The Unique Device Identification (UDI) program was created by the U.S. Food and Drug Administration (FDA) in 2013 as a central, globally harmonized tracking system for medical devices. A primary data repository called the Global Unique Device Identification Database (GUDID) is where all information related to the program is stored. The database itself can only be accessed and updated by government employees and authorized officials but a complementary website called AccessGUDID is available for public access to individual records.
This post will explore 4 major benefits that this program brings to the healthcare industry. Each UDI code contains a device identifier and additional production identifiers that make it easy to track the history of any individual device for its entire lifetime. The UDI program is tightly controlled by 3 agencies that have aligned their standards and practices with the FDA recommendations. These agencies are GS1, the International Council for Commonality in Blood Banking Automation (ICCBBA), and the Health Industry Business Communications Council (HIBCC). The success of the UDI program relies on close coordination between these governing bodies and the many manufacturers, distributors, and healthcare professionals that use medical devices.
One of the main benefits of the UDI system is a more secure global supply chain for medical devices. Given the highly specialized nature of these devices, it’s a major challenge to understand differences in performance and capabilities among models from different vendors. A central database allows for the categorization of similar technology that can be a major resource in the event of a global health crisis or shortage of a particular medical device.
Additional supply chain benefits of the UDI system include improved inventory accuracy and reduced counterfeit devices found in the market. The high degree of supply chain traceability also streamlines the approval process for new devices, providing the FDA a faster route for authorizing use for novel applications that can have a benefit for patients.
Medical devices are prone to production errors and other issues that could impact their use. As a result, product recalls are a natural part of the medical device lifecycle and are often coordinated under the direction of the FDA. The UDI system gives the FDA a complete picture of the number of medical devices in existence and where they are located. This can drastically reduce the amount of time needed to prepare and launch notifications in the event of a recall or safety advisory. In addition to adverse event reporting, the UDI system also supports safety investigations and the ability for manufacturers and agencies to prepare responses in the event of audits or other regulatory needs.
The UDI brings real-time medical device information directly to healthcare providers, allowing them to ensure quality care with each patient visit. This can help reduce medical errors or the improper use of devices by giving immediate access to the latest documentation and product safety information. UDI information may also be helpful for individual patients who have an implanted device, such as a stint. These patients could carry UDI information with them and share it with medical professionals at any time in the event of a medical issue or office visit. With the improvements being made in healthcare data sharing and security, there will be excellent opportunities in the future for further empowering healthcare professionals and patients.
Quality control (QC) is an extremely important function for companies that manage healthcare products and services. The UDI system helps protect medical device traceability by also defining detailed specifications for the UDI markings themselves. Some devices are sterilized or washed frequently and must receive a direct marking instead of a label. Other devices can use a label of a suitable material and design that includes a compatible GS-128 or GS1 data matrix code and properly formatted identifying text.
Metalphoto® photosensitive anodized aluminum is an ideal substrate of choice for UDI marking thanks to its exceptional durability. Anodized aluminum offers a non-porous surface that won’t harbor bacteria, fungus, or mold. Metalphoto photosensitive anodized aluminum, which complies with the FDA Amendments Act of 2007 for the establishment of a Unique Device Identification (UDI) System along with other standards and specifications, takes it a step further by producing an inorganic, sub-surface image that resists fading and corrosion even after thousands of sterilization cycles.
These markings help streamline the quality control monitoring process and make it easier to replace parts and order individual items. In some applications, these markings are also used to facilitate in-process instrument tracking that gives operators a real-time view of the performance for each device being used.
The UDI system continues to be a critical resource for the FDA, medical device manufacturers, and healthcare providers worldwide. Many benefits have also been realized because of this sophisticated standardization and the creation of a simple and robust system. Medical device identification will remain an important factor in the healthcare industry to maintain accurate and reliable data collection. Complying with these requirements gives medical device suppliers an excellent method for tracking equipment and responding to product requests over time.