Standard Issue

EPCglobal provides guidance in the growing world of pedigree technologies.



EPCglobal is working on a number of initiatives intended to standardize the use of electronic product codes. These updates have been shown at California Board of Pharmacy Enforcement Committee meetings since early 2007, to display the advancements in e-pedigree standard ratification. A meeting is slated for March, in which additional updates will be provided.
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As information technologies advance, the pharmaceutical and medical packaging industries must abide by rules to maintain interoperability and to comply with new legislation. To monitor this, the group GS1 and its subgroups continually work to create and update standards.

GS1 US recently announced the formation of GS1 Healthcare US, a patient safety and supply chain efficiency initiative undertaken by a group of industry members. The group plans to provide resources for the healthcare industry, including standards implementation guidelines, and standards-based solutions for healthcare needs.

“We’re looking to extend standards that are in the CPG [consumer packaged goods] world and have those, if need be, adapted,” says Rob Thibault, public policy director, GS1 EPCglobal North America, a GS1 subdivision. “Let’s have the healthcare market use standards like CPG does. I think it will make things easier for packagers.”

Participation in the group is open to manufacturers and distributors that serve the U.S. healthcare industry.

EPCglobal possesses the credentials to create such a program. According to Robert Celeste, director of adoption tools and action groups at EPCglobal US, the EPCglobal pedigree messaging standard is the only ratified standard that meets FDA, Florida, Nevada, and California pedigree requirements.

Other recent updates include the use of universal product codes (UPC). Open to UPC information, bar code information can now be used with EPC Information Systems (EPCIS). While it was “technically possible before,” according to Thibault, it is now officially part of the standard.

EPCIS was established to solidify a standard interface for EPC event-related data. It details material location and condition during its progress through the supply chain, to communicate information to manufacturers, shippers, and retailers.

As of this writing, the EPCIS standards are not interoperable with pedigree messaging.

EPCglobal/GS1 still plans to update as yet unfinished standards on pedigree and serialization technologies for RFID and 2-D Data Matrix tags as well. The remaining technologies in need of standardization include HF RFID Class 1, Gen2.

Although many packagers have moved to UHF RFID tags, the effect of radio waves on biologics remains uncertain, and potential damage can be incurred from readers. Additionally, liquids have the capacity to absorb the RFID signal and provide an inaccurate reading.

Currently, electronic signatures are required for all pedigrees. They are supported but not required for item-level serialization, RFID, inference, or manufacturer-initiated pedigree.

Helping to lead the California Board of Pharmacy to a decision on data carriers, EPCglobal keeps an eye on the development of various serialization and pedigree options. At the Board of Pharmacy’s Sub Committee on E-Pedigree meeting in December, the board praised EPCglobal on its efforts to collect this information and dispense it to the public.

According to Celeste, the role of EPCglobal is to consolidate standards around regulations, as he told the CA BoP in December. The BoP is encouraged by EPCglobal's commitment to updating standards, and holds them as the standard bearer for the pharmaceutical and medical packaging world.

Celeste spoke at a follow-up meeting in January and presented an updated chart showing standard advances. The board asked him to present the findings at their next meeting, in March.

Additional information has been shared with the public at symposia and shows across the country. In February, GS1 Healthcare’s vice president of market development, John Terwilliger, spoke in a round table discussion on the future of supply chain tracking at the HIMSS AHRMM Supply Chain Symposium in Orlando, FL. Michel van der Heijden, president GS1 Healthcare, is slated to speak at the 2nd International Patient Safety Congress in Turkey.

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