Presented by Terrie Reed, MS, Senior Advisor to the FDA for Unique Device Identifier (UDI) Adoption
More than a million hip and knee replacements are performed each year in the U.S., but most people don’t know the make, model, or serial number of their implanted device. The Unique Device Identification (UDI) system established and implemented by the Food and Drug Administration (FDA) will make it possible to identify medical devices, including artificial hips and knees, by assigning labels with unique numbers to them. The UDI system is important to patients for a number of reasons: It helps health care providers distinguish between two products that look the same but serve different purposes and it facilitates efficient recall in the case of a defective device or adverse reaction. Unique device identifiers will assist in better overall surveillance of device safety and effectiveness.
In this webinar, Ms. Reed presented the latest UDI system information from the FDA, and shared how patients can support efforts to improve device tracking and safety. Ms. Reed, who has a master’s degree in industrial engineering, has spent her career advocating for the development and use of data standards in health care and government systems to improve public health and patient safety.
Fast Facts from the Webinar
1. The Unique Device Identification System (UDI) is fundamental to making sure that the devices patients receive are clearly documented and identified in health records
The UDI is a globally unique number for all classes of medical devices that is assigned by manufacturers of medical devices and linked to the FDA. Information associated with the UDI that is linked to FDA is available publicly for patients to access at AccessGUDID. The Global Unique Device Identification Database (GUDID) is a database administered by the FDA that serves as a reference catalog for every device with an identifier.
2. The ultimate goal is for the UDI system to be a global standard
For example, The National Health Service in the UK has been very aggressive in their adoption of UDI. Once this system is global, information about devices can be used for safety tracking, device recall notifications, and comparative effectiveness research (CER). This means devices can be compared to understand which devices have the best outcomes and which may be best for you as a patient depending on your unique needs and preferences as a patient.
3. UDIs can improve research and innovation
The more UDIs are used in health data, the better the information will be to reduce the risk of adverse events and improve research and innovation to match patient characteristics with specific devices.
4. Patients should learn more about their devices
It is important to inquire about your device as part of the questions you ask your doctor when undergoing joint replacement surgery. When you receive an implant, ask if your doctor’s electronic health record (EHR) captures device information using the UDI system.
The Patient Perspective
Here’s what patient participants said they learned from this webinar:
- “I have had both shoulders and both hips replaced by the same orthopedic surgeon who did a marvelous job on me. In fact, the left hip implant was replaced when I fell, fracturing the femur and destroying the implant. All of them have been manufactured by Stryker but that is all I know. When I have a follow-up exam in November, I will ask for the UDI.” — Deane F., patient participant
- “I never knew patients had access to all this information about the medical devices that are in them. This information helps us feel more in control.” — Jane M., patient participant
Get Involved in Arthritis Research
If you are diagnosed with arthritis or another musculoskeletal condition, we encourage you to participate in future studies by joining CreakyJoints’ patient research registry, ArthritisPower. ArthritisPower is the first-ever patient-led, patient-centered research registry for joint, bone, and inflammatory skin conditions. Learn more and sign up here.
This webinar was produced with the Autoimmune and Systemic Inflammatory Syndromes Collaborative Research Group (ASIS CRG). As part of the National Patient-Centered Clinical Research Network, this research group collaborates with stakeholders including patients, caregivers, advocacy groups, providers, and funders early on to move research forward more quickly and more efficiently. Learn more about our work here.