Aug 14, 2009The Health Industry Business Communications Council (HIBCC), a nonprofit health-care industry organization formed in 1983, was established to develop health-care-specific standards for using bar codes and other forms of auto-identification technology in the health-care industry. The agency has received approval from the American National Standards Institute (ANSI) for a standard pertaining to the use of RFID labels to track products as they move through the health-care supply chain, or are put to use by health-care providers.
The group has issued a number of other standards in the past, under the Health Industry Bar Code (HIBC) moniker. The intended users of these standards are HIBCC member companies that manufacture, sell and consume medical products—everything from catheters to implantable devices and surgical tools. Such members include medical equipment and consumables manufacturers Johnson & Johnson Medical Supply and Stryker. Hospitals that are HIBCC members include Riverside Community Hospital, in Riverside, Calif., and the Greenville Hospital System, in Greenville, S.C.
While this new standard, known as ANSI/HIBC 4.0, provides guidelines for employing passive RFID tags, it uses the same data formatting as the HIBC. The HIBC is an alphanumeric identification system that not only incorporates product identification, but can also include other data specific to health-care applications, such as information regarding an implantable medical device, or the patient in which that device is implanted.
ANSI/HIBC 4.0 specifies the use of existing ISO standards for tag-data management. For the air-interface protocol, it specifies the use of a number of ISO standards: 18000-2 (operating at 130 kHz), 18000-3 (13.56 MHz), 18000-4 (2.4 GHz) and 18000-6c (870-930 MHz). However, it also specifies the applications for which tags operating at these various frequencies are to be used. For identifying individual consumable products within medical settings, such as within a hospital or operating room, it calls for utilizing either low-frequency (LF) tags (130 kHz or lower, compliant with the ISO 18000-2 standard) or high-frequency (HF) tags (13.56 MHz, compliant with the ISO 18000-3 standard). Ultrahigh-frequency (UHF) tags (870-930 MHz, compliant with the ISO 18000-6 standard) are only to be used on loading docks or warehouses, and for reading tags attached to pallets or cases of products.
HIBCC's reasons for keeping passive UHF RFID systems out of areas within health-care centers where patients reside are multifold, explain Kirk Kikirekov and Robert Hankin, presidents of HIBCC Australia and HIBCC North America, respectively. The possibility that passive UHF systems could create electromagnetic interference with other, vital equipment in health-care settings, they explain, was a main concern.
Hankin acknowledges that another study, conducted after JAMA published the University of Amsterdam's research, showed that UHF systems created no EMI when used with antenna positions and power settings that would be seen in a typical hospital setting—which contrasts with the University of Amsterdam study, in which power settings and configurations were tested that one would not likely see used in hospitals (see New RFID Study Finds No Interference With Medical Devices). However, he says, HIBCC deferred to the former study because it has more credibility, having been published in a medical journal, and because the secondary research was conducted with the help of an RFID service provider that has a stake in the RFID industry.
But Dan Mullen, president of AIM, an industry association for automated identification and mobility technologies, says that in forming its RFID standard, HIBCC should have conducted independent research, rather than relying on the University of Amsterdam study. "That, in particular, was disappointing," he says, "because we are trying to make standardized, repeatable test protocols for using RFID in health care." In late 2008, AIM Global announced plans to develop a set of test protocols that it hopes will be employed worldwide to study RFID's effects on medical devices, clinical instruments, pharmaceuticals, blood products and other biologics (see AIM Global to Develop Protocols for Testing Effects of RFID Emissions in Health Care).
To achieve this goal, AIM's RFID Expert Group is collaborating with the Georgia Tech Research Institute (GTRI) and MET Laboratories, and hopes to establish its initial protocols by the end of this year, according to Bert Moore, AIM's director of communication and media relations (see Team to Develop Standards for Testing RFID in Health Care).
