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Gs1 healthcare voor een betere patientveiligheid


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Gs1 healthcare voor een betere patientveiligheid

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Gs1 healthcare voor een betere patientveiligheid

  1. 1. GS1 Healthcare –Improving PatientSafetyUlrike Kreysa, Director HealthcareGS1 Global Office, BrusselsGS1 Healthcare Nederland Conference,Amsterdam, 27 January 2011
  2. 2. Standards – why do we care? Regulations emerge worldwide Supply Chain costs increase Electronic Health Records Medication errors Counterfeiting 2© 2008 GS1
  3. 3. GS1 Standards in Healthcare … Our vision GS1 Healthcare envisions a future where the healthcare sector utilises GS1 global standards for all items, locations, people and processes to drive patient safety and supply chain efficiency improvements-- starting with the manufacturer and ending with procedures or treatments for a specific patient.© 2008 GS1
  4. 4. Leading healthcare organisations pave the way… Corporate members of the global user group© 2008 GS1
  5. 5. Need for standards in Healthcare Diverging country requirements Manufacturing headache > Additional cost and risk© 2008 GS1
  6. 6. Leading healthcare organisations pave the way… Healthcare providers and Group Purchasing Organisations going global France Germany Netherlands Hong Kong Switzerland Austria Germany USA Austria USA Ireland Netherlands France USA USA© 2008 GS1
  7. 7. Advancing global standards in Healthcare • Global Healthcare User Group • Develop global healthcare standards • Drive global harmonization • Local Healthcare User Groups • Drive adoption & implementation of GS1 Standards • Help develop global healthcare standards© 2008 GS1
  8. 8. Local Healthcare user groups driving adoption 8© 2008 GS1
  9. 9. GS1 Healthcare around the World Members global user group Local participation Manufacturers Distributors/Healthcare Manufacturers Healthcare providers/Retailers Abbott Laboratories providers/GPOs/T&L 3M Alfred Hospital (Australia) Alcon Labs Cardinal Health (U.S.) Bayer Ascension Health (U.S.) Amgen CH Aulnay sous Bois (France) Becton Dickinson Capital District Health (Canada) Astra Zeneca Comparatio Health (Germany) Boehringer Ingelheim CHU de Québec (Canada) Baxter CVS (U.S.) Coloplast CHU Dijon (France) Becton Dickenson DHL Exel Supply Chain Draeger Medical HUG Geneva (Switzerland) B. Braun Erasmus MC Rotterdam (NL) Genzyme London Drugs (U.K.) Boston Scientific UNI.HA (representing 17 French Hospira Mayo Clinic (U.S.) Bristol Myers Squibb university hospitals) Kimberly-Clark Sisters of Mercy (U.S.) Cook Hong Kong Hospital Authorities Novo Nordisk Sobeys Pharmacy (U.K.) Covidien McKesson (U.S.) Purdue Pharma UHCS Augusta VA (U.S.) Edwards Lifescience Novation (U.S.) St. Jude Medical Walgreens (U.S.) Fresenius Orthopädisches Spital Speising Wien Stryker Wal-Mart (U.S.) Glaxo Smith Kline (Austria) Teva Pharmaceuticals … Johnson & Johnson Premier (U.S.) Terumo Associations King Pharmaceutical St. James Hospital, Dublin UCB AHA (U.S.) Medtronic Marienhospital Herne (Germany) Upsher-Smith CIP/ACL (France) Merck & Co. UMC Groningen (NL) … CHeS (U.S.) Novartis Pharma University Kentucky Healthcare Distributors/Wholesalers EFPIA (Europe) Pall Medical (U.S.) Aexxdis Eucomed (Europe) Pfizer Wiener Krankenanstaltenverbund Amerinet FENIN (Spain) Schering Plough (Austria) Amerisource Bergen GIRP (Europe) Smiths Medical Non-voting members CH2 HDMA (U.S.) Sakura Seiki AHRMM Depolabo International Hospital Federation Cladimed Galexis JFMDA (Japan) Solution provider EDQM – Council of Europe GAMMA Wholesale Medical Industry Association of Axway FDA USA Geodis Australia GHX Instituto Brasileiro de Ética McMahon NACDS (U.S.) Concorrencial – ETCO Owens & Minor Patient Safety Foundation (U.S.)© 2008 GS1 Public Health Agency of Canada … … US DoD And many more…
  10. 10. Working with International Organisations International European Health Level 7 International International Organisation for Committee for Health World Health Society for Blood Standardization Standardization Terminology SDO Organization TransfusionInternational Society European European United Nations for Quality in Association of World Customs Healthcare Medical Device Association of Organization manufacturer Hospital Pharmacists© 2008 GS1
