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Reprocessing

July 28, 2021

When do you need a drying step?

ISO 17664[1] specifies that ”where drying is necessary, at least one verified drying method shall be specified.” FDA provides more detailed information on the importance of drying steps following different stages of processing[2] as outlined below. One important merit of...

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July 15, 2021

Which of the following cleaning procedure rinses are important?

Initial rinse The first step in the cleaning process is often a rinse with cool utility water to remove any remaining gross (large) debris from the medical devices[1]. This is an important step given that many organic soils, including proteinaceous...

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July 8, 2021

How Do You Select a Correct Artificial Test Soil for Cleaning Validations?

Validating a cleaning procedure starts with selecting an appropriate artificial test soil that is representative of the worst-case challenges that are expected in clinical use for the device being evaluated[1],[2]. Various artificial test soils exist that have been developed to...

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July 2, 2021

Should simulated use testing always be a part of your reprocessing validations?

Simulated use is defined as “use that mimics the intended use of the medical device”[1]. In guidance documents such as the AAMI TIR12:2020[2] or AAMI TIR30:2011[3] simulated use testing often refers to test soil selection, specifying that “the test soil...

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June 25, 2021

Is there a difference between treatment at point of use and pre-cleaning instructions?

Instructions for use (IFU) documents can come in many different shapes and sizes and looking at these documents, the term “pre-cleaning” may pop up several times at different stages of the reprocessing instructions. Instructions are sometimes termed pre-cleaning when explaining...

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