Unique Device Identification (UDI)

Transcription

1 Unique Device Identification (UDI) How GS1 standards can help you comply with UDI regulations Supported by

2 Medical device suppliers and manufacturers do you comply with UDI? If you supply medical devices to the USA you must comply with the new US FDA UDI regulations Being able to identify, track and trace medical devices at a global level is important for patient safety. To help achieve this, the US FDA (Food and Drug Administration) has established a Unique Device Identification (UDI) system for medical devices in the US. The FDA has mandated that suppliers and manufacturers of medical devices must comply with new regulations. These state that all medical devices entering the US healthcare supply chain must be identified with a UDI. What does the US FDA UDI regulation mean for you? Any UK medical device manufacturer or supplier trading with the US healthcare market must comply with this regulation. This mandate is phased over a 6 year period and it started on 24 September You must check the FDA website to see which class or classes the products you supply fall under. Then you must check which compliance date or dates apply to the products you supply. Using GS1 standards to enable compliance Preparing for future regulations Similar regulations to the FDA mandate are expected to follow in the UK and EU. Adapting to these changes will be easy through the use of GS1 standards the industry benchmark in healthcare. And using GS1 standards will not only help you comply but also bring efficiency savings to the way you do business, and ensure compliance with the NHS eprocurement strategy. This says that all services or products procured by an NHS Acute Trust in England must be compliant with GS1 standards. GS1 has been accredited by the FDA as an issuing agency for UDIs. Our standards for identification and barcoding conform to all FDA UDI requirements, including: Product identification at each level of the packaging hierarchy The barcode symbols to use The production data to be included in barcodes The data that must be stored within the Global UDI Database (GUDID) specified by the FDA, using our accredited TrueSource data pool

3 US FDA UDI compliance dates 24 September 2014 Class III do you comply? Labels and packages of all Class III medical devices and devices listed under the Public Health Service Act must have a UDI. Data for these devices must be submitted to the Global UDI Database (GUDID). 25 September 2015 Labels and packages of implantable, life-supporting and life-sustaining devices must have a UDI. Data for these devices must be submitted to the GUDID. 24 September 2016 Class II 24 September 2018 Class I Labels and packages of Class II medical devices must have a UDI. Data for these devices must be submitted to the GUDID. Labels and packages of Class I medical devices that have not been classified as Class I, II or III must have a UDI. Data for these devices must be submitted to the GUDID. For full information visit the FDA website at

4 How we can help? As the experts on GS1 standards, we are ideally placed to help you comply with the FDA mandate, and ensure your compliance with the UK and EU requirements that will follow. Our training and implementation services are helping medical device manufacturers of all sizes to comply, and also operate more efficiently and save money. Webinars Healthcare supplier webinar Understand the background to UDI in our free webinar Background to UDI regulations and timelines for implementation by industry How GS1 standards can help meet compliance to the regulations Next steps for companies needing to get ready How GS1 UK can help TrueSource UDI webinar Understand more about the Global UDI Database (GUDID) in our free webinar Introduction to the TrueSource data pool Service overview and how TrueSource directly links to the GUDID and future medical device data bases How to use the service through direct data entry or spreadsheet upload The UDI data and process workflow Alignment to the future NHS and EU medical devices requirements All webinars are free. You can book your place at Training UDI training course Learn how GS1 standards will help you comply to UDI regulations in our one-day training course How GS1 standards are used for UDI Identifying devices Encoding production information Barcoding best practice UDI data requirements How TrueSource directly links to the GUDID and future medical device data bases Barcode clinic, with Axicon Have your device barcodes verified by industry experts in an interactive workshop How GS1 standards are used for UDI Encoding production information Barcoding best practice How your barcodes compare to industry best practice and UDI regulatory requirements Barcode analysis by the latest ISO/ANSI barcode verifiers Recommendations for improvement

