Surgical workflow is demanding. Precision is critical in every process – from the surgeon’s technique to the movements of OR staff in confined space, to availability and handling of instruments. There is a lot going on at once. Within this high-stakes environment where patient care is paramount, there is also a need for complete and accurate record-keeping – including the identification and digital entry of every device used in surgery.
Device identification
The U.S. Food and Drug Administration’s (FDA’s) Unique Device Identification Rule establishes a unique device identification system for medical devices. The rule requires medical devices to be marked with a Unique Device Identifier (UDI) – a unique numeric or alphanumeric identification code – on the device label and package in both human-readable (plain text) format and a format that can be read by automatic identification data capture (AIDC) technology (e.g., a barcode).
The UDI must always include a Device Identifier (DI) code identifying the manufacturer and the specific version or model of the device. Usually a device label contains production information, in which case the UDI will almost always include at least one Production Identifier (PI) such as the lot or batch number, serial number, expiration date, or date of manufacture. The UDI is useful in providing a standardized way to identify medical devices in health-related information systems, such as the electronic health record (EHR), claims, and device registries.
The majority of medical device manufacturers are using GS1 Standards to implement unique device identification – encoding the required information as a GS1 Global Trade Item Number® (GTIN®) into a barcode. In addition to labeling the device, the manufacturer also submits this information to the U.S. FDA’s Global Unique Device Identification Database (GUDID). The GUDID provides critical information about medical devices, where the DI is used as the key for accessing device information. For many healthcare providers, their first experience using GS1 Standards in their operations will come from the implementation of point-of-care (POC) scanning systems to capture UDIs from implantable devices.
Data capture for orthopedic implants
The full benefits of unique device identification will be realized when healthcare providers capture and record the UDI data in a patient record and in their own inventory system. Recording and exchanging UDIs in patient EHRs would enable clinicians to accurately identify a patient’s implantable device and potentially prevent the adverse events that could result from misidentification or non-identification of a device.
Non-sterile orthopedic implants (e.g., screws, plates, etc.) present unique challenges for point-of-care data capture. Since one surgery may use hundreds of these parts in a wide variety of shapes and sizes, they are usually stored and sterilized by the hospital in trays or sets (rather than by the manufacturer). Their UDIs are recorded in the operating room (OR) as they are used. After surgery, the trays are disinfected and returned to storage to be replenished and re-sterilized for the next procedure.
Developing process recommendations for the OR
A GS1 Healthcare USÒ Workgroup comprised of device manufacturers, healthcare providers, and solution providers observed live surgeries in two major hospitals to analyze the surgical workflow. Their objective was to understand requirements and challenges involved in maintaining unique device identification information with non-sterile orthopedic implants as they were used in the operating room. This gave them a unique opportunity to evaluate the feasibility, benefits and challenges of current data capture options and to develop suggestions for providers looking to integrate unique device identification scanning of non-sterile implants inside the operating room. As an outcome of their work, the group published a white paper, “Non-Sterile Orthopedic Implants & UDI Capture,” to summarize learnings and recommendations.
Non-sterile implant challenges
The usual process for surgical device tracking begins with the OR nurse, who fills out an Inventory Control Sheet before surgery — listing every device that may be used with vendor part numbers, descriptions, and Device Identifiers (e.g., the GTINs) and barcode. During the procedure, the quantity of each item used is then noted and entered or scanned into the patient’s record. Scanning is far preferable to manual entry; it provides a more reliable method to ensuring accuracy during the critical surgical procedure.
The Workgroup identified special challenges associated with maintaining unique device identification information with non-sterile orthopedic implants. For example, the size, shape and substrate of the implants can frustrate direct marking of the unique device identifier on the device itself, and often, the UDI gets lost when the device is removed from its packaging and placed into an orthopedic tray to be sterilized. Then there is the complex workflow of a surgical setting, where data capture is secondary to the many activities directly involved with patient care.
In the OR, the Workgroup observed that OR nurses and technicians can become frustrated and revert to manual data entry when barcodes fail to scan properly. Their analysis found that scanning failure is usually caused by missing information in the hospital’s data management infrastructure, as many providers only store product data for their most commonly used devices. Without a GTIN in the data system, an item’s barcode will not scan or match with inventory records. Therefore, one of the Workgroup’s key recommendations is for hospitals to resolve their system issues in order to promote the use of the barcodes, discourage manual data entry, and improve DI recording and accuracy. As part of this effort, providers should be working to obtain GTIN data from authoritative sources and store this data in their item master files.
Improving providers’ data management systems will go a long way towards enhanced device tracking at point of care. Another integral part of this effort is to address system integration issues so that OR systems have access to accurate, up-to-date GTIN data, and are connected with other providers’ systems to promote data quality and enhance data governance.
Coordinated industry effort
The implementation of unique device identification will fulfill its purpose of improving patient safety and the accuracy of patient EHRs when device identifiers are created and marked by the manufacturer and tracked through the supply chain, all the way to the patient. Practical implementation must be designed to fit the realities of end use, as well as the device characteristics. Non-sterile orthopedic implants in particular pose special challenges that must be addressed, but the benefits will be significant.
Angela Fernandez is the Vice President of Community Engagement at GS1 US and is responsible for driving broader adoption of GS1 Standards, the most widely used supply chain standards in the world, to help industry achieve their goals for improved product traceability, product information transparency, and data quality.
