Cleaning is a critical first step in medical device reprocessing, directly influencing the effectiveness of disinfection and sterilization. Inadequate cleaning can leave behind blood, tissue, mucous, or biological residues, creating an environment where microorganisms can survive, potentially leading to patient infections.
SteriLabs specializes in establishing effective cleaning methods tailored to the design and characteristics of reusable medical devices. Our services include developing multi-step cleaning processes, selecting detergents optimized for soil removal and material compatibility, and determining cleaning parameters such as temperature and cycle duration. Whether the method involves manual cleaning, ultrasonic cleaning, or automatic washer-disinfectors, SteriLabs ensures your devices are prepared for subsequent reprocessing steps.
For reusable medical devices and surgical instruments, cleaning validation is a regulatory requirement. A typical validation procedure includes contaminating devices with simulated clinical-use soil, reprocessing them, and evaluating residual contamination.
SteriLabs’ team of reprocessing scientists actively contributes to standards development through participation in CSA, AAMI, ASTM, and ISO committees. This expertise ensures that our cleaning validation processes align with the latest industry standards and guidance documents.
For devices incompatible with sterilization, disinfection validation is essential to ensure patient safety. The level of disinfection required depends on the device’s intended use and Spaulding’s classification, which categorizes devices into critical, semi-critical, and non-critical based on infection risk.
SteriLabs provides comprehensive disinfection validation services, including method development and agent selection, to achieve appropriate microbicidal effects. Our trained team ensures that your devices meet regulatory standards while mitigating infection risks.
Medical devices intended for sterile use must undergo a fully validated sterilization cycle. Manufacturers are responsible for ensuring their products can be sterilized without compromising their integrity or functionality.
SteriLabs offers sterilization validation services across a range of sterilization methods, including:
Our process involves inoculating devices with a known microbiological challenge, performing sterilization, and evaluating sterility and materials compatibility. Following current standards, we demonstrate a sterility assurance level (SAL) of 10⁻⁶, ensuring your devices are safe and compliant.
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