5 UDI on-site training Bespoke training delivered on your premises, to meet your specific needs How GS1 standards are used for UDI Barcoding for UDI How to allocate numbers correctly UDI data requirements How TrueSource directly links to the GUDID and future medical device data bases UDI in UK and Europe For more information and to book your place visit Professional services 1 day UDI consultancy service On-site service providing an actionable plan on how to comply with UDI regulations Aim What you ll get To provide you with a thorough understanding of UDI regulations and how GS1 standards will ensure compliance, and provide you with an action plan that will lay out the steps to compliance. An action plan that includes: Understanding of the UDI regulations and how they will impact you, now and in the future The data you must provide about your products and how to manage it The barcode symbols you need to use How to encode additional data into barcodes How to ensure correct placement and print quality of barcodes The impact of barcodes on your packaging and production lines Migration from any existing standards you are following UDI discovery review A full assessment of UDI compliance for your company covering strategy, people, process, data and technology to meet best practice Aim What you ll get Our approach To provide you with a full understanding of UDI regulations and how GS1 standards will ensure compliance. This review will ensure your strategy, people, process, data and technology meet best practise and benefit fully of the efficiency and cost savings of using GS1 standards. Review and identification of gaps for UDI compliance covering: Product identification and labelling Product master data management Order to cash process Despatch process A presentation ready for your leadership team that details recommendations and a roadmap towards UDI compliance with GS1 standards. We will request information and documentation ahead of a project kick-off and through a series of meetings, workshops and demonstrations we will gather further information from your organisation to provide a: High level compliance gap analysis Verification of findings Recommendations for UDI compliance through the use of GS1 standards, covering strategy, people, process, data and technology Contact us to discuss your specific requirements and how we can help.

6 TrueSource data pool for Global UDI Database (GUDID) compliance Our TrueSource data pool provides a single point of entry for publishing a medical device s product master data to the FDA Global UDI Database (GUDID). Using TrueSource helps compliance with a direct interface removing any technical complexity and reducing costs for your organisation. TrueSource UDI solution Product data flow 2. Publish data FDA GUDID 1. Load data 3. Confirm & inform 3. Confirm & inform MEDICAL MANUFACTURER TRUESOURCE 1. Load data the medical manufacturer loads the FDA required product data 2. Publish data the medical manufacturer publishes the required product data via TrueSource, to the FDA GUDID 3. Confirm & inform FDA sends a confirmation to TrueSource. The confirmation is then passed, by TrueSource, to the manufacturer, with notification regarding successful transmission or potential errors. A detailed report is made available to the medical device manufacturer. TrueSource provides a secure environment to enter and maintain medical device product information, and secure communication of this information to the FDA GUDID. As part of your TrueSource subscription you will also receive training on how to use the service, covering: How to code data in direct to TrueSource or use the spreadsheet upload templates Releasing and publishing your data Understanding TrueSource messages and exceptions How to allocate numbers correctly Creating templates Getting your first item published to the UDI data base for FDA approval TrueSource UDI powered by 1WorldSync

7 About GS1 UK GS1 UK is a community of over 28,000 members working in many industry sectors. We are one of 111 independent, not-for-profit GS1 organisations operating across 150 countries worldwide. GS1 standards have provided a common foundation for business since the first barcode was scanned over 40 years ago. In recent years our standards have been adopted by healthcare authorities around the world. In 2014 the Department of Health published the eprocurement strategy, setting out a range of measures to enable transparency and efficiency in NHS procurement to help support patient safety. The strategy includes a mandate that means any service or product procured by an NHS Acute Trust must be compliant with GS1 standards. We are working with Department of Health and the NHS to ensure our standards are implemented through the UK healthcare sector - helping save thousands of lives and millions of pounds. Next steps To find out more about how GS1 standards can help you comply with UDI regulations please visit our website at Or contact us to discuss your specific requirements T or E Healthcare@gs1uk.org

8 Contact us GS1 UK Staple Court, 11 Staple Inn Buildings London WC1V 7QH T +44 (0) F +44 (0) E info@gs1uk.org Member Support Team GS1 UK is a company limited by guarantee and registered in England and Wales under company number Registered office Staple Court, 11 Staple Inn Buildings, London, WC1V 7QH. VAT number GB /15