  11. 11. GS1 Standards for Healthcare Standards development continues, but global standards are ALREADY available to build on: AIDC Application Standards for 90% of medical products AIDC Application Standards for small instruments Healthcare extension in next GDSN release Global Traceability Standard for Healthcare GTIN Allocation Rules for Healthcare Guideline for plasma derivatives© 2008 GS1
  12. 12. Government & regulatory developments FDA Amendments Act of 2007 Serialised Numerical Identifiers (SNI) system for drugs – aligned with GS1 standards (AI(21)) Authority to develop regulations establishing a Unique Device Identification (UDI) system for medical devices “Pharma Package” - Prevention of the entry into the legal supply chain of medicinal products which are falsified in relation to their identity, history or source, introducing a harmonised coding system to enable traceability Recast of Medical Device Directive - To establish a UDI System EDQM Project: Track & Trace Service Phase 2 (live demo development) start Q1 2011© 2008 GS1
  13. 13. Government & regulatory developments (cont’d) China – Shanghai Regulation 7 November 2006 – Established a traceability system for implantable medical devices in 2007 India – Ministry of Health & Family Welfare – Tender requirements for GS1 Standards for all medical supplies procured by the MoHFW Australia – National eHealth Transition Authorities – To accelerate the adoption of eHealth established: • National Product Catalogue based on GS1 Standards • GLN Registry with GS1 Australia Turkey – Ministry of Health and SKG • National databank for medical devices • Track and Trace for pharmaceuticals based on GS1 standards – GS1 DataMatrix with GTIN, lot/batch number, serial number and expiry date – already in place France – enabling traceability Identification of drugs with GS1 Data Matrix containing GTIN, lot/batch number and expiry date – no serialisation - from 1 January 2011 onwards© 2008 GS1
  14. 14. Industry developments US – Sunrise dates – GLN 2010 and GTIN 2012 – targeting for the adoption of GLN and GTIN by 2010 resp. 2012 US – Tender requirements – Endorsement by GPO’s and healthcare providers envisioning tender requirements for GS1 Standards Canada – Sunrise dates – GLN 2010 and GTIN 2012 – targeting for the adoption of GLN and GTIN by 2010 resp. 2012 Canada – Tender requirements – Endorsement by GPO’s and healthcare providers envisioning tender requirements for GS1 Standards Canada – Pharmaceutical Bar Coding Project - ISMP Canada and CPSI 14© 2008 GS1
  15. 15. DataMatrix on pharmaceuticals France: AFSSAPS Belgium: Pilot project unit Serbia: Pilot regulation (2011) dose markingSpain: Pilot Korea: pharma regulatory requirement (2011)Switzerland:SmartLog PilotTurkey: Regulatory Japan: option forrequirement (2010) instruments markingBrazil: traceabilitypilot successfullycompleted – ANVISAregulation = country requires DataMatrix = country using DataMatrix in pilots and/or developing© 2008 GS1 requirement for DataMatrix 15
  16. 16. Position on Camera-Based scanners (June 2007) Preparing members, solutions providers and end users for the future… Get your copy at: mera_Based_Scanners.pdf 16© 2008 GS1
  17. 17. The need for global standards • Healthcare is local • Healthcare providers are local • Regulations are local • Healthcare is global • Healthcare supply chains often cross borders Country-by-country solutions are not sufficient nor effective© 2008 GS1
  18. 18. GS1 Standards in Healthcare • Enable automatic identification systems • Enable traceability systems • Enable « clean » data GS1 Standards in Healthcare improve patient safety worldwide© 2008 GS1
  19. 19. 19th Global GS1 Healthcare Conference Washington 6-8 April 2011 More information: soon on 19th Global GS1 Healthcare Conference Washington DC Metro Area – 6-8 April 2011 Registration open at 19© 2008 GS1
  20. 20. Contact DetailsUlrike KreysaGS1 Global OfficeT +32-2-788.78.37E ulrike.kreysa@ gs1.orgW