Barcoding Is Only the Beginning
The FDA's Unique Device Identification (UDI) system has developed in fits and starts since becoming law back in 2007, but the intervals of inactivity should shorten if not cease altogether on Nov. 7. Yes, that's the day after a certain high-stakes election, but, more to the point for UDI watchers, it's when time runs out for stakeholders who wish to weigh in on the agency's proposed regulation to govern the system.
Jay Crowley, MA, senior advisor for patient safety at FDA's Center for Devices and Radiological Health, tells Clinical Innovation + Technology that the UDI initiative—which, when finalized, will require manufacturers of medical devices to affix standardized barcode tags to nearly every regulated device they produce—may one day lead to such once-unimaginable scenarios as homecare patients opting to self-manage device recalls and safety alerts.
With the consent of the homecare provider as well as the patient, a device vendor "would be able to communicate with patients directly and in an automated way," Crowley says. "They will know everyone who has this particular device and the serial numbers that are affected." Patients also will be able to go to the FDA website, he adds, and "very easily see" whether their device is included in a given recall or alert.
The hardest part of getting UDI off the ground has nothing to do with barcodes and everything to do with information management, says Crowley. For example, the project requires setting standardized definitions and determining which data different users need. Describing a recent meeting to define attributes for cardiac stents in a demonstration project, he says the group "spent all day—and still didn't resolve—what significant attributes you need to know about cardiac stents to do the kinds of things that clinicians and researchers will want to do in the future."
In writing the proposed rule, the FDA sought input from consumer groups—which support UDI largely on the strength of the tracking it facilitates throughout device life cycles.
The sector most directly and immediately impacted by the initiative—the device industry—lives in a state of ongoing tension with the FDA, Crowley says, "but the companies that have implemented this see tremendous value for themselves and their customers." He says the agency has worked to allow for flexibility on timing so that, for example, a manufacturer needn't discard all its stores of labeling materials unsuited to the initiative. "We don't want to cause the device industry to incur unnecessary costs."
Some medical professionals also have expressed apprehension, with hospital technology managers fretting over UDI's coming disruption of in-house labeling systems that have been customized for inventory management. "This is one of the problems we're trying to solve," says Crowley. "We have not only healthcare providers but also distributors, GPOs and others creating their own numbering systems. The confusion plays out from there."
In the end, greater control over healthcare decision-making is "what patients really want," says Crowley. As a healthcare consumer himself, he adds, "I want to know, in a way that I often have not been able to, what really is going on with me, my kids, my parents or for whomever I'm caring."
Jay Crowley, MA, senior advisor for patient safety at FDA's Center for Devices and Radiological Health, tells Clinical Innovation + Technology that the UDI initiative—which, when finalized, will require manufacturers of medical devices to affix standardized barcode tags to nearly every regulated device they produce—may one day lead to such once-unimaginable scenarios as homecare patients opting to self-manage device recalls and safety alerts.
With the consent of the homecare provider as well as the patient, a device vendor "would be able to communicate with patients directly and in an automated way," Crowley says. "They will know everyone who has this particular device and the serial numbers that are affected." Patients also will be able to go to the FDA website, he adds, and "very easily see" whether their device is included in a given recall or alert.
The hardest part of getting UDI off the ground has nothing to do with barcodes and everything to do with information management, says Crowley. For example, the project requires setting standardized definitions and determining which data different users need. Describing a recent meeting to define attributes for cardiac stents in a demonstration project, he says the group "spent all day—and still didn't resolve—what significant attributes you need to know about cardiac stents to do the kinds of things that clinicians and researchers will want to do in the future."
In writing the proposed rule, the FDA sought input from consumer groups—which support UDI largely on the strength of the tracking it facilitates throughout device life cycles.
The sector most directly and immediately impacted by the initiative—the device industry—lives in a state of ongoing tension with the FDA, Crowley says, "but the companies that have implemented this see tremendous value for themselves and their customers." He says the agency has worked to allow for flexibility on timing so that, for example, a manufacturer needn't discard all its stores of labeling materials unsuited to the initiative. "We don't want to cause the device industry to incur unnecessary costs."
Some medical professionals also have expressed apprehension, with hospital technology managers fretting over UDI's coming disruption of in-house labeling systems that have been customized for inventory management. "This is one of the problems we're trying to solve," says Crowley. "We have not only healthcare providers but also distributors, GPOs and others creating their own numbering systems. The confusion plays out from there."
In the end, greater control over healthcare decision-making is "what patients really want," says Crowley. As a healthcare consumer himself, he adds, "I want to know, in a way that I often have not been able to, what really is going on with me, my kids, my parents or for whomever I'm caring."
Dave P. has worked in journalism, marketing and public relations for more than 30 years, frequently concentrating on hospitals, healthcare technology and Catholic communications. He has also specialized in fundraising communications, ghostwriting for CEOs of local, national and global charities, nonprofits and foundations.