Reprocessing Medical Devices: Current Standards, Guidance, and New Developments in Validation, Cleaning, Disinfecting, and Sterilization Processes
AAMI standards recommend that manufacturers support product label claims of reusability by providing complete and comprehensive written instructions to all individuals, companies, and any other type of organizations that reprocess devices used on patients. Manufacturers should also conduct and document testing activities to validate the suitability of their instructions particularly for cleaning, disinfecting, and sterilization, all essential elements of reprocessing.
AAMI presented Reprocessing Medical Devices: Current Standards, Guidance, and New Developments in Validating, Cleaning, Disinfection, and Sterilization Processes, a two-hour webinar event that drew 375 members of the medical device community. If you would like to hear directly from industry experts and the FDA on what you need to know about industry standards, cleaning validation issues, acceptance criteria, labeling, cleaning protocols, and testing methods — this CD package is for you.
Speakers
- Steve Goldstine, Ph.D., President, Steve Goldstine Consultants
- Trabue Bryans, Executive Vice President and General Manager, AppTec- Altanta
- Victoria Hitchins, Ph.D., Senior Research Scientist/Geneticist, U.S. FDA, Center for Devices and Radiological Health
Program At-A-Glance
- Current standards and guidance for cleaning, disinfecting, and sterilizing medical devices
- Recognition and use of consensus standards
- Current acceptance criteria for cleaning, disinfection, and sterilization
- Choosing and developing reprocessing instructions using documents such as:
ANSI/AAMI ST81: 2004 – Sterilization of medical devices—Information to be provided by the manufacturer for the processing of resterilizable medical devices.
AAMI TIR-12: 2003 – Designing, testing, and labeling reusable medical devices for reprocessing in health care facilities: A guide for medical device manufacturers. - Test methods for validation based upon published guidance documents and industry standards such as:
AAMI TIR-30 – A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices (2003)
ISO/TS 15883-5 – Washer-disinfectors — Part 5: Test soils and methods for demonstrating cleaning efficacy of washer-disinfectors. (2005) - Solutions to typical validation problems
- Recent trends in validation methods
- Differences between USA and international standards
- Recent changes in guidance documents
Webinar CD
- Includes handout material and CD.
- $245 for seminar registrants/$345 for non-registrants
- Domestic and international shipping rates apply.
Three Ways to Order
1. Phone – 1-877-249-8226 / 240-646-7031 to order with credit card
2. Fax – Select and download the order form and fax to 240-396-5781
3. Mail – Select and download the order form and mail with payment to:
Reprocessing Webinar CD Package
AAMI Publication
PO Box 0211
Annapolis Junction, MD 20701-0211
Questions?
For questions about ordering the CD, please contact AAMI’s Publication Center at 1-877-249-8226 / 240-646-7031.