Nelson Labs offers a full range of medical device cleaning, disinfection and sterilization validation services to validate manufacturers’ reprocessing instructions for reusable devices. This is essential to ensuring that medical devices processed in a health care setting are safe for their intended use or reuse.
Medical device manufacturers should validate end-of-life cycles for reusable or reprocessed medical devices to demonstrate functionality with repeated exposures and clinical simulations.
In addition, reusing single-use devices that have been safely reprocessed by a third-party reprocessor can enable health care providers to maintain high-quality patient care while saving on costs and reducing medical waste. Validated functionality testing must be paired with validated cleaning, disinfection, and/or sterilization processes to ensure safety and compliance with regulatory requirements for third-party reprocessing.
Clinical Reprocessing Cleaning Validations
Medical device manufacturers of reusable instruments, trays, surgical kits and similar products must perform cleaning validations. This includes contamination, cleaning and post-reprocessing effectiveness evaluations. Simulated-use testing practices are employed to simulate actual surgical procedures rather than direct inoculation methods. Options are available to use validated or customized test soils to create clinically relevant conditions. The reprocessing scientists at Nelson Labs actively serve on applicable AAMI, ASTM and ISO committees and have expertise in creating appropriate worst-case testing conditions to help device manufacturers meet regulatory expectations. Cleaning validations are performed in compliance with AAMI TIR12, ANSI/AAMI ST98*, and FDA guidance documents.
* As of August 2022, AAMI TIR30 has been replaced by ANSI/AAMI ST98. Learn more about this change in our comprehensive blog post.
Single-Use Reprocessing Disinfection Validations
Following cleaning validation, a full disinfection validation is performed to validate the manufacturer’s disinfection instructions which require that each device or component be disinfected separately. These tests are typically needed when a device cannot be sterilized using elevated temperatures (e.g., steam sterilization, dry heat) or is not compatible with eythyene oxide (EO) or sterilization methods. Validations should be performed with clinically relevant and approved disinfectants. Disinfection validations are performed in compliance with AAMI TIR12, ANSI/AAMI ST58 and FDA guidance documents.
Single-Use Reprocessing Sterilization Validations and Functionality Studies
A sterilization validation test confirms the appropriate Sterility Assurance Level (SAL) of the medical device. The testing establishes the pertinent sterilization parameters for health care reprocessing instructions. Based on the data obtained through testing, the manufacturer will be able to provide health care facilities with validated sterilization parameters. Nelson Labs can validate using steam (gravity or prevacuum), EO, or dry heat. For certain devices, liquid chemical or thermal disinfection may be acceptable alternatives.
In addition, manufacturers should validate end-of-life cycles for reusable or reprocessed medical devices to demonstrate functionality with repeated exposures and clinical simulations. Nelson Labs can assist in study design and execution of functionality and repeated use studies.
ANSI/ASMI ST79, ANSI/AAMI ST77, ANSI/AAMI ST81, and AAMI TIR12 are guidelines for testing reusable medical devices. Nelson Laboratories has the equipment and qualified personnel to help guide you through the process. Our experts will provide individualized consultation and are here to help simplify the complex regulatory and standard recommendations.
Endoscope and Scope Validations
Nelson Labs offers 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 directions for use which must be fully validated. In addition, automated endoscope reprocessors (AERs) should be validated for their intended use for each unique scope type and configuration. Our staff has extensive experience with scope cleaning, disinfection and sterilization validations working with scope and AER manufacturers as well as US FDA.
Endoscope manufacturers, regulatory bodies and health care facilities are increasingly concerned about the spread of communicable diseases, including clinically relevant microorganisms, on reprocessed medical devices. Healthmark Industries and Nelson Labs have partnered to create an endoscope sampling kit for flexible endoscopes with a purpose of monitoring and reporting objective microbiological results from reprocessed clinical scopes.
The Flexible Endoscope Sampling Kit is sold by Healthmark Industries and test services are provided by Nelson Labs as a full-service kit.
If you have additional questions about Clinical Reprocessing Validation services, or would like to consult with the experts at Nelson Labs, just send us a request or call us at +1 (801) 290-7500.