Reusable Device Cleaning, Disinfection, and Sterilization Validations: Key Design and Compliance Issues as They Pertain to Protocol Development
Validation of reusable medical devices requires that the manufacturer develop methods for cleaning (after use) washing to remove all foreign matter possibly disinfecting and repackaging for the next use.
The diversity of medical devices their intended use and classification in accordance with the food and drug administration requires that the manufacturer develop and validate the reprocessing of the medical device.
Reprocessing usually entails that the manufacturers thoroughly understand the design of the device and what potential hazards can occur if the device is not properly cleaned before reprocessing. This usually means that the manufacturer must establish clear and efficacious instructions on how to reprocess the medical device before reuse.
Why you should attend
: To assist you in the identification of key factors during the development of your protocol. you will be guided on how to identify key factors in the protocol design process. Key factors such as selection of chemical agents specifically biocidal agents and or biostatic agent(s). Identify testing that will be required to evaluate these proposed agents
Biocompatibility issues, such as should you test for cytotoxicity, tolerable contact limit (TCL) as stated in ISO 10993-7.
If you require sterilization of your reusable should packaging and penetration issues be addressed. What will be the required sterility specifications for your product. Sterility assurance issues will be discussed.
You will be able to write and review medical device reprocessing protocols and assists in the revision process, in order to eliminate or minimize process interruptions.
Areas Covered in the Session:
Who Will Benefit:
- Key points regarding protocol development
- A summary of standards
- Key tests to be familiar with
- Expected results
- Packaging issues
- Labeling issues
- Process/ Scientist
- Regulatory Affairs