UDI: Where Do We Go From Here?

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  • Healthcare

    Greg Bylo, GS1 US

    UDI: Where Do We Go From

    Here?GS1 US Supply Chain Visibility

    June 15, 2016

  • 2016 GS1 US All Rights Reserved

    Antitrust Caution

    GS1 US is committed to complying fully with antitrust laws.

    We ask and expect everyone to refrain from discussing prices,

    margins, discounts, suppliers, the timing of price changes,

    marketing or product plans, or other competitively sensitive topics.

    If anyone has concerns about the propriety of a discussion, please

    inform a GS1 US representative as soon as possible.

    Please remember to make your own business decisions and that all

    GS1 standards are voluntary and not mandatory.

    Please review the complete GS1 US antitrust policy at:

    http://www.gs1us.org/gs1-us-antitrust-compliance-policy

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    http://www.gs1us.org/gs1-us-antitrust-compliance-policy

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    Legal Disclosure

    GS1 US, Inc. is providing this presentation, as is, as a service to interested

    parties. GS1 US MAKES NO REPRESENTATIONS IN THIS REGARD AND

    DISCLAIMS ALL WARRANTIES, EITHER EXPRESS OR IMPLIED, INCLUDING

    BUT NOT LIMITED TO, ANY WARRANTY OF ACCURACY OR RELIABILITY OF

    ANY CONTENT, NONINFRINGEMENT, MERCHANTABILITY OR FITNESS FOR A

    PARTICULAR PURPOSE.

    GS1 US shall not be liable for any consequential, special, indirect,

    incidental, liquidated, exemplary or punitive damages of any kind or nature

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    arising out of the use of this presentation or any content herein, even if

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    could have been reasonably foreseen.

    GS1 US employees are not representatives or agents of the FDA, and the

    content of this presentation has not been reviewed, approved or authorized

    by the FDA.

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    Agenda

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    Anti-Trust Caution / Legal Disclosure Standards in Action UDI The Basics Holistic Approach to UDI Leveraging Your Investment

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    Standards in Action

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    GS1 Standards in Action

    The following link provides a basic review of the

    GS1 standards for Healthcare and how they can

    improve operational efficiency and patient

    safety.

    http://www.gs1us.org/industries-

    old/healthcare/standards-in-action-video

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    http://www.gs1us.org/industries-old/healthcare/standards-in-action-video

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    The Global Language of Business

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    Identify GS1 Identification Numbers

    Companies, Products, Locations,

    Logistics, Assets, and Services

    Capture GS1 Data Carriers

    Barcodes and EPC-enabled RFID

    Share GS1 Data Exchange

    Master Data, Transactional Data,

    and Physical Event Data

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    GS1 Standards

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    Implemented GS1 Standards in the Supply Chain

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    GS1 Interface Standards for Electronic Commerce

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    GS1 Interface Standards for Electronic Commerce

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    Data Flow for the Global Data Synchronization Network

    Select one data pool as a SINGLE point of entry to the GDSN

    The GS1 Global Registry is a single repository where basic data is registered. The GS1 Global Registry identifies the data pool location of source data.

    Data Pools provide data that is standards conformant, and interoperable in the GDSN. The data pool performs the transactions of sending and receiving validated product information between partners inside or outside the data pool.

    Step 1 : Load Data

    Step 2 : Register Data

    Step 3 : Subscription Request

    Step 4 : Publish Data

    Step 5 : Recipient Confirmation

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    FDA GUDID

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    UDI Basics

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    Meeting UDI Requirements

    Step 1 - The Device Identification

    (DI)

    - Identify your devices

    - Adhere to one of issuing agencies

    GS1, HIBCC, or ICCBBA

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    Step 2 Select Bar Code

    (AIDC) and design label and

    packaging

    Step 3 Identify the

    Production data

    GTIN Global Trade Item Number

    Expiry Date

    Lot

    Number

    Serial Number

    UDI = Device Identifier (DI) + Production Identifiers (PI)

