The deadline is coming: On September 24, a UDI compliance deadline will affect Class II devices. If your company is still unsure on how to proceed with UDIs, here are 3 ways you can get yourself ready and avoid non-compliance with the FDA.
September 24 has become a date that inspires anxiety among medical device manufacturers.
September 24, 2014 was the UDI (unique device identifier) compliance deadline for Class III devices and September 24, 2015 was the deadline for Class II life sustaining and life supporting devices.
This year, the deadline affects Class II devices and Direct Marking for Class III devices. We’ve touched on UDIs in a previous post. In this post, we turn to one of the FDA-accredited issuing agency, GS1, to help you formulate an action plan to become compliant with the regulations.
What is an FDA-Accredited Issuing Agency?
In September of 2013, the FDA released a final rule that stipulated most medical devices should carry a UDI. It established three FDA-accredited issuing agencies to establish standards for complying with the regulations. The agencies can help manufacturers comply with the requirements, from establishing a UDI tracking code to registering it with the FDA Global Unique Device Identifier (GUDID) Database.
- If you’re using existing codes from one of the agencies
- If your customers prefer you use one of the agencies
- If your products are sold internationally, and you need an agency with a global reach
- How many UDIs you need, which will influence cost
More insight on the agencies is detailed in this post. For this article, we reached out to GS1 for their perspective.
Why Do We Need UDIs in the First Place?
According to Beth Gibson, Senior Director of Industry Engagement, Healthcare, of GS1 US (the US-based branch of the global organization), over 650,000 devices have been uploaded into the GUDID, a number that is going to swell dramatically. “The next two compliance dates are expected to push millions of products into the database,” she said.
Listen to this expert interview with Beth for more insight.
UDIs for the medical industry function in much the same way as a VIN number does for the auto industry.
If there is a global recall for a seatbelt, every car manufacturer has registered a VIN number, and that number can be tracked as it exchanges hands with various owners. In the event of a significant recall, car companies can find the current owner, and ensure consumer safety.
The same applies to medical devices with UDIs. If your grandmother, for example, has a hip implant and there is a defect, there’s currently no way to track everyone who received that specific hip mechanism.
That will change with the new regulations, and UDI implementation will allow for similar customer safeguards employed in the food and auto industry.
Why Do You Need to Work Through an FDA-Accredited Issuing Agency?
Issuing agencies administer the standards companies use to meet the requirements of UDIs. Essentially, the FDA is concerned with the production information, so you can quickly access who currently owns the product. They’ve chosen the accredited issuing agency to provide the standards, framework, and perhaps most importantly, the support to adhere to the guidelines of the standard.
GS1, for example, has a set process for licensing company prefixes, which uniquely identify your company in the supply chain. Once a company licenses a company prefix, they have the ability to create their own GTINs (Global Trade Item Number), which uniquely identifies your product in the supply chain.
To illustrate the importance of standards, Gibson referred to the software used in the healthcare industry. By using a standard set of UDIs, the software developers don’t have to work around 15 different models of device identification, for example. They just need to be able to accommodate to the three models.
The Big Concern: Companies Aren’t Taking Action
The biggest concern for Gibson? The level of unawareness and inaction in the industry. “Too many companies have waited for the last minute to take action toward compliance,” she said.
The reason many companies may be sitting on the sidelines and delaying the inevitable is because they might view the new regulations as something an organization can address quickly, and then return to business as normal. That’s not the case, Gibson says.
“This is a continued new process for your organization,” she said. It’s going to involve an all-encompassing implementation plan, one that should be headed by a designated project owner who will work with regulatory, engineering, operations – all aspects of the company.
“They need to own it, and educate the respective areas of the organization as it moves forward,” Gibson said.
UDI Implementation Costs: What You Can Expect to Pay
The FDA describes the overall the costs in the following way:
One-time costs: The largest components of one-time costs include:
- Planning and administration and the costs to integrate the UDI into existing information systems
- Installing, testing, and validate barcode printing software
- Training employees
- Redesigning labels of devices to incorporate the barcode and date format
- Purchasing and installing equipment needed to print and verify the UDI on labels
- Recordkeeping and reporting requirements
- Direct marking of certain devices
Annual costs: The largest annual cost components include:
- Labor, operating, and maintenance associated with equipment for printing operations
- Labor related to software maintenance and training needed to maintain the UDI information system
Taking Action: 3 Different Paths to Get You Moving
We’ve created three ways you could approach UDI implementation. Naturally, most people will choose a hybrid option of some sort, but we thought it best to sketch out scenarios and then what the considerations are with each approach:
1. DIY Implementation
First, you’ll need to become well-versed in the FDA regulations. Second, you’ll have to understand and implement one of the three standards being employed by the issuing agencies. (They do provide you with tools for the DIY approach, or at least GS1 does.) You’ll also be responsible for uploading your UDI tracking codes to the GUDID.
Third, you’ll need to purchase and operate the technologies that will allow you to print the UDI on your medical device, as well as track for mistakes. (We touched on that in our last post.)
2. Limited Partner Implementation
In a limited partner role, you can work with a series of experts in the specific areas, and rely on them for strategic advice and guidance. For example, you might decide to turn to an issuing agency to understand the process of obtaining UDI tracking codes, but buy the printing equipment and handle the printing yourself.
3. Full-On Outsource Implementation
In this case, you’d work completely with an outside consultant to assume a kind of “general contractor” approach to UDI implementation. This consultant is likely experienced in UDI regulations and has the connections to complete the entire task.
Resources for Every Option
Based on the approach you take, here are some resources offered by GS1 US:
For those of you considering the DIY or Limited Partner approach:
If you’re considering a Limited Partner approach:
If you’re considering the Complete Outsource:
One Essential Takeaway: UDI Implementation is an Ongoing Process
UDI implementation is a process. If you read the FDA document, you’ll see vagaries and ambiguity. Gibson notes this is almost “by design.”
“They realize they don’t understand everything about the med device supply chain,” she said. “They couldn’t put clear requirements to cover every product or company situation.”
Medical device manufacturers must be patient. If you document your interpretations of the rule, Gibson feels the FDA should understand your intent. There will likely be compromises, but if you’re committed to the vision of UDIs, then you’ll land on the right side of regulations.
“The overall goal is not to punish,” Gibson stress. “It’s to ensure patient safety.”