This training program will explain the rationale, the legal requirements and some methods commonly used for reprocessing and validating reusable medical devices.
Why Should You Attend:
Any firm reprocessing another manufacturer's medical device becomes the legal manufacturer with all the responsibilities for compliance, especially sterility. Failure to prove sterility is almost certainly a cause for either voluntary recall or FDA mandated recall. The same is true if you are reprocessing your own medical device. If intended to be resterilized by the user facility, cleaning and sterilization instructions must be precise and validated.