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Solving the Problem of Medical Device Duplicate Unique Identifiers

Solving the Problem of Medical Device Duplicate Unique Identifiers. Department of Veterans Affairs Veterans Health Administration Peter Kuzmak, Dr. Ruth Dayhoff, Dr. Daniel Carozza, and Keith Campbell June 2, 2005. The VA Success Story.

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Solving the Problem of Medical Device Duplicate Unique Identifiers

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  1. Solving the Problem of Medical Device Duplicate Unique Identifiers Department of Veterans Affairs Veterans Health Administration Peter Kuzmak, Dr. Ruth Dayhoff, Dr. Daniel Carozza, and Keith Campbell June 2, 2005

  2. The VA Success Story • VA was a pioneer in the early integrator of medical imaging devices • Needed to specify and validate modality conformance • Over a quarter billion DICOM images are stored in VistA Imaging

  3. Wide variety of images integrated with the online patient record Permits access from any workstation at anytime Workstation image manipulation allows examination of image features not otherwise visible VistA Imaging

  4. Background • Both DICOM and HL7 Medical Devices generate Unique Identifiers (UIDs) to identify different instances of clinical information objects • It is our experience that occasionally the same UID is generated for different objects • This is caused by poorly designed generation methods and can impact patient safety

  5. Example of two images with the same Unique Identifiers

  6. Root Cause of Problem • DICOM & HL7 standards define format only • Vendors are free to choose implementation method • DICOM and HL7 SDK’s treat UID generation as an “exercise left to the user” • Many vendors devise private methods that fail

  7. Using Natural Primary Keys vs Synthetic Keys to Create UID • Natural Primary Keys • Have Business Meaning • Facility ID, Patient ID, Study ID • Synthetic Keys • Have no Business Meaning • Because of this, Synthetic Keys are better

  8. Problems Using Natural Primary Keys • Have Business Meaning Semantics • Some applications attempt to decode information • Organizations change business rules • Schema, values and meaning of fields change • Fields become obsolete and are replaced by others • Implementation responsibility may change

  9. Medical System Problems Using Synthetic Value Keys • UUID widely used computer system software • Uses MAC address to insure device uniqueness • Rarely used in DICOM or HL7 though • Medical vendor methods often fail in real life • One-up counters (reset by technician) • Local computer time (reset by operator) • Use high resolution timer (battery fails) • Non-unique device identification • Same device identifiers at multiple sites • Internet addresses (which are not unique)

  10. Needed: Failsafe UID Generation for Medical Devices • Creates UIDs that are universally unique • Contains integral generation check method • Must be utilizable by HL7 and DICOM • Must be externally certifiable • Research needed to find “best” solution

  11. Dealing with existing Duplicate UIDs • Must be detected and properly handled by the PACS (Picture Archiving and Communications System) • What is the best method for handling Duplicate UIDs? • How should a system handle objects once it has encountered them?

  12. Challenges in Achieving a Solution • Acknowledgement of problem and desire for solution • Exposure to Liabilities • Diverse Federal, Public, and Commercial Stakeholders need to be organized and involved to solve this issue • Cost associated with software upgrade and compliance

  13. Milestone Roadmap • Educate stakeholders on issue criticality • Measure the extent of the problem • Select and standardize effective methods for generating UIDs • Determine the best method of handling existing duplicate UIDs (mitigation strategies) • Develop verification test tools and demonstrate the validity of the methods

  14. Milestone Roadmap (continued) • Establish a Certification Process • Customers request and procure a certified solution • Vendors develop to the guidelines and certify solutions • Deployment of the solution and implementation issues are resolved

  15. Final Word • Medical Errors were estimated to kill up to 98,000 Americans each year • To achieve safer, higher-quality care, we need to redesign medical device software with failsafe methods • “Quality is never an accident; it is always the result of high intention, sincere effort, intelligent direction and skillful execution; it represents the wise choice of many alternatives.” William A. Foster

  16. Thank You!

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