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Time to Reclassify Noncriticial, Non-Patient-Contacting, Reusable Medical Devices?

Published In: Biomedical Instrumentation & Technology

The industry currently is lacking sufficient guidance from regulatory bodies regarding the disinfection requirements for non-patient-contacting, noncritical medical devices or equipment. A more practical disinfection level is needed – one that represents the actual use and probable contamination of these products. Because not all noncritical devices fit into the same contamination level category, evaluating these devices under one umbrella has posed considerable challenges in terms of disinfection validations.

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Authors: Alpa Patel and Griffin D. Cammack

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Alpa Patel

Alpa Patel

Director of Scientific Improvement and Reprocessing Expert

Alpa Patel is a certified microbiologist and has been part of the medical device industry for 20 years specializing in cleaning/disinfection and sterilization of reusable medical devices, endoscopes and validation of tissue disinfection or sterilization processes. Her current role as a Director of Scientific Improvement at Nelson Labs involves overseeing test method validations for reprocessing,...