May 5, 2021
ISO17664:2017 provides guidance on this issue and states that “At least one validated automated cleaning method (which may include a validated manual cleaning method as part of the automated cleaning validation) shall be specified unless the medical device cannot withstand...
See BlogApril 2, 2015
Every year Nelson Laboratories tests and validates thousands of medical devices. One particular family of reusable medical devices, endoscopes, can present unique challenges for manufacturers and healthcare reprocessing facilities. Responding to recent attention on reusable endoscopes, particularly the reusable duodenoscopes...
See BlogOctober 15, 2014
Nelson Laboratories, Inc. Alpa Patel, senior scientist in healthcare reprocessing, presented at the annual American Association of Tissue Banks (AATB) meeting last month on the topic of Equipment Cleaning and Disinfection Validations, something she calls, “the tissue industry’s compliance challenge.”...
See BlogMay 15, 2014
Department Scientist-Healthcare Reprocessing I recently attended the 10th Annual FDA and Changing Paradigm for HCT/P Regulation Conference, with my colleague Wendy Wangsgard, Department Scientist, Bioburden. We presented topics of interest that have surfaced the validation realm, in addition to learning...
See BlogMay 14, 2014
On April 14-16, 2014, I attended the Association for the Advancement of Medical Instrumentation (AAMI) semi-annual Sterilization Standards Meeting. These Association meetings, and the standards discussed during them, have a major impact on medical device manufacturers, testing facilities, HCF managers,...
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