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White Paper: Test & Measurement

Disinfection Validation: How to Classify and Validate Your Medical Device Disinfection Process


Medical device reprocessing, and the scientific validation of reprocessing instructions, are critical steps to ensuring devices are safe and effective for patient use. The pandemic caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus responsible for COVID-19, as well as past infection outbreaks, have prompted increased concern over disinfection and sterilization of reusable medical devices.

FDA requires manufacturers to validate the reprocessing instructions of reusable medical devices to ensure they can be used repeatedly as intended. These validations provide data demonstrating that the methods and chemicals used to reprocess and destroy microorganisms, are effective, as well as compatible, with your product.

While medical device manufacturers can’t control what happens once their device enters the healthcare setting — for example, whether central sterile services departments (CSSD) have the time and resources to follow manufacturer guidelines or whether hospital staff receive proper training — they can ensure they properly classify their medical devices and provide accurate Instruction For Use (IFU) based on reprocessing validations.

Device classification is based on patient contact and directly relates to the level of disinfection required or, in some cases, sterilization, based on the risk of infection from contamination. This white paper provides guidance on how to ensure your device reprocessing instructions ensure patient safety and comply with all regulatory standards.

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