Unique Device Identification and HL7 Messages

HL7 Working Groups27th Annual Plenary Meeting

September 2013

Terrie Reed, Associate Director, InformaticsLeslie Tompkins, Informatics Staff

FDA, Center for Devices & Radiological Health

Types of Medical Devices and Examples• Capital Equipment

– cribs, beds, scales, wheelchairs, IV poles, infusion pumps, bathing tubs, blood pressure equipment, MRI and CAT scanners, radiology equipment

• Instruments– surgical staplers, glucose meters,

orthopedic tools and hardware

• Monitoring Systems– cardiac, telemetry, vital sign

monitors, pulse oximeters

• Clinical Lab– IVD tests and reagents– Chemistry analyzers

• Disposables & Accessories– ventilator breathing circuits, filters– needles, syringes, trocars, IV

catheters, IV tubing, foley catheters, feeding tubes, gloves

– electrodes• Implantable

– defibrillators, breast implants, ventriculoperitoneal shunts,, tissue expanders, pacemakers

• Computerized Medical Systems

– Workstations, hardware– software

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Identifying a single device:BD 1/2 mL Insulin Syringe/28 G needle

Business Name Item Number Type Item NumberBD Mfg Catalog Number 329461

BD GTIN 00382903294619Cardinal Health PV Order Number BF329461Owens & Minor PV Order Number 0722329461American Medical Depot Vendor Catalog Number 777127217

Government Sci Source Vendor Catalog Number FSC1482679CS

Alliance Joint Venture Vendor Catalog Number 888021932

Thomas Scientific Vendor Catalog Number 8938M25

VWR International Vendor Catalog Number BD329461

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Easier to identify the dogfood you bought at the grocery store…..

UDI Legislation: Standardizing Device Identification

FDAAA 2007; FDASIA 2012

Not later than December 31, 2012, the Secretary shall issue proposed regulations establishing a unique device identification system for medical devices requiring the label of devices to bear a unique identifier, unless the Secretary requires an alternative placement or provides an exception for a particular device or type of device. The unique identifier shall adequately identify the device through distribution and use, and may include information on the lot or serial number. The Secretary shall finalize the proposed regulations not later than 6 months after the close of the comment period and shall implement the final regulations with respect to devices that are implantable, life-saving, and life sustaining not later than 2 years after the regulations are finalized, taking into account patient access to medical devices and therapies.

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Final Rule PUBLISHED!!!September 24, 2013

www.fda.gov/udi

Unique Device Identifier (UDI)A globally unique device Identifier:• To be obtained from an FDA-accredited issuing agency• To be applied by manufacturer to the label of devices• To be submitted by manufacturer to Globally Unique Device

Identification Database (GUDID) along with associated device attributes – Common Product Model

• To be made publically available at no charge• To be used by FDA applications (MAUDE, Recalls) and external

systems (EHRs, Claims, Inventory Systems) as the device ID standard

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UDI Representation

• (01) 00643169001763(17) 160712 (21) 21A11F4855• UDI = DI (Device Identifier) + PI (Production Identifier)

– Placed on the Device Label– DI is lookup key for pulling out other attributes from GUDID– Scanners/middleware can parse out PI (lot, serial, expiration and

manufacturer date) from the UDI barcode (where available)– GUDID will capture ONLY the DI portion (static portion of UDI)– Manufacturers or hospitals/end users are responsible for recording PI

information on individual device packages

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Global Unique Device Identification Database - GUDID

– Submission of DI records made through web interface and HL7 SPL

– Stores DI and other regulatory device identification information

– Download, Webservice and Search for Device Information – no charge from FDA

– Potential to link device information in procurement, inventory control, recalls, clinical care (including registries and clinical trials), clinical material management, incident systems etc.

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GUDID – Characteristics• Device Catalog - Contains static device information• NOT a Patient Registry – does NOT contain patient or

device specific production information, such as lot or serial numbers

• NOT for track/trace or other similar purposes requiring the full UDI

• Provides link to product information – not a replacement for FDA Recalls/Adverse Event Databases

• GUDID is not a requirement for hospitals – it is a tool that will provide the following benefits if all stakeholders buy in EHRs, Claims, Inventory Systems, Incident Systems, Clinical Maintenance…

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Example: Parsing a UDI *– (01)51022222233336(11)141231(17)150707(10)A213B1(21)1234

Issuing Agency

Identifying Symbol Identifier Data type

Human Readable Barcode

Field SizeDatabaseField Size

 

GS1 (01) DI numeric 16 14 

GS1 (11) Manufacturing Date

numeric [YYMMDD]

8 6 

GS1 (17) Expiration Date

numeric [YYMMDD]

8 6 

GS1 (10) Lot Number alphanumeric 22 20  

GS1 (21) Serial Number

alphanumeric 22 20 

GS1   Base UDI alphanumeric 76 66  

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*http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM369248.pdf

