IHE USA®

Observations about Unique Device Identifiers (UDI)

Testimony to HIT Standards Committee 28 March, 2011 – Washington, DC

Elliot B. SloaneDrexel University

Center for Healthcare Information Research and PolicyCo-Chair, IHE International

UDIUnique Device Identification

DifferentiatingRecall management

vs.EMR-ready data capture from medical devices

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– 21st 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

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_AXIL 10. TEMP_NASOPH

2. TEMP_FOLEY 11. TEMP_ORAL

3. TEMP_CORE 12. TEMP_RECT

4. TEMP_EAR 13. TEMP_ROOM

5. TEMP_ESOPH 14. TEMP_SKIN

6. TEMP_FINGER 15. TEMP_BODY

7. TEMP_INJ 16. TEMP_TOE

8. TEMP_MYO 17. TEMP_TYMP

9. TEMP_NASAL 18. TEMP_VEN

IHE-PCD Rosetta ProjectCross-vendor measurement Semantics Interoperability

• Open consensus process• Observation identifiers and co-constraints• New terms incorporated into standards• hRTM used for conformance testing

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Rosetta for Semantic Interoperability

http://wiki.ihe.net/index.php?title=PCD_Profile_Rosetta_Terminology_Mapping

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Group REFID DIM UOM_MDC UOM_UCUM(http://www.daylife.com/photo/

03ub1GZa3R1le?q=Barack+Obama)

CVS_ECG_HR MDC_ECG_HEART_RATE T-1 MDC_DIM_BEAT_PER_MIN {beat}/min(http://www.daylife.com/photo/

03ub1GZa3R1le?q=Barack+Obama){beats}/min 1/min /min

CVS_ECG_ST MDC_ECG_AMPL_ST_I ML2I-1T-3ML2I-1T-3

MDC_DIM_MILLI_VOLTMDC_DIM_MICRO_VOLT

MDC_DIM_MILLI_M#

mV

uV (added by scripting rule)

mm# (voted “off-the-island”)

GASMON_AA_ENFL MDC_CONC_ENFL_ET L3L-3LMT-2L-2LMT-2L-2

MDC_DIM_VOL_PERCENTMDC_DIM_KILO_PASCALMDC_DIM_MMHG

%{vol}kPamm[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 sitesnumeric codes, where appropriate

An extract from the hRTM is shown below:

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RTM & hRTM HighlightsUnified 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.

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”)

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