Many modern medical devices are manufactured out of high-tech materials such as metallic alloys or synthetic plastics. Working with these materials may require the use of various agents to aid in the manufacturing process or may produce contaminants that may need to be removed later. These devices need to be clean in order to (1) ensure patient safety and (2) ensure the device will continue to function as it is intended.

In this paper, author Patrick Kenny reviews medical device regulation under 21 CFR Part 820 – Quality System Regulation. Several sections of Part 820 can be directly related to device cleanliness. For manufacturers, the challenge is to validate the cleaning process to ensure the devices are free of residue (chemical and particulate) in order to ensure patients are safe. Kenny presents a five-step process that provides a framework to assist medical device manufacturers in their cleaning validation efforts.

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