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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

Senior Scientist, RM (NCRM)

Alpa Patel is a certified microbiologist, RM(NRCM) with the National Registry of Certified Microbiologists and has been with Nelson Laboratories, Inc. since 2003. Currently, she is a senior scientist at Nelson Laboratories, and was a department scientist and a study director over Cleaning, Disinfection, Sterilization and tissue process validations from 2004-2010.