In addition to the recent FDA proposal to renew the Medical Device User Fee Modernization Act, Congress is pushing for further medical device legislation in the form of a unique device identification (UDI) system. Bar-coding rules were established for drugs in 2004, but medical devices were excluded from the legislation due to cost, size constraints, technical hurdles, and the number of devices on the market.

Not only are these concerns as pertinent today as they were when medical device UDIs were initially proposed, but the benefits to patients, healthcare providers, and industry remain unclear, making the recent congressional push for a UDI mandate all the more curious.

Best Potential Application The best potential application for unique device identifiers lies in the field of retained foreign bodies, primarily surgical sponges. Bar-coded sponges and those using RFID tracking currently are being marketed to healthcare facilities. But the question is whether potential patient safety (secondary operation, mortality) and cost (O.R. time, litigation) benefits outweigh the price of these systems.

Preliminary estimates show that the first year of UDI implantation alone would cost healthcare facilities nearly $2 billion, with another $500 million in training and maintenance expense in each subsequent year. In contrast, the annual savings from UDI is estimated to be $35 million, with most of the savings coming in the form of reduced staff hours spent searching for and segregating recalled devices. With today's emphasis on evidence-based medicine, many healthcare facilities are reluctant to spend large sums in hopes of reaping such hypothetical cost savings.

Limitations In Technology Technological limitations also make UDI impractical. Bar codes are easily printed on a variety of packaging materials, but integrating them onto small devices or those with unusual geometries remains a significant challenge. Bar codes must be fully in tact, well-defined, and visible to be accurately scanned. Bar coding is likely to be an impractical and obsolete technology for UDI applications in the future due to improvements in radiofrequency identification (RFID).

RFID tags possess a much better read rate, do not require direct line of sight, and can contain much more information than bar codes. But they cost more and, unlike bar codes that can be printed directly upon a device, cannot be made integral to existing devices without vast design and manufacturing changes. These changes, as well as proving that the tag is reliably affixed to the device, will require revalidation of the majority of devices.

It is well accepted that medication errors occur all too frequently and sometimes with dire consequences. It has been estimated recently that such incidents harm 1.5 million people at a cost $3.5 billion annually, illustrating the need for accurate identification of all pharmaceuticals. However, a similar correlation has not been shown between misidentifying medical devices and patient safety. Also, single-use devices, unlike pharmaceuticals, are subject to reuse and reprocessing and it remains unclear how these situations would be addressed.

FDA Exemptions Would Be Needed Just as the FDA exempts certain Class I and Class II devices from 510(k) submissions, similar exemptions would certainly have to be made for UDIs to be practical for medical devices. Just as all drugs are not equal in magnitude of effect or potency, e.g., acetaminophen vs. oxycodone, not all devices are equal in determining surgical success or post-operative quality of life. While some Class I and Class II devices such as skin markers and surgical drapes are vital to patient safety, it is unlikely that these products warrant the time and expense required to incorporate a UDI.

Without screening devices for applicability, it is conceivable that larger medical device manufacturers would have to redesign, revalidate, and repackage thousands of product codes and at great expense. One must also consider the time and cost of revising and retranslating thousands of pieces of artwork and instructions for use as part of this process. These increases in front-end cost will assuredly be augmented by increasing sales prices to hospitals and surgical centers, thus diminishing any cost savings that these facilities would potentially reap from UDI systems.

Ultimately, the time, effort, and cost of unique device identifiers do not result in safer, more cost-effective, and more clinically efficacious products with reduced probabilities of recall, but instead make it easier to identify these products should they be recalled. While it is acknowledged that improvements can and should be made to the processes of device recalls and adverse event reporting, a far greater benefit would be realized from creating devices that improve patient safety and outcomes rather than making it easier to track those that do not.

About the Author

Perry De Fazio is an analyst for Tolland, Conn.-based Nerac Inc., a research and advisory firm for companies developing innovative products and technologies. He advises medical device companies on subjects ranging from technology licensing, development and patenting to medical device regulations and competitive technical intelligence. For information, please visit www.nerac.com.