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.
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.
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.
- “Unique Device Identification System,” Federal Register 78, no. 185 (September 24, 2013)
- 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.