Inventory Management and Recall Capabilities with RFID Technology

The Michigan Congenital Heart Center (MCHC), located within C.S. Mott Children's Hospital at the University of Michigan, has earned the reputation as a national and international leader in providing comprehensive care for congenital heart patients. With a talented team of cardiac surgeons, cardiologists, intensive care specialists, nurses, anesthesiologists, radiologists, and other allied professionals, we provide care to children and adults suffering from congenital heart disease and perform nearly 1,000 cardiac catheterizations and over 200 interventions annually. In 2005, MCHC evaluated information technology solutions to help address key operational needs associated with effective management of medical device and supply utilization. As a pediatric facility, MCHC must carry a wide range of inventory sizes and quantities. Our single-item costs range from several hundred dollars to over $20,000. It is extremely important that our inventory processes be tightly controlled. Key issues we sought to address included: Security and accountability. In addition to our own departmental operations, MCHC works within other departments at the hospital, such as the PCTU and OR. The system had to support secure storage of items within inventory and keep staff accountable for their inventory use, particularly when crossover between areas occurred and items were used for those procedures. Improving documentation processes. MCHC relied on clinical staff to manually enter information into a hemodynamic system to record device and supply utilization. In our busy clinical environment, at times the documentation did not occur, leading to errant or overlooked entries of item utilization. In turn, this produced missing billable charges, inaccurate inventory levels and unreliable management systems. Supporting regulatory and quality standards. Many of the items used by MCHC have product expiration dates or could be subject to recall. These items must be closely monitored to align with our own internal quality standards as well as support external regulatory and quality standards. We needed a system able to help us quickly facilitate the identification, removal, and substitution of any items close to expiration or identified for recall. Based on this set of needs, MCHC identified a system that allowed us to automate many of our manual processes for inventory management. It also provided a unique item-level tracking capability to support issues such as recalls or product expiration. The technology, called iRISupply, is provided by Mobile Aspects (Pittsburgh, PA) and uses a technology called radio frequency identification (RFID) to store, track, and manage our medical device and supply inventory. In early 2006, the cabinet-based system was implemented in two cardiac catheterization laboratories, an electrophysiology (EP) laboratory and a central supply storage area to manage our inventory of stents, catheters, balloons, wires, atrial septal defect (ASD) devices and EP devices. Operational Improvements With its closed-cabinet design and user login technology, the system created a more secure, controlled mechanism for medical device storage. Our prior storage approach consisted of having small quantities of inventory stored in open cabinets in the procedure rooms, along with much larger quantities of inventory located in open cabinets, carts, and shelving throughout our hallways. Staff members relied primarily on memorization to locate items and often spent time searching through storage areas for needed items. With the new system, all inventory stored in the cabinets is systematically organized by cabinet compartment and storage location. If a staff member has difficulty locating an item, a touch screen console on each cabinet allows for a query search by product to locate the item's specific cabinet compartment. As a result, the system has permitted staff to be more efficient with their time. Also, a more structured approach on storing inventory has helped address training issues for new staff. The process of documenting item utilization now has several automated steps. Retrieving medical devices and supplies requires a quick user login with an identification badge and the selection of the appropriate patient on the touch screen console. Items are then removed and the clinician returns to patient care needs. When our staff needs to support the PCTU or OR, they are able to remove items from the cabinets for use in those areas. The system maintains a detailed audit trail of inventory use specifically for those settings, including which items were removed, at what time, and by whom. As a by-product of the automation, all information on item use is captured automatically, creating an accurate and detailed summary of item utilization without the need to manually chart or electronically enter information. In turn, this information is used to review the accuracy of charge capture and to manage our inventory levels. We have seen our inventory management improve simply by having more accurate and accessible data regarding our on-hand inventory. Previously we would perform a cycle count of our on-hand inventory once a year. In addition to taking a day's worth of labor or more, this approach proved unreliable. Within