1. IHE USA ® Observations about Unique Device Identifiers (UDI) Testimony to HIT Standards Committee 28 March, 2011 – Washington, DC Elliot B. Sloane Drexel University Center for Healthcare Information Research and Policy Co-Chair, IHE International

2. UDI Unique Device Identification Differentiating Recall management vs. EMR-ready data capture from medical devices

3. Role/Value of Unique Device Identification (UDI) As we understand it, the proposed UDI will assign a single “intelligent identifier” to medical device –UDI will disclose brand, S/N, “type” medical device –Intent is good; may support recalls –21 st Century dilemma is huge, espec. for EMR uses Devices morph from one moment to another Bluetooth may allow multiple sensors moment to moment Knowing the device still requires a clinical data code with each piece of data transmitted or stored by the device

4. Can UDI replace separate semantic data tagging for IHE-PCD or any other EMR application? Consider UDI: “Thermometer” Potential “temperatures” in the IHE Rosetta Project SO FAR: FDA Amendments Act 2007 “…Secretary shall promulgate regulations establishing a unique device identification system…” “…shall adequately identify the device through distribution and use…” 1. TEMP_AXIL10. TEMP_NASOPH 2. TEMP_FOLEY11. TEMP_ORAL 3. TEMP_CORE12. TEMP_RECT 4. TEMP_EAR13. TEMP_ROOM 5. TEMP_ESOPH14. TEMP_SKIN 6. TEMP_FINGER15. TEMP_BODY 7. TEMP_INJ16. TEMP_TOE 8. TEMP_MYO17. TEMP_TYMP 9. TEMP_NASAL18. TEMP_VEN

5. IHE-PCD Rosetta Project Cross-vendor measurement Semantics Interoperability

6. Open consensus process Observation identifiers and co-constraints New terms incorporated into standards hRTM used for conformance testing 53 Rosetta for Semantic Interoperability

7. http://wiki.ihe.net/index.php?title=PCD_Profile_Rosetta_Terminology_Mapping 54 GroupREFIDDIMUOM_MDC UOM_UCUM(http://www.daylife.com/photo/03ub 1GZa3R1le?q=Barack+Obama)http://www.daylife.com/photo/03ub 1GZa3R1le?q=Barack+Obama CVS_ECG_HRMDC_ECG_HEART_RATET-1 MDC_DIM_BEAT_PER_MIN {beat}/min (http://www.daylife.com/photo/03ub1GZa 3R1le?q=Barack+Obama)http://www.daylife.com/photo/03ub1GZa 3R1le?q=Barack+Obama {beats}/min 1/min /min CVS_ECG_STMDC_ECG_AMPL_ST_I ML2I-1T-3 MDC_DIM_MILLI_VOLT MDC_DIM_MICRO_VOLT MDC_DIM_MILLI_M# mV uV (added by scripting rule) mm# (voted “off-the-island”) GASMON_AA_ENFLMDC_CONC_ENFL_ETL3L-3 LMT-2L-2 MDC_DIM_VOL_PERCENT MDC_DIM_KILO_PASCAL MDC_DIM_MMHG %{vol} kPa mm[Hg] Harmonized Rosetta (hRTM) Specifies for each IEEE 11073 REFID observation identifier: the 11073 MDC and UCUM units‐of‐measure includes dimensional analysis to ensure correct ‘units‐math’ enumerated values and measurement sites numeric codes, where appropriate An extract from the hRTM is shown below:

8. 55 RTM & hRTM Highlights Unified semantics and semantic model are essential prerequisites for safe and effective interoperability between devices and systems. The hRTM rigorously defines what may be sent and informs recipients of what they may expect to receive. For each observation identifier, the hRTM specifies the units‐of‐measure, enumerated values, measurement sites and other co‐constraints. The hRTM is based on the ISO/IEEE 11073 standards and leverages and extends that work by using an open consensus process. The hRTM is publicly available for IHE PCD clinical devices and will be available shortly for IEEE 11073 personal health devices. The hRTM supports message conformance testing frameworks that can be used for both clinical and personal health devices.

10. We empathize with the need and the intent, for recall purposes… Possible: “One size fits all” individualized bar coded unique UDI, with mfr, SN, primary medical device role Very complicated: Extending to dozens of possible medical device roles and configurations Very, very complicated: Extending to hardware, software, & firmware revision numbers, features, accessories Making such a tag “human readable” is daunting, too Providing UDI at “date of mfr” seems clear; managing it over a 20-year product lifecycle? Whatever UDI is selected by FDA, IHE-PCD can probably include it in the data stream to the EMR (as long as it doesn’t need an online “lookup”)

11. IHE USA ® – here to serve. Thank you for allowing me to share these perspectives with the ONC FACA today. Elliot B. Sloane, PhD, CCE, FHIMSS