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Reusable Device Sterilization Validation

February 24, 2025

Understanding Reprocessing Validations for Reusable Medical Devices Made by Hospitals or Used for Clinical Trials

The reusable medical device industry has advanced over the last decade, which has led to an increase in new reusable devices. New devices require extensive testing that must be reviewed by the Food and Drug Administration (FDA) or other regulatory...

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November 23, 2022

Reprocessing Validations for Hemodialysis Machines

Dialysis machines have been used for decades to help improve the lives of people with kidney malfunctions. Developed in the 1930s, these machines have evolved to ensure the delivery of lifesaving solutions to patients who suffer from kidney complications. The...

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September 14, 2022

Are You Ready for the New ANSI/AAMI Standard, ST98, Regarding How to Perform Cleaning Validations for Health-Care Products?

Reusable medical devices need to have validated cleaning instructions to ensure patient safety and minimize health-care-acquired infections, corrective actions, recalls, and to ensure compliance with current regulatory standards. For devices that need to comply with US FDA, the requirements regarding...

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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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April 2, 2015

Important Considerations for Reusable Medical Endoscope Processing and Reprocessing

Every year Nelson Laboratories tests and validates thousands of medical devices. One particular family of reusable medical devices, endoscopes, can present unique challenges for manufacturers and  healthcare reprocessing facilities. Responding to recent attention on reusable endoscopes, particularly the reusable duodenoscopes...

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