In December 2018, the National Health Service (NHS) England announced an extension to its eProcurement deadline for in-vitro diagnostic devices. Instead of being required to comply by September 2019, manufacturers now have until September 2021.
I caught up with Gary Saner for a quick refresher on how unique identification (UDI) is enabling eProcurement for NHS England. Gary explains some of the requirements—and why medical device manufacturers should press on despite the extension.
Question: First, can you provide a brief overview of NHS England and its eProcurement initiative?
Gary Saner: Sure. As part of the UK Department of Health, NHS England provides more than 90% of healthcare in England. eProcurement is NHS England’s initiative to increase the speed, efficiency and accuracy of procurement processes, and it aims to do that by leveraging master data, standardization and technology in the supply chain. Any company that does business with NHS England will have to comply with the eProcurement requirements.
Fortunately, NHS England is rolling out those requirements in phases by type of service or product. Medical devices have been the top priority, and deadlines for eProcurement compliance have already passed for the highest-risk categories—Class III, Class IIa and Class IIb devices.
Question: At a high level, what does eProcurement require medical device manufacturers to do?
Saner: Anyone who has addressed the FDA’s requirements for unique device identification (UDI) will have heard of the GS1 Standard for UDI. In the U.S., the FDA allowed companies to choose from several possible standards, but in England, everyone is mandated to use GS1 Standards. That said, there are three legs to the eProcurement stool.
First, manufacturers must add a GS1 UDI, which includes device ID in the form of a Global Trade Identification Number (GTIN) plus production ID, on the device label and package. The UDI must appear in both human-readable plain text and in Automatic Id and Data Capture (AIDC) technology, such as 1D/2D barcode or RFID.
The second requirement is direct marking—that is, permanently marking UDI on devices that are reprocessed and used multiple times. A scalpel is a great example of a device that would quickly be separated from its original UDI-labeled packaging but would need to have a permanently etched UDI.
Finally, the third requirement has to do with data sharing, with companies mandated to submit device ID and attributes to NHS via GS1’s data pool—the Global Data Synchronization Network (GDSN)—and to set up order and invoice support using the Pan-European Public Procurement Online (PEPPOL).
There are several steps companies must complete to comply with those requirements, and that’s true whether you’re managing a Class III device like a pacemaker or an in-vitro diagnostic device like an MRI machine.
Question: Speaking of in-vitro diagnostic devices, NHS England has extended the deadline for eProcurement for this class until September 2021—about two years beyond the original deadline. What does that extension mean for manufacturers?
Saner: Clearly, it provides a bit more time and space for companies to meet the requirement. However, I would caution against putting eProcurement on the backburner.
To date, about 900 medical device manufacturers have complied with NHS England’s eProcurement requirements. Interestingly, I’m not aware of any penalties being assessed against those that haven’t met the deadlines, which can be a source of frustration for those that have put in the work to prepare.
Although I understand there could be frustration about the lack of a “stick,” there are some “carrots” to be had. For one thing, achieving full compliance can position your company to be differentiated through favorable placement in NHS England’s supplier and product listings.
The potential value extends beyond a company’s business with NHS England. For example, once your product data is published through the GDSN, it’s available to any customer in the data pool. That could include GPOs and large health networks in the U.S. And once your products have been assigned unique identification—including your GTIN, barcode symbology and printing mechanisms—you can leverage that work to meet upcoming European Union requirements.
The bottom line is that there are always solid business reasons to manage data in a central and controlled fashion. If you aren’t sure how to get started with eProcurement or if you need help jumpstarting a stalled project, Reed Tech is here to help. We can explain the process and show you how an automated platform can help you connect the data dots—and see an enduring return on your eProcurement efforts.
NHS England eProcurement questions? Contact us MedDevice@ReedTech.com