Medical Device Materials And Design | Disinfection Testing

The development of a medical device from the concept phase to full-scale production involves multiple steps that vary based on the novelty and complexity of the finished product.

The process also requires checkpoints for testing and validating the new device, its materials as well as its functionality and performance.

Manufacturers of medical devices have the responsibility to support product label claims of reusability by providing written instructions for the use, cleaning, disinfection, packaging, and sterilization of their products.

These obligations are under the Health Canada, FDA and European medical device regulations.

Medical Device Materials And Design | Disinfection Testing

You are the expert in making the device functional and performing the intended use; we are the experts in testing the cleanability and sterilizability of the device. Many innovative medical devices did not make it to market because they cannot be properly cleaned or sterilized.

Let us help you ensure your device can be safely used by staff and patients

SteriLabs consulting team members are active participants in the development of medical device standards and have the capabilities to assist manufacturers and research institutes in the areas of reusable and single-use medical device materials selection and design. SteriLabs has access to a wealth of knowledge with respect to medical device performance under various cleaning, disinfection and sterilization processes performed at SteriPro's reprocessing facility. Issues with materials and designs of different types of medical devices have been documented. This will be made available to you along with recommendations for device materials selection and designs for optimum cleanability and sterilizability.

Device Materials

The surface properties of any material can significantly affect its protein binding ability, wettability and biocompatibility. Cleaning, Disinfection and Sterilization processes can significantly alter the surface properties through chemical reactions such as oxidation, alkylation and reduction.

This can cause the leaching of chemicals from polymers and can make metals weak, dull, rust or discoloured.

Device design

The device must be designed to meet end-users' needs from a functionality standpoint and also with consideration for reprocessing. The ability to effectively clean, disinfect and sterilize a device affects the safety of the device, and the design of the device determines the length of the reprocessing process.

Overly complex designs make it difficult for the users to adequately clean and reprocess the device.

It is critical to ensure that your device can be safely and effectively reprocessed and this begins with the materials selection and design for the device.

As a result, it is imperative to involve SteriLabs team at the early stages of the development of a device in order to address all materials and design characteristics that affect the ability of end users to clean, disinfect and sterilize the device adequately.

For further information about these services or to receive a quotation, please contact us and fill out this form

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Medical device testing and development requirements can be complicated; our experts are on hand to help inform you of every aspect of this.

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