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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