RFID Survives Sterilization to Deliver Medical Device Tracking Solution

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1 RFID Survives Sterilization to Deliver Medical Device Tracking Solution and UDI Compliance Introduction Healthcare providers are increasingly turning to technology solutions to help improve patient outcomes, reduce costs, improve efficiencies, and comply with new federal regulations governing management of patient records and medical equipment. Radio frequency identification(rfid) technology is one tool that hospitals, medical device manufacturers, and distributors have deployed to increase supply chain efficiency and provide real- time document, asset, and patient tracking capabilities. Now, pending regulations from the U.S. Food & Drug Administration (FDA) will require unique identification of medical devices, including implantable items like pacemakers and stints. Healthcare providers and medical device manufacturers have an opportunity to leverage RFID to not only meet these new requirements, but also provide real- time tracking of these items to improve asset and inventory management, speed recalls, reduce shrinkage, and increase patient safety in the operating room. In order for RFID to be universally deployed in these applications, a new class of highly durable RFID tags that can withstand high temperatures and exposure to harsh sterilization processes (including bombardment with gamma radiation) have had to be developed. In this whitepaper, we will examine the requirements of the new FDA guidelines, how RFID can be used to improve the medical device supply chain, and how new radiation- resistant RFID tags can enable point- of- use applications in the hospital and operating theater. FDA Requires Unique Identification In 2007, the U.S. Food and Drug Administration Amendments Act of 2007 was signed into law, requiring the establishment of a Unique Device Identification System (UDI) for medical devices. These UDI marks are intended to identify the device through distribution and use, and include the lot or serial number if specified by the FDA. These identifiers are to be consistent, standards based (using HIBCC or GS1 standards), and harmonized globally. The FDA is still in the process of drafting the proposed standards, but Class III medical devices (including things like implantable pacemakers) will require UDI tracking by 2013, with other classes of devices to follow in the ensuing years.i 375 Pond Road, Waltham, MA

2 02451 The purpose of UDI is to help track adverse events by specific device in order to improve safety surveillance, thus identifying device defects more quickly, speeding the recall process, and improving patient care. While the legislation calls for unique identifying numbers, there are a variety of ways in which this information can be applied to a medical device, including standard and 2D bar codes, direct part marking, and the use of RFID tags. RFID has an inherent advantage in these applications, in that the tags can be encoded not only with the UDI information, but also other data (such as maintenance history or sterilization records). The tags can also be read automatically, without requiring the direct line of site necessary for reading serial numbers or bar code labels. Standards- based RFID tags can also be read across the supply chain, from the manufacturer to the distributor and to the point of use at the hospital or other facility, meaning that participants in the medical device value chain can realize benefits beyond simple compliance real- time tracking can also reduce shrinkage and theft, improve delivery operations, speed shipping and receipt process, and provide more accurate information about what products are in transit and where they are. And once these tagged medical devices arrive at a healthcare facility, they can be tracked and monitored in real- time, providing improved asset tracking. Such asset visibility saves time and reduces cost by allowing staff to quickly locate equipment, and preventing costly over- purchasing of items that have simply been misplaced. According to AMR Research, between 10% and 20% of a typical hospital's mobile assets are lost or stolen during their useful life at an average cost of nearly $3,000 per item, so the potential savings from real- time tracking could be significant. There is also great potential to improve patient safety, even in the operating room. Surgeries typically require dozens or even hundreds of different instruments. These items have to be tracked and verified before and after procedures. Some items are discarded after use, but others (particularly any unused implantable or instruments) are often re- sterilized and sent back into inventory or back to suppliers. Millions of devices flow through the medical supply chain every week, and are sterilized using gamma irradiation or ebeam or ETO. Many are selected for individualized procedures, such as orthopedic implants or cardiac stents. These are typically shipped in kits of different sizes, with unused items being returned from the operating room for re- kitting, a manually intensive process with a very high cost of errors. Additionally, surgical items are occasionally left behind inside a patient, leading to infections and other complications. If an item is unaccounted for after a procedure is complete, staff has to locate it, often at a cost of hundreds of dollars per minute. 375 Pond Road,

