White Paper: Medical

Successful Medical Device Cleaning Validation


Validating cleaning instructions for a tray of reusable orthopedic devices is an important milestone on the path to obtaining FDA clearance for those devices. Although the process of validation can seem daunting at first, medical device manufacturers seeking to successfully navigate this process can do so confidently and efficiently if they are armed with knowledge, education, and guidance.

All reusable medical devices, regardless of their criticality classification, must be processed between patient uses and the instructions for use covering those processing activities must be validated. Validation is governed by standards and regulatory guidance documents. A few of these important documents are highlighted in this white paper.

Validating the cleaning instructions for medical devices is critical for both obtaining FDA clearance and keeping patients safe. Validation parameters – such as soiling, dwell time, cleaning, and residual testing – also described in this paper as well as how to find the right testing laboratory.

This white paper provides a comprehensive overview of reusable medical device cleaning validations, highlighting what a medical device manufacturer needs to know, where to start, and with whom to partner.

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