UDI (Unique Device Identification) and patient safety latest regulatory developments

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1 UDI (Unique Device Identification) and patient safety latest regulatory developments Ulrike Kreysa, VP Healthcare, GS1 Global Office Medical Devices Innovation Program Munich, 14 October 2016

2 Agenda UDI what is it? Global standards to get ready for UDI across the world Regulatory developments beyond US FDA Imagine 2

3 UDI purpose Objective A common, worldwide system for product identification should eliminate differences between jurisdictions and offer significant benefits to manufacturers, users and/or patients, and regulatory authorities. 3

4 UDI system

5 A comparison UDI & 5

6 is like Munich & The October Fest 6

7 More than 90% of products in US FDA GUDID carry GS1 as UDI primary device identifier 7

8 What is GS1? GS1 is a neutral, not-for-profit standards organisation that helps companies do business across the world Member Organisations around the world - Developing standards for over 1 million companies worldwide - 25 industries served across 150 countries - Barcodes scanned more than 5 billion times a day globally

9 GS1 Healthcare: 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.

10 Our vision The vision of GS1 Healthcare is to be the recognised, open and neutral source for regulatory agencies, trade organisations and other similar stakeholders seeking input and direction for global standards in healthcare for patient safety supply chain security & efficiency traceability product data 10

11 GS1 Healthcare: an expanding, committed community of globally engaged stakeholders and there are many more companies working with GS1 at a local level

12 and implementation by leading healthcare providers 12

13 GS1: global system of standards to ensure visibility 13

14 UDI & the GS1 system UDI in GS1 identification (identify) terms 14

15 UDI in GS1 data carrier terms Common industry practices All data carriers are for illustration only, not to scale and not in proportional size to one another. Please refer to GS1 General Specifications for detailed & up-to-date GS1 System information. UDI requirements may vary by geography -please refer to regional UDI regulations.

16 GDSN (Global Data Synchronisation Network) as an important enabler Data is registered in the GUDID by the Source Data Pool Manufacturers are able to provide data to any UDI database and their customers (hospitals, distributors, wholesalers, GPOs), with a single connection. 1

17 The value of trusted data 17

18 EU Medical Devices and IVD Regulations Status: - Q3 2012: EC proposals MD and IVD Regulations - April 2013: EC UDI Recommendation - Oct. 2015: Trilogue starting and ongoing - 15 June 2016: negotiated texts agreed and released - Q (tbc): publication Regulations OJUE Purpose: Medical Devices Identification system Open point(s)/upcoming dev.: - UDI specifications are part of the core of the Regulations - A lot of remaining questions on the EU DataBase (Eudamed) implementing acts expected - Some different approaches to US FDA - UDI assigning entities: GS1, HIBCC and ICCBBA until the EU Commission potentially designates others - traceability requirements - healthcare providers have to store the UDIs PP Database Dossier #: 200EUMD

19 Future Eudamed? EUDAMED European MD/IVD database Registrati on - Devices - Economic operators - SSCP Certificates - Issued - Suspended - Withdrawn - Refused - Restricted Vigilance - Serious incidents - FSCA - FSN - Corrective actions Clinical investigatio n - Sponsor - Purpose - Status - Approval - Summary? Market Surveillanc e - Measures taken by MS - Preventive health measures - Non compliant devices UDI Static data elements 19

20 Many open questions remain Connection of national databases to Eudamed Manufacturer versus labeler Obligation for healthcare institutions to implement Process for applying for exemptions? Basic UDI DI concept 20

21 21 England NHS Objectives: Deliver efficiency and productivity gains Improve data, information and transparency Re-think clinical engagement in procurement Improve trust capabilities in procurement Actions: Mandate through contracts GS1 standards GTIN, GLN and GDSN Create a single NHS GS1 data pool Define standards for eprocurement Establish standards for datasets/classification Put implementation support in place

22 Time for change 22

23 Leverage UDI benefits Pursue a global UDI strategy Gain business value from UDI Use a globally unique system for identification Develop a Global Data Governance approach Connect to multiple data recipients (incl. UDI Databases) UDI Build systems do more than check the UDI Regulatory box Leverage the UDI throughout the Supply /Patient Care Chain Create a win/win relationship with your partners on UDI data 23

24 a world where 24

25 the patient rights were reality, all the time! right route right caregiver right medical device right patient right time 25

26 Imagine a world where bedside scanning confirms that the patient gets the right product in the right dosage at the right time and the patient records captures all the details. where hospitals and pharmacies know the exact location of short-supply medical devices and drugs and when they can be delivered. where regulators can recall products with accuracy and speed from every point in the supply chain and there is no possibility of receiving a counterfeit product.

27 Huge cost savings and patient safety benefits when adopting a single global standard in healthcare 27 Implementing global standards across the entire healthcare supply chain could save 22,000-43,000 lives and avert 0.7 million to 1.4 million patient disabilities Rolling out such standards-based systems globally could prevent tens of billions of dollars worth of counterfeit drugs from entering the legitimate supply chain [We] estimate that healthcare cost could be reduced by $40 billion-$100 billion globally from the implementation of global standards Adopting a single set of global standards will cost significantly less than two (between 10-25% less cost to stakeholders) SOURCE: McKinsey report, Strength in unity: The promise of global standards in healthcare, October 2012

28 Let s move forward to achieve the highest quality care for all patients 2016 & beyond 28

29 Contact Details Ulrike Kreysa GS1 Global Office, Brussels E ulrike.kreyss@gs1.org T W

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