Children's Hospital Boston Joins Others
`Using RFID to Track Implantables
`
`A growing number of hospitals and surgical suppliers are employing passive RFID tags to help them monitor the inventory
`and usage of implantable surgical devices, as well as to manage billing.
`
`By Beth Bacheldor
`Tags: Health Care, Packaging, Asset Tracking, Standards, Inventory / Warehouse Management
`
`Mar 05, 2008—More and more hospitals and surgical suppliers are leveraging RFID to help track the usage, storage and
`inventory of surgical implants. These include knee replacement kits, neurological devices, tissue implants and other specialty
`surgical products.
`
`Such tracking helps health-care organizations monitor the expiration dates of implantable devices, as well as maintain detailed
`device and lot data necessary in the event of a recall. The technology can also assist in tracking the implants to remain in
`compliance with health-care regulations such as those from the Joint Commission, requiring the documentation of patient implant
`histories. In addition, RFID can help ensure hospitals maintain optimum inventory levels and accurately charge patients for
`implants used.
`
`Orthopedics supplier Zimmer attaches a passive 13.56 MHz RFID tag to packaging
`of each implant kit it ships out.
`
`This week, Children's Hospital Boston announced its implementation of an RFID tracking system from Mobile Aspects to help it
`manage and track its inventory of tissue implants and other items. The system, known as iRISupply, features RFID-enabled
`storage cabinets with built-in 13.56 MHz RFID interrogators compliant with the ISO 15693 standard. Hospital staff members
`attach passive RFID labels to the packaging of implantable devices, which are then placed in the cabinet. The interrogators scan
`the items' passive RFID tags, recording any that are removed from or returned to the cabinets.
`
`In 2006, Biomet Europe began using Magellan Technology's 13.56 MHz tags and interrogators to identify items included in its
`orthopedic knee implant kits. Each implant kit contains around 100 parts, and the plastic packaging surrounding each part is
`fitted with an RFID tag (see Biomet Tags Its Orthopedic Knees).
`
`Biomet has been using a tunnel RFID reader to ensure that kits are complete before shipping them to hospitals. When a hospital
`returns a kit, Biomet reads its tags to quickly determine which items have been removed so it can invoice correctly for items
`used and replenish the kit with the missing parts.
`
`Magellan's RFID technology leverages phase-jitter modulation (PJM), which the Australian company created, and the tags
`
`http://www.rfidjournal.com/articles/view?3957
`
`© 2008 RFID Journal
`
`1 of 3
`
`Page 1 of 3
`
`Health Care Logistics, Inc.
`Exhibit 1010
`
`

