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 Draft Rules For Medical Device Labeling Are Coming Soon
FDA is looking to allow alternatives in technology and data formatting for unique device identification (UDI), as it develops proposed regulations for labeling medical devices.
Rules for UDIs will most likely provide leeway on marking options, while defining a minimum data set for device
tagging, says Jay Crowley, senior advisor for patient safety, FDA’s Center for Devices and Radiological Health (CDRH). Crowley says CDRH is looking to publish draft rules on a
system within a year.
“We are in the process of developing draft regulations. We will get [them] out as quickly as we can. We are hoping to see a final rule published in 24 to 36 months,” Crowley says.
The FDA Amendments Act of 2007 directs the agency to establish a labeling system for identifying medical devices throughout the supply chain. The law does not state a deadline, however, the regulation is a high agency priority, says Crowley.
“Congress provided the agency with quite a bit of latitude for defining what a UDI system will look like. We want to establish a system that provides patient safety health benefits, but isn’t too burdensome for the manufacturers and the back-end users,” he says.
For instance, a UDI database, or Product Data Utility (PDU), will contain the minimum data sets for devices and synchronize data between trading partners. Crowley hopes a working database will be available in advance of the final regulation.
“A skeleton of a database will probably be up and running by the end of the calendar year, with a production version in place six months thereafter. Manufacturers will be able to populate it ahead of the regulations, if they choose. We will try to provide as many routes as we can for manufacturers to submit data by facilitating data transfer. Small manufacturers with a few products could submit data through a Web interface.
“I want the hospitals and distributors to see what it looks like so they can start to plan for their own implementations, and we can begin to see benefits,” he adds.
FDA in 2006 sought industry feedback on several issues. They included whether the agency should specify technology, and whether UDIs should be considered for all devices. What is the minimum data set, and should it differ between devices? the agency asked.
“When we were considering the bar code rule six years ago, the push back we received from the healthcare community said that they wanted the agency to specify the technology,” he recounts. (FDA requires encoding the NDC number in a linear bar code on the lowest unit of use for drugs supplied to hospitals).
“We want to be much less prescriptive for medical devices, while providing a framework so hospitals and distributors will have an idea of what to expect. Manufacturers should have options to use what they think is best for their device types and for the people using the data on the back end.”
Crowley says there will be some trade-offs. “How specific should we be on the data content? What do we say, if anything, about the technology? From an implementation standpoint, we are trying to work out how requirements would be imposed based on risk. There are many Class I consumable products, such as syringes and other sterile devices, where marking could provide a healthcare benefit.”
Crowley says CDRH favors a system comprised of a device ID and a production ID, provided in human readable and auto ID format. The production ID includes expiry date and lot or serial number. The minimum data set could include Global Medical Device Nomenclature (replacing the product code) that provides a generic level descriptor for classifying similar products.
Manufacturers will likely be able to choose between GS1’s GTIN and HIBCC’s HIBC data formats, which many device manufacturers currently use. Device makers would assign the item reference number (GSI) or product identifier (HIBCC) for creating the device ID. The ID incorporates labeler codes obtained from GS1 or HIBCC.
NDC and NHRIC numbers are not favored. “The NDC is a U.S.-only system. As part of its program for improving the NDC system, FDA is phasing out the NHRIC.
“We are working toward an internationally harmonized system with numbers maintained outside of the U.S. regulatory scope. If manufacturers follow the GTIN or HIBCC rules, the theory is that the numbers will always be unique,” Crowley says.
Certain devices that are supplied like drug products and ordered and dispensed by pharmacies will continue with NDC codes for the near future to support product movement in that channel, he adds.
Crowley says identifying instances of devices might be required in some cases, but “we are not going down the path of serialization. We wouldn’t require devices controlled by lot to be serialized. An exception might be serializing reusable surgical instruments, which are typically identified by lot now. We are discussing orthopedic implants, which are not currently serialized or directly marked, though some of the smaller devices don’t lend themselves well to direct marking.”
With UDI now on a defined track for implementation, the benefits of a standard labeling system are within reach for medical device manufacturers, distributors, and hospitals. Crowley notes that some companies have standard labelingsystems already in place. Medtronic, for example, marks all products with GS1 formats. “But very few people on the backend are using these data once [products] leave the shipping dock.”
A UDI system with PDU will support trading partner collaboration. Safety can be better ensured through precise product recalls and tracking of adverse events. Caregivers will have access to information on safe device usage. FDA’s primary focus is public safety. However, a standard labeling system also promises major efficiencies and cost savings from enhanced management of medical devices.
David Vaczek
Senior Editor
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