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GS1 standard for medical device tracking gathers steam

A standard for medical device tracking and infrastructure deadlines for 2010 and 2012 have emerged through a joint effort among hospitals, manufacturers and distributors.

Whether or not the health care reform bill sets a deadline for the Food and Drug Administration (FDA) to establish a federal standard for medical device tracking, one industry group is set to adopt the GS1 standard device-numbering system, which is similar to the bar code and radio frequency identification (RFID) systems employed by grocery stores and hardware retailers.

The nonprofit GS1 US serves as a central registry of product data, including health care devices, for more than 200,000 U.S. manufacturers in 25 industries. A video outlining the GS1US effort to standardize medical device tracking demonstrates it has a broad base of support from hospitals, distributors, manufacturers and the FDA. The group’s goal is to improve patient safety and supply chain efficiency through better tracking.

It’s important, especially in such situations as product recalls or the issuing of manufacturer safety bulletins, to have a standardized database accessible to all parties in the supply chain, said Joe Pleasant, FHIMSS, senior vice president and CIO of Premier Inc. in Charlotte, N.C. His organization’s Premier Healthcare Alliance represents 2,300 nonprofit hospitals for group purchasing and quality improvement initiatives.

The importance of standardized medical device tracking

Today, proprietary bar code and RFID systems at the manufacturer, distributor and hospital levels may or may not be accessible to one another. The GS1 health care database, already in place, represents the first piece of the standardization process: creating one identification number that will work throughout the supply chain.

It doesn’t make sense for us to have a unique standard just for medical device [tracking]. Why not use the standard that’s already in place for everything else the hospital buys?”

Joe Pleasant, senior vice president and CIO, Premier Inc.

Having a neutral third party control identification data and its accessibility will enhance patient and worker safety by getting information about problem devices into the hands of health care practitioners and patients much more quickly and effectively than it does today, Pleasant said.

Pleasant, currently participating in a GS1 pilot project charged with getting standardized product and manufacturer data to patients at the point of care, said many health care providers have no idea what data is contained in a product’s manufacturer bar code.

“What happens today is, you end up not really having a number that you can count on to represent that specific product,” Pleasant said. “If the manufacturer does a recall on a product number, the hospital doesn’t have an identifier to determine whether they got that product or not.”

The next step, assigning Global Location Numbers for manufacturers and their facilities, will begin this year, according to GS1’s sunrise dates for rolling out medical device tracking. In 2012, manufacturers will begin assigning Global Trade Item Numbers to the products themselves. More than 60 suppliers have signed on.

Predicting federal action on medical device tracking

Will the FDA mandate GS1’s numbering system? Pleasant predicted that the agency won’t make GS1 the exclusive standard, leaving the door open for manufacturers to choose GS1 or a competing standard under development from the Health Industry Business Communications Council. However, given recent FDA tests of unique device identifiers (UDI), it appears they are modeling pilot projects on GS1 standards, he said.

“We’re endorsing the GS1 sets of standards,” Pleasant said. “It doesn’t make sense for us to have a unique standard just for medical device [tracking]. Why not use the standard that’s already in place for everything else the hospital buys, so they don’t have to have one that’s different for medical devices?”

Regardless of whether health care reform passes Congress, the health care industry is moving toward adopting standardized bar codes anyway. The Joint Commission’s endorsement of UDI rulemaking in the proposed health care reform bill before Congress could signal interest among hospitals that the organization is at least considering codifying UDI in either its patient-safety standards or guidance documents for accredited hospitals.

“We’re already seeing the customers saying, ‘We’ve got to have this,’” Pleasant said. “FDA coming out with a UDI [standard] would be an added benefit, and probably make it clear to the industry it’s what everybody’s asking for. But even if they don’t, I think it’s going to happen.”

Let us know what you think about the story; email Don Fluckinger, Features Writer.


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