This week marks the two-year anniversary of the publication of FDA’s final Unique Device Identification rule, and with it comes compliance deadlines for the labels and packages of implantable, life-supporting, and life-sustaining devices. FDA did report recently that because the Global Unique Device Identification Database (GUDID) was temporarily unavailable, it intends “to exercise enforcement discretion to extend the September 24, 2015, GUDID submission compliance date for the implantable, life-supporting and life-sustaining medical devices to October 24, 2015.”
Enforcement discretion aside, this next compliance deadline is a significant one, reports Beth Gibson, senior director of healthcare for GS1 US. “The Class II volume is greater than that for Class III,” she says. “The healthcare industry is very excited about the amount of information that will be available.” She explains that information on as many as 1.5 million Class II products is expected to be added to the GUDID; by comparison, today there is information on 600,000 to 700,000 Class III products loaded and published in the GUDID, she says.
Gibson also reports that the medical device manufacturing industry has learned a lot with the first exercise. Explains Greg Bylo, vice president of healthcare for GS1 US: “Unique Device Identification has really made them go back and review how and why they do things. Companies don’t necessarily have SOPs around UDI and labeling. A lot of what companies do is how Notified Bodies direct them.”
When asked how many MDMs are including in their unique device identifiers such production identifiers as serial numbers and expiration dates in addition to device identifiers, Gibson says that “companies that have always had application identifiers are making every effort to include them in the UDI. They feel they might as well do it all at one time.”
Bylo says that GS1 US receives a lot of questions from MDMs, and he offers the following top-five questions (and answers):
Who needs to apply the UDI? “In most cases, the brand owner, even if the labeler is the manufacturer,” says Bylo.
Why is the date on the label and the date encoded in the GS1 bar code of a different length? The US FDA UDI rule provides that all “dates on medical device labels intended to be brought to the attention of the user” must be presented as a fixed length, eight (8) digit, all numeric field composed of 4 digits for the year (YYYY), two digits for the month (MM), and two digits for the day (DD) or “YYYY-MM-DD,” explains Bylo. For example for the “October 15, 2013” would be represented “2013-10-15.” The dashes (or “hyphens”) between the digits are mandatory as noted in the FDA final rule, he says. However, the FDA has stated specified use of YYYY-MM-DD for “dates on medical device labels intended to be brought to the attention of the user” does not affect the format or use of those dates when represented in AIDC technology,” he says. The GS1 standard requires a 6-digit field yymmdd field. Two digits for year, two digits for month and two digits for day with no hyphens, he explains.
What about unmarked GTINS? “Products below the saleable unit (often called unit of issue or unit of use) have a GTIN (Global Trade Item Number), but it is not the saleable GTIN,” says Bylo. “They do have to have a GTIN applied to them that serves as a UDI.” Adds Gibson: “It is a key disconnect. From the providers’ perspective, it becomes critical. The unit of issue goes into the electronic health record.”
What about accessories? “Many accessories are meant to be used along with a medical device,” explains Bylo. “Consider a catheter for monitoring brain pressure. A 3-ft stand is meant to be used to help guide the laser that identifies where to insert the catheter. The catheter is considered a Class II implantable device, but the stand may be a Class I or Class II device. Collaboration is needed with regulatory teams in order to make a decision on UDI.” Bylo adds that regulatory teams, supply-chain teams, and master data teams should all be involved in UDI decision making.
What about orthopedic implants already in the field? Class II implants that are required to be permanently marked with a UDI have been given until September 24, 2016 to comply, says Bylo. “The field inventory of orthopedic implants must be retrofitted to be compliant,” he says. “Companies are trying to figure out what to do and then go to FDA to request an extension to the 2016 deadline. Each company requesting an extension should be able to justify their extension based on the project plan showing how they’ll comply by that date. Many of these items are nonsterile and unpackaged, and PI information is not readily available. Companies might have to replace the inventory or etch a bar code on them, but then a question is raised because they have been reworked.”
Adds Gibson: Etching a bar code “re-engineers them, essentially, and [the change] must be researched and investigated.”
And these questions aren’t the only ones. Gibson and Bylo expect there will be even more as the rule is implemented. “It’s a journey, not an event,” says Gibson. Adds Bylo: “the industry is learning as the implementation continues and more questions will arise. You don’t know what you don’t know.”
Bylo says it is important for medical device manufacturers to develop a UDI strategy. “But in addition to a strategy for compliance, have a value proposition behind it,” he advises. “Consider how it will benefit the company internally for recalls and for inventory visibility and management.”
He also advises companies to look at “their master data and make sure it is clean and accurate,” and to keep in mind “the government will audit the facility against the data in the GUDID.”
“Make sure you have a good data quality governance program, and look at more than compliance,” Bylo urges.
Gibson says UDI benefits are already being realized. “We’ve heard that the identification of product inventory involved in a recall has gone from as much as four days to hours,” she says. “That benefit can trickle down to distributors and providers.”
In addition, she says that the GTIN is being seen on purchase orders and invoices. Purchasers “know they are ordering the right product and the right unit of measure,” she says. “We have heard of reductions in errors if they are ordering by GTIN.”
Gibson says there is potential for the standards to demonstrate efficiency and benefit along two pathways. “There is the clinical pathway, for patient safety, and the administrative or logistics pathway, for operational or process efficiencies.”
Adds Bylo: “We’ll see overall improvements in the efficiency of healthcare.” And given the passage of the Drug Quality and Security Act, “there’s the potential to save billions of dollars because of supply-chain efficiencies. But we need quality data and data accuracy.” GS1 US has a data quality program on how best to manage and maintain master data, he adds. “Without good data/information, everything will be flawed,” he warns.
Bylo adds that while GS1 US has always been an educator around standards, “we are also looking to provide more use cases on return on investment. We are taking a practical, implementable approach where the value proposition is evident. The challenge is that everyone is competing for resources, project dollars, and people’s time. If they don’t see the ROI from a management perspective, a project doesn’t get worked on.”
Adds Gibson: “Because it is a journey, if you do not have the staff to own standards implementation, it just doesn’t get worked on beyond compliance.”
Gibson came to GS1 US in April 2015 after spending 27 years at medical/surgical distributor Owens & Minor. “I’ve been interfacing with manufacturers for efficiency for years,” she says.
And Bylo came to GS1 US in June 2015 after spending 13 years managing aerospace inventory programs; nearly 16 years managing ERP projects at Becton Dickinson, which involved heading business processes for the supply chain; and then led supply chain management at Integra Life Sciences for 2 1/2 years.
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