FDA Guidance: Validation of Cleaning Process

From “Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling: Guidance for Industry and Food and Drug Administration Staff

VIII. Validation of Cleaning Process

A. Validation of the Cleaning Process Using Worst-Case Testing

1. Artificial Soil, Inoculation Sites, and Simulated Use

a. Artificial Soil

The manufacturer should select an artificial test soil, the composition of which accurately represents materials that the device would likely be exposed to during an actual clinical use, and would create the greatest (worst-case) challenge to the cleaning process.

b. Inoculation Sites

Soil inoculations should mimic worst-case clinical use conditions. We recommend you use the artificial soil to inoculate the device in all locations likely to contact patient materials, including all locations that are difficult to clean.

c. Simulated Use Conditions

If after clinical use of the device, drying of soil might occur and cleaning might not be performed immediately after use (such as with loaner devices that will be shipped without adequate reprocessing), the validation methods should allow soils to dry for a length of time that simulates worst-case (longest duration).