Reusable Devices

Reusable Devices

LexaMed assists medical device manufacturers in the design, testing and labeling of devices intended for reuse and reprocessing in health care facilities by establishing cost-effective cleaning and sterilization validation programs to meet FDA requirements. LexaMed’s team of professionals has extensive knowledge and experience in designing and conducting these programs. We are available to assist at each phase of the process and are considered industry leaders in this field.

When a medical device is labeled as “reusable”, manufacturers of these devices must provide complete written instructions for the handling, cleaning, packaging and sterilization of the products to support the label claim. Manufacturers are obligated under the Food and Drug Administration (FDA) labeling regulations (21 CFR 801) to have the suitability of these processes validated.

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