GS1 Standards in Healthcare
Contact GS1
Alan Gormley
Standards Conformance and Training Manager
Tel 01 208 0671
Mob 087 970 5222
eMail [email protected]
GS1 Ireland
Second Floor, The Merrion Centre, Nutley Lane, Dublin 4
Web www.GS1ie.org/Healthcare
Agenda
• GS1 the organisation
• Why we need Standards in Healthcare
• The benefits of using GS1 Standards in Healthcare
• Focus: Unique Device Identification
• GS1 Standards in Action
• Patient Safety
• Visibility
• Regulation overview
• A Case Study in Irish Healthcare – St James’s Hospital
•What does it mean for you?
Who is GS1?
• Not for profit, member driven
• 111 Member Organisations
• Close to 2 million member companies
• 150 countries served
• 20 sectors
• 2,000 people helping us
GS1
International Standards Organisation
Global reach, Local presence
We are 40 years young!
GS1 (2005)
EAN (1977)
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Building industry collaboration
GS1 is an organisation driven by its users
• Understanding industry issues
• Facilitating collaboration amongst trading partners
• Leading the coordination to answer industry needs
• Supporting implementation of GS1 standards
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LACK OF STANDARDS IS INEFFICIENT AND ANNOYING . . .
• Reduce complexity
» Between organisations
» Within organisations
» For hardware and software suppliers.
• Reduce the cost of implementation
• Facilitate trading partner collaboration
• Allow organisations to focus on how to use the
information rather than how to get information
GS1 Standards are the global language of business
a language for identifying, capturing, and sharing information automatically and accurately,
so that anyone who wants that information can understand it, no matter who or where they
are.
GS1 Standards
Identify: GS1 Identification
Used to uniquely distinguish all products, trade items, logistic units, locations, assets
and relationships in the supply chain—from manufacturers to consumers.
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Capture: GS1 Data carriers
Capable of holding varying amounts of data to accommodate different needs such as
traceability and expiration dates.
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SHARE: GS1 Information Standards
Interoperability, made possible by identification standards, data capture standards and interface
standards, allows electronic commerce information to flow through the supply chain.
Why are standards for Identifying,
capturing and sharing information
needed?
What is Driving the Need ?
v Current systems of product catalog numbers include duplicate identifiers for the different products
across manufacturers
v Current system allows product re-identification by every stakeholder in the supply chain, making product
tracking efforts extremely difficult
Manufacturer Product #
305905
DistributorProduct # MT305905
Hospital or Healthcare Provider Product # M-
5905
Manufacturer Catalog # DescriptionMedtronic 305905 Mosaic ® 305 Porcine Heart Valve ………….BD 305905 3mL BD SafetyGlide ™ Syringe ………..J & J 305905 Protectiv ® IV Catheter System ………..
Source, Jackie Elkin, Medtronic
Benefits of UDI for Patient Safety
• Improved recall procedure and adverse event reporting
• Documentation of product/patient relationship – in electronic health
records (EHR) and registries
• Visibility of inventory – availability of devices
• Reduction of medical errors
• Supply chain security/anti-counterfeiting
Effects on Supply Chain Efficiency
• Reduction of inventory levels
• Reduction of obsolete stock
• Order to invoice process improved
• Recall procedures accelerated and facilitated
• Consignment goods
• DRG – cost calculation per
patient
Regulators recognise this?
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FDA’s UDI Final Regulation
2007 FDA Amendments Act of 2007 (legislation)2012 July 10th – UDI Proposed Regulation Publishes2012 July – FDASIA provisions added (legislation)2012 Nov 7th – original comment period closes2012 Nov 19th – FDASIA amendment publishes (reg)2012 Dec 19th – FDAISA comment period closes
2013 September 24th –UDI Final Rule/Regulation
and draft GUDID Guidance
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GS1 is an accredited UDI issuing agency
MEDIA RELEASE18 December 2013
GS1, a leading global standards organisation, today received accreditation by the U.S. Food and Drug Administration (FDA) as issuing agency for unique device identifiers (UDIs). Global GS1 Standards meet the US government’s criteria for UDIs and will help medical device manufacturers to address requirements of the new FDA UDI regulation aimed at supporting patient safety, traceability and supply chain security.
The Unique Device Identification system aims at creating a common worldwide system for product identification that will improve healthcare business processes and patient safety. The U.S. FDA UDI rule is the first to be released but is expected to be followed by other similar regulations worldwide, including the EU.
