Water, water everywhere—and all of it eligible for survey!
For those of you keeping tabs on the regulatory landscape, you might already know that the Association for the Advancement of Medical Instrumentation (AAMI) has initiated a new standard—ST108—that defines levels of water quality suitable for various stages of medical device processing, with the ultimate goal of making those devices safe for patients. The intent is for the standard to apply to water provided to automatic endoscope reprocessors, ultrasonic sterilizers, autoclaves, and local steam generators. Over the years, I’ve seen any number of issues in which the quality of the water/steam used for device processing has negatively impacted those devices—pitting, staining, etc. and this very much speaks to the potential impact of water quality and device processing/reprocessing. As this all started about a year ago (August 2023), there’s been more than enough time for folks to mull this over. But who might be doing that mulling?
As a general thought, we know that our friends in the regulatory oversight business (i.e., CMS, the various accreditation organizations, etc.) are always keen to embrace what are oft described as best practices, and I have a sneaking suspicion that this will be adopted by the noted regulatory cabal. To a fair degree, this is very much an extension of the water management plan (it is, after all, an aspect of water that would require management) and the standard itself recommends that this should be managed by the same team that oversees your water management program. So, not a reinvention of the wheel structure-wise, but the compliance and testing aspects are somewhat more rigorous than to what you may be accustomed.
Fortunately, the good folks at HCInfo have put together a video to help explain the requirements and to get you started on the road to compliance. Per usual, I think you’ll find the information presented to be fairly compelling (there can’t be too many organizations left in which devices are not processed/reprocessed) and easy to understand. I think the barriers are not going to be so much the understanding as the complexity of the requirements, particularly in the area of testing, but you’ll find some good ideas on managing that when you view the video.
About the Author: Steve MacArthur is a safety consultant with The Chartis Group. He brings more than 30 years of healthcare management and consulting experience to his work with hospitals, physician offices, and ambulatory care facilities across the country. He is the author of HCPro's Hospital Safety Director's Handbook and is an advisory board member for Accreditation and Quality Compliance Center. Contact Steve at stevemacsafetyspace@gmail.com.