11

In attempting to arrive at the truth, I have applied everywhere for information, but in scarcely an instance have I been able to obtain hospital records fit for any purposes of comparison.

If they could be obtained, …they would show how…money was being spent, what amount of good was really being done with it..; and… these improved statistics would tell us more of the relative value of particular operations and modes of treatment .. and the truth thus ascertained would enable us to save life and suffering, and to improve the treatment and management of the sick…

Florence NightingaleNotes on hospitals (1859, revised 1863)

Update on CDRH Informatics/UDI WorkUpdate on CDRH Informatics/UDI Work

Terrie ReedTerrie ReedSenior Policy AnalystSenior Policy Analyst

FDA Center for Devices and Radiological HealthFDA Center for Devices and Radiological Health3/12/103/12/10

33

How do you define Health How do you define Health Informatics?Informatics?

• Methods used to optimize the Methods used to optimize the acquisition, storage, retrieval, and acquisition, storage, retrieval, and analysis of health information. analysis of health information. Tools include not only computers Tools include not only computers but also clinical guidelines, but also clinical guidelines, formal medical terminologies, and formal medical terminologies, and information and communication information and communication systems.systems.

44

How do you define Health Informatics?How do you define Health Informatics?

• For CDRHFor CDRH

– Standard VocabulariesStandard Vocabularies

– Standard Methods of Data ExchangeStandard Methods of Data Exchange

– Alignment of Database Information Alignment of Database Information

• GOAL of Health InformaticsGOAL of Health Informatics

– Facilitate sharing of data across TPLC Facilitate sharing of data across TPLC and with other Stakeholdersand with other Stakeholders

55

CDRH Informatics WorkCDRH Informatics Work

Examples of Standard VocabulariesExamples of Standard Vocabularies• Event Problem Codes – Fully Live 4/2/2010Event Problem Codes – Fully Live 4/2/2010

• Evaluation Codes – Under DevelopmentEvaluation Codes – Under Development

• Global Medical Device Nomenclature (GMDN)Global Medical Device Nomenclature (GMDN)

• Product Dictionary – Unique Device Identifier Product Dictionary – Unique Device Identifier (UDI)(UDI)

66

CDRH Informatics Work (cont’d)CDRH Informatics Work (cont’d)

Examples of Standard Methods of Data ExchangeExamples of Standard Methods of Data Exchange

• Health Level Seven (HL7)Health Level Seven (HL7)

– Regulated Product Submission (RPS) – STEDRegulated Product Submission (RPS) – STED

– Individual Case Safety Report (ICSR) - eMDRIndividual Case Safety Report (ICSR) - eMDR

– Structure Product Labeling (SPL) Product Structure Product Labeling (SPL) Product Information + Content of the LabelInformation + Content of the Label

Examples of Aligning Databases – Examples of Aligning Databases –

• Product Codes =>UDIProduct Codes =>UDI

77

The Need for UDIThe Need for UDI

• US Has No Good System To Track Medical Implants

• AP Enterprise: United States Has No Reliable System To Track

• Defective Medical Implants

• (AP) New York October 5, 2009. Three years ago, the maker of a surgical clip called the Hem-o-lok issued an urgent recall notice warning doctors to stop using the fasteners on living kidney donors. It said the clips could dislodge. in their bodies, with "serious, even life-threatening consequences.“ Not everyone got the message. Last October, a surgeon in Brooklyn used one of the clips to tie off Michael King's renal artery when he donated a kidney to his ailing wife. Twelve hours later, the clip popped off. King bled to death internally in the hospital as his wife lay helplessly nearby. He was 29.

http://www.cbsnews.com/stories/2009/10/05/ap/health/main5364655.shtml

888

Device Information LifecycleDevice Information Lifecycle

Distributor

Direct Hospital

Clinical Use Unit

AE Reporting

Population Databases

PostmarketSurveillance

Hoarding

Off-masterpurchase

Rentals

Recall

ManufacturerSold

Sales Rep

GPOs ClinicalSubstitution

Device XLot Y

Exp Date ZReuse

Reorder

Registries

Physicianpreference

ComparativeEffectiveness

EHR

Reimbursement

FDA’s Sentinel System

99

Current Device IdentificationCurrent Device Identification

• Non-standard device identification systems; Non-standard device identification systems; • Standards used in different waysStandards used in different ways• Not necessarily unique or unambiguousNot necessarily unique or unambiguous• Manufacturers’ own number/catalogue numberManufacturers’ own number/catalogue number• Distributors’ – apply different, proprietary number; lot Distributors’ – apply different, proprietary number; lot

or serial number not capturedor serial number not captured• Hospital – yet different identification number/codeHospital – yet different identification number/code

