There are lots of medical devices out there. But what measures are necessary to identify and track them? How are regulators, medical professionals, and patients to know that devices are safe? To address these issues, FDA last year published its final rule on unique device identification (UDI), the purpose of which is to substantially reduce existing obstacles to the adequate identification of medical devices used in the United States. “By making it possible to rapidly and definitively identify a device and key attributes that affect its safe and effective use, the rule will reduce medical errors that result from misidentification of a device or confusion concerning its appropriate use,” according to the agency. “The identification system established under this rule will lead to more accurate reporting of adverse events by making it easier to identify the device prior to submitting a report.”
However, while the rule promises to increase patient safety and standardization, it places a considerable regulatory burden, not to mention a high price tag, on medical device manufacturers, remarks Gary Saner, senior manager of information solutions—life sciences at Reed Tech. “Thus, six months after new federal labeling requirements for medical devices were issued, many device manufacturers still have not begun preparing to meet the regulation’s looming deadlines.”
|Figure 1: UDI data must be displayed on most medical device labels in both plain text and in a machine-readable format such as a bar code. (All Figures courtesy of Reed Tech)|
The implementation of the rule, according to Saner, will require that most medical devices distributed in the United States be labeled with specific information, as illustrated in Figure 1. Most device labeling and packaging, and many devices themselves, will be required to display this UDI information in both plain text and in a machine-readable format such as a bar code.
FDA is also creating a repository of information on medical devices known as the Global Unique Device Identification Database (GUDID). Medical device manufacturers will be required to submit substantial amounts of information on each of their device products to FDA so that it can be entered into the database. This database, in turn, will be available to the public.
In addition to enabling the public to identify medical devices more rapidly and precisely while allowing regulatory officials to better monitor adverse events reports, the new labels and informational database should render adverse events reporting more efficient and thorough. “This is a landmark step for FDA,” states Jeffrey Shuren, the director of FDA’s Center for Devices and Radiological Health. “UDI may be an acronym for Unique Device Identification, but what it really stands for is better patient health.”
UDI: What to Expect Next
|Figure 2: Timeline for medical device companies to comply with the new UDI regulations.|
“FDA’s final rule on UDI did not come as a surprise to most medical device makers,” Saner says. “The effort had been underway for years, and the government solicited input from industry representatives during the process of formulating the rule. Nevertheless, many companies are now grappling with the reality of having to comply with the UDI regulations.” A timeline for compliance is presented in Figure 2.
From September 24, 2013—the issue date of the final UDI rule—manufacturers will have from one to five years to comply with both the UDI label and GUDID submission regulations, depending on the complexity of the device. For example, manufacturers of Class III medical devices must comply within one year, or no later than September 24, 2014. On the other hand, manufacturers of implantable, life-supporting, or life-sustaining devices—such as implantable pacemakers or automated external defibrillators—must comply within two years, or by September 24, 2015. Finally, manufacturers of lower-risk devices will have more time to comply.
|Figure 3: For inclusion in the GUDID database, companies will have to gather 55 points of data for every individual product and product version.|
“Compliance with the new regulations will be no easy task,” Saner comments. “GUDID submissions alone will present substantial investments of time and resources that will grow in relation to a company’s product portfolio.” For example, as detailed in Figure 3, companies will have to gather 55 points of data for every individual product and product version. This information will be included in the GUDID database.
Great uncertainty still surrounds the implementation of the UDI system, according to Saner, and many device manufacturers are just beginning the planning process for UDI compliance. Meanwhile, many companies are unsure about what types of data they will have to submit, while many do not know how long it will take to gather this information. Moreover, companies have not yet decided which of the four methods they will use to submit the required data: the FDA’s online interface, a hosted software solution, an interface offered by an outsourced service provider, or an internally administered software system.
According to a February survey conducted by Reed Tech, which offers a UDI/GUDID solution to device manufacturers, only about one in three respondents had begun UDI compliance planning, and many didn’t know how to begin. At the same time, nearly nine out of 10 respondents were unsure when they would begin submitting the required data to GUDID or what submission method they would use. Only 1% of the 407 respondents had completed the planning phase.
To begin the process, medical device companies must obtain a unique device identifier from one of three FDA-accredited agencies, according to Saner: GS1, a global, not-for-profit company that developed the first universal product code, or UPC, in 1973; Health Industry Business Communications Council, an internationally accredited nonprofit standards development organization; or International Council for Commonality in Blood Bank Automation, a nonprofit company that manages the ISBT 128 international information standard for the identification of medical products of human origin.
Then, companies should review FDA’s final UDI rule, identifying the requirements and the deadlines to be met, after which they should begin identifying and gathering the data required for product labels and submissions to the GUDID. In addition, companies should evaluate which method they prefer for submitting information to FDA’s database, including FDA’s online interface, a hosted software solution, a vendor-provided interface, or an internally administered software system. A company’s preference will depend on the cost, labor, and expertise involved. Finally, companies should evaluate the different UDI/GUDID vendors to determine which ones will help them achieve full FDA compliance in the most cost-effective manner possible.
Bob Michaels is senior technical editor at UBM Canon.