Is one the loneliest number?

Does the industry need one numbering system for products and providers, or are we OK the way we are?

The premise underlying data standards is simple: If everyone agrees to use the same number to refer to a specific medical product, and the same number to refer to a specific healthcare provider, then data can flow freely, easily and accurately among trading partners. Sounds simple.

But according to some with whom the Journal of Healthcare Contracting spoke, it’s more complicated than that. The issue isn’t necessarily which of two standards – HIBCC or GS1 Healthcare US – should be adopted by the industry, they say, but whether one of the two needs to be adopted by everyone. Strong arguments are made either way.

Two systems have emerged to identify medical products and specific customers. One is that of the Health Industry Business Communications Council, the other that of GS1 Healthcare US.

HIBCC was created in 1983 to develop a standard for data transfer using bar code labeling. Since then, it has created industry codes for medical products (the Labeler Identification Code) and healthcare providers (the Health Industry Number). The HIN database contains nearly 1.6 million healthcare and non-healthcare locations, and is used by hundreds of pharmaceutical and medical products manufacturers and distributors, according to HIBCC. In addition, HIBCC serves as a repository for unique product numbers, which the organization calls the UPN®, or Universal Product Number initiative, originally developed by the U.S. Department of Defense in the mid-1990s. The UPN consists of both HIBCC and GS1 product codes.

But the momentum as of late has been with GS1 Healthcare US. Formerly known as the Uniform Code Council, GS1 developed the now-ubiquitous Universal Product Code, or UPC, for the retail and grocery industries 35 years ago. GS1 US created GS1 Healthcare US in January 2008 to make its mark in healthcare data standards.

Most if not all the major hospital group purchasing organizations as well as the Association for Healthcare Resource & Materials Management have climbed aboard the GS1 Healthcare US train, calling for the industry to adhere to so-called “sunrise date” deadlines for implementation of its standards. Those dates are Dec. 31, 2010, for implementation of the Global Location Number (to standardize location identification); and Dec. 31, 2012, for implementation of the Global Trade Item Number (to standardize product identification).

Not needed
Despite the intrigue of the HIBCC-vs-GS1 debate, the industry should keep in mind that data standards already exist for designating medical products and providers, says Greg Stivers, vice president of customer technology for McKesson Medical-Surgical, and current chair of HIBCC. All the players in the supply chain have already agreed on which data elements need to be in place to denote individual medical products and provider locations. For example, a product ID number typically incorporates a code for the supplier, the manufacturer’s code for the product, the unit of measure, etc. And both the HIBCC and GS1 systems contain this information. To the extent that there are differences between HIBCC and GS1 Healthcare US, they are labeling-related, says Stivers. But today’s scanning technology can read either with little problem.

“The debate has become more of a marketing debate,” he says. “And the irony is, it’s under the veil of cost-savings. But if we as an industry or the FDA were to choose one of the two, [we] would increase cost to the industry faster than what I believe would be saved by driving true adoption of the data standards through these different labeling standards. And that’s frankly the thing that the industry should be most concerned about.”

Worse, if one labeling standard were to emerge as the “winner,” whoever controlled that system and database would in essence constitute a monopoly, with all the adverse consequences that the term implies, says Stivers.

Rather than engage in debates about labeling standards, the industry needs to ask itself why unique product identifiers have not been affixed to all products at the lowest unit-of-measure, that is, the patient level, says Stivers. The issue is patient safety. Delivering the wrong product to the patient not only can be costly in terms of wasted time and effort, but it can result in harm to the patient if not caught in time. “That’s where our focus and attention should be.”

Rick Mears, senior vice president and chief information officer of hospital supplier Owens & Minor, has a different perspective. The Mechanicsville, Va.-based distributor is a GS1 member company and has a history with GS1. The company was a long-time member of the National Alliance for Healthcare Information Technology, which several years ago created the Healthcare Supply Chain Standards Coalition, which itself merged with GS1 Healthcare US in May 2008. “Owens & Minor is fully committed to the adoption of industry standards and is fully supportive of the positive impact that such standards would have,” says Mears.

The absence of standards leads to inefficiencies in the supply chain, he says. “We spend so much money trying to reconcile our data against that of all our business partners. We create all this cross-referencing. There’s our item number, then the manufacturer has one, the provider has one, and the [group purchasing organizations] have one. In the worst case, there are four numbers for the same item. And that doesn’t even account for unit of measure.

“Granted, we’ve done a pretty good job of making [information flow among trading partners] seamless, but you can imagine the efficiencies if everyone used the same item number. There’s a huge amount of labor involved in keeping these cross-references up to date across thousands of providers and manufacturers, and thousands of items.” The lack of standards really makes a difference when products are recalled due to a defect or potential hazard to patient safety.

Room for both
“On a technical basis, I think there’s room for both [HIBCC and GS1],” says Napoleon Monroe, managing director, New Directions Technology Consulting, Huntington, N.Y. “They are both widely recognized, and both have their advantages.” GS1 holds a marketing advantage, but HIBCC has a long history of use in the medical device industry.

One huge buyer of medical products, devices and equipment – the U.S. Department of Defense – is more concerned that international product-identification standards (specifically, a standard referred to as ISO/IEC15459) as well as established bar-code standards be used by its suppliers than in the HIBCC-GS1 debate. “We have absolutely no interest in creating a proprietary standard or endorsing any specific industry approaches,” says Rob Leibrandt, deputy, Unique Identification and Information Assurance, Office of the Under Secretary of Defense. “We will continue to support multi-sector interoperability through the ISO standards and the necessity for the supplier to choose the method that best supports their business practices, vs. imposing it as a customer.

“From the U.S. Department of Defense standpoint, it is not relevant which of the several ISO 15459 recognized methods are used to create the unique item identifier. For example, HIBCC, GS1 or ANSI MH10 users can create a [unique item identifier] by serializing items within their respective product identification schemes. That is perfectly acceptable to the Department, because the procedure to create a number under 15459 results in a unique number under whichever product identification system the supplier chooses.

“Once created, the unique item identifier will be permanently recognized in our business systems as the single identifier for that item, whether it is in inventory, in transit, in a fleet hospital or implanted in a patient, and no other [unique item identifier] will ever be assigned to that item.
“Our goal is to ensure interoperability is enabled by use of these international standards for identification and marking.”

FDA’s role
A dark horse in the debate is the Food and Drug Administration, which is promising to issue proposed rules for what’s called “unique device identification” some time this year. The agency’s primary interest is not necessarily in enhancing supply chain efficiencies, but rather, ensuring that defective products can be easily located and taken out of circulation in case of a recall.

It’s not certain whether the FDA will in fact come down on the side of either HIBCC or GS1 Healthcare US. But according to those with whom JHC spoke, it’s more likely the agency will stay away from that debate altogether, focusing instead on what the elements of a device identifier should be.

“What the FDA has said very clearly is, ‘We’re not in the business of picking the tools or technology needed to [adhere to] our standards,’” says Andrew E. Van Ostrand, vice president, policy and research, for the Health Industry Distributors Association. “That’s why the FDA has kept up a dialogue with both GS1 and HIBCC.” (HIDA is one of six member organizations with permanent seats on the HIBCC board. The others are the Advanced Medical Technology Association, American Hospital Association, Federation of American Hospitals, Healthcare Distribution Management Association, and the Pharmaceutical Research and Manufacturers Association.)

HIDA too has avoided endorsing one or the other. “We read the same press releases and reports that everybody else does,” continues Van Ostrand. “GS1 has a lot of supporters. But a lot of manufacturers have had the HIBCC systems in place for decades. That’s why we’re not in the business of selecting one or the other.”

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