Five years after first talking about a unique device identifier that medical device makers would need to put on most medical devices and packaging, the Food and Drug Administration is nearing the end of the comment period for its proposed rule.
The goal of the new identification system is ultimately track and trace so that recall efforts and patient safety can both be boosted.
The proposed guidelines released in July are complex, and is prompting siloed part of companies to begin interacting, said Jackie Elkin, Global Process Owner of Standard Product Identification Initiatives at Medtronic, in an an educational session, hosted by trade group LifeScience Alley Wednesday. The session aimed to explain the ramifications of the proposed rule and some ways to comply with whatver the final regulation is .
“UDI is forcing collaboration among people in the same business unit that had never met each other,”, Elkin said of finance people talking to regulatory people who are now also talking to the supply chain people.
But just talking internally is not going to be enough.
Both Elkin and Gerry Gunderson, a packaging expert and VP of engineering at Quality Tech Services Inc., stressed that making sure suppliers, including original equipment manufacturers, are in compliance with the regulation will be key.
You “shall consult your supply chain partners,” Gunderson said, making it sound almost like a commandment.
Talking with suppliers is not just critical for developing UDIs but also for doing business overseas.
Elkin explained that certain countries are asking medical device manufacturers choose specific standards from particular standards bodies for their coding scheme to identify products. Spain, India (and eventually China) have asked that device manufacturers get product codes generated by GS1, the global supply chain standards organization that provides unique prefixess used to create a Global Trade Item Number.
The topic of device identifiers and FDA’s UDI is so complex and wide ranging that LifeScience Alley handed out a glossary of 22 acronyms to members of the audience who came to hear Gunderson and Elkin.
“There are more questions than answers in the proposed rule” Elkin said.
For instance, what would prompt a change in the unique device identifier? The proposed rule says a change in specification of a product with a UDI would require a new one, but that is vague, Elkin said. A best guess is that a new UDI would be required if the device maker was informing the FDA of some change in the device.
The vagueness of some portions of the rule prompted the second theme of the UDI conversation.
“Go out there and comment,” Gunderson urged the audience. “Say what you like, what is confusing, what is unworkable. This is very difficult work. We are laying the foundation. Once the building goes up, no one will care how the basement was built.”
Congress wants FDA to issue a final regulation by May 2013 after which the rules are phased in depending on the type and class of device. But Elkin said there is no guarantee that FDA will be able to comply with Congress.
[Photo Credit: FreeDigitalPhotos user David Castillo Dominici]