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Reprocessing

June 7, 2021

A General Overview of Requirements for Marketing Topically Applied Skin Antiseptics in the United States

The importance of topically applied skin antiseptics was first recognized and demonstrated by Ignaz Semmelweis in the mid-1800s when he first proposed handwashing with chlorinated lime by physicians.  Since that time, use of skin antiseptics has become an important tool...

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May 27, 2021

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

Choosing a detergent will depend on a combination of three considerations: the device materials, the users, and the cleaning procedure. Reprocessing instructions When selecting a detergent, it is important that the label claim of the cleaning agent you wish to...

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May 19, 2021

What kind of terminal processing step should be in place after cleaning?

FDA’s guidance on reprocessing re-usable medical devices[1] indicates that in addition to reprocessing instructions that allow for thorough cleaning, an appropriate microbicidal process should be in place. Which terminal processing step should be included will depend on the device’s potential...

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May 11, 2021

I Have an Automated Cleaning Program, Should Thermal Disinfection be a Part of my Reprocessing Validations?

Before looking into the validation requirements of thermal disinfection, let’s first go a bit more into what thermal disinfection is and why you should consider having a thermal disinfection procedure in place. What is thermal disinfection? Thermal disinfection is defined...

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May 5, 2021

What Cleaning Procedure Should You Have in Place For Your Reusable Device?

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...

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