SPL R5 – DI Representation• SPL collects the Device Identifier without its

production identifiers• Device Identifier indicated by code

(00643169001763) • Issuing agency indicated by codeSystem

(GS1=1.3.160)

ICSR R1 –UDI Representation in Adverse Event Reporting • Unique Device Identifier includes the Issuing agency

prefix, device identifier and production identifiers

Draft

HL7 v 2.x Messages - Representation of UDI

Insert Solution Here

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FHIR – Representation of UDI

Insert Solution Here

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GUDID attributes (see Appendix B in Guidance)• Device Identifier* (DI of UDI)

– From Accredited Issuing Agency *• Manufacturer/Labeler Information (DUNS

#) • Brand Name *• Model/Version # *• Catalog #• Device Description• In Commercial Distribution• Procode (3-digit code, name)• GMDN Preferred Term

– 5-digit code– Term name – Definition

• PMA/510K number• FDA listing #• Size

– Dimension– Number– Unit of measure

• Storage and Handling– temperature, humidity

• Controlled by:– Serial#– Lot#– Manufacturing date– Expiration date– HCT/P

• Contains Natural Rubber Latex? *• For Single-use? *• Convenience Kit? *• Combination Product? *• Human Cell, Tissue or Cellular- or Tissue-

based Product (HCT/P)?• Prescription Status• MRI Safety?• Packaged as Sterile? *• Device Count *• Packaging Info

– (box, carton, case, etc)

Which Attributes to Retrieve from GUDID and Store? How to Retrieve? How to Transmit?Basics• Device Identifier* (DI of UDI)

– From Accredited Issuing Agency *

• Manufacturer/Labeler Information (DUNS #)

• Brand Name *• Model/Version # *• Catalog #• Device Description• In Commercial Distribution• GMDN Preferred Term

– 5-digit code– Term name – Definition

Patient Safety• Contains Natural Rubber Latex? *• For Single-use? *• Prescription Status• MRI Safety?• Packaged as Sterile? • Size

– Dimension– Number– Unit of measure

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Ideas?

Criteria for selecting the Data Elements *

• Does it reflect natural patient care documentation?

• Is it useful in patient care communication and transfer of care?

• How does the data element assist in charging?

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• Adapted From Stella Mandl Plenary Session

EHR Adoption – Meaningful Use Stage 3

Stage

Stage 2 Final Rule Stage 3 Recommendations

NEW – NOT IN STAGE 2

MENU objective: Eligible Physicians and Eligible Hospitals should record the FDA Unique Device Identifier (UDI) when patients have devices implanted for each newly implanted device.

MENU Measure: Eligible Physicians and Eligible Hospitals should record the UDI when patients have the device implanted for 80% of patients seen within the EHR reporting period.Proposed

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UDI RequirementsPatient’s implant is documented in EHR and other relevant systems as part of patient care by:• Representing UDI as the standard code to document device

use • Providing parsing instructions for decoding and storing DI +

PI• Using DI portion of UDI to obtain other relevant attributes

that link to patient episode of care (from GUDID or inventory system or ??)

• Making links between EHR, inventory and claims systems -store DI, PI and sufficient clinical and administrative attributes to maximize benefit to patient, care providers, hospital systems (materials management, biomedical engineering, risk management, recalls)

Potential Future Benefits• The UDI of an implanted medical device could be captured

upon implant and become a permanent part of a patient’s medical record. Then:– A clinician could view all of the patient’s implanted devices

and associated UDI’s in the same manner as a medication list is viewed.

– This hospital would be able to report adverse events using the UDI (and appropriate associated attributes) linked to the EHR patient record.

– If an implantable device recall occurred, the hospital or physician would be able to use the UDIs of the recalled devices to pull up all patients in their EHR that have in their record the device identifier, and lot/batch/serial number combination specified in the recall notice. 20

Devices would be better identified as part of care

• UDI and other implantable device information could be provided at time of patient transition in :             – View, Download and Transmit functions (VDT)– Summary of Care documents– Transition of Care documents– After visit summary documents

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UDI and HL7 - questions• Which HL7 Standards need to support UDI for capturing

implant and linking to patient surgical procedure?• Does an HL7 standard need to define the UDI attributes

to link to patient? If not, what standard would?• Should UDI representation be resolved by M&M?• Should there be an Implementation Guide to define how

to represent UDI in SPL, v2.x, FHIR, medical device interoperability? Who coordinate?

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UDI Resources now available• UDI website – Portal for all Resources

– www.fda.gov/UDI• UDI Help Desk• GUDID Draft Guidance

– http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM369248.pdf • Appendix B – Vocabulary• Appendix C - UDI Specifications by

Issuing Agency23