The new year is nearly here.
If you make sparkling wine, then you’re probably excited about the new year, as bubbly is bound to be in demand. If you’re an orthopedic medical device manufacturer grappling with compliance ahead of the FDA’s UDI Final Rule effective dates, however, you might be feeling a little less festive.
That’s because 2019 brings new compliance deadlines, the first in a series of rolling requirements set to take effect between 2019 and 2021. Against this backdrop, there is a lot of interest and concern about UDI compliance and its effect on orthopedic medical devices. What’s the best strategy to employ?
Across the industry, companies are taking varied approaches to compliance, and some are still formulating a plan. At ImplantBase, we are developing features that support some of the facets of UDI compliance. But to support the real (and evolving) needs of the industry, our product development will require input from our existing and future customers. After all, it’s our goal to be fully ready when UDI compliance is an absolute known—and when you need us.
FDA regulatory classifications—in general
Broadly and as background, the FDA has established classification for about 1,700 different types of medical devices. These are sorted into three regulatory classes based on the level of control the FDA feels is necessary to assure device safety and efficacy. Assignment into Class I, II, or III can depend on the length of time the device will be used, how invasive its use is, and whether or not the item itself contains medicinal substances, among other factors.
Class I, II and III
In the FDA’s opinion, Class I devices present the lowest level of risk and are therefore subject to the lowest level of regulatory control. As Class I devices include elastic bandages, dental floss, and enemas, you can see why.
Class II devices are still relatively simple. In some cases, they present a slightly higher risk, so there are slightly higher levels of regulation associated with them. Class II devices include, among others, powered wheelchairs and pregnancy testing kits.
Class III devices are the most complex—and are and will be subject to the most regulation. Of course, Class III is the category into which the vast majority of orthopedic implants fall, and so this is the regulatory class on which the industry is most focused.
Reasons for FDA regulations
The FDA’s objective is twofold. First, it mandates consumer safety for everything, from devices to pharmaceuticals. Second, it demands efficacy, which means anything allowed onto the medical market has to be demonstrably effective at solving a particular condition. In a rapidly evolving industry like the medical device field, it’s important to manage risk for patient-consumers, such as protecting them from device or part recalls and ensuring that implants are genuine, not counterfeit.
Hence the UDI regulations, which are intended to inform chain of custody—or the traceability of something’s origin and the information on where it is now—and provide transparency that hasn’t existed previously.
A UDI—which stands for Unique Device Identification—is an alphanumeric string that provides detailed specifics about a specific item: who manufactured it, and where and when it was manufactured. The formula for creating it starts with your DI (Device Identifier) for that specific item and then adds on the lot number and the expiration date. (For more information on DIs and the anatomy of a UDI, check out this ebook.)
Three UDI options
There are currently three options for UDI compliance on individual items:
- Sterile packing with UDI listed on the package label
- Breakaway, where the UDI is on a piece of the part that is separated and catalogued at the time of implantation
- Direct part-marking, where the UDI is permanently marked on the device itself
Direct part-marking, the last of these three, is what will eventually—as the FDA UDI Final Rule goes into effect—be the standard across the industry, for every part. (Of course, there will be exceptions, especially for parts that are only 1-2 mm wide, but this is what the FDA is saying at the moment.)
No matter which route you choose, orthopedic medical device companies will have to make sweeping changes to become compliant.
Organizing for compliance
As the result of effective lobbying efforts by the device industry, the FDA has signaled “discretionary enforcement” and has offered deadline extensions via its most recent communications. Despite these updates, manufacturers are struggling mightily with matters of ambiguity and complexity. Put simply, the departure is this: companies have never before had to organize their products in a way that facilitates compliance. Up to this point, most manufacturers, especially those that produce metal hardware products, have placed items in large metal caddies and shipped them to the field. UDI compliance will force them to rethink packaging and manufacturing—for everything they produce.
Of course the challenge of UDI compliance is complex enough when you’re contemplating how to comply while producing new products. But what about dealing with the inventory you already have in the field? If you have multiple brands and product lines, you have to bring each of them into compliance. And failure to achieve compliance before the deadlines go into effect could result in an adverse outcome from an inspection, like a Form 483 letter. While the FDA has issued guidance that effectively delays enforcement, compliance deadlines aren’t going to be extended forever.
UDI compliance is going to bring another level of challenge at the system level. From generating UDIs themselves to adding them to sales orders to determining location at the UDI level, a digital system is going to be an absolute necessity. Being proactive and putting your system in place ahead of the compliance deadlines means thinking through how to calculate UDIs and have them move through your systems.
At ImplantBase, we’re already focused on providing clients the ability to have all UDI generation and tracking capability happening passively in the background, at all times. For those of you who are direct part-marking with scannable codes, we’re integrating a solution. This system will seamlessly provide another level of automation to benefit you and your sales team.
Yet, while we’ve certainly done a deep dive into this issue and its ripple effects, we don’t have a crystal ball. As we mentioned early in the article, we’re sourcing input from existing and future clients to help us focus product and feature development on UDI compliance needs (and so we’re all ready when those regulations actually do take effect, between now and 2021). To that end, we’ll be releasing a short industry survey and, once responses are in, sharing some takeaways on our findings.
What are you doing to be UDI-compliant? How are you planning for future product launches?
ImplantBase is a leader in digital transformation for the orthopedic implant industry. Its platform provides manufacturers of every size with a unique cloud-based solution that transforms how the business operates on every level and across your critical functions of finance, sales, and operations. Learn more at implantbase.com.