HIBC UDI IMPLEMENTATIONFOR THE DENTAL INDUSTRY

Presented to:

Dental Trade AllianceOctober 8, 2014

Robert A. Hankin, Ph.D.HIBCC President

HIBCC AND THE DENTAL COMMUNITY

• Use of the HIBC within the dental industry began in the 1980s and included consultation with the DMA and ADTA (DTA predecessors);

• The letter “D” identifier in the HIBC LIC (Company Prefix) was set aside in 1989 for use by the US dental industry, and is assigned regularly to US domestic labelers;

• HIBCC serves as the secretariat for the American Academy of Dental Group Practice (AADGP) and participates on the ADA National Roundtable for Dental Collaboration.

HIBCC is accredited by the American National Standards Institute (ANSI), the European Committee for Standardization (CEN) and is recognized by the International Organization for Standardization (ISO).

The HIBC Supplier Labeling Standard (SLS) is a recognized standard under FDA's UDI programand has been identified by the European Union (EU) in their developing regulation on device identification, as well as by the International Medical Device Regulators Forum (IMDRF).

Our standards efforts are supported worldwide by a network of affiliate offices in Europe and Asia Pacific.

INTERNATIONAL STANDARDS DEVELOPMENT

HIBC is included in the pending international UDI system:

excerpt of version 2.0:

5. Definitions: Device Identifier (UDI-DI)The UDI-DI is a unique numeric or alphanumeric code specific to a model of medical device and that is also used as the "access key" to information stored in a UDID. Examples of the UDI-DI include GS1 GTIN, HIBC-LIC, ISBT product code.

HIBC UDI allows you to directly use your specific self-assigned product identifiers. No cross-referencing to other codes is necessary.

ALPHANUMERIC (0 – 9), (A-Z)Provides a larger set of possible identifiers and the ability for literal incorporation of

product identifiers, eliminating risky cross-referencing of data.

VARIABLE LENGTH PRODUCT DATA (1-18 CHARACTERS)Enables manufacturers to incorporate their exact product identifiers within the data

structure, eliminating need to truncate or add digits.

HIBC UDI – ONE LIC ASSIGNMENT COVERS ALL YOUR PRODUCTS

HIBC UDI-Label Symbologies: Use of Special Characters

Primary Data StructureSpecial characters (-, ., $, /, +, %, and space) are excluded in the Primary data structure, except for “+” and “$” at the beginning of the HIBC LIC symbols.

Secondary Data StructureThe use of the special characters “.” and “-” can be used in the secondary data structure.

HIBC UDI encompasses multi-levels of packaging in a format standardized for domestic and international markets. Your LIC registration covers its use throughout the world.

PACKAGE LEVEL CONSISTENCYHIBC symbols are consistent on all levels of packaging – i.e. SKU, carton, case. This allows for easier identification within various packaging configurations.

GLOBAL MARKET CONSISTENCYHIBC format is globally consistent so identifiers are the same everywhere in the world.

HIBC UDI – ONE LIC COVERS ALL YOUR PRODUCTS

THE HIBC UDI FORMAT

FDA UDI REQUIREMENTS

An FDA device identifier that identifies the specific version or model of a device and the labeler of that device; and

HIBC UDI FORMAT – FDA Device Identifier

Labeler Identification Code (LIC)Product/Catalog IDUnit of Measure

FDA UDI REQUIREMENTS

An FDA production identifier that identifies one or more of the following, when present on the label of the device:

The lot or batch within which a device was manufactured; the serial number of a specific device; the expiration date of a specific device;the date a specific device was manufactured.”

HIBC UDI FORMAT – FDA Production Identifier

Date/Lot/Batch/Serial NumberExpiration Dateetc, as specified

HIBC UDI Expiration Date Formats

Common Question:

HIBCC UDI expiration date formats comply with the FDA UDI requirementsFDA states that “the date format must be YYYYMMDD…only for plain text dates.”

All of the following date formats are acceptable within your bar code/human readable AIDC:MMYYYYMMDDYYMMDDHHYYJJJYYJJJHH

The FDA has emphasized that the cost of UDI should not cause an undue financial burden on manufacturers and other labelers. HIBCC Agrees!

LIC REGISTRATION IS:

• A one time fee - there are no reoccurring annual costs to maintain the registration;

• The Fee is based upon gross sales in the fiscal year prior to the application date;

• The fee is based on last year’s gross annual sales, not by individual packaging configurations;

• Your LIC is applicable at every level and variation of packaging with no additional fees;

• Your LIC is globally compatible and can be used throughout the world with no additional fees;• Your LIC can be used an unlimited number of times with no additional fees.

LIC REGISTRATION FEESONE-TIME

USING HIBCC’S ONLINE UDI FORMATTER

1. If you do not already have a registered LIC, apply to HIBCC by submitting an application online, by mail or by fax.

2. After HIBCC assigns your LIC, you can then begin creating UDIs using the HIBC Supplier Labeling Standard (SLS).

3. Then you can confirm your UDIs using the HIBC UDI Formatter available online.

HIBCC & GUDID

The UDI data is submitted to a public database to encourage broad integration within various healthcare delivery support systems.

HIBCC will apply it’s extensive database resources currently deployed for administration of systems such as the Health Industry Number (HIN) to provide services in support of GUDID standardization and submission to FDA.

Sample Package Labels

Sample Package Labels

HIBCC UDI RESOURCES

The HIBC UDI Resource page can be found at www.HIBCC.org/UDI-Resources and includes informational materials such as:

HIBCC UDI GUIDELINESLIC APPLICATION FORM

HIBC SUPPLIER LABELING STANDARD (SLS 2.4)UDI DATA FORMATTER – BETA VERSION

CURRENT HIBC REGISTRANTS BY COUNTRYCURRENT DENTAL REGISTRANTS

DEVELOPING GUDID SPECIFICATIONSTHIS SLIDE SET

Questions can be addressed to the HIBCC Resource Desk @ 1.855.HIBC.UDI (1.855.442.2834);

CONTACT US

www.hibcc.org

info@hibcc.org

(602) 381-1091

HIBCC2525 E. Arizona Biltmore CircleSuite 127Phoenix, AZ 85016