days, our count was off due to errant methods of documenting our item utilization. With the RFID-based system, we track the location and quantity of items in real-time as well as compare on-hand quantities to par levels to determine which items require replenishment. A key step in addition to the new technology was our decision to centralize responsibility for inventory management by hiring a dedicated staff position. Our prior organizational structure assigned our six technologists joint responsibility to manage inventory. This proved to be a challenge, as they had to balance responsibilities for technical support on cases with responsibilities to review inventory and manage the ordering and stocking processes. By shifting the responsibility of inventory management to a single individual, our technologists have been able to return to their patient care responsibilities, focusing on what they do best. As we move forward, this new staff position will also provide an opportunity for us to look at detailed sets of data on our device utilization patterns. We will be able to make more informed decisions on the items we carry and their quantity and par levels. With over a year's worth of utilization data, we can have productive discussions with our physicians and make decisions that will positively impact clinical practice patterns and our operational performance. Improved Device Recall Management Device recalls have caught national attention over the last few years as recalls from several major cardiovascular device manufacturers made headlines. The Food and Drug Administration estimates that 111,000 deaths and injuries occur annually due to problems with medical devices1 with more than 600 medical device recalls issued each year.2 While we initially focused on improving inventory management to prevent device expiration, MCHC was soon faced with an unexpected need to respond to device recalls. Although generally a rare occurrence at our facility, addressing this issue was an obligation to our patients and to our commitment of providing the highest levels of care. Since products are monitored at the item level within the system, an accurate and real-time data set is available for each item, including lot number, serial number and expiration date. In addition, the RFID-based tracking information also provides the specific cabinet and shelf location for each item. With this precise information, our staff can work to efficiently identify and remove all items that could pose a risk to patient care either through expiration or recall. One example occurred during the fall of 2006 during the recall of an implantable ASD device. MCHC was alerted by the manufacturer that the implantable device packaging could potentially be damaged, jeopardizing the item sterilization. The manufacturer provided over fifty lot numbers to identify the devices subject to recall. Normally, completing a thorough inventory search would have taken several hours for our staff. Their efforts would have consisted of manually pulling all of the devices and then cross-referencing their lot numbers with the list of lot numbers provided by the manufacturer. Not only is this process time- and labor-intensive, but it can also have downstream effects, delaying or rescheduling cases in which these items are required for use. Instead of using manual processes to identify and remove the recalled items, our cardiac catheteriztion technician, Sharon Tomaston, and others from our team were able to leverage the system to efficiently complete the process. The steps involved searching for the manufacturer's products through a query in the system's software application. Once the products were identified, all lot numbers for the products were displayed and quickly cross-referenced with those provided by the manufacturer. Following this short step, the search was quickly narrowed down to identify eleven items that were subject to the recall. Included in this list were the exact cabinet and shelving locations. Furthermore, data was also available to identify any patient who might have already been implanted with the recalled devices. A process that used to take several hours to complete was shortened dramatically. Staff could be confident that all items subject to the recall had been identified and the risks to patient care were eliminated. Conclusion Medical device technology will continue to play a significant role in our ability to treat patients with complex congenital heart problems. Through the use of information technology to help better manage our storage and utilization of inventory, MCHC is well-positioned to maintain an operationally efficient and fiscally successful department. More importantly, we also feel that we have strengthened our ability to provide the highest levels of quality care for our patients. Dorothy Nalepa can be contacted at dnalepa (at) umich. edu.

1) Rados C. FDA Works to Reduce Preventable Medical Device Injuries. FDA Consumer magazine. July-August 2003. Accessed at: http://www.fda.gov/fdac/ features/2003/403_devices.html(2) Haugh R. Recalled. Now What? Hospitalconnect.com. December 18, 2006. Accessed at: http://www. hhnmag .com/hhnmag_app/hospitalconnect/search/article.jsp?dcrpath=HHNMAG/PubsNewsArticle/data/2006December/0612HHN_Inbox_PatSafety&domain=HHNMAG