In the ever-evolving field of medical device reprocessing, staying abreast of the latest standards is crucial. Recently, the Association for the Advancement of Medical Instrumentation (AAMI)—an organization dedicated to advancing safety in medical technology—replaced its earlier recommendation, TIR34, with a new national standard titled AAMI ST108: Water for the Processing of Medical Devices. This update is not just a change in nomenclature from “reprocessing” to “processing,” but represents a significant shift in the industry’s approach to medical device sterilization and reprocessing water.
AAMI ST108 essentially codifies what has been recognized as best practices for more than a decade in feeding medical sterilizers and reprocessing water. This new standard underscores a more stringent approach, particularly focusing on the reduction of organics, bacteria, and endotoxins. Such enhancements in requirements are reflective of a growing emphasis on patient safety and equipment efficiency within the medical community.
Notably, AAMI ST108 brings forth specific updates and requirements, including maintaining the 0.1 megohm-cm water quality requirement and placing more emphasis on controlling bacteria/endotoxin and total organic carbon (TOC). The standard also highlights the necessity of addressing specific contaminants, stipulating requirements such as recirculation with disinfection (avoiding direct feed), exclusive use of cone-bottom tanks, specific recirculation rates, and the setup of reverse osmosis (RO) systems for effective cleaning and disinfection. Additionally, it advises against the sole use of deionization (DI) for treatment due to bacteria concerns and recommends monthly loop disinfection.
Water Control Corporation (WCC) is fully equipped and prepared to meet these new standards. Their team of skilled engineers and fabricators is adept at designing and constructing water treatment systems that are compliant with ST108. They focus on delivering systems that not only meet but exceed these new rigorous standards, ensuring the highest level of safety and efficiency in medical device processing.
To understand more about how reverse osmosis and RO systems play a crucial role in complying with these new standards, WCC invites you to explore further. For those interested in delving into the specifics of AAMI ST108, the standard is available for purchase on the AAMI website. Rest assured, with WCC, you are in capable hands for aligning with the latest advancements in medical device processing standards.
Source: Water Control Corporation