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Author: Alpa Patel





April 25, 2024

A New Approach to End-of-Life Testing

Reusable medical device manufacturers should provide users with a method or mechanism to determine when a device has exceeded its intended use life, or they should specify a number of times it can be reused. Guidance documents stipulate that manufacturers...

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June 21, 2023

Do DHFs Need Updates with Changes Involving Reusable Devices?

Nelson Labs reusable devices expert Alpa Patel recently discussed regulatory changes and what they could mean for cleaning validations of new devices, validations of legacy devices, and studies conducted prior to recent standard updates. Read the full Q&A article published...

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June 13, 2023

How to perform cleaning validations for semi-critical and critical devices according to the new ANSI/AAMI ST98 standard?

Cleaning validation requirements for reusable medical devices according to AAMI TIR30 did not distinguish between non-critical devices on the one hand and semi-critical or critical devices on the other. Additionally, many validation testing requirements were formulated using generalities rather than...

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May 30, 2023

How to Perform Cleaning Validations for Non-Critical Devices According to the New ANSI/AAMI ST98 Standard

Cleaning validation requirements for reusable medical devices according to AAMI TIR30 did not distinguish between non-critical devices on the one hand and semi-critical or critical devices on the other. Only general recommendations were formulated, which resulted in one validation approach...

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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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