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Standardization of Test Soils for Reusable Medical Devices to Soon Become a Reality

One of the most difficult questions for medical device manufacturers is which test soil to use for validating their reusable medical device’s cleaning instructions. The AAMI, ISO, and ASTM standards committees, as well as the FDA, have all been working independently on an answer to this question.  AAMI, ISO, and the FDA have all recommended that the test soils used to contaminate reusable medical devices for validation be focused on clinical relevancy. An ASTM committee has been drafting a new working document (Standard Practice/Guide for Standard test soils for validation of cleaning methods for reusable medical devices) to help reusable device manufacturers determine the appropriate test soil to validate devices.

Scientists at Nelson Laboratories are very involved with the ASTM committee writing this working document regarding test soils. The committee believes the document is close to completion and a final draft should be available in November for committee members to provide comments. Once approved by ASTM committee members, the document will become a standard.

This document will help in standardizing clinically relevant test soils used for cleaning validations of reusable medical devices. Clinically relevant test soils are necessary to simulate as closely as possible the materials and fluids which will be encountered during actual procedures.  Using these soils help manufacturers ensure their device’s cleaning instructions are accurate and the devices will be cleaned sufficiently and effectively.

The FDA has also shown a great interest in the creation of this test soil standard and has been actively involved in the development and drafting of it.

The ability to use standardized test soils will allow medical device manufacturers to develop and validate cleaning instructions for their devices more efficiently and more cost effectively than before. This is especially important as many devices are becoming more complex and difficult to clean.  Determining the correct test soil for cleaning validation will ensure that the processes required will be effective and sufficient to ensure that the device can be cleaned before reuse.

For more information about soils, cleaning standards, and procedures, contact Nelson Laboratories’ experienced scientists and staff who are available to assist you in developing and validating cleaning procedures for your reusable medical devices.