Traceability
The HSE National Track and Trace
Program
Overview of Instrument Set Traceability
“Systems should be in place to record the decontamination process used on RIMD (tracking) and link them with
service users on which they have been used (tracing)”
HSE Recommended Practices for Central Decontamination Units. Version 2.0, 2011
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GS1 Standards help enable the traceability of surgical instruments
Issue(s)
• Ineffective traceability of surgical instruments from theatre through to hospital sterilisation process
• Time wasted on manual processes (searching for instruments, documentation etc.)
Solution
• Implementation of an integrated tracking and traceability system
• Identification of Instrument Trays using GS1 numbers
• Implementation of GS1 Standards, including GTIN, GLN and Global Traceability Standard
Results
Effective traceability of surgical instruments during sterilization process
• Reduced manual effort and increased efficiency due to automation
• Increased inventory management – better stock visibility
• Increased traceability from theatre through sterilisation
• Improved workflow through automation/scanning
• Process to share loan sets much more efficient and effective
Hoe Does the system work?
Project status
1. A Total 37 Hospitals are now using the system.
2. Endoscopes are now included in the scope• 27 Endoscopy Reprocessing Units
• 6 Central Decontamination Units
3. Two major loan set providers and on Endoscope manufacture are participating and there are more to follow….
4. Independent research/dissertation has being conducted in conjunction with Trinity university and PWC.
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Key Benefits identified by independent research
Automatic Tracking of Instrument Sets» No longer need to stick head in the washer
Much easier to share Loan Sets» Interoperability between hospitals
» Lists more accurate and legible
Tray Checklists printed when scanned» Accurate and right version, no longer need to search
All records stored digitally» Can be referenced post-event
Link between tracking system and theatre» Closes the link between patients and sets reprocessed
Improved Workflow» Scanning of instrument sets mean team has to communicate and be more organised
Reporting» More reports (doing more audits), Enables asset management
GS1 Standards in Action: Interoperability
The HSE National Asset Tracking Project
Global Individual Asset Identifier - GIAI (AI 8004)
In the GS1 System an individual asset
is considered as a physical entity of any characteristics
• A typical application is to record life-cycle history
of aircraft parts or medical instruments. Assets can be tracked from acquisition until
retirement.
• Fixed assets in a buisness such as computers, printers, tables and chairs can be identified
and tracked.
The GS1 128 A GS1 Data MatrixAn RFID Tag
Asset identification for the HSE
GCP(5391111997) GCP(5392222997) GCP(5393333997) GCP(5394444997)
National Asset Registry
(8004)53944449970000001
Benefits of Asset Tracking
An Asset management system provides a complete resource for managing:
• equipment inventory information,
• work orders,
• service contracts,
• spare parts,
• purchasing and stock-control
Q&A
GS1 Standards for Patient Safety, Efficiency and
Traceability in Healthcare
Bon Secours Hospital Group
Siobhain Duggan GS1 Ireland Healthcare – 29th May 2014 (Cork)
New McKinsey report “Strength in unity: The promise of global standards
in healthcare”
Highlights the cost savings and patient safety benefits of adopting a single
global supply chain standard in healthcare
Available at:
http://www.gs1ie.org/healthcare
Source: http://www.mckinsey.com
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New McKinsey & Company report on benefits of a single
global standard
Source: http://www.mckinsey.com
New McKinsey & Company report on benefits of a single
global standard
“We found that 25% of clinical staff’s time is spent looking for things, and 10-15% of their time in the OR is spent looking for instruments.” Hospital administrator
“Imagine a world where Doctors and Nurses could spend less time with paperwork and more time with patients”
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0%
20%
40%
60%
80%
100%
2003
2011
2013
% No Code
% Not GS1
%GS1
Medicines
Year %GS1 % Not GS1 % No Code
2003 73% 0.3% 26.5%
2011 86% 9.8% 4.2%
2013 97% 1.1% 1.8%
Medical DevicesYear %GS1 % Not GS1 % No Code2003 56% 11.4% 32.5%2011 57% 10.0% 32.6%2013 76% 13.4% 11.0%
Source GS1 Australia
Barcode Levels in Healthcare
What are the Regulators saying?
Unique Device Identification (UDI)• (01) Product Code/GTIN
• (10) Batch
• (17) Expiry
• Serial number (where applicable)
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Deadline for EU: 2016
Falsified Medicines Directive (FMD)• (01) Product Code/GTIN
• (10) Batch
• (17) Expiry
• (21) Serial Number
Deadline for EU: 2017
Note: FDA Deadline for Class 3 – Sep 2014