UDI Overview. Jenny Gough

Transcription

1 UDI Overview Jenny Gough

2 Agenda UDI a global Vision a top level view of which countries are developing UDI legislation and customer requirements. UK e-procurement Strategy - how is the NHS meeting the requirements for UDI as set out by the IMDRF. How Mölnlycke Health Care is currently working towards being able to meet the developing requirements from a global supplier perspective.

3 A Global Vision of UDI - Legislation Country Timeline STD Label Requirements Data Reporting Spain 2006 GS1 Device Identifier, Production Identifiers to Unit of Use Level Turkey 2009 GS1 HIBC Device Identifier, Production Identifiers to Unit of Use Level Japan 2009 GS1 HIBC Device Identifier, Production Identifiers to Unit of Use Level India 2012 GS1 Device Identifier, Production Identifiers to Unit of Use Level Reimbursement SAS - Department of Health Andaluz TITUBB: Reimbursement SGK Social Security Institute MEDIS: Reimbursement Ministry of Health, Labor and Welfare Procurement Ministry of Health & Family Welfare IMDRF Release 2013 GS1 HIBC Device Identifier, Production Identifiers to Unit of Use Level UDI - International Medical Device Regulators Forum (IMDRF) USA Class III: 2014 All Implants, LS/ LS: 2015 Class II: 2016 Class I: 2018 (DM + 2 years) GS1 HIBC ISBT Device Identifier, Production Identifiers UDI Database: Regulatory US Food and Drug Administration Argentina Phase 1 Feb 2015 Phase 2 Aug 2015 GS1 Device Identifier, Production Identifiers and Global Location Numbers (GLN) Database Traceability ANMAT

4 A Global Vision of UDI - Legislation Country Timeline STD Label Requirements Data Reporting EU Proposal for Regulation Delayed. Possible 2016 GS1 HIBC Device Identifier, Production Identifiers to Unit of Use Level Eudamed Database: Regulatory European Commission China Expected 2015 TBD TBD UDI Canada Expected 2016 TBD TBD UDI Brazil TBD TBD To Follow IMDRF UDI S. Korea TBD TBD TBD UDI Saudi Arabia TBD TBD TBD UDI

5 US FDA UDI Ruling US Ruling - barcoding All secondary packaging levels for all classifications of product have the same requirement of DI + PI Class 2 & 3 unit of use also requires both the DI + PI Class 1 unit of use only requires the DI For single use items this is on the packaging. No exemptions For multiple use items this needs to be direct part marked onto the device itself in a format that will be scannable after reprocessing for the duration of the product life. Exemptions apply when: Lack of space Unsuitable for direct part marking Implantable device

6 US FDA UDI Ruling US Ruling GUDID (Global UDI Database) 62 attributes to be entered into the database Three ways to input data Web portal Mass upload via HL7 Third party

7 US FDA UDI Ruling FDA UDI Implementation Timelines: High Risk Low Risk

8 A Global Vision of UDI - Customers US GS1 bar codes down to unit of use level and provision of product data into GS1 certified GDSN datapools. Australia GS1 bar codes down to unit of use level and provision of product data into GDSN certified datapool. New Zealand - GS1 bar codes down to unit of use level and provision of product data into GDSN certified datapool. Sweden customers requesting GS1 bar codes down to unit of use level and provision of product data into Validoo Netherlands requesting GS1 bar codes down to unit of use and product data via spreadsheet (currently) UK more detail in following slides

9 UK Department of Health & the NHS Third largest employer globally, 1.3 million in England & Wales Treat 1 million patients every 36 hours In 2013/ ,030 million operations 21,779 million patients attended to A & E Net expenditure 109,721 billion 433 Trusts Clinical commissioning groups, acute trusts, mental health, ambulatory 34 Community providers 8,000 GPs 853 independent sector organisations caring for NHS patients from 7331 locations.

