Medtec Ireland. Joint Presentation: Role of standards to support post market surveillance. GS1 Ireland 5 th October 2017

Transcription

1 Medtec Ireland Joint Presentation: Role of standards to support post market surveillance GS1 Ireland 5 th October 2017

2 Disclaimer Neither GS1 nor its member organizations nor their staffs have real or apparent authority to speak for the regulatory authorities or grant exemptions. GS1 offers advisory services focused on the GS1 standard after a supplier s staff including its internal regulatory experts have determined the correct path to compliance. GS1 is a voluntary organization and its members have and must continue to determine their own course of action. GS1 provides recommendations. GS1, GS1 member organizations and GS1 staff assume no liability for members actions taken upon its advice. GS

3 Agenda Introduction UDI and the Basic UDI-DI Understanding UDI and effects on PMS and vigilance Main impacts for the industry Examples of healthcare provider initiatives driving standardisation and the impact on PMS and vigilance Beyond UDI compliance Benefits and future considerations GS

4 It all starts with a simple scan The first scan in 1974 today GS1 2016

5 GS1 key to implement requirements on medical devices ccredited as UDI Issuing Agency by the US FDA 99% of medical devices identified with GTIN in Japan MHLW Annual Survey, 2012 UDI assigning entities listed in the EU MDR Mandated by ANMAT for traceability of certain devices in Argentina 3 million on average saved each year in every NHS hospital in England Lord Carter interim report, ,8% of devices identified with GTIN in Turkey Turkish National Drug and Medical Device Databank (TITUBB) 5 Copyright GS1 AISBL, All Rights Reserved.

6 The Vision for Patient Safety I am a location I am an asset I am a syringe I am a doctor I am an instrument I am a patient Recall Inventory Payment GS1 Standards enable many applications and uses within industry sectors GS1 2016

7 The GS1 System: A need for standards IDENTIFY CAPTURE SHARE USE GS1 standards for identifying, capturing and sharing information, about people, products, locations, assets and more, make it possible for companies to speak the same business language the global language of business GS1 standards are device and system agnostic and At its simplest it s a barcode! GS1 Ireland 2015

8 More than 85% of products in US FDA GUDID carry GS1 as UDI primary DI GS

9 UDI system and GS1 system UDI system as defined by IMDRF GS1 system Identify Share Capture GS

10 Identify using GS1 Standards Unique Device Identification UDI Device Identifier DI Production Identifier PI (if applicable) GS1 standard Product Identification Global Trade Identification Number GTIN Application Identifier AI Expiration Date AI (17) Lot/Batch AI (10) Serial Number AI (21) DI + PI = UDI GTIN or GTIN + AI(s) = UDI The HRI format shall follow the rules of the UDI Issuing Agency GS1 Ireland 2015

11 Where the Basic UDI-DI will be used? Part that the U.S. FDA UDI system focuses on today... Basic UDI-DI is the main key linking device data across Eudamed GS

12 EU Basic UDI-DI AT100A AT100C Identifier AT100X Before or after the supply chain, where Basic UDI-DI is needed Level UoU UDI-DI Base Pack 2nd 3rd QTY DI 1 GTIN A 50 GTIN B 250 GTIN C QTY DI GTIN D 10 GTIN E 50 GTIN F 250 GTIN G UDI Unit of Use Base Package DI Package DI Package DI LABEL CONFIG. CE Mark, FR, DE, EN US Only EN, ES QTY DI 1 GTIN H 20 GTIN I QTY DI 1 GTIN J 20 GTIN K In the supply chain, where trade item ID (GTIN) is to order, deliver, or invoice GTINs GS1 2016

13 Capture data using GS1 standards UDI Sample Label FDA UDI Rule UDI barcode symbol Production Identifier (PI) Dynamic portion Application Identifiers (e.g. serial number, lot number & expiry date) Device Identifier (DI) Static portion GTIN (product identifier) GS1 Ireland 2015

14 UDI in GS1 AIDC terms Example Each GTIN Box of 50 GTIN GS

15 Storage and traceability requirements in the EU Storage: store and keep, preferably by electronic means, the UDI for class 3 implantable devices and for devices identified via implementing acts Only class 3 implantable devices for health institutions Traceability: identify any operators/health institution to whom have directly supplied a device and any operator who has directly supplied them with a device: one-up-one-down traceability model 15 GS1 2016

16 Understanding UDI and effects on Post Market Surveillance GS1 Ireland 2016

17 What we do in healthcare around the world GS1 standards provide the foundation for integrated patient care by enabling the globally unique identification of every person, every product, every place and more Support implementation FDA & EU Regulation (MD & Pharma) UK DH mandate / eprocurement strategy >> Clinical engagement in NHS Derby & Standardisation at NHS Portsmouth and other Demonstrator sites Healthcare agencies in Australia, Canada, Netherlands, Denmark, France working with GS1 standards GS1 Ireland 2016

18 Benefits of the system - UDI More accurate reporting, reviewing and analyzing of adverse event Reducing medical errors by providing health care professionals access to information Enabling to document device use in electronic health records, clinical information systems, claim data sources and registries. A more robust post market surveillance system Manage product recalls Foundation for a global, secure distribution chain, helping to address counterfeiting and diversion and prepare for medical emergencies. *report from Stericycle Expert Solutions GS

19 What is driving the need for Standardisation? Cross border trade Recalls Hospitals/ Healthcare Providers Government requirements Supplier efficiencies Regulation Hidden Benefits GS1 Ireland

