Notes
Slide Show
Outline
1
"We make technology easy to live with"  
2
How to Project a Developing Trend 
3
Forecasting Labor Trends through Universal Drivers 
4
Progression to Unified Data, Standards and Interoperability 
5
Increasing Exposure causes Regulatory Momentum 
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Medical Device & Instrumentation Pedigree: Defined
  • MD & I Pedigree states: That tagging instruments with a communication technology could be used to authenticate, monitor, report and track a particular instruments’ history relative to a predefined event cycle, involving maintenance, sterilization history (all TTL elements), a patients surgical procedure in order to achieve maximum utilization and security through out the device’s life cycle.


  • Right Patient
  • Right Procedure
  • Right Location
  • Right Instrument
  • Right Maintenance


  • Process improvement based on regulatory initiative coupled with affordable integration of commercial technology solutions, will enable and amplify the positive results to the manual process.


  • The synergy of process improvement and technology solutions will result in a stronger case with practical and verifiable results.
  • Medical Device and Instrumentation Pedigree provides a compelling public safety reason, affordable healthcare provider solution and a profitable vendor product result.
7
"A Case for Medical Device..."
  •  A Case for Medical Device & Instrumentation Pedigree
    • Regulatory Momentum with Complimentary Efforts
      • FDA and other agencies
      • State regulatory support
    • Escalating Infrastructure
      • Pervasive wireless networks
      • Commercial acceptance
        • Pharma initiative and DoD commitment to EHR
      • Major interoperability developments
          • HL7: ANSI-CDC-FDA: submitted to Intl’ community
          • SNOMED® (the Systematized Nomenclature of Medicine)
          • Global Harmonization Task Force (GHTF) Int’l harmonization regulation of medical devices
    • Vendor Trend
      • Existing technology healthcare segmented vendors forming alliances with vendors adjacent to their core skill sets to increase product and service offerings.
8
"What is missing"
  •  What is missing?


    • Increasing Public Awareness of Hospital-Acquired Infections (HAIs)
      •  2 Million infections,  $4.5 Bil cost, 90,000 Deaths (CDC) http://www.ncsl.org/programs/health/shn/2006/statenews460.htm


    • Accurate reporting of adverse events


    • Infrastructure funding
      • Canadian Gov. has committed $281m vs. USA $111m to EHR
        • Population Proportional Equivalent in US:  $2.7 Billion
      • Healthcare lags other industries IT investment by 1% (2006)


    • Medical Device and Instrument Manufacturers forming an industry consortium to drive the process.
9
"Infection Control Concerns (Medical..."
  • Infection Control Concerns (Medical Device and Instrumentation Pedigree)


  •  will overtake Pharma Control Concerns (Pharma Pedigree) by 2007!


      • The numbers are “felt” by more people
        • 2 million suffer from infection vs. ?? Pharma
          • Higher accountability


      • There are fewer high margin items to track.
        • Yielding a faster ROI.


      • The current acceptance of wireless technology will drive infrastructure


      • Infection control is a global concern


10
"Infection Control Concerns (Medical..."
  • Infection Control Concerns (Medical Device and Instrumentation Pedigree) will overtake Pharma Control Concerns (Pharma Pedigree) by 2007!


  • Major Interoperability developments


    • The benefits will first be realized in closed loop systems.
      • Several systems will seamlessly be integrated, allowing staff and patients to automatically drive process changes through a hospital’s internal systems.

  • Vendor Trend


      • Look for increased activity in mergers and acquisitions in 2006.
      • Technological developments specifically addressing infection control