A single, globally standardized identification system for medical devices is required in light of growing concerns regarding patient safety and effective supply chain management.The United States of America implemented a Unique Identification System (UDI) for all medical devices distributed through the country’s supply chain.By 2020, the system is expected to be fully operational.The UDI system is being used as a foundation by other nations as well.Labelers will benefit from improved traceability and target recalls of medical devices thanks to the UDI system.
Introduction In the rapidly evolving healthcare sector, supply chain and patient safety issues are of the utmost concern.Traceability becomes a major issue as a result of the wide variety of medical devices on the market, which can lead to false product recalls, inadequate reporting of adverse events, and counterfeit goods.In order to clearly identify medical devices in the healthcare supply chain, a specialized global identification protocol is required.A Unique Device Identification (UDI) system was put into place by the Food and Drug Administration (FDA) of the United States to give each medical device that is sold in the country a unique identifier.In addition to Asian and European nations, Japan, Brazil, and other nations are increasingly adopting the UDI system.
What exactly is an UDI (unique device identifier)?
The medical device is given the Unique Device Identifier (UDI) so that it can be identified by a single numeric or alphanumeric code.Both human- and machine-readable versions of the UDI data must be displayed on the device.There are two parts to the code as shown in Exhibit 1:i) the Device Identifier (DI), which is linked to the model of the medical device; ii) the Production Identifier (PI), which is related to the product information and unique identification code of the device (only applicable to human cell, tissue, or cellular and tissue-based products).There are two types of UDI code: (i) data matrix or 2D code; ii) linear barcode or 1D code.The illustrative UDI coding is illustrated in Exhibit 2.
The US Food and Drug Administration (FDA) has developed the Global Unique Device Identification Database (GUDID), a centralized public database that serves as a reference catalog for medical devices that are encoded with UDI.DI is in GUDID, and it is the primary key used to access the database’s device information.GUDID contains PI flags to indicate which PI attributes are present in the UDI, but PI is not stored there.
There are two ways to submit UDI and the information associated with it to GUDID:GUDID Web Interface for structured manual UDI data entry and low-volume submissions; HL7 SPL for multiple UDI submissions in the XML file format (up to 500 at a time).
How can UDI be of use?
The UDI system has a number of advantages for identifying medical devices, including:
Effective management of post-market safety-related activities, such as adverse event reporting and medical device recalls, is necessary to prevent the counterfeiting of medical devices.
Combined data connected with clinical gadgets to diminish clinical blunders by medical care experts
Uniform documentation for hearty pre-market evaluation of clinical gadgets for the medical care industry and public
How is the UDI framework implemented?
A single, globally standardized identification system for medical devices is advocated by the UDI system.GS1 (previously known as the Uniform Code Council), the Health Industry Business Communications Council (HIBCC), and the International Council for Commonality in Blood Banking Automation (ICCBBA) are the three FDA-accredited organizations that issue UDI.They all provide advisory services for adhering to regulatory authorities’ guidelines.The technical formats that each agency uses to comply with the UDI system are depicted in Table 1.
Another way to identify a generic medical device group is through the use of the term “Global Medical Device Nomenclature” (GMDN).The GMDN, which is managed by the GMDN Agency and provides internationally accepted descriptors for identifying medical devices, is comparable to the FDA Preferred Term (PT) Code on GUDID.For instance, electrocardiographic monitor-related products are included in the GMDN 35195 category.
How difficult is it to enforce the UDI system?
A major obstacle in the UDI system’s implementation is effective data management.The UDI data may be altered by a minor modification to the medical device, which may result in modifications to all units where such data is stored.As a result, sophisticated methods and tools are needed to precisely manage the regulatory data.
In addition to the FDA in the United States, a number of international regulatory bodies are working to implement the UDI system in nations other than the United States.The directives pertaining to UDI have been declared in all 28 European Union member states.The European Database on Medical Devices (EUDAMED) is the name of the European repository for medical devices.Since every nation has its own UDI system, there are differences between national approaches.As a result, the primary objective of establishing a single, globally harmonised system for the identification of medical devices might not be accomplished.For instance, while eudamed does not require labelers to enter any such product attributes, such as sterilization methods or packaging type, GUDID does.Another issue is that the timetable for enforcing the UDI system varies from country to country.Table 2 details some of the countries’ enforcement timelines for the UDI system.
Major medical device regulators from the United States, Europe, Australia, Brazil, Canada, China, Japan, Russia, Singapore, and South Korea form the International Medical Device Regulators Forum (IMDRF).The international medical device regulatory frameworks, such as the UDI system, are being strengthened by the IMDRF group.The discussion gives rules to administrative specialists of part countries to create and execute a uniform UDI framework.
What actions must be taken by labelers of medical devices?
All layers of medical device packaging must include UDI.After the device has been unpacked, UDI may need to be printed on it if it is intended for extensive use.Direct marking is a method that aids in device identification in the absence of packaging.The idea is to track the medical device throughout the entire supply chain. For instance, an implantable device can be tracked using UDI all the way through the supply chain, from the manufacturer to the patient who receives it.Labelers of medical devices face the following issues:
In the case of direct marking, technical issues, such as device size and interference with the safety or efficacy of the device, may arise. Ambiguity may arise when labeling combination products (a device with an active pharmaceutical ingredient). Several consulting and data management companies have begun offering comprehensive solutions to support labelers’ efforts to comply with UDIs.ConnectSx, for instance, is an Illinois-based e-health startup that supports UDI compliance for the medical device supply chain.The company introduced UDidentify, a mobile software-as-a-service (SaaS) scanner that allows labelers and medical representatives to validate UDI barcodes (HIBCC and GS1 barcodes) against the GUDID database.On Google Play and the Apple App Store, you can download UDidentify.
Another organization, Vuemed, fostered a Radio-recurrence Recognizable proof (RFID) arrangement known as the VueTrack-UDI, which is a SaaS-based independent arrangement that names UDI-consistent, latent RFID labels on the gadget utilizing printers/RFID encoders.Using cutting-edge scanners, it also verifies that the RFID data matches the information printed on the device packaging provided by the manufacturer.The visibility and effectiveness of the medical supply chain are both enhanced by these solutions.
Software for UDI compliance has been developed by a number of businesses to help reduce implementation errors and simplify government regulation compliance.Labelers may be able to easily meet the UDI standards and reduce the costs associated with iterations in the UDI system implementation thanks to this.One such programming is TrackWise® UDI eSubmission Supervisor created by Sparta Frameworks.It is a web-based software that aids in the management of quality and compliance issues related to the UDI.Another UDI solution created by PTC to assist labelers in adhering to the UDI standards is PTC Windchill 10.2.Labelers shouldn’t worry about the short-term cost of complying with UDI standards because the long-term cost of not complying is much higher.
A long road ahead Despite the fact that the UDI system contributes to improved patient safety, efficient target recalls, and improved traceability, it must be globally implemented for all classes of medical devices.In addition, the uniformity and compliance of this regulatory data must be monitored by an independent regulatory body.In the United States, the UDI system was implemented six years ago;However, not all countries have fully implemented the regulation.As a result, the UDI system’s implementation protocol and robust data management system are essential.Labelers of medical devices need to be ready to change with the development and widespread acceptance of UDI.
