|Unique device identification (UDI) will not only change |
the face of your med device labels, but it will
also affect processes spanning your entire operation.
by Beth Pedersen, Marketing Communications Specialist, MasterControl
Labels are everywhere. Virtually every manufactured item is labeled with product information, and even fresh produce from the grocery store often bears a scannable barcode and ID number. Not only are things labeled, but people, too – any visit to the hospital comes with a bracelet displaying your personal medical details, identification information and a barcode. For the most part, we have become so desensitized to barcodes and labeling information that we rarely pay it any attention; presented in the form of random lines and number series, it can seem completely meaningless to us.
But the information contained on the labels of medical devices is far from meaningless. And although product information labels can come in all shapes, sizes and formats, there are now strict requirements for medical device labels and the information they contain, as mandated by the U.S. Food and Drug Administration’s (FDA) unique device identification (UDI) system. By the year 2020, the FDA will require virtually all medical devices available on the U.S. market to be labeled with a unique device identifier in human- and machine-readable form. According to Linda Chatwin, Esq., RAC of Underwriters Laboratories (UL), medical device companies should start thinking now about the rule and how it will affect their entire businesses.
“One of the mistakes that companies make is that they think, ‘it’s just about putting a label on my product’,” Chatwin said at the recent Masters Conference in Berlin. “But it’s much more than that.”
What is UDI?
According to the results of a study commissioned by the FDA, medical providers in 2005 used up to 10 different tracking mechanisms to monitor medical devices. This made it impossible for the FDA to learn of potentially dangerous product issues – and notify patients – in a timely manner, or to trend what was happening in the device industry. Of the 66,000 adverse events reported in 2007, 60 percent of the products implicated could not be linked to any meaningful identifier, Chatwin explained. In response, Congress directed the FDA to publish a rule mandating uniquely identifiable information linked to all medical devices, similar to the system used in the pharmaceutical industry.
The UDI final rule, published in September 2013, mandates that a unique two-part numeric or alphanumeric code consisting of a device identification (DI) and a production identification (PI) must be labeled on a device or its packaging. DI is mandatory and identifies the labeler and specific details about the model or version of the device itself. PI is conditional and variable, and can include production information about the product. Additional information must also be included on the label, such as product name, expiration date, reference and lot numbers, labeler contact information and other details about the item and manufacturer. The rule applies not only to medical devices, but also to combination products containing both pharma and medical device components, along with standalone life-supporting or life-sustaining medical software.
This article is related to the Whitepaper: Five Trends Transforming the Medical Device Industry in 2015.To get the full details, please download your free copy.
In addition to physically labeling devices and packaging, companies must report detailed information about each device to the FDA’s Global Unique Device Identification Database (GUDID), which is accessible to the public.
The UDI rule aims to make tracing, monitoring and searching adverse events related to medical devices much easier. Once fully implemented, it will also allow for easier recall of devices and help prevent counterfeiting.
Who Needs to Follow the UDI Rule?
Anyone who puts a medical device on the market in the U.S. – whether a manufacturer, importer or distributor – is required to understand and comply with the UDI regulation. Compliance dates vary depending on the class type of the device and any applicable exemptions. By Sept. 24, 2015, all implantable life-supporting or life-sustaining Class II, Class I and unclassified medical devices must bear a UDI on their labeling.
“If you have a Class II product that’s for sale on the U.S. market, you really need to start immediately if you haven’t already started,” Chatwin advised.
Tips for Implementing UDI
UDI implementation is a complicated process, affecting everything from manufacturing processes to quality management systems, particularly in multisite companies. External support is vital to organizations that do not have the necessary resources or expertise needed for UDI project planning and implementation. From her experience with Class III implementations, Chatwin has learned there are pitfalls lurking in any UDI project because of the complexity involved. Avoiding these pitfalls can go a long way in UDI implementation.
Chatwin suggested focusing on the following areas to aid in successful UDI project management:
1. Product Assessment
“It’s really important to identify and prioritize the types of products that the company has and which ones are going to require which types of UDIs,” Chatwin said.
Product attributes must be collected and reported into the GUDID. Developing a project plan can help make gathering this information for each product more efficient.
2. Labeling and Process Assessment
Existing label artwork must be examined to assess whether changes are needed to meet UDI requirements, and valuable “real estate” on product labels must be allotted to include the necessary information.
Device identifiers, product identifiers and packaging levels are also impacted by the UDI rule, and new processes or modifications to existing ones may be needed to accommodate UDI.
There are two different methodologies for reporting information to the GUDID. Organizations must determine which method is most appropriate and establish their own procedure for entering UDI data into the GUDID, along with deciding which of the many optional attributes they will report.
Chatwin urged organizations to prepare early for the approaching implementation dates and to think of UDI compliance as a complete solution affecting not only labeling but also informatics and companywide processes. While the U.S. works to fully implement UDI and Europe begins its own UDI effort, the rest of the world will keep a close eye on what works and what doesn’t. In the meantime, organizations should prepare early for the approaching implementation dates.
For more information about UDI implementation, check out a recording of the entire presentation. You can also learn more by visiting UL’s UDI webpage.