Nutrace, a health-care efficiency solutions company owned by Belgian firm Besco, has opened an office in Winston-Salem, N.C., to access the U.S. market for its hybrid RFID and bar-code solutions to track surgical tools through the cleaning, sterilization and kit-packing processes. The system is designed to help hospitals efficiently monitor which processes each tray of tools undergoes before reaching an OR and a patient.
Several of Besco’s customers in Europe have been employing the hybrid system for at least the past three years, in order to identify trays and create a digital record of when those trays were loaded with surgical instruments, as well as the patient on which they were used and when they were cleaned and sterilized. The system consists of Belintra passive high-frequency (HF) 13.56 MHZ RFID tags attached to trays, Panmobil handheld RFID readers to interrogate those tag IDs, and Nutrace’s Stemato software to manage the collected data. Users can also purchase instrument trays that come with integrated Steri-ID tags.
Radio frequency identification is only one component of the solution. Nutrace also provides a service whereby it laser-engraves data-matrix bar codes onto the surgical tools. The bar-coded ID numbers are linked, in the Stemato software, to the unique identifier encoded to the tray’s RFID tag. In that way, a hospital can track not only which processes a particular tray has been through, but also which items are packed on it, as well as their own cleaning and sterilization status.
Traditionally, hospitals have tracked trays and tools manually to ensure that both the tools and the trays are properly cleaned and sterilized, and that the correct tools are packed on the trays destined for a particular surgical procedure. Tighter safety regulations in Europe and United States have led hospitals to seek more automated solutions, according to Gus Vargas, Nutrace’s CEO. Besco, founded in 2002, has long offered a bar-code-only solution that helps make the process more efficient. However, Vargas says, bar codes pose some shortcomings when it comes to tracking trays. Printed bar-code labels are not indestructible—and, in fact, must be replaced every few months due to the washing and sterilization processes.
While Nutrace offers engraved data-matrix bar codes on the tools, ensuring that the bar codes aren’t damaged over time, that process won’t work on trays, which are considerably larger than surgical tools. What’s more, an individual might need to go hunting for the laser-engraved bar-code number in order to scan it, which wastes time and efficiency. Workers would have a harder time spotting a laser-engraved bar code on a tray than they would a printed bar-code label like the ones Nutrace had been using. Trays are stacked in washers, on travel carts and on shelves in a variety of orientations, making it even more difficult for personnel to locate the etched bar code.
For those reasons, Nutrace is now offering an RFID version of its solution, with tags attached to trays. The company never considered using RFID tags on tools, Vargas says, because it felt that such a tag, which is typically very small, could fall off the tool to which it is attached and into a patient’s incision. While there haven’t been reports of this actually happening, the firm believes that the glue used for attaching tags is vulnerable to damage during the cleaning and sterilization processes, and so it didn’t want to expose hospitals and patients to that risk.
The Nutrace solution consists of Belintra’s Steri-ID loop tags (either attached to a hospital’s own trays and cases, or integrated into the Belintra trays), in addition to a Panmobil SmartSCANNDY reader that can scan bar codes and interrogate HF RFID tags, the tags themselves and the trays to which those tags are attached. Nutrace’s software resides on a user’s database and tracks each step of the cleaning and packing processes.
Nutrace first laser-etches a data-matrix ID number to each tool, and then links that number with the tool’s description. A Steri-ID loop tag, compliant with the ISO 15693 standard, consists of a round, 1.1-inch RFID inlay encased in silicone and integrated with a stretchable loop, also made of silicone, which is used to attach the tag to a tray or case. The Steri-ID tags integrated on trays measure 1.85 inches square. Each tag is encoded with a unique ID number.
At the hospital, a worker uses the Stemato software to link a tray’s ID with the type of procedure for which it is intended, such as a hip replacement. That classification comes with a list of appropriate tools for that operation.
When a tray of used tools returns from the OR, a staff member utilizes the handheld to read its RFID tag, indicating that the tray has arrived in the decontamination area. The tools are then separated from the tray and undergo separate wash processes. A worker interrogates the tray’s tag via the handheld reader as it enters the washing unit, and again as it comes out of the wash cycle. The tag is read a fourth time as the tray is being packed, at which time a worker pulls up details regarding the tray by reading the HF tag, views a list of what should be stored on it and scans each instrument’s bar-coded ID as it is repacked on the tray. The software captures each scanning event and determines whether the right tools are being packed; if any are missing, it displays an alert for the individual using the software for packing.
Once this step is completed, the tray is covered with sterilization wrap. A bar-coded label is then attached to the exterior, which is scanned in order to link the label’s bar-code ID number with the tray’s RFID number.
When the packed tray is used in surgery, its bar-coded label is scanned one more time before the tray is opened and used by surgeons. The purpose of the final scan is to link the tray and its instruments with the particular surgeon and patient involved. Vargas says the company is now testing whether the tray’s RFID tag could be reliably read through the wrapper. However, the wrapper’s bar-code label would remain on the item since the label is printed with other human-readable information, such as the date of sterilization and the name of the technician who packed it.
Nutrace’s software not only displays an alert in the event that a mistake is being made, but also stores historical data and provides such analytics as how efficiently tools and trays were cleaned and sterilized, the number of trays available at any given time and whether the quantity of available trays meets surgery schedules—for example, five knee replacement surgeries being scheduled when only three trays are available that day.
The company is now also selling a scale provided by Sartorius as part of its solution, so as to meet demands from regulators about the weights of tools and trays as they enter a sterilization device. To protect the chamber inside the devices, as well as the health of workers who must lift the items being placed within, a maximum weight load (such as 25 pounds) is specified for a single sterilization cycle. Users can weigh the tools and trays when they are first acquired, and that measurement is stored along with the the history of the item or tray so that when a tool’s bar code is scanned or a tray’s RFID tag is read, the software adds up the weights of all items and records the sum. The weight information could be used not only to confirm that weight limits were not exceeded during sterilization, but also to track when a specific tray might be missing an item if its weight is not as high as it should be for the tools it is supposed to be carrying.
“It’s a really powerful solution,” Vargas says. “We built a history of every instrument and tray.,” This enables a hospital to monitor how often a tool or tray has been used, as well as link that tray to a particular patient in the event of an infection. For instance, if a patient suffers from Creutzfeldt-Jakob disease (a rare and fatal brain ailment that could be transmitted to another individual by exposure to infected brain tissue or spinal fluid), that condition could be stored in the software, and any instruments used on that patient would thus be flagged in the system to ensure that they are reprocessed according to appropriate infection-control regulations.
To date, Nutrace has had no customers for the RFID version of its solution in the United States. However, Vargas reports, the company is currently in conversations with multiple American hospitals about the technology.
Belintra, which is also based in Europe, opened an office in South Carolina in 2014, and is marketing its tags in the United States as well. The firm offers the Steri-ID loop tag (the model used in the Nutrace solution), which is attached to trays, or the Steri-ID instrument basket, consisting of a surgical tool tray (basket) in a variety of sizes with an integrated RFID tag. Belintra does not make RFID readers.
Belintra’s European customers include GZA Antwerpen and the University Hospital of Leuven. Both Belgian hospitals are tracking surgical instruments via the Belintra RFID tags and Nutrace Stemato software.