Now that medical devices are being labeled and uniquely identified to meet the requirements of the U.S. Food and Drug Administration (FDA) Unique Device Identifier (UDI) Rule, healthcare providers have an opportunity to capture and leverage the data contained in these unique device identifiers (UDIs) to improve the quality of care.
The ability to include the device identification and production information details of a patient’s medical implant in their electronic health record (EHR) offers tremendous potential for life-saving improvements should complications arise, device updates, or replacements become necessary, or even if a product recall occurs. Additionally, when UDI data is captured electronically at the point of care, the entire healthcare system benefits as well — from realizing inventory management efficiencies to cost savings.
The U.S. FDA UDI Rule, passed in 2013, specifies that the healthcare community and the public be able to identify a device through a Unique Device Identifier that appears on the label and package of a device.1 UDIs must be presented on device labels in both a plain-text format and a format that can be read by automatic identification data capture (AIDC) technology (e.g., a barcode). A UDI is a unique numeric or alphanumeric identification code assigned to medical devices by the labeler (e.g., manufacturer, reprocessor, or repackager) of the device.
The goal of the UDI rule is to establish a system for the adequate identification of medical devices through distribution and use. To that end, the UDI provides a standardized way to identify medical devices in health-related information systems, such as electronic health records, claims, and devices registries.
A unique device identifier includes two segments: a “device identifier” and a “production identifier.” The Device Identifier (DI) is a mandatory, fixed portion of a UDI that identifies the labeler and the specific version or model of a device. For organizations using the GS1 System of Standards, the DI is represented by a GS1® Global Trade Item Number® (GTIN®). The Production Identifier (PI) is a conditional, variable portion of a unique device identifier that identifies one or more of the following: lot or batch number; serial number; expiration date; and date of manufacture.
Orthopedic surgeries utilize numerous medical devices, including non-sterile orthopedic implants (e.g., screws, plates, etc.). These present special challenges for capturing UDIs at the point of care.
Generally, non-sterile orthopedic implants are delivered unsterile from the manufacturer, intended to be sterilized by the hospital. Due to the number, variety, and small size of these devices, they are usually stored in trays (or sets). These trays (holding hundreds of these small devices) may be assembled by the manufacturer or by the hospital itself. The entire tray gets sterilized prior to being used in a procedure.
During surgery, the surgeon uses what is needed. Then, the tray is disinfected and returned to storage to be replenished periodically on site and resterilized for the next surgery.
In 2016, GS1 US® established the Orthopedic Implant Workgroup to support industry in making the full U.S. FDA Unique Device Identifier available at the point of use — including all required data elements as described above — for non-sterile orthopedic implants. The workgroup, comprised of device manufacturers, healthcare providers, and hardware and software solution providers, convened to examine current processes to identify requirements and challenges to maintaining UDI information with the implant and to evaluate UDI capture options in terms of benefits and challenges from both the manufacturer and provider perspectives. The workgroup set out to satisfy these goals through three efforts:
Detailed analysis of data and device process flows.
Site visits to hospitals to observe a live orthopedic surgery to enhance the participants’ understanding of the complexity of the operating room (OR) environment where the UDI is to be captured.
Analysis of the various options for feasibility, benefits, and challenges based on the process flows and site visit experiences.
Through this collaboration, the workgroup’s analysis, impressions, and insights are available to support ongoing industry efforts to identify solutions and are published in a new white paper, “Non-Sterile Orthopedic Implants & UDI Capture.”2
The workgroup identified three main challenges of UDI capture for nonsterile orthopedic implants. First, the UDI is often lost when the device is removed from its packaging and placed into an orthopedic tray to be sterilized. Second, the size, shape, and substrate of the implants can complicate and/or frustrate direct marking of the UDI on the device itself. And finally, these devices are used in a surgical setting where UDI data capture is complicated, and options are restricted by heightened patient safety concerns. In fact, the workflow of an operating room is so critical and demanding that much of the workgroup’s conclusions are driven by its parameters.
Workgroup participants found the site visits to be invaluable. Observing orthopedic surgeries at two major hospitals enabled them to learn about the challenges that providers face on a daily basis, considering that the most important thing in the OR is the patient — not how to capture the UDI. Even manufacturers who are accustomed to being in ORs to assist with their devices found the experience to be extremely valuable, since their prior visits had usually been focused only on the patient and the devices. This was the first time many of them had focused on OR systems and processes, which they felt provided tremendous insights to help them support their provider customers.