energy, maintenance, and labor
- TOTEX or Total Expense: The total cost of ownership over the system’s lifecycle
Outdated systems stretch a facility’s OPEX through inefficient methods and costly resource consumption.
As healthcare professionals seek a better way to manage water quality, hot water thermal sanitization is gaining traction in the U.S., building on its track record as a proven global approach to compliance. Systems like EndoTherm, built on established RO technology, help minimize TOTEX through automated thermal sanitization (hot water disinfection) and reduced downtime.
Free and Clear: A Path Forward
This is where Envirogen’s EndoTherm Reverse Osmosis (RO) water purification range comes in, a solution that touts proven, full-scale performance for sterile processing water purification. In compliance with similar quality standards in the UK since 2008, EndoTherm uses continuous hot-water recirculation with thermal sanitization to ensure consistent, high-quality water without the need for harsh disinfectants or other chemicals. The Endotherm system enables benefits like:
- Deliver faster processing cycles and improved throughput
- Lower long-term operational costs and enhance reliability
- Reduce staff risk and operational burden from chemical handling and disposal
- Achieve sustainability gains through the elimination of chemicals, lower carbon footprint, and alignment with green hospital initiatives
Real-Time Monitoring with IXON Cloud
Additionally, Envirogen’s EndoTherm systems are equipped with IXON Cloud, a secure remote monitoring platform that offers unparalleled access to real-time data and customizable notifications based on specific needs. IXON Cloud provides timely system insights, automated logging, and predictive maintenance alerts, allowing technicians to identify and address potential issues before they arise. The IXON difference lies in how it enables remote diagnostics and adjustments, thus reducing potential downtime and minimizing the need for on-site, manual interventions.
IXON Cloud also puts facilities at ease by including critical cybersecurity and compliance reporting features to help SPDs remain aligned with ST108. Automated logging and traceability features mean facilities can produce audit-ready reports on water quality performance, reinforcing compliance and infection prevention.
Strategic Compliance Starts Now
ST108 compliance is not a checkbox on a daily list; it’s a strategic imperative that begins with an essential water purification resource. Facilities that invest in future-ready solutions like the EndoTherm RO water purification range, position themselves for long-term success, regulatory assurance, and optimal operational efficiency. Smarter systems combine hot water thermal sanitization, built-in redundancy, secure data management, and lifecycle cost advantages, ensuring SPDs remain compliant and resilient. As the healthcare landscape evolves, proactive investment and implementation in systems like EndoTherm will help keep the focus on patient safety and operational excellence for years to come.
Schedule your FREE AAMI ST108 Consultation
Ensure compliance with ST108 with confidence. Envirogen’s team of experts specializes in water purification solutions for hospital and healthcare facilities. Take advantage of a complimentary initial consultation to assess and optimize your water treatment systems, including the proven EndoTherm range of solutions, guaranteeing seamless adherence to ANSI/AAMI ST108:2023 Water for the processing of medical devices.
Request a Copy of Envirogen’s Whitepaper
Visit Envirogen’s webpage to request our whitepaper: Building Future-Ready Water Purification Systems for Sterile Processing.