Medical Device & Diagnostic Industry Magazine
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Originally Published MDDI August 2005

NEWSTRENDS

Heather Thompson

To many manufacturers, incorporating radio-frequency identification (RFID) into medical devices seems like a no-brainer. But there are still steps that manufacturers must take to ensure they gain all its benefits.

RFID could transfigure patient care by incorporating safety checks for pharmaceuticals, surgeries, and general in-patient care that could reduce the risks associated with improper treatment. The potential is enormous.

But RFID will only begin functioning when manufacturers build tags into 100% of applicable devices, when hospitals begin to carry the necessary scanning equipment, and when hospital staff has the necessary technical savvy to operate that equipment.

According to Brad Sokol of American RFID Solutions and Fast Track Technologies (both Chicago), OEMs are meeting demands more quickly than hospitals, but they could do more to ensure that RFID is a successful venture. Sokol is the author of an industry study, RFID & Emerging Technologies Guide to Healthcare. The guide is a business tool that describes and analyzes the effect that RFID, wireless, and connectivity will have on the healthcare industry. It is designed to help companies assess cost impli- cations and benefits of these technologies.

According to the study, around 50% of all medical device manufacturers are already incorporating RFID into products. “Awareness [among manufacturers] is tremendous,” Sokol says. Manufacturers are actively building a dark network of tags that will be used in hospital settings. “These products could have connectivity today if hospitals had the infrastructure,” he says.

Even among manufacturers, however, RFID is a sleeping giant. OEMs could use it for regulatory compliance, in accordance with medical device tracking standards 21 CFR 821 and 820.70(g). Irwin Thall, RFID manager for healthcare at Precision Dynamics Corp. (San Fernando, CA), says that a lot of companies could use RFID for tracking. “We have one manufacturer who is using our wristband tags to have employees sign off on the production line. The information is automatically recorded and kept for FDA filing.”

But embedded tags used in the production stage would also allow manufacturers to go beyond compliance. “RFID allows for individual product pedigree—companies can trace each product, not just batches of product,” Sokol says. He identifies several aspects of the manufacturing process that can be improved by RFID. These include

• Better life cycle management.
• Reduced labor and time costs.
• More-complete and simultaneous FDA filing.
• Quicker firmware updates.
• Better exchanges of resources.

Beyond manufacturing is the potential for hospital use, which Sokol estimates could cut 10% from the $3.8 million spent in liability exposure. But with nursing and doctor shortages on the rise, Sokol wonders whether implementation is happening fast enough. “It should have happened last year. The government was supposed to allocate $25 million, but only gave a little less than $10 million.” With proper funding, Sokol expects RFID to be in use within the next five to seven years, with nearly 200 hospitals in the United States fully digitized by 2010.

So what can manufacturers do in the meantime? Keep abreast of newer technologies, for one thing, says Thall. He points to organic RFID to help manufacturers' success. Precision Dynamics has a partnership with Orfid Corp. (Los Angeles), a company researching polymer-based RFID. By replacing silicon-based transistors with polymeric ones, manufacturers may dramatically decrease the cost of embedded RFID, Thall says.

Sokol says the OEMs that most successfully use RFID will have a very specific business plan. Increasing profits with the technology may require manufacturers to adopt a strong digital infrastructure using the following strategies:

• Adopting a cohesive strategy for interacting with hospitals.
• Defining an accountability chain and allowing for external and internal communication.
• Having a complete hardware solution—quality management must be integrated with enterprise systems, and those need to integrate with products at an individual level.
• Creating a service support structure for hospitals.
• Designing Web-based healthcare
products based on harmonized standards and protocols.

To use RFID, early organization is the key to success for manufacturers, even if hospitals take 5 or 500 years to go live. OEMs cannot afford to wait for point-of-care use. “Using RFID requires a new way of doing business,” Thall says.

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