US FDA issues White Paper on automatic identification of medical devices
31 August 2005
The US Food and Drug Administration (FDA) has issued a White Paper giving a
general overview of some of the most prevalent technologies for and the
issues involved in the automatic identification of medical devices. It
reviews the published positions and standards of the stakeholders in the
medical device industry and user community, and highlights some of the
general applications. It reviews the technology of barcode identification
systems and radiofrequency identification systems, how the technology is
being used with medical devices, the benefits of an automatic identification
program, unique device identifiers and standard medical device
nomenclatures.
The information was derived primarily from the published literature
supplemented with information from an FDA-sponsored workshop on automatic
identification of medical devices that was held April 14 and 15, 2005.
The paper concludes that the FDA needs to continue to seek input from a
range of stakeholders before deciding what action, if any, it needs to take.
It says that there are difficulties in legislating for automatic
identification of medical devices: "The lack of a universal, unique device
identifier is a key barrier to implementing automatic identification and
data capture technology, particularly as it relates to medical device
surveillance and risk assessment activities. This will be an essential focus
as FDA moves forward to develop a program for automatic identification
involving medical devices. A unique device identifier that incorporates, or
that is used in tandem with a standard medical device nomenclature offers a
number of opportunities for improving patient safety and medical device
surveillance at a number of levels, as well as supporting initiatives such
as the electronic medical record."
The full report is available at
www.fda.gov/cdrh/ocd/ecritask4.html
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