Those with long-enough memories to recall how metrication in device packaging and labeling roiled the regulatory waters for years may get a sense of déjà vu now that CDRH is adding a requirement for a standardized date format to its Unique Device Identifier (UDI) proposed rule.
Industry comments on the date format requirement have been pushing back, CDRH senior advisor for patient safety Jay Crowley told a Loftware-hosted Webcast in October. The bone of contention is that CDRH’s determination to require the U.S. date format which puts the month first (MM/DD/YYYY) when the rest of the world tends to put the day first.
Just as it did four decades ago with metrication, the issue pivots on the size and power of the domestic market, and the government’s tendency to opt for whatever is more comfortable for U.S. consumers, even if that adds cost and inconvenience to foreign suppliers.
In the case of metrication, U.S. consumers vigorously resisted the federal government’s duly enacted decision to “go metric” on a date certain, the law lapsed, and the country is still using miles, feet, gallons, pounds, and ounces while the healthcare professions with the collaboration of the domestic drug and device industries have of their volition and on a non-legislated timetable largely gone metric.
The same result could follow the standardized date format for UDI, although that wasn’t made clear during the Webcast.
Crowley said the standardized date format must be met one year after the agency publishes the final rule, which is expected in May, and he encouraged industry to comment on “an appropriate date format that can be used globally,” adding vaguely that “I’m sure we can come to resolution on this issue.”
It seems feasible that the barcode readers could be trained to instantly convert non-standardized date formats into standardized ones and the other way round as well, depending on country of end-use. And old-fashioned hard-copy labeling could bear both formats.
The UDI rule is one of the key components in the CDRH’s postmarket surveillance system. It will be tailored to interact with electronic health records, clinical information systems, and claims data sources, according to the agency.
UDIs will allow FDA, the healthcare community and industry to more accurately report and analyze device-related adverse events by ensuring that critical device information is included in the reports. The identifiers may also help reduce medical errors by enabling healthcare professionals and others to rapidly identify a device, obtain important information concerning the device’s characteristics (whether it, for instance, contains latex or is compatible with magnetic resonance imaging) and improve the clinicians ability to trace the device through the supply chain to the point of patient use.
Crowley said the recently enacted FDA Safety and Innovation Act (FDASIA) requires that UDI be implemented for Class 1 and 2 implant and life-sustaining/supporting devices within two years after the final rule. The rest of the Class 2 devices would be required to comply with UDI three years after the final rule, and the rest of Class 1 would be required within five years, he added.
Asked when CDRH will begin considering UDI exception requests, Crowley told his Web audience this would not be until the final rule is published. “We are working on a SOP,’ he said, “and so we will publish a guidance on this when we publish the final rule.
In response to a question on whether CDRH plans to specify a barcode standard, Crowley said the current plan is not to issue such a standard, “but we are interested in what the comments say about this. We would like to stay out of the technology debate. There are a number of technologies that could be used and these are evolving at a rapid rate... We do need to do this intelligently and in a way that is predictable... We would like to allow multiple technologies that are reasonable and to allow the technology to evolve without getting in the way. At the same time, we are very concerned that the UDIs are readable by those who need to capture that information.”