20 Source: MHRA Traceability and Identification, Andy Crosbie GS1 Ireland 2016

21 Source: MHRA Traceability and Identification, Andy Crosbie GS1 Ireland 2016

22 UDI also in hospitals GS

23 The Carter Report Lord Carter of Coles refers to GS1 Standards A typical hospital can save 3m every year by adopting GS1 standards GS1 standards support the 750m Procurement Transformation Programme deliver the structured data supporting electronic prescribing and medicines administration enable erostering, Electronic Patient Records and Patient Level Costing GS1 Ireland 2016

24 What is Scan4Safety? Scanning of people, product, place, procedures etc.. Scan4Safety is a world first in healthcare and a vital part of this government s drive to make the NHS the safest and most transparent healthcare system in the world Jeremy Hunt, Secretary of State for Health Starting with 6 Demonstrator sites.. GS1 Ireland 2016

25 UK DH Mandate Jeremy Hunt announces six demonstrator sites of excellence Core Enablers Patient Identification Location numbering Catalogue Management Use Cases Inventory management Purchase to pay processing Product safety recall GS1 Ireland 2016

26 Scan4Safety North Tees & Hartlepool Transformation within our Trust - Coding GS1 Ireland 2016

27 Source: MHRA Traceability and Identification, Andy Crosbie GS1 Ireland 2016

28 The data search should always be in the first instance by the device identifier and then by the batch/lot number and or serial number as per this example: GS1 Ireland 2016

29 Key GS1 projects in Ireland National Patient ID Instruments Haemophilia T&T Scan4Surgery Location ID Procurement eprocurement Automatic tracking (RFID) Hospital Level GS1 Ireland 2016

30 Scan for Surgery at St James s Hospital Use GS1 Barcode Standards Approach Modern Track and Trace Technology SJH can now track 89% of cost to the patient (prev. 4%) Deliver Multiple Benefits Operational Efficiency Automation of product supply chain processes for nursing Make additional time available for patient centric activities Managed minimum inventory levels Patient Safety Product Traceability to individual patients Product Expiry Identification Patient Level Cost Analytics Increased visibility of real-time patient and procedure level costs Improved data analytics for decision making GS1 Ireland 2016

31 Scan for Surgery Benefits Patient Scan Nursing Time Taken to Order Theatre 1 & Theatre 2 (Hours) 25 Automated Message to SAP Scanning system sends automated message to SAP based on Stock Requirements Automated Message to Supplier SAP sends automated / manual PO to Supplier 5 0 Theatre 1 Theatre 2 Overall Est. Manual Automated Supplier Fulfils Order Supplier Fulfils order Replacement products are delivered to Theatre GS1 Ireland 2016

32 Source: HSE, UDI from an Irish healthcare perspective, Ronnie McDermott GS1 Ireland 2016

33 Key Clinical Benefits GS1 Ireland 2016

34 Key Clinical Benefits GS1 Ireland 2016

35 Scan4Safety on a piece of soda bread! 4% GS1 GTIN = Global Trade Item Number GS1 Ireland 2016

36 The Future Hospital Supply Chain It is no longer a case of IF but When!! It is time to Get Started!! Patient Safety Regulatory Compliance Operational Efficiency GS1 Ireland 2016

37 UDI Resources and Papers Are you ready for UDI? Overview of Unique Device Identification Recommendations on Medical Devices and IVD Field Safety Corrective Actions and Recalls using Unique Device Identifiers & GS1 Standards GS1 Guide on Unique Device Identification (UDI) implementation in the USA and in the EU GS1 Ireland 2015

38 BACKUP GS1 Ireland 2016

39 GS1 Ireland Advisory Services On-site implementation support and advice Implementation specification design and/or review Barcode Verification Training and Education Register for FREE UDI Webinar Register for Updates GS1 Ireland 2015

40 CONTACT DETAILS GS1 IRELAND SECOND FLOOR, THE MERRION CENTRE NUTLEY LANE, DUBLIN 4 Siobhain Duggan Director Healthcare & Innovation T: M: E: siobhain.duggan@gs1.ie.org

41 Real-life examples: Order-to-cash benefits 73% reduction in discrepancies EDI, Becton, Dickinson and Company (BD) and Mercy ROI 1 EDI, Becton, Dickinson and Company (BD) (USA), a medical technology manufacturer, and Mercy ROI (healthcare provider Mercy s supply chain company) achieved the following: 31.1% improvement in the ROI/Mercy ready-to-pay timing 75% improvement in the ROI/Mercy receive-to-match timing 30% reduction in days payable outstanding, improving cash flow 73% reduction in discrepancies on purchase orders, increasing accuracy and cost savings due to significantly fewer reworks 1 EDI Implementation Kit 2016 GS

42 Real-life examples Inventory management 72% reduction of waste Bernhoven Hospital (Netherlands) 1 Implemented GS1 standardised unique barcode identification on medical devices used in the operating rooms, such as implants, and internal database with all information about the availability and location of medical devices. Total value of stock/inventory of medical devices in the hospital s financial statement 807,000: Reduction of stock by 31% Reduction in stock value by 23% Decrease of interest based on the reduced stock value 2,517 Reduction of waste by 72% 1 GS1 Reference Book GS

43 Real-life examples Inventory management Portsmouth Hospital NHS Trust (UK) 1 In order to resolve the challenge of managing products with 13 different types of barcodes, it implemented the use of GS1 standards (GTINs, batch and lot numbers, expiry date and, where needed, serialisation number) to identify all products at inner and outer packaging level. <1% waste ROI = 8.5:1 20% stock reduction <1% waste 1 Case Studies GS1 UK 2015 GS