`

`Children's Hospital Boston Joins Others
`Using RFID to Track Implantables
`
`comply with the ISO 18000 Part 3 Mode 2 air-interface protocol. "Magellan's technology is a combination of very high data rates,"
`says Ken Laing, the company's VP of sales and business developments, "meaning that you can read and write to many tags
`almost simultaneously; eight separate reply frequencies that allow up to eight tags to reply at once; the ability to read and write
`to many hundreds of tags stacked, touching or overlapping; and tunnel readers that can identify tags in any orientation."
`
`Zimmer is another orthopedics implant maker employing Magellan's PJM technology. The company says it uses hundreds of
`thousands of tags to track its products—including hip, knee, shoulder, elbow, spinal and trauma implant kits—as they're shipped
`to hospitals worldwide. The benefits, according to Zimmer, include more accurate inventory and invoicing, as well as faster
`picking, packing and shipping processes. This has led to reduced labor costs, easier tracking of returned products and a
`significant reduction in errors fulfilling orders.
`
`Based in Warsaw, Ind., and operating worldwide, Zimmer reported sales of about $3.5 billion in 2006. The company first began
`utilizing RFID in late 2005 to track implants shipping from its five distribution centers in Australia (Sydney, Melbourne, Adelaide,
`Perth and Brisbane) and its center in Auckland, New Zealand. Since then, it has added the technology to its centers in Bangkok,
`Thailand;
`in Singapore; and in the Japanese cities of Gotemba, Heiwajima and Fukuoka. Overall, says Michael Schaffler,
`Zimmer's operations director, the firm has tagged more than 700,000 products—approximately 200,000 each year.
`
`According to Schaffler, Zimmer decided to implement RFID largely to help it manage the complex supply chain, which he says is
`typical of the orthopedic industry. Most often, he notes, hospitals use consigned implants owned by the supplier but residing at
`the hospital, ready to be used in joint replacement or trauma surgery. In some cases, implants are loaned to a medical facility for
`a single surgery.
`
`Because every patient is different, surgeons require a multitude of implant variants and sizes for each case. "In most cases, 100
`to 150 implant kits are sent for each case," Schaffler says, adding that only about 3 percent of these devices are used in a
`particular surgery. As a result, many implant kits are shipped out and later returned to Zimmer's distribution centers.
`
`Before Zimmer implemented RFID, each kit was bar-coded and manually scanned, which was a time-consuming, labor-intensive
`process. "We had a significant bottleneck in bar-code-scanning each orthopedic implant as it left a Zimmer warehouse and was
`then returned after each case, " Schaffler says. "Often, emergency surgery requirement did not allow for sufficient time to bar-
`code scan each implant as it left the Zimmer distribution center."
`
`the company now utilizes Magellan's passive 13.56 MHz RFID tags and
`Instead of using bar codes to identify each kit,
`interrogators. A tunnel reader,
`fitted over a conveyor belt, automatically scans the RFID tag affixed to an individual
`tote
`containing all the kits pertinent to a customer order. Each tote's tag is associated with the product and lot number of a particular
`implant in a back-end database, and thus collects the tag's serial number, product number, lot number, expiration date and
`manufacture date.
`
`The scan is then checked against the order—which contains a surgery requirements list—to make sure the tote contains all the
`correct kits, each of which has its own individual RFID tag. "Instead of individually scanning each item using a bar-code
`scanner," Schaffler says, "the tote can be placed in the tunnel and all the tags are identified irrespective of whether any of the
`tags are touching or overlapping, or the orientation of the tag." The tote is packed in a box, which is also RFID-tagged, and that
`unique ID number is correlated with all the individual tags on the implant kits contained in that box.
`
`"The key benefit of using RFID is that an entire surgery order can be scanned at once and compared to a surgery requirements
`list," Schaffler says. "If there is a perfect match between the pick and the requirement, the box is sealed and sent. The hospital
`now only needs to check that all outer boxes are present, rather than having to check the content of each box. In addition, we
`have placed an RFID tag on the box. This enables an association between the box and its contents. This allows nursing staff to
`locate a particular implant and the exact box number it was delivered in."
`
`With the bar-coding system, the bar codes on the kits contained in a shipment couldn't be scanned once the kits were packed
`and ready to ship, because the scans were conducted at the picking station, prior to their being placed into a tote. "We needed a
`system to verify that every implant required for the surgery was actually picked and packed," Schaffler says. "In this business, a
`
`http://www.rfidjournal.com/articles/view?3957
`
`© 2008 RFID Journal
`
`2 of 3
`
`Page 2 of 3
`
`Health Care Logistics, Inc.
`Exhibit 1010
`
`

`

`Children's Hospital Boston Joins Others
`Using RFID to Track Implantables
`
`picking error discovered in the operating theater when that patient is on the table is not an option."
`
`After all the kits in a given shipment are packed, their tags are interrogated to reveal the contents, which are again checked
`against the order. If there's a match, the box is sealed and shipped, and the shipment is documented. "The possibility of adding
`the wrong products to the shipment is reduced," Schaffler states.
`
`Once products are returned, the tags on the implant kits are read once more to determine which devices were utilized. "When the
`serial number is detected, the system identifies which hospital
`it was sent to and [records] the returned inventory," Schaffler
`says. "We need a reader that could cope with accurately reading a tote of implants in multiple orientations, and the reader read
`rate had to be fast and robust."
`
`http://www.rfidjournal.com/articles/view?3957
`
`© 2008 RFID Journal
`
`3 of 3
`
`Page 3 of 3
`
`Health Care Logistics, Inc.
`Exhibit 1010
`
`