Innovapaedics Develops RFID System for Tracking Surgical Implants, Tools

By Claire Swedberg

The company hopes to soon launch beta tests of its MedEx solution, which uses Xerafy passive UHF tags to record which items are utilized during medical procedures.

image_pdfimage_print

Texas startup Innovapaedics, a provider of medical implants, is partnering with tag manufacturer Xerafy to offer an RFID-based solution for tracking implants and surgical tools via ultrahigh-frequency (UHF) radio frequency identification tags. The solution, which has yet to be released commercially, consists of tags placed on implants and tools, and an RFID reader station to capture the ID numbers of EPC Gen 2 passive tags placed on a surgical tool tray. It also includes a cloud-based server to store data and provide reporting to customers regarding the location, use and status of each instrument utilized during surgery, as well as devices implanted into patients.

Innovapaedics and Xerafy are currently in discussions with several potential end users, and hope to launch a beta test of the technology with a possible customer sometime within the next few months. Innovapaedics expects to release the solution commercially by the fourth quarter of this year.

Innovapaedics’ long-term (approximately five-year) goal is to offer a “Smart Implant” solution that would include RFID tags and sensors permanently attached to implants. After an item is implanted into a patient, its RFID sensors would detect pressure and temperature changes, among other events, in order to track a patient’s healing process, as well as the device’s condition, and transmit that information to a reader. It will take time, however, for the company to completely develop that technology, and to procure the necessary regulatory permits to launch, says David Crook, Innovapaedics’ president. The permitting process could be completed within approximately three years in Europe, he estimates, and five years in the United States.

Therefore, as an interim offering, the company has developed MedEx, an RFID solution for tracking implants prior to their use within a patient, to track which items were used on that individual. The resulting data would be incorporated into medical and billing records. In addition, the MedEx system would enable hospitals to track surgical tools. The complete system will include Xerafy Dot-in XS on-metal RFID tags, manufactured with Alien Technology‘s Higgs-3 chips; and an off-the-shelf RFID reader, built into an Innovapaedics workstation, that would read the tags of tools and implant items placed onto it after surgery, as well as a tag on the tray itself. Hospital personnel could then access Innovapaedics’ cloud-based software in order to determine which tools are located in which trays, or for which patient an implant was used.

Crook says his firm teamed with Xerafy to provide a whole solution that includes Xerafy’s tags and Innovapaedics’ software and reader station. The system, he notes, could be marketed by either company to hospitals or integrators.

When hospitals utilize the solution for implants, a sterilized “InnovaCollar” with a built-in RFID tag is temporarily attached to the device inside its packaging. The tag’s ID number is linked in the MedEx software to the part’s serial number and description. Once the implant is used for a surgical procedure, the medical staff will remove its InnovaCollar and place it on a tray dedicated to collecting discarded items, such as sharps used during the procedure. After the surgery is complete, the tray is moved to the MedEx reader station, where employees enter an ID number or swipe an ID card in order to identify themselves. They can then input patient information and read the discarded tags, thereby creating a record of which items were used on that particular patient.

A tag can also be permanently affixed to each surgical tool via medical-grade adhesive, and the tag’s ID number is linked to specific data about that tool in the MedEx software. The tray is then brought to the reader station. As a new tray of tools is created for use during a specific type of surgery, each tag is interrogated as the tool is placed into the tray and linked to that tray’s RFID number. Post-surgery, the tools are cleaned and sterilized, and are then placed in a tray once more. The MedEx software stores a record of which tools belong in that tray, and also displays an alert if the wrong tool is placed there, or if a tool is missing, rendering the surgical tray incomplete. Once the tray is loaded with the appropriate tools, it is then closed and locked.

Each tag read is sent to the software via a Bluetooth connection between the reader device and a PC that then forwards that data to the cloud-based server. Users can also plug a UHF RFID reader into their cell phones, Crook says, to read a tag on a tool—for example, to obtain data about that item and where it should be located.

The software can not only track the tray in which a specific tool is stored, or to which patient a particular implant has been administered, but also enable automatic billing to a patient, or the reordering of inventory based on which implants were used.

The MedEx system could be sold with tagged InnovaCollars attached to Innovapaedics implants, Crook says. Alternatively, it could be purchased independently, allowing hospitals to attach the tags to any type of implant or tool.

For end users, the system would reduce the incidence of errors by ensuring that the proper tools are in the correct tray. In this way, Crook explains, staff members will know that when they open a tray during surgery, all required tools will be present. What’s more, it helps to make the inventory process faster.

A solution involving tagged implants is very complex, says William Michalek, Xerafy’s sales manager and health-care practice lead, with numerous regulatory and compliance issues that must be considered. The tag manufacturer is thus partnering with companies like Innovapaedics, he says, “that provide that level of knowledge and expertise.” He adds that “Xerafy is well positioned due to the ceramic construction and size of our tags, which are designed to be embedded and withstand the chemicals, high heat and pressure of the sterilization process.”

According to Michalek, Xerafy is helping to connect Innovapaedics with systems integrators, as well as potential customers who may wish to trial the technology. The full solution, he says, could be sold by Innovapaedics, by Xerafy or by a systems integrator.