Evaluating the Cleanliness of Medical Devices

How clean is clean? In the medical device industry, there are specific requirements that must be met to pass certain quality standards. For medical devices such as surgical blades, glucose sensor needles, sutures, and surgical tools, a cleaning procedure is typically included in the manufacturing process to qualify the cleanliness of these products before they are released to market. As part of a medical device manufacturer’s internal quality control process, an evaluation of the level of cleanliness is needed to verify how effective their cleaning procedure is. This type of testing may be done regularly throughout the year for monitoring and quality assurance.

In addition to regularly monitoring the quality and effectiveness of a cleaning procedure, there are other scenarios that may require the evaluation of product cleanliness. When a manufacturer makes changes to their cleaning procedure, they may need to compare or evaluate the results to verify that the new procedure is on par with the previous process. When a manufacturer buys certain parts used in their product from different suppliers, the manufacturer may want to compare the cleanliness of the same parts from different suppliers to determine which supplier to choose. When there are multiple manufacturing sites, verification may be needed to confirm that cleaning procedures are consistent and equally effective between sites. Cleanliness evaluation may also be needed to help determine which process is more optimized, less costly and more effective.