The medical device industry is anticipating publication of FDA’s proposed rule on unique device identification (UDI) in the first quarter. Then follows a one year review period, after which manufacturers will implement the finalized regulation to a time table based on product risk classes.
The agency will require the coding of a minimum data set using RFID or bar codes and human readable numbers. The standard labeling system will then be the foundation for agency and industry device tracking encompassing product recalls, policing counterfeiting, and post market surveillance.
The rule in all likelihood will allow for both the GS1 and HIBCC standards for product identification and traceability, although a broad segment of suppliers, distributors, and hospitals have embraced GS1 standards, and some have called for a single standard in a UDI system.
Kaiser Permanente, Mayo Clinic and Sisters of Mercy Health System, Geisinger Health System, and Intermountain Healthcare this month jointly announced their support for GS1. “The implementation of GS1 standards in healthcare is critical to helping industry drive reform in supply chain processes. We believe that a single standard is essential to rapid adoption and believe that GS1 is the only valid standard we plan to support.”
The largest GPOs have announced that use of GS1′s Global Location Number (GLN) and the GLN Registry For Healthcare as a source for hospital location data is well underway for meeting the December 2010 Sunrise date for the GLN.
“Many in our family of hospitals will be live (this month) or over the course of 2011. We have seven integrated (hospital) delivery networks live on GLN today, using purchase orders that use a GLN instead of account numbers assigned by a manufacturer or supplier. (And) 15 additional systems have declared their readiness through the GS1 GLN readiness self-declaration form,” says Dennis Byer, senior director of industry standards, Novation.
The GPOs have agreed they will all use the same GLN if they have the same location for a hospital.
“In all of our contract terms today, we require a GLN for sales reporting, all supporting documents, all tier pricing, and rebate payments, Byer says.
“The GLN lends itself to supply chain transparency and efficiency. A hospital with 100 locations and 1,000 vendors might have 100,000 different account numbers assigned by suppliers and distributors. By standardizing on 100 GLNs, the hospital is reducing location management identifiers by 98 %,” he adds.
Novation and other GPOs are requiring manufacturers to use GS1′s GTIN for meeting the 2012 Sunrise date for product marking. And they are pressing for the use of GS1 GDSN product data utilities (PDUs) for interoperable data sharing in supply chain transactions using the product (GTIN) and location (GLN) numbers.
Premier is using the 1SYNC certified GDSN data pool with 60 suppliers in its network. “A critical element of data standardization is the ability for hospitals to synchronize product data with suppliers through the GDSN, a centralized (global, and interconnected) repository of product identification numbers . . . that works like a World Wide Web for the data. The GDSN also facilitates the sharing of this data . . . in an automated standards based electronic environment,” Premier says.
Since the GS1 and HIBCC numbers are in theory not duplicative if manufacturers follow the GTIN and HIBCC rules, both systems can be used to support a unique device coding system, says Karen Conway, director, industry programs, GHX, the exchange for automating healthcare transactions.
“The problem now, with the lack of wide spread use of industry standards for product identification, is that many organizations are using proprietary numbers to identify products. With the use of industry standards, a single number, whether HIBCC or GS1, would be used to identify a specific product at a specific unit of measure, and that number could not be used to identify any other products.
“Many products are still identified with HIBCC standards, especially in the dental world, and even organizations that plan to move to GS1 standards have stated that it will take some time before they make that transition,” Conway says.
GHX runs a certified GDSN data pool to which a hospital preparing to cut a purchase order can subscribe for supplier-published data. For the past ten years, GHX has also coordinated supply chain transactions with its Allsource repository.
“For suppliers that choose to use HIBCC standards and the HIBC-LIC as the product identifier they want customers to use for e-commerce, we can synchronize those product ID codes with the data held by providers with whom they do business through GHX,” Conway says.
“The only real challenge (of a two standard system) is for organizations that need to configure their bar code scanners to read the different product code configurations. But the technology does exist to read both from a single machine,” she adds.
Many medical device and surgical products are today not identified with any numbers, or one device is assigned different numbers by supply chain parties. In some cases, different numbers are assigned to the same product.
As FDA imposes requirements on manufacturers for UDI, the agency is piloting development of an internal data base that would provide a single central source for device product data for supporting device surveillance. Regardless of whether a single coding standard prevails, a uniform labeling system should go a long way toward improving supply chain efficiencies and patient safety.