    GTIN + Application Identifiers (AI)

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    Meeting UDI Requirements

    Step 4 The GUDID

    Global Unique Device Identifier Database (GUDID)

    - Operated by the FDA to collect information on Medical Devices

    - Will have public facing website to share data with anyone

    - Some information submitted to the GUDID will be private (for FDA only)

    All medical devices which are regulated under the UDI regulations will be

    required to be listed in the GUDID

    - Sunrise for each class is the same for GUDID as assigning a UDI

    Class III devices- 1 year from final rule publication (September 24, 2014)

    (complete with extensions)

    Class II life sustaining devices- 2 years from final rule publication

    (September 24, 2015) (GUDID extended to October 24, 2015) (complete with

    extensions)

    Class II remaining devices- 3 years from final rule publication (September

    24, 2016)

    Class I devices- 5 years from final rule publication (September 24, 2018)

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    Holistic Approach to UDI

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    Implementation & Integration Implications to Consider

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    1 MDM business process needed to maintain UDI attributes

    UDI Rule provides data definitions for each attribute

    Need BP Owners for each attribute

    2 Incorporate UDI into it Labeling/Packaging process

    Address both global & local UDI requirements

    Impacts all product labels unit of use through case

    3 Create ECR BP to meet UDI Requirement

    48 hour requirement for design change notification

    Product Design incorporate GTIN assignment process

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    Identify all SOPs which need to be updated & include in project plan

    Document integrated process in SOPs

    SOPs need to be completed before project is completed

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    Update the systems to utilize the UDI GTIN (DI)

    Map product attributes from source to GUDID

    Identify GUDID process & owner

    Validate automated GUDID transfer process

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    Determine sharing strategyGDSN?

    Integrate ECR process with data update process

    Integrate data sharing with GUDID update process

    Global and Local Approach

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    Leveraging Your Investment - Supply Chain Visibility using GS1 Standards

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    Critical Tracking Events

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    Critical Tracking Events

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    CRITICAL TRACKING EVENT DEFINITIONS

    TRANSFORMATION-TYPE EVENTS are those events that typically support internal traceability within the four walls of a supply chain company.

    TRANSFORMATION INPUT (T1) EVENT: The event where one or more materials are used to produce a traceable product that enters the supply chain.(NOTE: Materials used to produce products for immediate consumption by consumers are reported as Consumption events)

    TRANSFORMATION OUTPUT (T2) EVENT: The event where a traceable product is packaged and labeled for entry into the supply chain.

    TRANSPORTATION-TYPE EVENTS are those events that typically support external traceability between supply chain companies.

    SHIPPING (S) EVENT: The event where traceable product is dispatched from a defined location to another defined location.

    RECEIVING (R) EVENT: The event where traceable product is received at a defined location from another defined location.

    DEPLETION-TYPE EVENTS are those events that capture how traceable product is removed from the supply chain.

    CONSUMPTION (C) EVENT: The event where a traceable product becomes available to consumers.

    DISPOSAL (D) EVENT: The event where a traceable product is destroyed or discarded or otherwise handled in a manner that the product can no longer be used as a food ingredient or become available to consumers.

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    Key Data Elements

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    Shipping Receiving Input Output Consumption Disposal

    Event Type R R R R R R

    Event Owner R R R R R R

    Date R R R R R R

    Time R R R R R R

    Event Location R R R R R R

    Item ID Type R R R R R R

    Item ID R R R R R R

    Batch/Lot/Serial# BP* BP R R BP BP

    Quantity R R R R R R

    Unit of Measure R R R R R R

    Batch/Lot Relevant Date C^ C C C^ BP BP

    Activity Type C C R R

    Activity ID C C R R

    Supplier Identity C C C C

    Trading Partner Location R R

    R = Required Data

    BP = Best practice is to capture the batch/lot number for transport and depletion events whenever possible;

    however, if not feasible, Batch/Lot Relevant date or Activity ID must be p