Reusable Medical Device Cleaning Validation and Testing Requirements

An Industry Perspective

A white paper by Steven Richter, Ph.D.

The US Food & Drug Administration's (FDA) draft guidance document, "Draft Guidance for Industry and FDA Staff – Processing/Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling" has the potential to significantly impact cleaning validations and testing requirements regarding reusable medical devices.

Although the FDA guidance document is not legally enforceable, it describes the agency's "current thinking and should be viewed as recommendations," according to a new management brief by Steven Richter, Ph.D., president and scientific director of Microtest Laboratories — and former FDA official.

While the FDA document was issued last May for industry comment and is not for implementation, Richter notes that the medical device industry understands that changes from current best practices will be required immediately.

The brief raises a timely discussion of the variety of industry issues that Richter says must be anticipated, discussed, and thoroughly evaluated for the time when implementation is required.

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