June 15, 2023
At the Spring 2023 ASTM E61 Radiation Processing meeting in Jackson Hole, WY, Nick Brydon, NextBeam Head of Sterilization, hosted a discussion with other committee members on the use and acceptance of virtual dose mapping tools for medical device sterilization. The purpose of the discussion was to recognize the strengths of virtual dose mapping tools and determine what it would take for the industry and regulators to accept the use of these tools as equivalent to physical dose mapping.
The consensus of the discussion was that it may be a long time before virtual dose mapping tools have enough credibility to replace PQ dose mapping, but that there are significant and valuable activities that these tools could be used for that would be lower risk such as evaluating product configurations during R&D, assessing product design changes, or selecting the most challenging design from a range of candidate products.
Pat Weixel (FDA, Center for Devices and Radiological Health) commented that the FDA is in process of updating its Software Validation Guidance, providing additional information about what tests, evidence, and documentation would be expected for a computer program to be recognized as validated in context of medical device regulations.
Kevin O’Hara (Sterigenics) noted that ASTM has recently published E2232-21 Standard Guide for Selection and Use of Mathematical Methods for Calculating Absorbed Dose in Radiation Processing Applications. This guidance document provides information about which virtual dose mapping tools and mathematical models are appropriate for different experiments based on particle type, energy level, and other factors.
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