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Introducing RapidCert™ Biological Indicator (BI) Sterility Testing — Nelson Labs’ patent-pending solution for quicker sterility confirmation. Learn More
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Author: Lise Vanderkelen





September 28, 2021

Can you randomly choose analytes to use as end-points for the cleaning validation of a reusable device?

The FDA guidance on reprocessing medical devices in health care settings: validation methods and labeling states, that when performing cleaning validations, the artificial test soil that is chosen should allow for at least two clinically relevant soil components to be...

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September 15, 2021

Under what quality system should your reprocessing validation be performed?

ISO 17664[1] and ISO17664-2[2] clearly state that all reprocessing instructions provided in the Instructions For Use (IFU) document must be validated; and FDA[3] as well as other guidance documents provide information on how these validations should be performed. However, that...

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September 8, 2021

Are you required to perform reprocessing validations for all your devices?

It is important that all reprocessing instructions included in the Instructions For Use document are validated to ensure patient safety and minimize healthcare-acquired infections; however, validating the reprocessing instructions for every device is a costly affair. Luckily, when an array...

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September 1, 2021

What should you consider when choosing a chemical disinfectant for your reusable device?

Choosing a chemical disinfectant will depend on a combination of considerations with regards to the reprocessing instructions, location of the users, possible adverse effects on biocompatibility/patient safety and device materials. Reprocessing instructions A first consideration when selecting the proper disinfectant...

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August 25, 2021

Can manual cleaning and disinfection be combined into a one-step process?

ISO17664:2017[1] notes that disinfection can be carried out concurrently with manual cleaning of a medical device but does not provide any additional guidance. On the other hand, FDA specifies that cleaning steps should be validated separately and independently from disinfection...

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