Eagle Europe Press Release (July 2016): The United States Food and Drug Administration (US FDA) now requires all medical devices sold and distributed in the US to carry a bar-coded Unique Device Identifier (UDI). All information pertaining to each device will be held in a US FDA-managed database. This means that any UK medical device manufacturer wishing to trade with the US healthcare market will require a UDI number to comply with the new regulation. Initial rulings from the US-FDA became law in September 2014 but further compliance will be phased in over the coming years.
The ability to identify, track and trace medical devices is obviously highly important for patient safety, as healthcare products are increasingly manufactured, shipped and sold around the world. The implementation of the new US FDA ruling will lead to greater efficiency and reduced costs for healthcare organisations worldwide.
GS1, a leading global standards organisation, has been accredited by the US FDA as a UK issuing agency for unique device identifiers and, as a GS1 member, Eagle Europe is perfectly positioned to assist our customers in fully understanding the requirements of the new ruling, adapting to the necessary timescales and achieving full implementation. In the long term, this ruling will benefit patients, the healthcare system and the medical device industry as UDI’s will enable healthcare organisations to uniquely identify and locate medical devices through every step of the product lifecycle, improving supply chain visibility and enhancing patient care and safety.
Eagle UDI Experience
Many Eagle clients have started projects around UDI. In 2015, Eagle completed their first project with a UK based Medical Device Manufacturer, whose requirements were to make sure that all serial controlled labels at multiple levels on the packaging matched each other and cross referenced the associated paperwork.
The scope was to match the production control sheet with the cleanroom label to the label sets that will be added at each step in the process. The scope also included rework and reject handling and reopening batches after they are completed. Barcodes were used at all points to match both item batch records and serials at all levels of the packaging process.
The reminder of this Blog aims to give a detailed understanding of this UDI, happy reading!
What is a Unique Device Identifier (UDI)?
A UDI is a unique numeric or alphanumeric code, located on the label or directly on the product, which identifies a specific product on the market. It holds device-related information stored within the Global UDI Database (GUDID), so users of a medical device can refer to information about that particular product.
The UDI itself contains two parts: the Device Identifier and the Production Identifier, both of which must be individually recognisable.
* Device Identifier – the unique code specific to a medical device.
* Production Identifier – the numeric or alphanumeric code that provides information about how the device is controlled. Different types of
Production Identifiers include combinations of serial numbers, lot/batch numbers and manufacturing and/or expiration dates.
Medical device manufacturers will be required to place barcodes containing the two separate identifiers on their products: the device identifier (manufacturer name and device product code); a production identifier (batch number, expiry date and serial number).
GS1 standards require that both device and production identifiers are encoded into a single barcode.
This will result in both a device identifier and a production identifier being present on the packaging of medical devices in the form of either a single barcode or separate barcodes for the device and production identifiers. Scanning of the barcode(s) at the point of receipt, at the point of storage and again at the point of use will enhance visibility and traceability.
The UDI system requires manufacturers to provide information to the user in both plain-text format and code format, such as a linear, 2D DataMatrix barcode or RFID tag. This information will then be fed to the UDI database from the ERP system and the labelling management system.
Improved Patient Safety & Increased Efficiency
Incorporating UDI for every applicable medical device product that electronically stores its critical information in an accessible database will bring a number of significant and valuable benefits for both the medical device manufacturer and the patient:
- Rapid and precise identification of a device and its characteristics, giving accurate reporting and analysis. This will reduce medical error and ensure problem devices can be identified and recalled more quickly.
- Consistent coding on products will enable greater use of automated inventory management systems, reducing inventory cost and the expense of consignment stock. This will also eliminate unnecessary and costly product scrappage.
- Enhanced analysis of devices on the market will standardise and document use in electronic health records, clinical information systems and registries. This will allow manufacturers, distributors and healthcare facilities to effectively manage device recalls.
