Medical Device Reprocessing Validations

It's necessary to ensure your products and instruments processed in a health care setting are sterile and safe every time for their intended contact with the patient or user. Manufacturers of reusable medical devices have the responsibility to provide clear and understandable reprocessing instructions for the product, and the procedures are required to be valited to demonstrate reprocessing is safely and effectively conducted in compliance with regulatory standards. Generally, reprocessing include cleaning, disinfection, and sterilization depending on the risks associated with the use of the device.

"Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling", the guidance for industry and food and drug administration staff, gives out the general considerations that should be taken into account when validating the reprocessing instructions for reusable medical devices. Manufacturers of 510(k)-exempt devices should follow the recommendations of this guidance, unless, for example, the device is specifically exempted by regulation from specific QS requirements.

Our Reprocessing Validation Services

Our Reprocessing Validation Services include Cleaning Validation, Disinfection Validation, and Sterilization Validation.

• Cleaning Validation

It's required for reusable instruments, trays, surgical kits, and similar products to finish cleaning validations. Cleaning validations include contamination, cleaning, and post-reprocessing effectiveness evaluations. Simulated-use testing practices are applied to simulate surgical procedures instead of direct inoculation methods, validated or customized test soils to create clinically relevant conditions are also available for this testing.

• Disinfection Validation

Disinfection validation is performed to validate the manufacturer’s disinfection instructions which require that each device or component be disinfected separately. Disinfection validation studies should look at "worst case" scenarios to prove devices can be reliably disinfected by end-users when instructions are followed.

• Sterilization Validation

A sterilization validation test confirms the appropriate Sterility Assurance Level of the medical device. The manufacturer will be able to provide validated sterilization parameters based on the parameters obtained from the testing. Validation can be established by steam, EO, or dry heat. For certain devices, liquid chemical or thermal disinfection may be acceptable alternatives.

STEMart offers Reprocessing Validations Services following the ISO, AAMI, and ASTM standards to validate reprocessing instructions for reusable devices. Our full range of medical device cleaning, disinfection, and sterilization validation services helps you demonstrate the resuable medical device functionality and safety with repeated exposures and clinical simulations.

If you have additional questions about medical device reprocessing validations or would like to find out more about our services, please feel free to contact us.