– Information on use not usually capturedInformation on use not usually captured–Control numbers rarely capturedControl numbers rarely captured

1010

UDI Can Improve… VisibilityUDI Can Improve… Visibility• Medical device recallsMedical device recalls• Adverse event reporting and postmarket surveillanceAdverse event reporting and postmarket surveillance• Tracking and tracing, supply chain security; and anti-Tracking and tracing, supply chain security; and anti-

counterfeiting/diversion (location systems)counterfeiting/diversion (location systems)• Comparative effectiveness (e.g., registries)Comparative effectiveness (e.g., registries)• Disaster/terror preparation and shortages/substitutionsDisaster/terror preparation and shortages/substitutions• Reduce medical errorsReduce medical errors• Documenting medical device use in patient’s EHR/PHR, hospital Documenting medical device use in patient’s EHR/PHR, hospital

information systems, claims datainformation systems, claims data• Sentinel Initiative - strengthening FDA’s ability to query data Sentinel Initiative - strengthening FDA’s ability to query data

systems for relevant device informationsystems for relevant device information

1111

Medical Device IdentificationMedical Device IdentificationDevelop a system to identify medical devices, which is:Develop a system to identify medical devices, which is:• ConsistentConsistent• Unambiguous (differentiates among all dimensions)Unambiguous (differentiates among all dimensions)• StandardizedStandardized• Unique at all levels of packagingUnique at all levels of packaging• Harmonized internationallyHarmonized internationally

And facilitates the:And facilitates the:• Storage, Storage, • Exchange, and Exchange, and • Integration of data and systemsIntegration of data and systems

1212

Future Information LifecycleFuture Information Lifecycle

Distributor

Hospital

EHR

Population databasesSurveillance

Recall

Manufacturer

Registries

Clinical Use

Re/order

Safe?

Recalled?UDIDevice XModel Y

Reimbursement

Expiration date?

Counterfeit

AE reporting

Effectiveness

1313

FDA Amendments Act of 2007FDA Amendments Act of 2007

September 27, 2007, the FDAAA signed into law:September 27, 2007, the FDAAA signed into law:

The Secretary shall promulgate regulations establishing The Secretary shall promulgate regulations establishing a a unique device identificationunique device identification system for medical system for medical devices requiring the devices requiring the label of devices to bear a unique label of devices to bear a unique identifieridentifier, unless the Secretary requires an alternative , unless the Secretary requires an alternative placement or provides an exception for a particular placement or provides an exception for a particular device or type of device. The unique identifier shall device or type of device. The unique identifier shall adequately adequately identify the device through distribution and identify the device through distribution and useuse, and may include information on the lot or serial , and may include information on the lot or serial number.number.

1414

HR 3962 – Health Care ReformHR 3962 – Health Care Reform

SEC. 2571. NATIONAL MEDICAL DEVICE REGISTRYSEC. 2571. NATIONAL MEDICAL DEVICE REGISTRY(b) Electronic Exchange and Use in Certified Electronic Health Records of Unique Device Identifiers-(b) Electronic Exchange and Use in Certified Electronic Health Records of Unique Device Identifiers-……

(2) STANDARDS, IMPLEMENTATION CRITERIA, AND CERTIFICATION CRITERIA- The Secretary of Health and (2) STANDARDS, IMPLEMENTATION CRITERIA, AND CERTIFICATION CRITERIA- The Secretary of Health and Human Services, acting through the head of the Office of the National Coordinator for Health Information Human Services, acting through the head of the Office of the National Coordinator for Health Information Technology, Technology, shall adopt standards, implementation specifications, and certification criteria for theshall adopt standards, implementation specifications, and certification criteria for the

electronic exchange and use in certified electronic health electronic exchange and use in certified electronic health records of a unique device identifier for each covered records of a unique device identifier for each covered device referred to in paragraph (1), if such an identifier is device referred to in paragraph (1), if such an identifier is required by section 519(f) of the Federal Food, Drug, and required by section 519(f) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360i(f)) for the device.Cosmetic Act (21 U.S.C. 360i(f)) for the device.

