GPO Forges Ahead with Device Identification Standards

NEWS TRENDS

Premier Inc. (San Diego) is now requiring that all medical device manufacturers it has contracts with comply with GS1 supply-chain standards. It is the first group purchasing organization (GPO) to take this step, which comes in advance of anticipated FDA action. Premier expects the requirement to streamline processes and improve patient safety.

The GS1 standards enable automatic identification, tracing, and data transmission from a product's manufacture to its treatment of a patient. Despite Congress' passage of the FDA Amendments Act of 2007, which mandated the creation of a national unique device identification system, the agency has yet to announce a standard system. Premier will be making changes to its new contracts to require the GS1 standards adoption and expects full implementation within five years.

“I think it's going to have a major impact. The industry has been talking about doing this for some time,” says Dennis Harrison, president of GS1 Healthcare US (Lawrenceville, NJ). “Premier has taken the first step here, but I think other GPOs are going to follow. This is just the beginning of finally getting the ball rolling.”

Using standard identification for devices will help clinicians accomplish more tasks because they won't be spending so much time trying to locate products, he says. It will also give hospitals more information on new, discontinued, replacement, or recalled products, which should improve patient care.

There are several categories of GS1 standards in healthcare. The specific ones that Premier is adopting include the following:

“We've spent a lot of time testing and piloting [the standards]. This [is a] significant improvement in terms of patient safety,” says Joe Pleasant, chief information officer of Premier. “I think all of those [results] have convinced us that it's time to make a statement and declare the direction we feel is appropriate for the benefit of patient safety. It has been driven by our members, who are asking us to have a voice moving in this direction.”

At least one representative from a medical device trade association has hinted that promoting the standards as a way to enhance patient safety isn't completely honest. AdvaMed's Jeff Secunda says there are definite long-term patient safety benefits to a device identification. Secunda is the associate vice president of technology and regulatory affairs at AdvaMed. He says that many AdvaMed members use product ID standards and codes. However, he says, “it appears that Premier is not just endorsing GS1, but requiring the use of only GS1. It is not clear how Premier will accommodate those companies that are using the HIBCC standard for both supply-chain efficiency and postmarket surveillance.”

Pleasant says the supply-chain efficiencies will also help patients. He says that implementing the standards require manufacturers to change their procedures, but that in the end, it will simplify matters. “By having a common data stream and identification of product, manufacturers can streamline that process, and distributors can do the same,” he says, adding that standards benefit patients because all parties will be working in a common database.

So far, Pleasant has seen a positive response from Premier's endorsement of the GS1 standards. He says that if manufacturers are expected to invest in making changes, they're finding it helpful to have a direction and time frame related to expectations surrounding the standards.

“The industry's been looking at adoption of the [GS1] standards for some time, so I don't think that's going to change,” says Harrison. “I think what's going to happen is that you're going to see true implementation—you're going to see people starting to really do it.”

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