Irish Group Creates Clinical Lab Automated Stockroom System

Feb 23, 2011Three nonprofit organizations in Ireland have joined efforts to develop a model for endovascular-device tracking that would include RFID technology and bar codes from the point of manufacture to the operating room. With that goal in mind, Georgia Tech Ireland (GTI), standards organization GS1 Ireland and the Western Vascular Institute (a clinical vascular research foundation) have completed a pilot at Galway Clinic, finding that UHF RFID tags on high-value implantable endovascular products, such as catheters and stents, can be successfully used in a high-volume clinical setting to improve patient safety and lower costs by reducing the risk of errors, out-of-stocks and product expiration.

The team intends the project, known as the Clinical Laboratory Automated Stockroom System (CLASS) Project, to provide a model solution, based on global standards, for more effectively managing inventory throughout the entire medical-device supply chain, from manufacture through to point of use.

With support from medical-device manufacturers Boston Scientific, Medtronic and Cordis (owned by Johnson & Johnson), the group began the collaboration in an effort to improve supply chain efficiency and reduce the cost of missing or expired items used in endovascular procedures. Improved patient safety and greater efficiency and visibility in the supply chain, the group believes, could help address the escalating costs for health-care services as well as meet regulatory demands, such as the Unique Device Identification (UDI) requirements of the U.S. Food and Drug Administration (see U.S. FDA Seeks Research for Medical Device Tracking System). The project's focus was on using the global EPC RFID standards to track and trace medical devices from the point of manufacture to the patient. "In order to be efficient and effective in data sharing, a common language of globally accepted standards is essential," says Jim Bracken, GS1 Ireland's CEO.

The solution trialed by the group included a single, shared database on a server that a variety of players could access via the Internet using software based on EPCglobal's Electronic Product Code Information Services (EPCIS) specifications, and the use of GS1 standard bar codes and UHF EPC Gen 2 tags. EPCIS software allows multiple players to securely access data on a database and selectively share that data with others. Georgia Tech Ireland provided the RFID hardware installation and software to building and testing the RFID system. The Galway Clinic provided the real-life setting for the system and GS1 Ireland provided identification numbers for the RFID and bar-coded labels, as well as technical guidance on the application of GS1 and EPC standards.

The research group's ultimate goal is to help members of the medical-technology industry, health-care providers and clinicians to implement RFID- and bar-code-based traceability systems and share data from those systems to make the supply chain and inventory management more visible. In that effort, they hope to design a traceability system that would reduce health-care costs and enhance patient safety by thwarting counterfeits as well as providing a view into inventory stock, thus ensuring that items are available when needed and that no product expires on a clinic's shelves. The CLASS project demonstrated that RFID could identify and track the movement of high-value endovascular devices, says Kevin McGuinness, senior project manager at Georgia Tech Ireland.

The Galway Clinic performs about 8,000 surgeries annually, with another 2,000 catheter lab procedures. The clinic's managers volunteered to be part of the program. Because of the large volume of patients being treated, the facility was interested in finding an automated system to optimize patient-safety by ensuring devices are correctly assigned and safely implanted into selected patients. Additionally the clinic was eager to source an automated system to manage its medical inventory to review inventory levels, eliminate out-of-stocks, decrease the waste that comes from discarding out-of-date products and increase charge capture by more accurately tracking which items were used on what patient.

"With 10 to 20 procedures being performed each day—many of which are complicated enough due to the variety of patients—the last thing surgeons need to worry about is whether we have the right product in stock or if the product has passed its expiry date," says Sherif Sultan, the clinic's consultant vascular and endovascular surgeon.

The 10-week pilot consisted of attaching an adhesive paper label printed with a serial number, batch and lot number and expiration date, and containing a UPM RFID DogBone EPC Gen 2 passive UHF RFID tag encoded with an EPC number. Also printed on the label was a Data Matrix 2-D bar code encoded with the same full EPC number , as well as batch and lot info. The bar code's purpose was twofold: to show that it could also be used in instances where RFID was not an option, and to provide redundancy and backup were there any issues during the pilot.

The clinic's staff attached the labels during intake of new product (a total of about 660 endovascular products including guide-wires, catheters, endografts, stents and balloons were tagged) and inputted data into the EPCIS software residing on a dedicated server, along with the unique ID number encoded to the label's tag. The tagged products were then taken to the clinic's endovascular suite stock room. There, they were pushed past an Impinj Speedway RFID reader, which captured the EPC number of each RFID tag, and EPCIS software updated the status of the items as being in the stockroom and therefore "in-stock."

When required, items were then removed from the stockroom for use in the operating room, where clinic staff inputted the specific patient's electronic medical record number (MRN), thus creating a link between the item and the patient. The software also updated the item as having been used and no longer available in the clinic's inventory. The labels were read a final time in the operating room at the time the item was being implanted, using another Impinj reader fitted with a near-field antenna.

During the study, the read rate was 99.7 percent, McGuinness says. The system also identified 12 products due to expire, as well as two incidences of a product mismatch (the wrong product for a particular patient), which was also caught and intercepted by manual inspection. The clinic would like to adopt the system on a permanent basis going forward, but would like to see the manufacturers applying the tags, instead of the clinic.

In June 2010, the researchers also conducted a survey of leading clinicians from 24 hospitals in Europe and the United States, finding that stock items can cost hundreds of thousands of U.S. dollars and are typically tracked either by paperwork alone, a computerized manual key entry system, or in some cases, with a bar-code scanning system for data capture. The majority, when asked if they would like to use an RFID system, indicated they would.

Now that the Galway Clinic pilot is complete, the group is investigating options to implement the system in health-care facilities in the United States and Europe using a mixture of RFID and bar codes.

"In order to build, scale and show the system operates on a global basis, further implementations of the model system are proposed in the future in a number of other clinics," says McGuinness. The research group expects clinics to use a mixture of RFID and/or bar-code technologies. Eventually the project's goal is to provide a model that participants—including manufacturers, distributors, health-care providers and clinicians—can use to share data about items as they move through the supply chain.

Other RFID projects that GTI is currently working on include the "Factory of the Future," a collaboration with NUI Galway's information technology department. In this case, the group is developing an RFID tracking system that improves efficiencies in manufacturing sites with clean-room facilities. Currently in the proposal stage, this project is being demonstrated to a multinational company.