RFID Standards Come to Life
EPCglobal’s Health and Life Sciences Industry Action Group has finished a draft standard for e-pedigrees.
The Health and Life Sciences (HLS) Industry Action Group (IAG; previously referred to as a Business Action Group) of EPCglobal has just completed its draft standards for radio-frequency identification (RFID) use for drug pedigrees. Robert Celeste, director, healthcare, for EPCglobal (Lawrenceville, NJ; www.epcglobalus.org), gave a standards update to attendees at October’s EPCglobal U.S. Conference 2006 in Los Angeles.
EPCglobal formed the HLS BAG two years ago to develop voluntary standards to meet pending drug pedigree requirements. “There was a pressing need for manufacturers, retailers, wholesalers, and even hospitals to respond to pedigree laws developing in Florida and California,” Celeste explained to PMP News before his presentation. EPCglobal invited representatives from these types of organizations to join the HLS BAG. Celeste noted that some of these these pending laws weren’t requiring electronic pedigrees, but rather approaches that led to serialization, with a means of tracking product history.
“RFID was one of many mechanisms,” he said. “RFID gets you close. With some regulations requiring authentication prior to receiving, the industry is taking a close look at RFID to determine the contents of cases without opening them (and breaking security mechanisms on the case).”
A pedigree prototype test was devised to identify the most challenging use cases for testing pedigrees in the supply chain.” The group came up with seven cases, and six companies put each of them to the test.
Celeste says that there were no “normative changes to the e-pedigree draft standards based on the 42 tests.
Next up is a series of standards reviews, Celeste explained, which include ensuring that no intellectual property restricts standards use. The draft standards will then be passed to the EPCglobal board of governors for ratification.
Celeste hopes that all 50 states as well as FDA rally around EPCglobal’s e-pedigree and track and trace standards. “Fifty states and FDA could mean 51 different directions and inhibit the flow of medications throughout the United States.”
Even though the pharmaceutical industry is in the early stages of RFID use, says Celeste, “RFID technology, once readable, is stable. It does not deteriorate.”
In fact, the U.S. Department of Defense is putting RFID through some extreme environments, he says. And RFID is being studied at low frequencies for applications involving sterilization.
RFID may even be technologically better than bar codes in several cases. “In some low-temperature environments for handling blood and tissue, for instance, printed inks for bar codes don’t hold up, but RFID does, at any frequency,” he says. “The cost of obtaining tissue is quite high—a certain amount of tissue is unusable because the markings are no longer readable.”
For instance, Celeste says that he has seen more antenna form factors developed in the past year than ever before. These include small form factors for vial antennas. Also, European vendors are working on placing RFID on foil packages. And RFID tags are being microwelded to devices like scissors—in one embedded-RFID use, devices went through several cleaning cycles and still had a 100% read. RFID can be an alternative to marking, which can suffer from wear and sterilization processes.
Another EPCglobal working group, Sensors and Batteries, which covers many industries, is developing standards for tracking goods and recording their environments. “Yes, it is the right product. But has it been kept at the correct temperature?” Celeste muses.
In 2007, Celeste hopes that EPCglobal will be able to bring the medical device manufacturing industry together with hospitals and other trading partners to discuss the electronic product code for that market.
The EPCglobal e-pedigree standard will use the GS1 numbering standard, the Global Trade Item Number (GTIN). Celeste hopes the e-pedigree standards will be final in early 2007.