Global standards in healthcare - GS1 Portugal...Jun 01, 2016 · Only accessible for global GS1...
Transcript of Global standards in healthcare - GS1 Portugal...Jun 01, 2016 · Only accessible for global GS1...
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Global standards in healthcare
Tania Snioch, Director Healthcare
23 June 2016
A picture of current status
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Agenda
• Introducing GS1 Healthcare
• Why global standards are needed
• What is happening around the world
• Questions
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What is GS1?
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GS1 – an international standards organisation
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Not-for-profit
112 Member OrganisationsOver one million user companies
(from SME to global companies)
Member driven150 countries served; 20 different domains
2,700 people helping usOver 6 billion transactions a day
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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.
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GS1 Healthcare: an expanding, committed community of globally engaged stakeholders…
…and there are many more companies working with GS1 at a local level…and there are many more companies working with GS1 at a local level
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…as well as with leading healthcare providers to implement…
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…and with global organisations…
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Health Level 7International
Clinical DataInterchange Standards
Consortium
World HealthOrganization
World CustomsOrganization
International Council for
Commonality in Blood Banking Automation
International HospitalFederation
InternationalSociety for Quality
in Healthcare
Integrating the Healthcare Enterprise
InternationalHealth Terminology
SDO
InternationalOrganisation for Standardisation
EuropeanCommittee forStandardization
Digital Imaging and Communications in
Medicine
European Association of
Hospital Pharmacists
European Federation of
Pharmaceutical Industries and Associations
European Medical Devices Industry
Association
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Why are stakeholders implementing GS1 standards?
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The Healthcare Supply Chain
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Manufacturer
Distributors/Wholesalers
Patient
Healthcare provider
Retail
Consumer
Internet
Transporter providers
Counterfieter
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Think about this...
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• 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
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The solutionGS1: global system of standards
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AIDC for Healthcare… the Vision
EVERY item hasONE set of key identification data carried in
ONE data carrierable to be scanned by EVERYONE
at every key process step…
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What is happening around the world?
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GS1 Healthcare - Public Policy Database
• 40 countries• 64 dossiers• 233 documents
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.
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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
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GS1 Healthcare - Public Policy Database
It provides information about:• the latest relevant regulatory requirements, • stakeholder requirements related to Healthcare product identification, product catalogues and traceability at national, regional and local levels.
Only accessible for global GS1 Healthcare members –For a list of members and information on membershipplease see athttp://www.gs1.org/healthcare/membership
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GS1 DataMatrix: favoured data carrier for pharmaceuticals
Product Identifier (GTIN)
Serial Number
Expiry date
Lot/Batch number
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In Developing Countries – WHO VPPAG
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• Assessing the programmatic suitability of
vaccine candidates for WHO prequalification
(PSPQ v2) published at http://www.who.int/iris/bitstream/10665/148168/1/WHO_IVB_
14.10_eng.pdf
St James’s Hospital, Ireland
Outcomes/ROIValidated Cold Chain delivery Service using GS1
Datamatrix Bar coding on medication packaging
• Since Cold Chain delivery started all products verifiably delivered between 20-50 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
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)
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UDI in Europe
• On 15th 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 trilogue agreement.
• Legal review and translations to follow.
• Official publication – may be by end of the year.
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Why UDI?
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• Consistent referencing of medical devices in:
• In medical records• In implant registries• For recall • For reimbursement• For patient safety…
• And many other uses
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Ultimately, it’s all about…
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PATIENT SAFETY!
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Tania Snioch
Director Healthcare
Questions & Contact Details
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T +32 492 27 44 19