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.

UDI Basics

Due to the number, variety, and small size of these devices, they are usually stored in trays. (Credit: GS1 US)

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.

A nurse scans a barcode in the OR. (Credit: GS1 US)

Non-Sterile Implants

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.

Industry Collaboration

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

Key Challenges

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.

Site Visits

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.

OR Environment

The sheer volume of work and responsibility on the OR nurses reinforced the need for UDI capture to be accomplished easily and quickly. Also, since numerous devices and supplies are used in a surgery, they learned that the location and availability of markings need to be predictable so that the nurse can quickly locate and scan barcodes while a surgical procedure is in process.

Because there is a tremendous amount of work for the circulating nurse to manage, if a barcode does not scan on the first attempt, the nurses tend to stop scanning and go back to manual recording or not recording at all. Unsuccessful barcode scanning experiences can influence nurses to abandon barcode scanning altogether, opting instead to simply write in the required information. Since manual data entry is error-prone and slow, the workgroup concluded that promoting barcode readability in the OR is essential.

Promoting barcode readability in the OR is essential, since unsuccessful scanning experiences can influence nurses to abandon barcode scanning altogether. (Credit: GS1 US)

Causes of Barcode Readability Issues

When barcodes do not scan properly, providers may assume the issue is barcode quality. However, the workgroup found that readability issues are often not related to barcode quality — but to issues in provider IT systems related to data, systems integration, and item masters. Three key types of problems were identified in the workgroup’s analysis: absence of data, lack of systems integration, and lack of data governance processes.

Absence of data. The prevailing theory for item master management at healthcare providers has been to limit the product data stored in the item master to only those products that are routinely used (instead of storing data for all products). As a result, there are many products used in hospitals that are not in the item master. If the GTIN encoded in a barcode is not in the system, the scan will fail.

Lack of systems integration. EHR system modules used in the OR are not often integrated with Enterprise Resource Planning (ERP) or supply chain systems. The absence of systems integration in this area and/or incompatibility of systems can undermine data availability and data quality.

Lack of data governance processes. OR systems often do not have a data governance process in place to help them resolve data quality issues once they are discovered. For example, a typical pharmacy system has a reconciliation process. When an issue occurs, the data is recorded and held in a reconciliation page so the provider can address and resolve the issue (e.g., add to the item master; edit in the item master; mark as an exception; etc.). This type of mechanism provides a vehicle for working to resolve data quality issues. However, OR systems typically do not have this mechanism, making it harder to fix a data quality issue so that the scanning problem does not occur again in the next surgery.

Evolving UDI Capture Technologies

Using the process flows, observations, and insights gleaned from the site visits, the workgroup examined current UDI data capture options for feasibility, benefits, and challenges. They evaluated various technology-enabled solutions, such as online inventory control sheets that are provided by device manufacturers. Inventory control sheets are set up by the OR nurse before surgery, listing every device that may be used with vendor part numbers, descriptions and DIs, and barcodes for each device.

Since manual data entry is error-prone and slow, barcode readability in the OR is essential. (Credit: GS1 US)

During the procedure, when the surgeon calls for a device, the circulating nurse locates it in the inventory control sheet and enters the quantity in the space provided. After the surgery, the nurse gathers all of the inventory control sheets and enters the information for the devices used into the patient record by either scanning the barcode on the sheet or via manual data entry.

Conclusion and Recommendations

The workgroup’s analysis highlighted and reinforced the complexity of the OR and the challenges associated with managing non-sterile orthopedic implants efficiently and effectively to support the safety of a surgical procedure. The insights gained enabled the workgroup to identify positive next steps.

They observed that the current method of using inventory control sheets is a proven, effective approach for capturing the DI. As efforts to find a solution for capturing the full UDI continue, there is a clear opportunity to improve and enhance this process. The workgroup emphasized that it is essential for providers to start small. Once they have the DI (GTIN) data available for most of the implantable devices in their item master files, they can expand to other technology-based options as they become available and feasible.

Supporting and expanding such efforts to help providers improve their data issues is a valuable and achievable next step, in order to promote the use of the barcodes, discourage manual data entry, and improve DI recording and accuracy.

Reference

  1. Unique Device Identification System,” Federal Register 78, no. 185 (September 24, 2013)
  2. White Paper: Examining UDI Capture & Orthopedic Implants

This article was written by Angela Fernandez, Vice President of Community Engagement at GS1 US, Ewing Township, NJ. She is responsible for driving broader adoption of GS1 standards for improved product traceability, product information transparency, and data quality. For more information, visit here .


Medical Design Briefs Magazine

This article first appeared in the August, 2019 issue of Medical Design Briefs Magazine.

Read more articles from this issue here.

Read more articles from the archives here.