It has been more than two-and-a-half years since the U.S. Food and Drug Administration (FDA) issued its final rule on the Unique Device Identification (UDI) system. So, come September 24, the third deadline will be reached, requiring the balance of Class II medical devices to be compliant with the UDI rule which includes submitting them to the FDA’s Global Unique Device Identification Database (GUDID).

With the first two phases already implemented, Vice President, Healthcare, at GS1 US, Greg Bylo, helps us understand the previous deadlines and what medical device manufacturers need to do to prepare for the third phase.

“The first deadline was Sept. 24, 2014, for Class III devices which are the highest risk medical devices. Following that was the Sept. 24, 2015 deadline for Class II life-saving, life-sustaining, and implantable devices,” Bylo says.

These two deadlines resulted in more than 500,000 devices being entered into the FDA’s GUDID. What will be interesting is that for the first time the medical device industry and FDA will know exactly how many medical devices exist, based on the GUDID. Bylo notes that after the balance of Class II devices are entered into the GUDID, “anywhere between 1.5 and 2 million additional devices will be added to the GUDID.”

Once past the staggering number of devices that will be known for the first time, the final deadline will approach on Sept. 24, 2018, and this is for the Class I devices – which opens up an entirely different, interesting situation according to Bylo (see sidebar to right).

“While the FDA addressed many of the issues which would arise from the UDI rule, there are still many questions arising with the organizations that are implementing the UDI rule,” Bylo states. “When you get into the details of how medical devices are being used, how they are being moved throughout the supply chain – those different nuances are now beginning to arise and need to be answered.”

Bylo offers a great example and one of the Top 10 questions GS1 US is receiving most as the deadline creeps closer.

The FDA’s intent with the UDI rule is not just to identify things at the “unit of sale” but also at the “unit of use.” For example, diabetics monitor their insulin levels several times a day with meters and strips. The strips are usually sold in a vial of 10 to12 strips. That bottle is the unit of sale, but also what has to be identified in the GUDID is the unit of use or each individual strip. In the past, companies haven’t always differentiated between a unit of use from a UDI perspective – OEMs typically determine a unit of sale because you have to sell it, market it, and so forth. However, the unit of use is the challenge here, and this is something GS1 US addresses often in training presentations. Bylo notes, he sees instant shock on individuals’ faces because they realize that, all of a sudden, they have to identify many of their products with unit of use. So in the case of the diabetic strips, they have to be identified as a unique Device Identifier (DI) and the corresponding data loaded into the GUDID. The company would be exempt from direct marking since it would damage the product.

Responsibility

As the FDA continues working through the requirements of the GUDID and deadlines approach, attribute-collection responsibility continues. Depending on the device, there are up to 62 attributes which properly describe the product that may need to be collected and stored in the GUDID. The physical UDI labeling requirements of these devices primarily consist of the DI and the Production Identifiers (PI), which consists of the lot/batch number, expiry date, serial number, and/or production date.

“If you look at the FDA rule, it says the labeler is the responsible party, and that is typically the design owner of that product,” Bylo states. “So, for instance if I am the OEM, and I run out of production capacity and outsource the work to a contract manufacturer, I am still the responsible party to submit all the information to the GUDID before the product can go into distribution.”

Alternatively, an OEM could ask the subcontractor to do the GUDID collection, but that would be a contractual obligation between those two entities. However, this isn’t common and the FDA still looks at the company that owns the product as the one responsible to upload the product information into the GUDID and maintain it.

Collection

“Data going into the GUDID describes the device – the product number, description, unit of measure, size, weight, quantity per container, etc. The production information which is created when the product is manufactured, such as the lot/batch number, serial number, expiry date and production date, is not sent to the GUDID database,” Bylo says. “So, whether the OEM or the contract manufacturer is producing it, the OEM really should already have captured all the information for the product because it’s based on the design characteristics of the product.”

What should be noted here is an OEM should inform a contract manufacturer how to label the product so as to meet the UDI rule. They should provide the DI (Global Trade Item Number for GS1) and the production data that they want to have presented on the label.

As Bylo explains, contract manufacturers should be told by the OEM precisely what is to be used on the label and, in most if not all instances, the OEM will be providing the label template. Then, once the contract manufacturer collects the information required, the OEM takes care of the rest. To ensure the contractor is following the proper steps, OEMs should regularly audit contractors for compliance.
Don’t wait, ask for help

Companies need to act quickly.

“The FDA and UDI group have worked diligently to make these approaching deadlines well known. Yet, as a UDI issuing agency, we have started to get an increase in inquiries the last few months, and we expect that to continue as companies realize they need help, don’t know what to do, and are unsure how to meet the requirements by the deadline,” Bylo says.

To answer these worried OEMs, GS1 US offers educational programs that help jump-start the process.

“The initial real challenge for many companies is knowing the steps/effort required to collect the data necessary for the GUDID,” Bylo explains. “It requires the OEM either to pull the premarket approval (PMA) or the 510k documentation to gather the information as it was originally submitted to the FDA for their devices.”

Yet often, small medical device start-ups haven’t had to do this before, and that’s where many ask what steps to take next, so Bylo offers his thought on the best two avenues. “Hire a UDI consultant. GS1 US offers a list of solution-providers certified in our standards on the GS1 US website under the Solution Providers Program.”

Another option is to attend a GS1 US class (visit http://goo.gl/IebZjG for upcoming GS1 US education events) or to leverage the GS1 US Advisory Services program, which provide customized technical and business expertise to address unique GS1 Standards implementation challenges.

An even bigger challenge is many companies under estimate the real effort required to stay compliant after the product has been labeled and the data has been submitted to the GUDID. Bylo mentioned the following areas that should also be addressed:

Product design process – Ensure the UDI requirements are addressed during the design phase of the product

Master data management process – Once you collect the GUDID data, a company needs to know if and when it changes and then update the GUDID within the timeframe specified by the FDA.

Labeling and packaging process – Update the Labeling and Packaging Standard Operating Procedures (SOP’s) to include the new UDI requirements.

ERP/information systems – Are you capturing the DI and PI data when you are manufacturing and moving product? Has this addressed the appropriate transactional steps and information management steps?

Internal audit process – Have you updated your audit procedures to select a representative product and its GUDID data and are verifying the data is accurate?

Bylo says, “In addition, during their audit process, the FDA is requiring companies to verify products and data submitted to the GUDID. In a number of instances they are requesting that companies confirm the date information was collected, asking for information collection records, and working with companies to make sure they did it correctly and the data is accurate.”

Before time runs out

Is it too late?

“That depends on the number of products a company has,” Bylo says. “If there are 10 products, it probably could achieve the deadline of Sept. 24, 2016. If a company has thousands of products and hasn’t started yet, it could be extremely challenged.”

As an OEM, it’s time to start thinking about how this is not just a labeling change and collection of some data, but how it impacts the fabric of how every healthcare company does business. It all starts at the design and goes through to the final product.

GS1 US

www.gs1us.org

About the author: Elizabeth Engler Modic is the editor TMD and can be reached at emodic@gie.net or 216.393.0264.