According to Hankin, HIBCC has a mandate to ensure that its members employ various technologies safely, but the RFID usage standard is completely voluntary. "If a hospital wants to deploy a [UHF] passive RFID system and they don't have any problems, then God bless them," he says. "But if they have problems down the road, they can reference our standards. We are not against the use of auto-ID technologies, and I don't want to leave the impression that we're against RFID—we're all for it—but we want it to be used safely."
A number of hardware providers now offer UHF RFID systems featuring short read ranges, designed specifically for reading item-level tags within large populations of tagged items (see A Shift to UHF Near-Field Predicted for Pharma and Metro Group's Galeria Kaufhof Launches UHF Item-Level Pilot). Impinj introduced its UHF near-field technology in early 2006, before HIBCC unveiled its RFID tagging guidelines, which formed the basis of the ANSI/HIBC 4.0 standard, yet Kikirekov says the technology was not proven when HIBCC wrote its RFID guidelines. Using only proven technologies, he maintains, is key to its standards process.
"For example," Kikirekov says, "with our bar-code standard, we held off incorporating 2-D technologies for many years. Recently, however, we have incorporated 2-D technologies in our bar-code standard." The technological maturity of passive HF systems, compared with passive UHF system, was another reason HIBCC specifies the technology. What's more, he adds, a number of HIBCC members, including orthopedics implant makers Zimmer and Stryker, are already utilizing passive HF tags and interrogators for identifying and tracking medical consumables and devices in the medical supply chain.
Nonetheless, excluding the use of UHF systems (with the exception of pallet and case tracking in warehouse settings) is not the best path for the health-care industry, according to Bob Celeste, the director of GS1 Healthcare US, a group created to promote the adoption and implementation of GS1 standards, including EPCglobal's RFID standards, by health-care organizations.
"We believe the recent publication of the ANSI/HIBC 'RFID HIBC for Product Identification' standard...may cause confusion in the industry and restrict appropriate use of RFID technology that could benefit U.S. hospitals and patients," Celeste says. "We believe multiple frequencies, such as UHF, HF, LF, Wi-Fi and others, can be deployed safely in clinical settings, in order to best match the unique properties of each frequency with specific applications."
HF tags and interrogators that comply with the ISO 15693 standard (another subset of the ISO 18000-3 standard) are already widely used in health-care applications as well (see Healthy RFID Rivalry for Hospitals and Tennessee Hospital Tracks High-Value Items).
ANSI/HIBC 4.0 does not make any recommendations regarding the use of RFID for tracking assets, such as wheelchairs or pumps. Active (battery-powered) RFID systems are already widely used for tracking the locations of high-value assets in hospitals and other health-care settings. "Active tags used for real-time location systems would be addressed by other standards," Kikirekov states. "Plus, with those devices, you likely already have a lot of [RF] shielding to prevent EMI."
EPCglobal, which is working to standardize RFID systems for use in supply chains and other applications, is close to ratifying an HF standard. But HIBCC was not interested in adopting this standard for its own members, Kikirekov says, because it wanted to use existing ISO standards, and because the HIBCC data system is based on alphanumeric numbers used in a specific format. Some products in the medical supply chain—such as pacemakers or other implantable devices that are composed of discreet parts from various suppliers and need to be tracked closely—are issued serialized identifiers under the HIBC system. But other products, such as catheters, which are manufactured in huge quantities by single suppliers, are monitored using non-serialized product IDs (wherein the specific lot number is encoded for traceability). What's more, Kikirekov says, to use EPCglobal-related services and the EPC numbering system, HIBCC members would have to subscribe to EPCglobal.
According to Kikirekov, HIBCC, as an ANSI-accredited organization, is tasked with following the ANSI standard-setting process when developing auto-ID standards for health-care applications. ANSI also routinely audits HIBCC, he adds, to ensure that the organization follows due process. The HIBCC Auto ID Technical Committee (AITC), which comprises representatives from manufacturers and hospital provider organizations, developed the RFID standard. However, he notes, ANSI rules stipulate that all members of the AITC must vote on key decisions relating to standards under development. Before ANSI approved the ANSI/HIBC 4.0 standard, it was made available for public comment for six weeks and received a unanimous vote by the technical committee.