(c) (c) Unique Device Identification System- The Secretary of Unique Device Identification System- The Secretary of Health and Human Services, acting through the Health and Human Services, acting through the Commissioner of Food and Drugs, shall issue proposed Commissioner of Food and Drugs, shall issue proposed regulations to implement section 519(f) of the Federal regulations to implement section 519(f) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360i(f)) not Food, Drug, and Cosmetic Act (21 U.S.C. 360i(f)) not later than 6 months after the date of the enactment of this later than 6 months after the date of the enactment of this Act.Act.

1515

11stst – Developing the Identifying Code – Developing the Identifying Code

– Develop UDI code according to ISO 15459 [GS1, Develop UDI code according to ISO 15459 [GS1, HIBCC]HIBCC]

– Created and maintained by the manufacturerCreated and maintained by the manufacturer– Concatenating Device and Production IdentifierConcatenating Device and Production Identifier– Device Identifier (DI)Device Identifier (DI): [static] Manufacturer, make, : [static] Manufacturer, make,

model [i.e., each catalogue number]model [i.e., each catalogue number]– Production Identifier (PI)Production Identifier (PI): [dynamic] if currently : [dynamic] if currently

serialized – serial number; if currently identified at serialized – serial number; if currently identified at the lot, the lot number, and expiration datethe lot, the lot number, and expiration date

– Risk based approach – DI; DI + lot; DI + serial (or lot Risk based approach – DI; DI + lot; DI + serial (or lot and serial)and serial)

1616

22ndnd – Applying code to Label – Applying code to Label

•• Applied at all levels of packaging, down to the Applied at all levels of packaging, down to the lowest level (the patient use level or unit of use)lowest level (the patient use level or unit of use)

•• Human readable and/or encoded in a form of Human readable and/or encoded in a form of automatic identification technologyautomatic identification technology

– Direct Part Marking (DPM) for some devicesDirect Part Marking (DPM) for some devices

– No specific technology would be identified No specific technology would be identified (technology neutral)(technology neutral)

– Identify a series of standards (linear barcode, 2-Identify a series of standards (linear barcode, 2-dimensional barcode, RFID)dimensional barcode, RFID)

1717

33rdrd – Developing UDI Database to Store – Developing UDI Database to Store Code and Other Attributes (GHTF)Code and Other Attributes (GHTF)

• Labeler Contact name, phone, emailLabeler Contact name, phone, email• Device Identifier Type/Code [GTIN, HIBCC]Device Identifier Type/Code [GTIN, HIBCC]• Brand/Trade Name; DescriptionBrand/Trade Name; Description• Device model number (or reference number)Device model number (or reference number)• Size; Unit of Measure/Packaging level/quantitySize; Unit of Measure/Packaging level/quantity• Control – Lot and/or Serial Number; Exp. DateControl – Lot and/or Serial Number; Exp. Date• GMDN Classification code/termGMDN Classification code/term• Storage condition; Sterility; Storage condition; Sterility; • Contains known, labeled allergen (e.g., latex)Contains known, labeled allergen (e.g., latex)• URL for additional information – Web address URL for additional information – Web address

For more details - see GHTF Draft Discussion Paper:For more details - see GHTF Draft Discussion Paper:http://http://

ec.europa.eu/enterprise/newsroom/cf/document.cfm?actionec.europa.eu/enterprise/newsroom/cf/document.cfm?action==display&doc_iddisplay&doc_id=5556&userservice_id=1=5556&userservice_id=1

1818

FDA’s UDI DatabaseFDA’s UDI Database

Distribution

HIBCC UPN

BusinessRules

Manufacturer(Acme)

GSI GDSN

The label of Medical Device 123 Size 45:Device Identifier (Device XYZ123)Production Identifier (Lot #ABC)Expiration date (MMDDYYYY)

