GS1 Standards in Healthcare

Contact GS1

Alan Gormley

Standards Conformance and Training Manager

Tel 01 208 0671

Mob 087 970 5222

eMail alan.gormley@GS1ie.org

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