Image courtesy of GS1 US
Orthopedic surgeries can be life-changing—enhanced patient mobility and quality of life are often expected outcomes. With so much at stake, best practices to document orthopedic implants are critical to providing the highest level of care.
Patients have placed their trust in their healthcare providers, and regulations such as the U.S. FDA’s Unique Device Identification (UDI) Rule serve to bolster patient safety when medical devices are used. The full benefits of UDI will be realized when healthcare providers capture, record, and exchange the UDI data in patient electronic health records (EHRs) as well as in their own inventory systems.
A GS1 Healthcare US Workgroup recently analyzed surgical work flow and developed recommendations to support hospitals in this effort. The workgroup, composed of device manufacturers, healthcare providers, and hardware and software solution providers, observed live surgeries in two major hospitals to identify the requirements and challenges to maintain UDI Device Identifier (DI) and Production identifier (PI) information with the implant and evaluate data-capture options.
The workgroup’s analysis, impressions, and insights have been published in a new white paper, “Non-Sterile Orthopedic Implants & UDI Capture.” The following provides high-level findings and key recommendations around inventory management, bar code readability, and the need for continued collaboration to support the fast-paced operating room (OR) environment.
How UDIs Are Used
Medical devices must be marked with a UDI – a unique numeric or alphanumeric identification code on the device label and package in both plain-text human-readable format and one that can be read by automatic identification data capture (AIDC) technology (e.g., a bar code). A permanent UDI is also required on the device itself if it is intended to be used more than once and reprocessed before each use.
Non-sterile orthopedic implants (e.g., screws, plates, etc.) present special challenges for UDI capture at the point of care because of the way they are supplied and used in an operating room. Generally, “non-sterile” means that the orthopedic implants are delivered unsterile from the manufacturer and are sterilized by the hospital prior to use. Due to the number, variety, and small size of these devices, they are usually stored in trays that are sterilized prior to a procedure. During surgery, the surgeon uses what is needed. Then, the tray is disinfected and returned to storage to be replenished and re-sterilized for the next surgery.
As the devices are used, their UDIs must be recorded, either manually or by scanning the device’s bar code. Manual data entry is inefficient and error-prone, so bar code scanning is a preferable means of data capture.
Challenges Specific to the OR Environment
Using the process flows as well as the observations and insights gleaned from the site visits, the workgroup examined current UDI data capture options for feasibility, benefits, and challenges, including various technology-enabled solutions such as direct marking, sterile field scanner systems, and online Inventory Control Sheets. Manufacturers have developed online tools that providers can use to set up online Inventory Control Sheets for their products (i.e., select products and the tool automatically populates the form with the information).
The OR nurse sets up an Inventory Control Sheet before surgery, listing every device that may be used with vendor part numbers, descriptions and DIs (e.g., GS1 Global Trade Item Number [ GTIN]) and bar code (e.g., the GS1 DataMatrix) for each device. During the procedure, the quantity of each item used is noted and entered or scanned into the patient record.
When bar codes failed to scan properly, the workgroup found the root cause of these problems usually lies in the provider’s data management infrastructure rather than the bar code itself. For example, many providers only store product data for their most commonly used devices; less-used items fail to scan because their GTINs are not in the provider’s data system. It is critical for data and readability issues to be tackled more proactively.
Conclusions and Recommendations
As efforts to find a solution for capturing the full UDI continue, there is a clear opportunity to improve and enhance this process. A positive and valuable next step is to help providers resolve system issues in order to promote the use of the bar codes, discourage manual data entry, and improve DI recording and accuracy.
Also, as industry implements more technology and automation, there is an opportunity for the industry to work together to evaluate other factors beyond technology. For example, the community as a whole should evaluate the reason behind data capture and its value to the hospital, as some providers do not record full UDI information.
The primary focus in the OR is, and must be, on the patient. Therefore, the timing and location of data capture should be fully considered when evaluating data capture options in order to not distract from or undermine focus on patient safety and the success of the procedure.
The workgroup’s white paper reviews current options and practices for capturing UDI data on non-sterile orthopedic implants as well as their benefits and challenges. Working together, device manufacturers and healthcare providers can and should continue developing data capture solutions that optimize the full, system-wide benefits of UDI.