Learn the EU-MDR Unique Device Identifier System from Voltron

6 minute read.

Life should be fun, and I try to find ways to bring fun into work. This article uses Voltron, Defender of the Universe, to teach the European Union Medical Device Regulations requirements for Unique Device Identifiers.

Background

The EU-MDR becomes mandatory in 2020 and will require that each medical device has a Unique Device Identifier to track it throughout distribution, similar to how the post-office or FedEx tracks mailed packages. The UDI is more than tracking – it’s a way to monitor the shelf-life of life-saving medical devices before they reach patients, locate and recall faulty medical devices anywhere in a distribution chain, and add safety to European citizens after former requirements failed to prevent 400,000 people from receiving unsafe medical implants in a scandal that led to the MDR.

Despite the MDR’s importance, few people would say that it’s fun, and even something as seemly straight-forward as the UDI system can be frustrating to learn. That’s where Voltron comes in.

Voltron has been a popular cartoon and toy franchise for decades. In the most common version of Voltron, he is assembled from five robot lions and has accessories like swords and shields that allow him to do his job better. This is like many medical devices that are assembled of different components with optional accessories, which can be confusing when applying UDI’s intended to track the final assembly.

UDI: Most Common Situation

Most medical devices don’t have multiple components. The company either manufactures or labels a medical device and ships it to distributors, physicians, or patients. That device is inspected and labeled with a UDI, and boxes with multiple devices also receive a UDI.

For example, a hip implant would be inspected by a company and shipped. They may package them individually, and individual packages may be grouped for distribution. In this case, the hip implant would have a UDI on it’s individual packaging describing the model number and manufacturing information that allows traceability throughout the supply chain, from raw materials to final product.

Bulk packages would include the model number, number of packages, and manufacturing information that also allows shipping boxes to be traced and recalled to protect patient safety.

Before the UDI system we learned the challenges of recalling medical devices when 35,000 hip implants were recalled after 9,000 were implanted with toxic machining oil and required revision surgeries. The company, Sulzer, went bankrupt from the $1 Billion in lawsuits, and over 4,500 people lost the ability to walk normally for the rest of their lives.

The UDI system will make it easier for governments to trace and recall medical devices when necessary. The UDI requires part numbers and manufacturing information on a barcode that can be scanned and recorded in computer systems; in the case of Europe all information will be uploaded to a database called EUDAMED.

The UDI format for these situations is straight-forward and available online from the European Union or from a user-friendly format from a consulting company, Oriel-STAT-A-MATRIX. The sections about UDI are in Article 27 and Annex VI, which lists everything required on the label and what to do in different situations, and the timing of UDI for different devices is in Chapter X. I also wrote an article that includes how the UDI fits into the MDR process,

What’s not obvious is what to do in ambiguous situations, or how to address companies that get stuck on words and definitions rather than the intention of regulations.

UDI: Ambiguous Situations

UDI’s are not as straight-forward when a company ships multiple components and a customer assembles them into the final device, similar to how Voltron is assembled from five lions, or when accessories are shipped that may or may not be used with the final device.

As an example, a medical respirator has many components and accessories, all of which could be shipped separately or replaced individually, some requiring UDI traceability and others not requiring UDI traceability.

The MDR defines a ‘component’ as being required for a medical device and an ‘accessory’ as a potentially optional addition, so when a device is assembled by a customer instead of the company each component must have a UDI and the most important or most stable component would have the complete device UDI.

In the case of Voltron, each Lion would have a UDI and the black lion, which forms Voltron’s head and torso, would have a UDI used for the final assembled Voltron. That’s because it’s reasonably expected that we would expect the head and torso to be the most consistent part of Voltron, and if he needed a replacement component it would more likely be a yellow or red lion used for an arm or leg.

This isn’t a critical nuance for most companies, but problems arise with accessories used as components, or components used as accessories. Let’s start with Voltron’s sword, which he forms late in battle, after all other options fail, and invariably uses it to kill evil robots.

There are two important questions here:

Why doesn’t Voltron start each battle using his sword?Would his sword require a UDI?

The first answer is that Voltron doesn’t always use his sword because kids enjoy the uncertainty of Voltron battling evil robots and get excited when he produces his sword at the last moment and saves the universe again! (I may be a kid, too 🙂

The second question is ambiguous in the MDR. In other words, it’s unclear if the sword is an accessory or a component. I’ll answer the question after relating it to a few medical examples.

Consider the respirator: it’s obvious that the computer controller would be necessary for the safety of the device and may have software upgrades or corrections that need to be traced by a UDI, but what about disposable face masks? Or, what about the disposable tube connecting different parts of the device?

Remember that the MDR defines a ‘component’ as being required for a medical device and an ‘accessory’ as optional or not critical, but there’s ambiguity for what is necessary for each device and what is a separate part that’s common in hospital settings.

For the second answer, my strong advice to companies is to make any part that touches a patient or could become an expected convenience by caregivers traceable and use UDI’s. This may not be associated with the main device, but would have UDI’s indicating each part number and manufacturing history in case there were a recall. Fortunately, the MDR allows parts and accessories to be classified differently than the main device, which allows less diligence if it’s not a critical part. Similar scenarios exist with devices for blood transfer, imaging, etc.

The extent of component or accessory traceability depends on risk to the patient and how the parts are used in the field. I use Voltron’s sword as an example. Even though the sword is considered optional, therefore an accessory, historical evidence suggests that Voltron needs it to successfully defeat the evil robots, therefore it needs a UDI. In other words, actions and historical evidence matter more than words or definitions, and if an accessory becomes ubiquitous it should be traced with a UDI.

Conversely, replacement wheels for the roller-cart probably wouldn’t be traced because they are considered non-critical replacement parts. And if respirators had an optional coffee-mug holder (unfortunately they don’t) that would be an accessory and probably wouldn’t need to be traced because it’s unlikely that a coffee holder poses any risk to patients.

I say “probably” rather than “definitely” when there’s ambiguity in the MDR because it’s a choice each company will have to make for themselves based on their unique marketing, customers, and distribution system. Each choice will have ripple-effects throughout the entire organization therefore it should be a team-driven decision; you can iterate that decision later based on real-world use scenarios.

Document your team’s logic and follow risk-management best-practices to periodically update assumptions per the European-modified standard of risk-management, EN ISO 14971, and ensure that field data is communicated to other departments per the international standard for quality systems, ISO 13485. Both standards are implied by the European Union Medical Device Regulations, and the concepts are used in the MDR Big Picture, which refers to the concept of using Post-Market Surveillance to reduce risk As Far as Possible.

Summary

The MDR will be required by 2020, with UDI’s phased in over the following few years.

UDI requirements are in Article 27 and Annex VI of the MDR, with dates in Chapter X.Ambiguity in UDI requirements should be handled with team-driven decisions and documented in risk-management procedures.

Next Steps

Efficient companies can continuously improve by using the process approach, linking different departments through shared risk-reduction procedures. The process approach and risk reduction is a core message of the MDR and Risk Management standards that I explain in other articles using pop culture to illustrate big-picture concepts. See my blog to find other medical device lessons using a wide range of pop culture.

Consulting companies can assist with your training or audits.

I consult with executives to apply regulations in ways that improve efficiency and innovation; and for team-training workshops I waive my fee when companies invest in nonprofits supporting equitable education and healthcare.

Thank You For Reading

I wish you happiness in work and life.

Just For Fun…

The 1980’s Voltron television opening:

The 2010’s version: