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Author: Jason Pope





February 22, 2022

Reusable Advices For Reusable Medical Devices eBook

Ensuring that reusable medical devices can be properly cleaned, disinfected, and/or sterilized is imperative to ensure patient safety and to minimize healthcare-acquired infections, corrective actions, and recalls. Regulatory agencies and healthcare facilities are increasingly concerned about the spread of diseases,...

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September 1, 2018

Reusable Medical Devices: BI Selection, Overkill Validation Approaches, and First-Time Validation Pass Rates in Common Healthcare Steam Sterilization Cycles

When validating the steam sterilization instructions for a reusable medical device, first-time pass rates are important to manufacturers. Failures in validation testing require resolution, adding to the total validation time, which can result in a delay to regulatory submission, getting...

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November 14, 2017

How to Select Sterile Barrier Systems for Reusable Medical Devices

Sterile barrier systems are key components in medical device sterilization, so selecting the right barrier is essential. Reusable medical devices, prior to use in healthcare facilities, must undergo validation testing to demonstrate the effectiveness of the cleaning instructions and the microbiocidal...

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October 1, 2013

Nelson Laboratories Stays On Top of FDA Reusable Device Sterilization Guidelines and Changes

It has been a challenge for the industry to stay current on the regulatory landscape as it relates to reusable device sterilization validation. FDA expectations tend to change so frequently, it can be difficult to keep up, but it is critical...

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