Diagnostics & Imaging Week Washington Editor

WASHINGTON — The drug industry is now deep in the waters of track-and-trace (TnT) for chain-of-custody security and validation of pharmaceutical products.

In contrast, the device industry – including diagnostics – has had little reason to venture into the world of radio-frequency identification (RFID) and other methods of securing the supply chain, largely because counterfeiting has been principally the bane of drugs, not devices. However, TnT clearly is drawing near for makers of devices and diagnostics.

The FDA is asking for input on how a unique identifier system might be structured for devices, mainly in an effort to make recalls easier as well as to cut down on medical errors and improve adverse event reporting. Accompanying its statement was a federal register notice on the subject.

While the agency and the drug industry seem to have settled on RFID to track drugs, the agency's announcement mentions only that RFID and bar codes are among the technologies that are under consideration to augment paper records. The announcement and the notice both appeared on the FDA's web site last week, but the notice is not considered official until today, which makes Nov. 9 the last day of the 90-day comment period.

In the announcement, Dan Schultz, the director of the agency's Center for Devices and Radiological Health, formally reiterated the underlying logic by stating that "a unique device identifier [UDI] system could have broad applications in reducing medical errors, facilitating device recalls, improving medical device adverse event reporting and encouraging cost effectiveness by improving delivery and supply chain efficiency."

The agency's concerns also run to the use of implanted devices, including whether such a device might interact with magnetic resonance fields and other diagnostics and treatments that rely on various types of emissions.

The notice discusses an April 2005 meeting hosted by the Food and Drug Law Institute (FDLI; Washington) that drew out comments from a number of stakeholders.

According to the FDLI report, some of the pitfalls associated with any TnT system would include the potential for radio-frequency (RF) interaction with hospital equipment and the logistics of "developing an infrastructure to handle the data," a concern that also came up during drug TnT talks.

The FDLI report also notes that cost/benefit analyses precluded the listing of lot number and expiration date for drugs because "the costs of encoding such information exceeded the benefit," leaving the task of conveying such data to paper documentation.

Privacy was also a concern at the FDLI meeting as indicated by a passage that suggested that "experts in the implementation of the Health Insurance Portability and Accountability Act (HIPAA) should be addressed."

The agency indicated that it will work with other federal parties in this pursuit, including the Center for Medicare & Medicaid Services (Baltimore) and the Agency for Healthcare Research and Quality (Washington) to find out what issues they might have with device TnT.

Andrew von Eschenbach, acting FDA commissioner, chimed in as well, remarking that the agency wants to beef up post-marketing data collection as part of a "total product lifecycle approach to how we look at medical device. . . focusing more attention on the kinds of systems and processes we need to have in place to monitor products after they are approved."

The FDA's federal register notice suggests that any rollout of TnT for devices could incur downstream regulatory liability for device and diagnostics makers. The proposed data set for device identification includes the manufacturer, make and model as well as "unique attributes (e.g., size, length, quantity, software version)."

The notice says that "a change to any of the above criteria would likely necessitate a new UDI," even changes such as "different size or length catheters of the same type."

The Federal Communications Commission recently posted a notice of public inquiry that sought comment on its regulation of radio frequency emissions in hospitals pursuant to a rewrite of rules that affect medical devices that emit radio frequency signals.

Among the issues that FCC is examining is a reallocation of various portions of the spectrum for devices, with the range of 90 kHz to 110 kHz as a suggested slice of the spectral pie. FCC is taking comments between Oct. 31 and Dec. 4.

In a statement, Stephen Ubl, president/CEO of the Advanced Medical Technology Association (AdvaMed; Washington) said that he is "encouraged that FDA is taking a methodical approach to exploring the feasibility and utility of a unique identifier system" and is pleased that the agency seems uninterested in a "one-size-fits-all approach."

Ubl added that while industry sees the value in a UDI system, AdvaMed is of the opinion that mandatory identifiers "should only be required where there is a clearly defined patient safety issue . . . as was the case with the mandatory bar code rule for drugs."

Ubl noted that "devices are extremely variable in size, shape and materials . . . and do not lend themselves to a single method of identification. Given the range of medical devices, we continue to believe adoption of any standardized rules should be voluntary."