Deciphering Regulatory Guidance on Reusable Device Validation and Testing Methods
1 Hour Video | Paul Boentges, Becton Dickinson
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
Participants that will find this webinar most beneficial will be those involved in medical device companies. Job titles of attendees that will be most applicable for this session will be:
- Sterility Assurance
- Verification and Validation Engineers
- Process Validation
- Quality Assurance
Paul Boentges is a Quality Manager supporting the Respiratory Solutions Sterility Assurance function at Becton Dickinson based in Vernon Hills, IL. With over 15 years of Medical Device experience, Paul has extensive knowledge in Radiation Sterilization, Ethylene Oxide Sterilization, Re-usable Device Reprocessing, Moist-Heat Sterilization, and Quality System Regulations. Prior to joining Becton Dickinson, Paul served as the Director of Quality at Devicor Medical Products and the Sterility Assurance Manager at Ethicon Endo-Surgery. Over the past 10 years, Paul has served as a contributor to several AAMI Sterilization Standards working groups including the Radiation Sterilization working group, the Ethylene Oxide Sterilization working group, and the Microbiological Methods working group.
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