Reprocessing of Single-Use Devices with Vanguard Medical Concepts

1. Reprocessing of Single-Use Devices with Vanguard Medical Concepts Cost Containment & Environmentally Preferred Purchasing Initiative Catholic Healthcare West February 14, 2003 Pam Johnson, RN, MHA Contract Administrator

2. Why Vanguard Medical Concepts? • Re-manufacturer of a diverse product list of disposable, single-use devices • FDA registered as 3rd party Medical Device Reprocessor • 8 million devices, 10 years experience • 100% function testing of re-manufactured devices at Vanguard plant • Quality systems regulations accountability • $25 million liability insurance for each device

3. Executing the Plan, Part I • Refer to Handout “Checklist for Getting Started” • Executive support for commitment to improved collection and use of re-manufactured devices • CFO & MM director meet Vanguard Rep • Analysis of new product purchase history • Facility Implementation Team (FIT teams) • Initiative sponsored by CHW clinical leaders from the Surgical Services & CV Councils, MMAC & ICPs/Risk Managers

4. Executing the Plan, Part II • Monitoring enterprise-wide compliance • Compliance equals savings • Access to Quality reports for ICPs - website • Department team meetings to present best demonstrated practice and answer emotional concerns by staff and MDs • Recognize High Performers • Patient charges & Questions about consent?

5. Threats to the Plan - and response • Impact to Original Manufacturer (OEM) profit • Expect letters from OEM’s directed at physicians & hospital managers to instill fear and stir emotions. • Response: Get the facts to physicians, board approved policies and FDA policy for 3rd party reprocessors. Reply to the OEM requesting that they stop the counterdetailing at your facility. • Emotional response from staff & MDs • Staff can de-rail the best plan with non-supportive actions • Response: Allow for meetings as a department group and individually (manager & staff/MD) to discuss personal emotions and respond with fact based answers and expectations for staff performance. Let them “kick the tires” and get their concerns openly addressed. Special emphasis to the Infection Control Practitioner support, Collection & Re-stocking of product.

6. More Resources • Handouts • A Department Managers Checklist for Getting Started • Website resources: Association of Medical Device Reprocessors (AMDR) & Vanguard Medical Concepts • FDA Classification of Medical Devices • Vanguard Class I & II product list & 510K submission • Publications • Biomedical Instrumentation & Technology, Nov/Dec 2002; “Development of a Program Model to Evaluate the Potential for Reuse of Single-use Medical Devices: Results of a Pilot Test Study” • Healthcare Purchasing News, May 2002; “Hospitals find Reprocessing Solutions to Financial and Risk Problems” (features Vanguard and Catholic Healthcare West partnership)

7. $$$ Savings • Sample Hospital Opportunity 273 beds: Surgical Services and CV service line Product Categories: Arthroscopic Shavers & Wands, BBB, GI biopsy forceps, DVT garments, EP catheters, Femostops, Laparoscopic Instruments, Open & Unused, Phaco needles, Suture Variables:newunits purchased, new unit cost, reprocessing fee, average # of turns per product, compliance to collection rate 30% collection = $88,000 annual savings 60% collection = $177,000 annual savings 90% collection = $266,000 annual savings

8. For More Information See these Web Pages AMDR www.amdr.org VANGUARD www.safe-reuse.com

9. CLASSIFICATION OF MEDICAL DEVICES CategoryPerceived Risk Class 1 Low Class 2 Medium Class 3 High