The idea of the FDA mandating the barcoding of medical devices has
never struck me as particularly good. In the following open letter to
the FDA, Michael Depsey, founder and CTO of Radainse describes why he
thinks it's a bad idea.

Open Letter to FDA

By Michael Dempsey

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.

Sincerely,

Michael Dempsey
Chief Technology Officer
Radianse Inc.

The biggest issue I have with government mandated solutions is
the problem of trying to pick the technology that would be the long
term market winner. Picking market winners is almost always a losing
game, and in some markets a long term winner never appears. Legislation
mandating a specific technology is bound to have short lived benefits,
resulting in long term detriments to patients, hospitals and vendors.

UPDATE: Inspired by this and other recent RFID news, commenter Peter Charbonnier lets loose a rant on implantable RFID chips in this post.