The medical device supply chain is poised for a major shake-up as the UK prepares to follow America by introducing unique device identifiers (UDIs).
The FDA in the States has recently mandated that all healthcare equipment sold into the US marketplace must carry a UDI, which is specific to a particular item and includes an identifying number and other information such as use-by date.
The UK is now waiting for the exact wording of the American directive before it too makes the measure compulsory this side of the Atlantic.
A lot of the costs will be recouped in the first year in terms of ease of procurement, less wastage, better stock management, and better materials management. This is really great news for healthcare in the UK and for the supply chain as a whole
Discussing the impact of this move, Roger Lamb, healthcare sector manager at GS1 UK, an independent, not-for-profit global standards agency that works closely with the NHS, told BBH this week: “The discussion is not about are we going to do this, but how and when we are going to do it.
“The problem at the moment is that there is no standard format to identify a product. A manufacturer can produce something with the code ABC123, for example, and another supplier could use the same code for a completely different device. Also, the manufacturer might have one reference, the wholesaler will use another, and the healthcare trust that buys the device may use yet another proprietary coding. This can cause all sorts of problems, particularly in terms of stock control.
“With a UDI this cannot happen. You will be able to trace a device right through the supply chain, just as the retail sector already does. In healthcare this has never happened before.”
The idea was first mooted around a decade ago, but more recently the US and the European Union, together with several other interested parties, have begun discussions about a worldwide rollout.
Lamb explained: “There have been a number of reports around the world saying that medical device identification is a problem. The US called for unique identification and then became aware of similar intentions in Europe. This led to regulators getting together to talk about the opportunities and what the legislation might look like. They all agreed it was a good idea, so brought in trade bodies such as Eucomed to start more indepth discussions.
You will be able to trace a device right through the supply chain, just as the retail sector already does. In healthcare this has never happened before
“There have been a few false starts, but the US has now sorted its text out and is just agreeing on possible exemptions. It is likely that the EU will adopt most of that document, changing just a few things that might be particular to member states. Most certainly, we will probably follow the same timescale for adoption.”
It is likely, said Lamb, the directive will come into force where the highest risk devices are concerned within the next year, followed over the next two years by a mandate on lower-grade equipment.
What will need to be decided now is what this UDI will look like and how it will be displayed.
“There is ongoing discussion to be had about the actual mark that is used,” Lamb said. “It is likely it will be a 14-digit GS1 Global Trade Item Number (GTIN) identifier that is carried in the form of a barcode or, more likely, a 2D data cell. These data squares take up less space, and one big problem with medical devices is finding space to put things on.”
He compared the impact of the introduction of UDI technology to the switchover to the Euro.
“This is an education process for industry,” he added. “The supply sector does welcome this move, but has been stalling on introducing the technology needed until there is clear guidance from regulators. Trusts themselves have also been waiting until they know what is going on before purchasing the scanning equipment they will need. Now the details are in the pipeline, action will need to be taken across the supply chain.”
Industry recognises the potential benefits of UDI, which go beyond patient safety, but these can only be realised if healthcare providers are engaged, motivated and correctly resourced to respond to the challenge
While there will inevitably be cost implications, both for manufacturers and healthcare providers, Lamb claims these will be quickly reimbursed. He said: “A lot of the costs will be recouped in the first year in terms of ease of procurement, less wastage, better stock management, and better materials management.”
There is also a knock-on effect for patient safety. Had this technology already been in place, much of the confusion that followed the PiP breast implant scandal could have been avoided.
Lamb said: “With this technology you can attach specific device codes to individual patient records. In the case of the PiP implants, or where there might be a problem with a device affecting only one batch, you would quickly be able to identify both the devices and the patients affected.
“This is really great news for healthcare in the UK and for the supply chain as a whole.”
The Association of British Healthcare Industries says it expects the regulations to come into full effect within 3-5 years and is involved in the development of the policy through its chairmanship of the Eucomed group.
But both the ABHI and Lamb agree there will need to be incentives in place. An ABHI statement says: “Industry recognises the potential benefits of UDI, which go beyond patient safety, but these can only be realised if healthcare providers are engaged, motivated and correctly resourced to respond to the challenge.”
