Manufacturers hold the responsibility of ensuring their products meet regulatory standards and supporting product label claims, including detailed instructions for use, cleaning, disinfection, packaging, and sterilization. These obligations are mandated under Health Canada, FDA, and European medical device regulations.
While you are the expert in making your device functional and effective for its intended use, we are the experts in validating its cleanability and sterilizability. Many innovative devices have failed to reach the market because they could not be properly cleaned or sterilized, compromising patient safety and regulatory approval.
The SteriLabs consulting team, with active participation in medical device standards development, is equipped to assist manufacturers and research institutions in material selection and design for reusable and single-use devices. Drawing on our expertise and access to SteriPro’s advanced reprocessing facility, we provide invaluable insights into device performance under various cleaning, disinfection, and sterilization processes. Documented issues with materials and designs across different devices are shared with clients, along with recommendations to optimize cleanability and sterilizability.
The surface properties of a medical device material can significantly influence protein binding, wettability, and biocompatibility. Cleaning, disinfection, and sterilization processes often alter these surface properties through chemical reactions such as oxidation, alkylation, and reduction.
These changes can lead to chemical leaching in polymers or cause metals to weaken, discolor, rust, or lose their luster. Proper material selection and preparation are essential to prevent these effects, ensuring the device’s durability and safety throughout its lifecycle.
Device design must balance functionality with reprocessing needs. A well-designed device not only meets end-user requirements but also ensures it can be effectively cleaned, disinfected, and sterilized. Complex designs often hinder the ability to adequately clean and reprocess the device, increasing risks to patient safety.
Reprocessing-friendly designs streamline cleaning protocols, enhance usability, and improve regulatory compliance, ultimately contributing to the device’s overall success in the market.
To ensure optimal materials and design characteristics that meet regulatory and usability standards, it is critical to involve SteriLabs early in the device development process. Our team works collaboratively to address all aspects of material selection and design, helping manufacturers create devices that are not only functional but also safe, efficient, and easy to reprocess.
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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