DECIPHERING REGULATORY GUIDANCE ON REUSABLE DEVICE VALIDATION AND TESTING METHODS

Deadly outbreaks of “superbugs” at several U.S. hospitals have called current sterilization practices among device manufacturers into question, with the FDA introducing new regulations requiring manufacturers to supply evidence that reusable devices can be cleaned reliably before obtaining regulatory approval. According to the agency, “manufacturers will be expected to conduct validation testing to show with a high degree of assurance that their cleaning and disinfection or sterilization instructions will consistently reduce microbial contamination”. It is crucial for validation engineers to understand best practices in testing reusable devices for reprocessing ease and capability to avoid harmful risks to patient health.

• Matching validation tests with appropriate medical devices
• Collaborating with the healthcare community to validate cleaning procedures in real-life settings
• Examining future implications for reprocessing validation within regulatory submissions

Speaker:
Paul Boentges
QA Manager, SA/BC
Becton Dickinson

Contact:

Brooke Akins | Manager, Market Intelligence | 312.224.1693 webinars@q1productions.com