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We and our partner, SMP GmbH, were heavily involved in the development and publication of the German Guidelines for Washer Disinfector validation. This document, which we find to be very useful is available for download here. Zentral Sterilisation
Among other important updates to ANSI/AAMI ST8 and ST24—two vital standards related to hospital sterilizers—the focus has been shifted away from the equipment to an increased emphasis on process, performance requirements, and equipment safety. This shift will afford manufacturers increased room for product innovation. Committee work on both ANSI/AAMI ST8, Hospital steam sterilizers, and ANSI/AAMI
Correctly cleaned instruments are a necessity for safe reprocessing and delivery of sterile items for patient use. In this paper, we explore the application of validated techniques of reprocessing to ensure proper cleaning, as well as methods of in-house verification of the cleaning process using commercial and do-it-yourself solutions, and suggested frequencies for those
Hospitals are under continual pressure to improve turnaround times for surgical procedures and to find ways to release sterilized product without the need to wait for biological indicator (BI) results. Current procedures used in healthcare do not allow for release of sterilized products based on parameters because hospitals do not validate their sterilization processes.
Given the recent events on Florida’s Gulf Coast, thanks to Hurricane Ian, and other water supply issues in Jackson, Mississippi, and even Baltimore, it’s time for me to climb down from the ivory tower of scientific purity and get my hands dirty and feet wet like we all have to do when things like
One of the things that I enjoy doing (although I don’t get paid for it, so what exactly is wrong with me?) is participate in the AAMI Standards Making Process. I have been, and continue to be, very involved in the development of the replacement for AAMI TIR34:2014 “Water for the reprocessing of medical
In three previous articles for NewSplash, I talked about installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ). In this article we go from those first principles to hands-on execution of these activities. This specific application is for a washer-disinfector.Installation qualificationHere’s the nitty gritty: IQ involves cataloging the state of the equipment delivered to
Wilder’s First Law of Sterile Processing: Each step of the processing should almost make the next steps unnecessary. Wilder’s Second Law of Sterile Processing: Cleaning’s goal is to get to zero residual soil. Background Washers (washer-disinfectors, ultrasonics) are only as good as they are measured to be. AAMI ST79:2017 sections 126.96.36.199 and Annex D recommend
Installation Qualification: Step One in Ensuring Reliable, Predictable Operation of Your SPD Equipment
“Wherever you go, well, there you are.”—Confucius (or Buckaroo Banzai) “How did I get here?”—David Byrne of Talking Heads In my previous article for NewSplash, “The Nuts and Bolts of a Quality System,” I wrote about the three aspects of equipment qualification: Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). This article
Operational Qualification: Step Two in Ensuring Reliable, Predictable Operation of Your SPD Equipment
“When all else fails, read the manual.”—Jonathan A. Wilder In one of my previous articles for NewSplash, “The Nuts and Bolts of a Quality System,” I wrote about the three aspects of equipment qualification: Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). This article is a deeper dive into the second of