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- 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.
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- 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.
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- 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.
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- 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
- There are fewer high margin items to track.
- The current acceptance of wireless technology will drive
infrastructure
- Infection control is a global concern
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- 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
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