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Open Letter to FDA

The Honorable Lester Crawford, Acting Commissioner
Food and Drug Administration
5600 Fisher Lane
Parklawn Bldg., Rm 14-7
Rockville, MD 20857

July 19, 2005

Dear Acting Commissioner Crawford:

Recently several members of the U.S. House of Representatives, the American Hospital Association, and several other leading national healthcare organizations have written to you encouraging swift action to require bar codes on medical devices as a way to promote patient safety, cost effectiveness, and supply chain efficiency. They urged you to reconsider this issue after bar-coding of medical devices was excluded from the Food and Drug Administration's final rule in February 2004 requiring bar codes on hospital-administered medications and biologics.

We applaud them for their efforts to encourage safety, quality, and efficiency in healthcare, but we believe their approach is shortsighted because it limits the solution to a particular technology rather than addressing the real need: to be able to immediately and accurately identify medical devices in the context of the healthcare environment.

The issue is not whether bar codes have value. They clearly do, but bar coding is only one tool in a larger technology array available today that can automate the identification of equipment in space and time. This solution also includes passive and active radio frequency identification (RFID), which are used for locating and managing medications, equipment -- or patients and staff -- within the complex and interdependent healthcare environment. Limiting a solution to bar codes today ignores the tremendous strides in wireless technology we have made since bar codes were first introduced in healthcare two decades ago.

What healthcare desperately needs is a logical framework for understanding how bar codes, RFID, and other wireless technologies can all be best used for the benefit of care. This is not about a single technology but about creating a new, wireless-enabled care environment.

By focusing on changes in context -- the location, identity, and time associated with a person or object -- healthcare can create "smart" clinical systems and spaces and "intelligent" responses from machines that can dramatically improve quality and efficiency of care. Devices can be made to alert staff, for example, if they are moved from one location to another.

Bar code, passive-RFID, and active-RFID systems all have their strengths and weaknesses. By considering the larger context rather than a single technology, we have a framework for understanding how they can all be best used to track devices as well as drugs, patients, and staff in healthcare. We strongly believe that any requirement for automated identification of medical devices should focus on patient safety and therefore remain technology agnostic.

We invite you to join us in a collaborative effort to educate the healthcare industry on how to leverage all the available technologies for identifying medical devices.


Michael Dempsey
Chief Technology Officer
Radianse Inc.
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