UDI Proposal Tacks on Standardized Dating

FDA’s proposed Unique Device Identification specifies more than just unique identifiers. It would also attempt to standardize date formats on medical device packaging and labeling, at least those intended for the U.S. market. The agency states “the rule would also contribute to improved identification of medical devices . . . by requiring dates on medical device labels to conform to a standard format. . . to ensure dates are unambiguous and clearly understood by device users.” FDA proposes that the date format be “Month Day, Year,” with the month shown as a three-letter abbreviation of the month (e.g., SEP 30, 2011). “This is the format most commonly used in the United States,” the agency writes.

The FDA-proposed format differs from ISO 8601-2004: Data elements and interchange formats—Information exchange—Representation of dates and times. This internationally accepted format expresses the year in four digits, the month in two digits, and the day in two digits (e.g., YYYY-MM-DD).

Medical device manufacturers and identification industry experts are questioning FDA’s approach. “It would make sense for FDA to attempt to lead standardization efforts to define a date format if an international standard didn’t already exist, but that is not the case. The ISO standard is already well adopted internationally,” says Peter Tomicki of Zimmer Holdings, Inc. Further, “manufacturers are attempting to drive efficiencies in the supply chain by creating labeling and packaging for multiple markets, leveraging internationally recognized standards such as ISO,” adds Tomicki. “Mutually exclusive requirements either impede this effort or add confusion, if both date formats are required for labeling and packaging. Education for those reading the printed dates or additional clarifications in line with the ISO standard, such as printing “YYYY-MM-DD” under the date, might arguably be effective in the United States and other markets where the ISO date format is less recognized.”

Adds George Wright IV, vice president, Product Identification & Processing Systems, (Port Chester, NY): “Quite simply, an all-numeric format eliminates language translation (and therefore potential multinational labeling) issues. The hyphenated YYYY-MM-DD format, which is explicitly called for in the ISO 8601 standard when the date is represented in plain text—and must be used when there is no day of the month given— should be readily recognized by caregivers and patients alike. It is the most universal and unambiguous. And it has the lowest implementation cost.”

Wright adds that “it is important to understand that the plain text date format does not have to be the same as either the date format encoded in an associated UDI bar code, for example, or the date format specified for the GUDID database. Of course they have to be equivalent; but not identical. Not everyone understands this distinction.”

FDA is considering international harmonization, but it only questions whether a different order—Day Month Year—would be more appropriate. The agency poses several date format related questions that stakeholders should address. Comments will be accepted through November 7.

Please visit www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdent....


No votes yet