- Improved device security through effective detection and the creation of a secure, global distribution chain will address the increasing issue of counterfeited products.
- The development of a medical device identification system that is globally recognized.
The Key Challenges for Manufacturers
The biggest challenge facing medical device manufacturers is adapting to the new UDI requirements. This is where Eagle’s long-held experience and systems knowledge will prove invaluable. Although storing data in GUDID has no cost element involved, incorporating the correct systems will mean initial extra expenditure and costs in complying with the US FDA ruling will be greater for organizations that manufacture in multiple countries and use different enterprise reporting and labelling systems. For small and medium size enterprises (SMEs), UDI compliance is projected to be costly not just in terms of software and labelling system upgrades, but also in terms of time and administration. However, Eagle’s quality service will ensure that UDI can be adopted by existing systems with minimum costs and difficulty.
The implementation of UDI requires both first-hand knowledge of the process and collaboration between all departments within a medical device manufacturing organisation. Eagle can help find the most effective way of communicating the new ruling and ensuring its implementation, on time and cost-effectively.
United States FDA Compliance Timescale
As the marking of UDI is an additional labelling requirement and not a replacement of any other form of product marking, substantial time needs to be allocated to ensure the process is implemented and managed correctly.
Medical device manufacturing organizations that still use paper-based methods and outdated labelling systems may find it difficult to manage the increased amount of data and information generated. Organizations should consider implementing a validated, secure label management solution, making it simpler to become UDI compliant. Eagle Europe can discuss these options for organizations in this position.
- 24 September 2014 – Labels and packages of Class III medical devices and devices licensed under the Public Health Service Act (PHS Act) must bear a UDI.
- 24 September 2015 – Labels and packages of implantable, life-supporting, and life-sustaining devices must bear a UDI.
- 24 September 2016 – A Class III device required to be labelled with a UDI must bear a UDI as a permanent marking on the device itself if this device is intended to be used more than once and intended to be reprocessed before each use.
- 24 September 2018 – A Class II device required to be labelled with a UDI must bear a UDI as a permanent marking on the device itself if this device is intended to be used more than once and intended to be reprocessed before each use
- 24 September 2020 – A Class I device (and devices that have not been classified into Class I, Class II, or Class III) that is required to be labelled with a UDI, must a bear a UDI as a permanent marking on the device itself if this device is intended to be used more than once and intended to be reprocessed before each use.
Failure to comply with the ruling by the required dates will have a severe business impact as wrongly labelled products shipped to the US will not be accepted.
NHS Guidelines
In the United Kingdom, the NHS is issuing guidelines in support of full UDI implementation with a view to increase traceability, aid identification and reduce counterfeiting. In establishing a common framework for UDI, health institutions will be required to electronically store and keep the unique identifier of devices, issuing an implant card that carries the particular UDI to patients receiving an implantable device. Staged implementation will take place across the NHS, beginning with high risk medical devices before extending to lower risk devices.
Eagle Europe and UDI
The US FDA’s ruling is a major part of the trend towards common global standards in the medical device and products industry. The benefits of UDI will prove enormous in the years ahead and the benchmark that is established now will see a huge improvement in overall patient safety and long-term care. Eagle is justifiably proud of its associations with the healthcare industry and we are determined to be a part of its future: helping our customers (both existing and new) is part of our strategy in supporting this industry.
With this new ruling, medical device manufacturers need to fully appreciate the long-term benefits of incorporating UDI into their current system capabilities, to ensure both US FDA compliance and long-term operational advantage. As an established provider of electronic data capture solutions, Eagle is on hand to provide full support and application for implementing UDI and ensuring our customers will be positioned to efficiently capture and submit the necessary data to GUDID and to train customer workforce in integrating this additional labelling requirement.
By planning and implementing a label lifecycle management strategy with the right processes and right solution, Eagle can guarantee UDI readiness and compliance for your organization on time and without adverse effects to your on-going production.