Reprocessing Reusable Medical Devices - Cleaning and Labeling Requirements

Overview

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 re-sterilized by the user facility, cleaning and sterilization instructions must be precise and validated. Much attention has been paid to the regulatory requirements of reprocessing single use devices.

However, there is increasing attention being directed towards reprocessing reusable medical devices and regulatory requirements.

The purpose of this webinar is to explain the rationale, the legal requirements and some methods commonly used for reprocessing and validating reusable medical devices.

Areas Covered in the Session

• Reasoning behind labeling requirements
• Regulatory requirements
• Intended use and design
• Standards/guidance
• Validating cleaning and sterilization

Who Will Benefit

• Design Engineers
• QA Managers
• Quality Engineers
• Regulatory Affairs Managers
• Manufacturing Engineers
• Hospital Operating Room Nurse Supervisors

Speaker Profile