Medical Device Link.

Originally Published PMPN March 2004

Interview

Dan Mullen president AIM Global

Ever since Wal-Mart asked its top-tier suppliers to place radio-frequency identification (RFID) tags on all cases and pallets shipped to the retail giant by 2005, interest in RFID has skyrocketed. At WestPack 2004, for instance, nearly every label printer provider touted capabilities to write and apply RFID tags as well. The technology promises to help facilitate inventory tracking at all points of the supply chain.

But will RFID have the same utility in pharmaceutical and medical device packaging? Dan Mullen, president of AIM Global, a global trade association and worldwide authority on automatic identification, explains in the following interview with PMP News editor Daphne Allen how RFID will find its way onto healthcare product packages.

Why is there a lot of interest in RFID?

Mullen: The recent, sudden interest has been generated by publicity about EPC [Electronic Product Code] and the announcements by Wal-Mart and the Department of Defense (DoD). But RFID has been successfully used in many applications for years.

The major advancement in RFID has been the development of globally acceptable open standards. In the past, the growth of RFID had been somewhat limited because of proprietary technologies. Many major users were reluctant to get locked into products from only one company. Open standards make it possible for multiple vendors to produce compatible tags and readers. AIM, the Association for Automatic Identification and Mobility, has long been an active proponent of such standards and has supported a variety of standards activities. International standards, under the auspices of ISO, have been developed and published. 

In addition, a new generation of tags using “backscatter” technology has dramatically reduced costs, making tags easier to justify in many applications. Although we may never see the five-cent tag, costs are coming down.

The use of RFID for pharmaceuticals is not just hypothetical. It will happen. Any company supplying pharmaceuticals to the DoD will have to RFID label shipments as a contract requirement. Also, the Healthcare Distribution Management Association has recognized the benefits of RFID and in December 2003 issued a recommendation that all distribution units be labeled with RFID by the end of 2005.

What benefits does RFID offer to the pharmaceutical industry?

Mullen: RFID labels can be applied at several levels in the pharmaceutical industry, each level providing additional security. Internally, reusable RFID tags can be used to track bulk items within the facility to provide a total audit trail.

RFID labels on cartons can provide total asset visibility throughout the supply chain. Because RFID is a passive, or automatic, technology, cartons or pallets can be identified as they are moved within a facility, loaded for transport, unloaded, and stored. The site of any product diversion can be more easily identified using RFID, particularly if an RFID reader is installed inside a truck or trailer.

RFID security seals can be used to instantly alert yard personnel to any breach of a sealed container. If integrated with a cab-mounted mobile communications system and GPS, security breaches or diversion of the truck can be immediately transmitted to a central facility.

And, RFID tags are virtually impossible to counterfeit. Labeling with tamper-evident RFID tags could help prevent counterfeit drugs from entering the supply chain.

What do manufacturers need to do to prepare themselves to apply RFID tags to their packages?

Mullen: Manufacturers should familiarize themselves with EPC standards, since those will be required by both Wal-Mart and the DoD. EPC, as proposed, is an integrated technology, communications, and coding standard.

On the technology side, EPC-compliant tags operate in the 900-MHz range. Manufacturers should be aware that not all available smart labels and label printer/encoders are EPC compliant. EPC labels can be produced on a variety of on-demand bar code printer/encoders, or they can be produced off-line and applied with a standard label applicator. Manufacturers should look at various labeling options to determine which is most cost-effective for their operation. They must also institute a label/tag verification program in addition to a bar code verification program to ensure that the RFID label is properly encoded, has the correct data and format, and is readable.

Is RFID more affordable these days?

Mullen: The cost of the most current generation of RFID tags and readers has come down considerably in the past few years. Part of the cost reduction is due to the advent of “backscatter” tag technology that is less expensive to produce. Additionally, higher-frequency tags can take advantage of relatively inexpensive foil antennas or those printed with conductive ink. These are much less expensive than the coiled-wire antennas previously used.

It’s important to realize that not all RFID tags are designed to be disposable. Rewritable tags that can be used and reused for five years or more are extremely cost-effective on a cost-per-use basis. A $50 tag that is read five thousand times over its life has a cost-per-use of one cent. Operational cost savings could make that tag less expensive to use than disposable bar codes.

What is AIM Global doing to educate manufacturers on RFID?

Mullen: AIM Global has two major functions: standards development and education. AIM is conducting regional educational sessions on RFID in 2004, and AIM actively partners with a variety of organizations to provide high-level, impartial education through its Speakers Bureau and cosponsored educational events. 

AIM also publishes the monthly RFID Connections e-newsletter to provide balanced and unbiased news and provide perspective on current events in RFID technology, standards, and applications. AIM has published a number of white papers and articles on RFID technology.

Finally, AIM provides information on the entire range of RFID solutions available, not just EPC. AIM continues to seek new venues and partnerships to educate potential users on RFID technology.

What steps is it undertaking to ease RFID use?

Mullen: AIM has long been an advocate of open standards. AIM’s support of standards activities has helped make multisourced products available. The availability of standardized products makes it easier for companies to implement RFID without fear of being locked into a proprietary standard. AIM has worked with a number of organizations to educate their members on the technology, benefits, limitations, and proper applications of RFID technology.

What will RFID be like in 5 years? 10 years?

Mullen: There are two views on that. One view is that RFID will be essentially the same as it is now, only smaller, faster, smarter, better, and cheaper. Considering that 2005 will be the year when RFID is widely deployed, it will take five and even 10 years to become as well accepted as bar codes. 

The other view is that technology will continue to amaze us and that advances in the design and manufacture of RFID tags will make today’s tags seem as old-fashioned as the first cell phones. 

Both views are probably correct.

Will RFID replace the bar code?

Mullen: It is unlikely that RFID will replace bar codes for many items. For pallet and carton identification, RFID will coexist with bar codes on smart labels for some years to come. The primary reason for this is that not everyone will be able to change over from bar code reading to RFID in all parts of an operation. It is also likely that it will take some years for all manufacturers to universally apply RFID labels. Therefore, there will still be many places where bar codes will need to be read.

For pharmaceuticals, particularly for scheduled medications, there is a greater justification than simple economics. Patient safety as well as regulatory and record-keeping compliance may prompt RFID labeling down to the level of bulk containers, such as those used in healthcare dispensing. Automatic matching of the medication to the prescription or doctor order will help eliminate any possible medication or dosage error. For unit-of-use pharmaceuticals, though, it is unlikely that the current RFID technology will be able to replace bar codes.

At some point in the future of the pharmaceutical industry, RFID might replace bar codes. However, the pharmaceutical industry is just now applying bar codes to unit doses, more than 30 years after the introduction of the UPC. Admittedly, one of the major impediments to such labeling was the lack of a suitable symbology. Now that Reduced Space Symbology Limited/ Composite and Data Matrix are available, that issue has been solved.

However, it’s conceivable that we will see imagers, similar to those now used to read Data Matrix, being used to interpret the human-readable elements on unit-of-use packaging and that we will do away with machine-readable codes completely. 

For more information about AIM and RFID, please visit www.aimglobal.org or www.rfid.org. 

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