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Reprocessing of Single-Use Devices with Vanguard Medical Concepts

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					         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
Supply Chain Management
         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

Supply Chain Management
                  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
Supply Chain Management
                 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?


Supply Chain Management
      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.


Supply Chain Management
                          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)


Supply Chain Management
                          $$$ 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: new units 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


Supply Chain Management
                    For More Information
                    See these Web Pages




         VANGUARD                    AMDR
      www.safe-reuse.com          www.amdr.org
Supply Chain Management
             CLASSIFICATION OF MEDICAL DEVICES

           Category              Perceived Risk

            Class 1                Low
            Class 2                Medium
            Class 3                High




Supply Chain Management
VANGUARD MEDICAL CONCEPTS, INC

Vanguard Establishment Registration Number              #1056128
Vanguard Owner/Operator Number                          #9006409
           Common or             Device Exempt          Submission
                                               Submission
          Ususal Name             Class  (Y/N)    T ype   Number
Ablative EP Catheter             III    N       PMA
Arthorscopic Wand                II    N      510(k)      K012695
Arthroscopic Shaver              II    N      510(k)      K012346
Diagnostic EP Catheter           II    N      510(k)
Femoral Compressor Device        II    N      510(k)      K011832
GI Biopsy (Hot) Forceps          II    N      510(k)      K011800
Inflation Device                 II    N      510(k)      K012480
Phacoemulsification Needle       II    N      510(k)      K012698
Pulse Oximeter Sensor            II    N      510(k)
Sequential Compression Device    II    N      510(k)      K012403
Laparoscopic (Hot) Instruments   II    N      510(k)      K012700
Burr                             I     Y      N/A      Exempt
Drill Bit                        I     Y      N/A      Exempt
External Fixation Device         I     Y      N/A      Exempt
GI Biopsy Forceps                I     Y      N/A      Exempt
Laparoscopic Dissectors          I     Y      N/A      Exempt
Laparoscopic Graspers            I     Y      N/A      Exempt
Laparoscopic Scissors            I     Y      N/A      Exempt
Pressure Bag                     I     Y      N/A      Exempt
Saw Blade                        I     Y      N/A      Exempt
 Supply Chain Management

				
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