Ralph J. Basile: Guide for Standard Test Soils

March 14, 2012

Sterilization

In November 2011, ASTM Committee F04:15:17 met to review a number of work items including WK33439: Standard test soils for validation of cleaning methods for reusable medical devices.

ASTM Committee F04 on Medical and Surgical Materials and Devices has jurisdiction of more than 250 standards related to medical devices and instrumentation. ASTM International was formerly known as the American Society for Testing and Materials (ASTM). F04 has 34 technical subcommittees that maintain jurisdiction over standards that play an important role in materials, orthopedic devices, testing, tissue engineering, and medical/surgical instruments.

ASTM Sub-Committee F04:15: Material Test Methods is responsible for standards for testing material compatibility, performance, and cleaning. WK33439: New Guide for Standard test soils for validation of cleaning methods for reusable medical devices provides standard test soils that can be applied to reusable medical devices in order to validate cleaning methodologies. The test soils are selected to be representative of biological residues likely to come in contact with reusable devices in a variety of application areas. The guide will be useful for reusable device manufacturers, manufacturers of cleaning systems, testing laboratories, and quality control divisions.

The group reviewed the first working draft of the work item, as well as proposed additions submitted prior to the meeting. Discussion also centered on the focus of the document. It was agreed that the goal of the standard guide would be to provide standardized soils and methods which testing labs could utilize when conducting validation testing of device reprocessing instructions. Given the great diversity of instruments and potential soils, the expectation is that the document will present a variety of soils which vary in formulation based upon the areas of the body in which a surgical instrument comes in contact. For example, a blood-based test soil would be for instruments that primarily come in contact with the vasculature. Soils representing the GI tract, orthopedic procedures (i.e., hip, knee, shoulder, etc), soft tissue, bone, eye, and others would also be included in the standard guide.

The goal for the next meeting scheduled for May in Phoenix, AZ will be to incorporate comments received into a new draft of the document. Part of this effort will be to reach out to experts both inside and outside the committee for soil formulas representing the different areas of the body. Members of AAMI are encouraged to participate, if they have not already.

Ralph J. Basile

Vice President of Marketing for Healthmark Industries Co.

ralphjb@usa.net

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