3 Waltham, Using RFID, surgical items can be tagged and tracked quickly and efficiently, eliminating the manual counting procedure for both surgical staff and suppliers. Sterilization processes can also be tracked this way, ensuring every item has been sanitized or disposed of properly after use. Rugged Tags Needed for Healthcare Applications While there is a clear value to tracking medical instruments, implants, and other devices in the operating room, what has been missing from these applications has been a reliable RFID tag that can withstand the extreme conditions of sterilization, cleaning, and in some cases exposure to radiation and x- rays. Data in conventional RFID tags can be corrupted or destroyed during these processes, which is why the technology has not been used to track pharmaceutical and life science consumables, process instrumentation, medical implants and surgical kits in the past. While some companies have attempted to track these items using direct part marking or bar coding, these strategies still require manual intervention. Luckily, there are now RFID tags available that can withstand repeated exposure to gamma radiation and other sterilization processes without losing their data. By tracking these items in real time, hospitals can not only improve asset and sterilization process tracking, they can ensure the right medical implant is available at time of need, the patient and hospital are only billed for what is used, and can minimize risk and liability by tracking which items have been sterilized on what date. Hospitals could also reduce losses incurred by throwing away expensive surgical items that can otherwise be re- sterilized and reprocessed. RFID tagging also helps manufactures and hospitals comply with UDI requirements, while reducing the cost associated with passing inventory audits. Six Sigma auditing processes can be labor intensive; RFID provides a rapid way to track and verify inventory. For example, Zimmer Ohio Distributionii, which sells and distributes Zimmer brand orthopedic products and instruments to Ohio hospitals, is using RFID to track trays full of medical instruments as they travel back and forth between Zimmer's warehouses and healthcare facilities.

4 When surgeons schedule a procedure like a hip replacement, the hospital places an order for numerous implantable parts that might be used, as well as trays of surgical instruments necessary to complete the procedure. However, many of these items aren't actually used during surgery, and are then sterilized and returned to Zimmer Ohio. Inventory specialists had to spend hours each day checking each order to ensure that no instruments or implants were left out of the shipment. Instruments trays, which can range in value from $1,000 to $20,000, were the most difficult to manage because of the number of small items contained within them. Zimmer teamed with RFID Enabled Solutions (RES) of Dublin, Ohio, to develop an RFID solution. Using an RFID tunnel, each tagged implant and tray can be read as it moves in and out of the facility. Trays are weighed on a highly sensitive scale in order to facilitate inventory tracking once they are returned from the hospitals. Not only does this speed the management of orders as they enter and leave the warehouse, but Zimmer expects to cut its warehouse inventory time from 40 man hours down to 20 minutes using hand- held RFID readers. Tags used for these applications have to be durable enough to withstand the rigors of sterilization, while at the same time adhering to industry standards, and providing tag performance and data capacity necessary to enable multiple medical applications. Sterlization- Proof RFID Solutions The TegoChip is a gamma- sterilizable IC that meets the requirements of FDA UDI, provides Six Sigma reliability, and compatibility with existing labels, processes and UHF RFID infrastructure and standards. The chip is based on the UHF EPC C1G2 RFID/ISO c tag standard. TegoChip is the only chip in the market to survive more than 150+ kgy of gamma or ebeam radiation and two temperature autoclave processes in its wet inlay form. Tego provides both low or high memory options for storing critical UDI information directly on the product s label or packaging. The RFID tags have a read range of up to 3 meters, can be stored to - 80 C, but operate at temperatures from - 40 C to +85 C with a predicted memory life of greater than 30 years. Tego offers a variety of different TegoTags, including inlays for labels and a semi- flexible, non- metal Radion Plus Tag for twist tie tethering to bags, pallets and products undergoing

5 steam sterilization or autoclave And as is true with all TegoTags, the high memory RFID chip option allows for all UDI information to be read from the Tego Inlay, label or tag and users can make decisions on information provided at the point of read anywhere throughout the supply chain, even when the tag is not within communication of back end information networks. Users can read and write tag data on the spot, without relying on back- end data systems, significantly reducing the time and cost for decision- making with assets and applications. A recent gamma sterlization study iii shows the Tego Inlay survived repeat exposure to gamma, ebeam and autoclave sterilization. Conclusion New FDA tracking requirements will require both medical device manufacturers and healthcare providers to improve their item- level inventory and tracking capabilities in order to enable safety and recall improvements. By utilizing radiation- proof RFID tags in labels one can track medical devices at the time of manufacturing, through the sterilization process, and all the way to the patient s bedside. Stakeholders in the medical supply chain can not only meet these new requirements, but also increase supply chain efficiency while improving patient safety. TegoTags are designed to withstand high autoclave temperatures, as well as repeated exposure to gamma radiation, making them uniquely suited to the requirements of medical device tracking. About Tego, Inc. Founded in 2005, Tego, Inc. is the leading provider of enhanced RFID solutions including tags, system software and chip design. Tego products take RFID beyond ID: tags with TegoChip inside support high memory applications in the most extreme environments, storing and sharing information free of immediate network dependence. Across all industries and vertical markets, Tego solutions address demand for improved asset tracking and management, performance management, regulatory compliance and supply chain management. Tego, Inc. is based in Waltham, MA. For more information, visit i ii iii content/uploads/2013/03/tego- Gamma- Radiation- Final pdf

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