EUROLABoffers a full range of medical device cleaning, disinfection and sterilization validation services to verify manufacturers' reprocessing instructions for reusable devices. This is necessary to ensure that medical devices handled in a healthcare setting are safe for their intended use or reuse.
Medical device manufacturers must verify end-of-life cycles for reusable or reprocessed medical devices to demonstrate functionality through repeated exposures and clinical simulations.
In addition, reuse of single-use devices that are safely reprocessed by a third-party processor can enable healthcare providers to maintain high-quality patient care while saving costs and reducing medical waste. Validated functionality testing must be matched with approved cleaning, disinfection and / or sterilization processes to ensure safety and compliance with legal requirements for third party reprocessing.
Clinical Reprocessing Cleaning Validations
Medical device manufacturers of reusable instruments, trays, surgical kits, and similar products must perform cleaning verifications. This includes contamination, cleaning, and post-reprocessing effectiveness assessments. Simulated handling test applications are used to simulate actual surgical procedures rather than direct grafting methods. Options are available to use validated or customized test soils to create clinically meaningful conditions. EUROLABReprocessing scientists at , actively serve on applicable AAMI, ASTM, and ISO committees and have expertise in creating worst-case test conditions to help device manufacturers meet regulatory expectations. Cleaning verifications are performed in accordance with AAMI TIR12, AAMI TIR130 and FDA guidance documents.
Single Use Reprocessing Disinfection Validations
After cleaning verification, a full disinfection verification is performed to verify the manufacturer's disinfection instructions, which require each device or component to be disinfected separately. These tests are typically required when a device cannot be sterilized using elevated temperatures (eg steam sterilization, dry heat) or is not compatible with the melting oxide (EO) or sterilization methods. Validations should be made with clinically relevant and approved disinfectants. Disinfection verifications are performed in accordance with AAMI TIR12, ANSI / AAMI ST58 and FDA guidelines.
Single Use Reprocessing Sterilization Validations and Functionality Studies
Sterilization validation testing confirms the appropriate Sterility Assurance Level (SAL) of the medical device. The test determines relevant sterilization parameters for healthcare reprocessing instructions. Based on the data obtained by the tests, the manufacturer will be able to provide approved sterilization parameters to healthcare institutions. EUROLAB Can validate using steam (pre-gravity or vacuum), EO, or dry heat. For some devices, liquid chemical or thermal disinfection may be acceptable alternatives.
In addition, manufacturers must validate life cycles for reusable or reprocessed medical devices to demonstrate functionality through repeated exposure and clinical simulations. EUROLABcan assist in conducting study design and functionality and repeat use studies.
ANSI/ASMI ST79, ANSI/AAMI ST77, ANSI/AAMI ST81, and AAMI TIR12 are guidelines for testing reusable medical devices. EUROLABhas the equipment and qualified personnel to guide you through the process. Our experts will provide individualized advice and are here to help simplify complex regulatory and standards recommendations.
Endoscope and Scope Verification
EUROLABoffers full cleaning disinfection and sterilization validation services for endoscopes and other diagnostic scopes for clinical use. Similar to reprocessed medical devices, scopes have unique validation criteria and complex reprocessing instructions or instructions for use that must be completely revalidated. Additionally, automated endoscope reprocessors (AERs) must be validated for their intended use for each unique scope type and configuration. Our staff has extensive experience with the US FDA along with scope and AER manufacturers in scope cleaning, disinfection and sterilization validations.
EUROLAB, with its highly expert team and internationally accredited laboratories, Reuse Tests It performs all test, analysis, measurement, evaluation and report generation services completely and reliably.
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