10 UK Department of Health & the NHS Trusts operate as individual businesses Individual Product Catalogues Only products relevant to the individual trust Individual trading methods (orders/invoicing/etc) Fragmented approach Inconsistent product data Duplication of products in systems Poor product traceability Poor stock control

11 UK Department of Health & the NHS August 2013 Department of Health released the NHS Procurement Programme - Better Procurement, better value, better care ta/file/226835/procurement_development_programme_for_nhs.pdf This document outlined four integrated initiatives: 1. Delivering immediate efficiency and productivity gains 2. Improve data, information and transparency including the adoption of GS1 coding standards. 3. Action to demonstrate ways in which the NHS can improved outcomes for patients at lower costs through clinical procurement review partnerships. 4. A longer term programme to improve leadership and capability through the creation of a new centre of procurement development to support the delivery of world class procurement throughout the NHS and develop improved trust level leadership, including the role of non-executive directors

12 UK Department of Health & the NHS April 2014 Department of Health released the NHS e-procurement Strategy _data/file/344574/nhs_eprocurement_strategy.pdf This document sets out the development of the infrastructure required to support the adoption of GS1 coding systems. The aim is to ensure all NHS purchase to pay transactions and all category management activities are undertaken by electronic means. This will cover all non-pay expenditure. It will also cover the use of master data and put in place measures to ensure accurate up to date product information.

13 UK Department of Health & the NHS Mandated GS1 & PEPPOL Standards for all non pay expenditure Suppliers Product Marking at all packaging levels (in line with developing UDI legislation) Populate NHS Database through a GS1 certified GDSN Datapool (98 product attributes & 31 pricing attributes) Introduce electronic trading via PEPPOL using GS1 GDSN standards GS1 standards included in NHS Terms of Contract from August 2013 and also in NHS Standard contracts from April 2014.

14 UK Department of Health & the NHS Mandated GS1 & PEPPOL Standards for all non pay expenditure Trusts October 2013 patient identity wrist bands made mandatory GS1 DataMatrix bar code including Patients NHS Number, First and Family names and Date of birth Implement electronic health records Initiate NHS EPC for procurement purposes Implement AIDC & GDSN 3 5 year timeline Patient Safety is the key lever, however this will initiate efficiencies which will help to save the NHS.

15 A Global Supplier Point of View Meet Legislative UDI requirements Bar coding Decide which standard to use (GS1, HIBCC, ICCBBA) What is best for the company? Are you already using something? Do you sell product in the retail sector? Allocate unique numbers to each product at each packaging level Check what information you need to have in your barcodes Implement the barcodes onto the labelling at all packaging levels Check the barcodes work Data Analyse the data requirements and ensure that you have all of the required data Ensure that the data is correct and up to date Obtain any missing data and incorporate it into systems Decide how you wish to store and transmit the data to the relevant solution Ensure that governance and processes are in place to ensure that all updates, amends and new items go into the system in a timely manner

16 A Global Supplier Point of View Meet customer requirements Barcodes Hopefully the coding requirements for customers will be the same as legislation, although in some cases there may be extra information required within the bar code Data Customers will require extra and differing data to the regulators so ensure that you also have this information and try to combine these attributes into the same solution that you have put in place for the regulators

17 A Global Supplier Point of View Meet business requirements Limit SKU proliferation Try to keep standard packaging globally without having to move to regional SKUs Keep costs to a minimum While it is important to meet the requirements look into the various options Implement what is required for your product types. Gain efficiencies where possible Use the barcodes to help automate internal processes and make your own supply chain more efficient.

18 A Global Supplier Point of View Where are we? GTINs allocated to all products at all packaging levels. Barcodes applied to all product labelling at all product levels in line with the US UDI Ruling Further assessment to take place as and when further requirements come into effect Data project underway pre-study will be complete in December ready for implementation from January End to end supply chain processes being investigated to see where GS1 standards can be applied internally.