Global standards in healthcare

Transcription

1 Global standards in healthcare A picture of current status Tania Snioch, Director Healthcare 23 June 2016

2 Agenda Introducing GS1 Healthcare Why global standards are needed What is happening around the world Questions

3 What is GS1? 3

4 GS1 an international standards organisation Not-for-profit 112 Member Organisations Over one million user companies (from SME to global companies) Member driven 150 countries served; 20 different domains 2,700 people helping us Over 6 billion transactions a day 4

5 Voluntary, Global Healthcare User Group To lead the healthcare sector to the successful development and implementation of global standards by bringing together experts in healthcare to enhance patient safety and supply chain efficiencies.

6 GS1 Healthcare: an expanding, committed community of globally engaged stakeholders and there are manymore companies working with GS1 at a local level

7 as well as with leading healthcare providers to implement 7

8 and with global organisations International Organisation for Standardisation European Committee for Standardization Health Level 7 International International HealthTerminology SDO Clinical Data Interchange Standards Consortium Integrating the Healthcare Enterprise Digital Imaging and Communications in Medicine World Health Organization World Customs Organization International Hospital International International Federation Council for Society for Quality Commonality in in Healthcare Blood Banking Automation European Association of Hospital Pharmacists European Federation of Pharmaceutical Industries and Associations European Medical Devices Industry Association 8

9 Why are stakeholders implementing GS1 standards? 9

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11 The Healthcare Supply Chain Distributors/Wholesalers Manufacturer Internet Consumer Transporter providers Retail Patient Counterfieter Healthcare provider 11

12 Think about this... Multiple bar codes on one package which one to scan? Different types of bar codes inconsistency; incompatibility No bar code need to bar code; re-package; re-label 12

13 The solution GS1: global system of standards 13

14 AIDC for Healthcare the Vision EVERYitem has ONE set of key identification data carried in ONEdata carrier able to be scanned by EVERYONE at every key process step

15 What is happening around the world? 15

16 GS1 Healthcare - Public Policy Database 40 countries 64 dossiers 233 documents

17 Arrival page Signing up: GS1 Healthcare Public Policy database Welcome! This database provides the latest relevant regulatory requirements, stakeholder agreements and user requests related to Healthcare product identification, product catalogues and traceability at national, regional and local levels. community, and governmental bodies and regulators involved in the Healthcare sector. Login Not yet a member? This information is only accessible for global GS1 Healthcare members and GS1 Member Organisations. Each registration application will require approval by GS1. Register here to access the GS1 Healthcare Public Policy Database Join GS1 Healthcare

18 GS1 Healthcare - Public Policy Database It provides information about: the latest relevant regulatory requirements, stakeholder requirements related to Healthcare product identification, product cataloguesand traceabilityat national, regional and local levels. Only accessible for global GS1 Healthcare members For a list of members and information on membership please see at

19 GS1 DataMatrix: favoureddata carrier for pharmaceuticals Product Identifier (GTIN) Serial Number Expiry date Lot/Batch number 19

20 In Developing Countries WHO VPPAG Assessing the programmatic suitability of vaccine candidates for WHO prequalification (PSPQ v2) published at _eng.pdf 20

21 St James s Hospital, Ireland Outcomes/ROI Validated Cold Chain delivery Service using GS1 Datamatrix Bar coding on medication packaging Since Cold Chain delivery started all products verifiably delivered between Celsius Documentation errors reduced from 12 to zero in the year post service implementation 5 Million worth of medication stock has been removed from the supply chain Stock rotation in 2011 saved 600,000 worth of stock Mock Recall identified location of all (100%) Medication within 10 minutes along with quantities of alternate stock available

22 Immediate outcomes post implementation of smartphone App (launched June 2010) Real-time recall alert Timeliness of infusion Prescription compliance (2000iu instead of recommended 1750iu) Automatic compliance (no manual record keeping) Compliance > 90% (for those with phone App) Real-time Alerts for specific bleeds Patient empowerment Significant savings (over 70,000 within first 3 months with only 20 users)

23 UDI in Europe On 15 th June 2016, the Environment, Public Health and Food Safety (ENVI) Committee of the European Parliament and the Council s Committee of Permanent Representatives (COREPER) voted on the negotiated text of the directive for Medical Device and IVD s and endorsed the trilogueagreement. Legal review and translations to follow. Official publication may be by end of the year. 23

24 Why UDI? Consistent referencing of medical devices in: In medical records In implant registries For recall For reimbursement For patient safety And many other uses GS

25 Ultimately, it s all about PATIENT SAFETY! 25

26 Questions & Contact Details Tania Snioch Director Healthcare T E tania.snioch@gs1.org 26