Webinar: Ready or not, here comes FDAs Unique Device Identification initiative
AAMI organized the session in advance of FDA’s draft regulation offering guidance on implementing the standardized, globally harmonized, barcode-like identification system. The draft is expected this fall. After a comment period, a new FDA rule will require manufacturers to affix a UDI tag to all devices so they can be tracked throughout their lifecycle in the healthcare system.
The participant who asked about hospitals’ existing tracking systems, Jim Bosman, a clinical engineering financial specialist at Baystate Health in Springfield, Mass., expounded on his question. “Is any consideration being given to placing these labels in such a way that they’ll be easily accessible? Sometimes these serial numbers are on the back or somewhere a machine is installed and you have to pull it out from the wall to see the serial number,” he said. “I guess I’m just wondering if the FDA is considering these issues. I doubt the industry is bringing these considerations forward; it’s got to be coming from hospitals.”
“We’ve seen some of the materials-management systems and the things you describe about the asset tags,” replied Terrie L. Reed, the FDA’s associate director of informatics. “In trying to improve adverse-event reporting and integrating UDI into the adverse-event reporting systems, it may be initially that those [existing] asset tags and numbers would be retained, but, at the very least, we’re hoping there would be some sort of mapping between the UDI and the electronic materials-management systems to that asset number. At least you retain, at some point, the UDI assigned by the manufacturer even if there is something assigned at the local level.”
The concern about obscured serial numbers “sounds like a good comment to the proposed rule when it comes out,” Reed added.
“I don’t see this necessarily taking the place of the fixed asset tag,” said co-presenter Tom Werthwine, a global supply-chain executive with Johnson & Johnson, “but there’s a lot of value in using the manufacturer’s UDI number because it will be unique and it will give that traceability back to the manufacturer.”
Werthwine seconded Reed's call for comments on the regulation draft when it comes out. “We are looking for that kind of information to influence manufacturers, so it would be of benefit to us. And I have supported many medical instruments in product development, so I understand [searching for serial numbers] on the bottom and on the back and all of that. If we want them to be used, they should be in a prominent position.”
Some constructive criticism for the hospital contingent followed. “I’ve gone into a lot of hospitals and found the hospital’s fixed asset tag applied over the serial number of the manufacturer,” said Werthwine. “When you’re going through a recall situation, you don’t know what the serial number is because you have this tamper-evident, permanent, fixed asset tag on there. You have to crack the box open and look inside to determine, ‘Is this one of the products being recalled?’”
Werthwine recalled a hospital customer who wanted to know if the supplier could help track down a number of IV pumps that had gone missing. It turned out the hospital had transferred many patients without following up on returns of IV pumps from ambulance companies and other hospitals. “Because we knew what serial numbers we had sold that specific institution, we were able to go through a 100-mile radius and find their pumps sitting in other ERs and whatnot,” he said. “So this number will be unique and it would help for things like traceability, understanding where the device really is.”
Another participant asked if there was a connection between two widely used identification systems—Global Trade Item Number (GTIN) and Global Medical Device Nomenclature (GMDN).
“I would say GTIN is UDI; it’s one way to have a unique device identifier,” responded Reed. “It’s the GS1 assignment of the Global Trade Identification Number. It meets ISO 15459, so it could be used for UDI. The GMDN is independent of GS1 (the most widely used supply-chain standards system in the world). It’s its own entity. There’s a GMDN agency. They work with manufacturers who assign these codes to their devices. What we’re requiring in the EDI [electronic data interchange] database is that you have a UDI on one of the [device’s] elements.”
Reed said the category of each device will be identifiable by its UDI. “We see this as a pretty pivotal attribute because, without that, it’s kind of like having a big catalog of devices with no table of contents,” she said. “The categories, the GMDN codes, kind of provide a way to group like devices together.”
“The thing that I want mention, especially for the hospitals in on the call, is that GMDN is designed to help regulators,” added Werthwine. “It was really designed by and for regulators.” Different regulators will have different panels of experts to look at the various categories of equipment, he pointed out, which can lead to confusion. The rest surely sounded familiar to the clinical engineers on the line.
“You can see a product and it could be called ‘catheter,’ and you don’t know whether it’s an IV catheter, an embolectomy catheter, a peripherally inserted central catheter or a central line,” said Werthwine. “GMDN would help the regulators determine which panel of experts needs to review the submission and do compare and contrast with other products on the market. It is not designed for supply chain. It’s not designed for things like stent management. It is not a replacement for the United Nations Standard Products and Services Code or other classification codes. It really is designed for regulators, not for business. So, we are truly talking about apples and oranges in terms of different classification systems. One is nomenclature and then the other could be for business informatics and management.”
Concluded Reed: “I look forward to the day when we can have one of these webinars to say that the proposed rule is out and answer questions specific to that regulation.”