Sterile; Latex free

Minimum Data SetFor each Device Identifier:• Manufacturer and model• GMDN Code• Other attributes

or

FDA’s UDIDatabase

Oth

er o

ptio

ns

FDA

FDA Managed

Public User Interface

SPL

Labeler

or

1919

44thth - Adoption and Implementation - Adoption and Implementation• • Resolve technology issues – barcodes, RFID, DPMResolve technology issues – barcodes, RFID, DPM– Develop appropriate UDI DatabaseDevelop appropriate UDI Database– Facilitate distributor uptake and useFacilitate distributor uptake and use– Facilitate hospital uptake and useFacilitate hospital uptake and use– Facilitate use of UDI throughout device lifecycleFacilitate use of UDI throughout device lifecycle– Develop medical error reduction (e.g., latex)Develop medical error reduction (e.g., latex)– Drive integration – MMIS-ClinicalDrive integration – MMIS-Clinical– Drive appropriate use of UDI in EMRsDrive appropriate use of UDI in EMRs– Determine appropriate role in reimbursementDetermine appropriate role in reimbursement– Address privacy concernsAddress privacy concerns

202020

UDI Database PilotUDI Database PilotPhase 1-3Phase 1-3Purpose: Purpose: Assess the feasibility of collecting, storing, and retrieving UDI data Assess the feasibility of collecting, storing, and retrieving UDI data

from initial creation (manufacturer) to point of use (hospital) . from initial creation (manufacturer) to point of use (hospital) . Results:Results:• Data suppliers (manufacturers) had concerns about data Data suppliers (manufacturers) had concerns about data

definitions, obtaining the data from various sources and definitions, obtaining the data from various sources and manipulating for UDI upload.manipulating for UDI upload.

• Participants confused about the purpose/use of UDID.Participants confused about the purpose/use of UDID.• Users (hospitals) liked UDID – it provided data they regularly need - Users (hospitals) liked UDID – it provided data they regularly need -

e.g. information related to recalls and identifying alternate e.g. information related to recalls and identifying alternate products/manufacturers for recalls.products/manufacturers for recalls.

212121

UDI Database PilotUDI Database PilotPhase 4Phase 4Purpose: Purpose: Assess how UDI data will impact FDA device information use in Assess how UDI data will impact FDA device information use in

current systemscurrent systems

Method:Method:• Vendors submit data via spreadsheetsVendors submit data via spreadsheets• FDA analyze data for completeness and accuracyFDA analyze data for completeness and accuracy• FDA analyze data for impact on current systemsFDA analyze data for impact on current systems• FDA use results to inform development of UDI DatabaseFDA use results to inform development of UDI Database

Results:Results:PendingPending

222222

Limitations of UDI and UDIDLimitations of UDI and UDID• UDID contains only “static” information.UDID contains only “static” information.• Includes identifying information and other Includes identifying information and other

attributes about the device.attributes about the device.• UDID does NOT contain production UDID does NOT contain production

information, such as lot or serial numbers.information, such as lot or serial numbers.• UDID is NOT track/trace or other similar UDID is NOT track/trace or other similar

purposes requiring the full UDIpurposes requiring the full UDI• UDID provides link to Better Product UDID provides link to Better Product

Information- not a replacement for Information- not a replacement for Recalls/Adverse Event Databases.Recalls/Adverse Event Databases.

2323

Conclusion: UDI as Foundational ElementConclusion: UDI as Foundational Element

UDI will facilitate integration of data across UDI will facilitate integration of data across disparate systems in the supply chain:disparate systems in the supply chain:

– more efficient and effective device recalls,more efficient and effective device recalls,– improved postmarket surveillance, improved postmarket surveillance, – better adverse event reporting, better adverse event reporting, – better device identification in registries,better device identification in registries,– ability to document specific device use in patient’s ability to document specific device use in patient’s

Electronic Health Records, Electronic Health Records, – collection of device information in population-based data collection of device information in population-based data

sets.sets.BUT – only if UDI is captured, stored, integrated and exchanged BUT – only if UDI is captured, stored, integrated and exchanged

by ALL stakeholders.by ALL stakeholders.

2424

Unique Device IdentificationUnique Device Identificationwww.fda.gov/MedicalDevices/www.fda.gov/MedicalDevices/

DeviceRegulationandGuidance/DeviceRegulationandGuidance/UniqueDeviceIdentifiersUniqueDeviceIdentifiers

Email: cdrhudi@fda.hhs.govEmail: cdrhudi@fda.hhs.gov