Although the unique device identification (UDI) system established by FDA has been effective for a few years, the implementation process has not been without hurdles. In addition, compliance with EU MDR requires all devices to be fully traceable through a UDI system, so device manufacturers must be on top of labeling processes.
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“The challenge manufacturers have with UDI implementation has more to do with understanding from a regulatory perspective what is happening,” said Jay Crowley, Vice President & Practice Lead, UDI Services & Solutions, USDM Life Sciences. “Structurally the way companies operate makes it hard to implement UDI well.” Crowley, who previously served at FDA for 26 years, most recently in the role of senior advisor for patient safety at CDRH, discussed the aspects of UDI that have and have not worked, along with the challenges ahead, during the MedTech Intelligence virtual conference “EU MDR Labeling, IFU, UDI and Eudamed” last month. The following is a snapshot of some of his key points on UDI implementation in the United States.
Successes (with caveats…)
- Not a new invention, but rather built on existing regulatory constructs
- Flexible regulation. However, this also means that companies must spend time understanding UDI implementation. “There’s not a cookbook that is going to tell you how to do this,” said Crowley.
- Focus on the label construct. However, some companies have misinterpreted UDI as a supply chain-only activity. “UDI is intended to support the supply chain, but also many other use cases. It’s not only a supply chain activity. We’re not just talking about boxes and cartons,” said Crowley. “We’re talking about a device, its label and the higher levels of packaging that you put the device in.”
- Phased implementation
- FDA’s Global Unique Device Identification Database (GUDID)
Some Areas that Haven’t Gone So Well
- Understanding whether the product your company distributes is a medical device or an accessory, and whether it falls under UDI
- Who is the labeler? In the United States the “labeler” is the party responsible for the UDI and is usually the manufacturer. (But, sometimes “manufacturer” can be too broad a term, leading to confusion. For example, a contract sterilizer may be a manufacturer, but it is not the party responsible for UDI)
- Convenience kits vs. a collection of devices. FDA published a final guidance on UDI and convenience kits in April, but the language is not completely clear. The guidance states “A convenience kit is ‘two or more different medical devices packaged together for the convenience of the user’”. Yet, “For purposes of the UDI regulations, FDA does not consider every medical procedure kit, nor every collection of two or more medical devices, to be a ‘convenience kit.’”
- Single-use device packaging exception.
- Barcode verification remains controversial.
What Are We Still Working On?
- Non-sterile implants. There continues to be a struggle with how to define non-sterile implants (i.e., orthopedic screws and plates; items that go into trays, etc.), and how to convey the UDI of a specific implant so it can be captured in a specific patient record.
- Differentiating stand-alone software versus integrated software.
- Implementation of Class I devices is still occurring and there are still some unknowns, as there is less visibility into Class I products due to less premarket scrutiny.
- Combination products: How UDI is applied to these products,; tackling issues such as change control, and the management of these devices over their lifetime.
- Devices that have long lives (i.e., MRI machines). They may exist in a hospital for 10–20 years before moving on to another facility, and they may evolve significantly over that time span. “The UDI I put on the device initially may not be relevant in 10 years as I add components or software that changes what the device does,” said Crowley. “We haven’t talked about how to manage the UDI of the system as the device evolves. Some of that might require relabeling, but [we] might not be able to.”
The Crystal Ball: Future Challenges
“We are going to see track and trace for medical devices. We’re seeing the beginning of it in Europe,” said Crowley. “One of the biggest challenges regulators face is traceability.” Other areas of potential future hurdles include:
- Full UDIs on all levels.
- Capturing all devices used.
- Blurred lines between devices, drugs and biologics.
- Integration of wearables and apps (non-regulated products).
- More data needed; The distribution, use and reimbursement of devices could be affected if data does not align.