FDA considers using RFID or bar codes to track medical devices

The Food and Drug Administration wants public input on the idea of using unique identifier (UID) systems, including bar codes and radio frequency identification (RFID) tags, to track medical devices such as external monitors, infusion pumps and implanted devices such as pacemakers.

Dr. Daniel Schultz, director of the FDA's center for devices and radiological health, said a unique device identifier 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.

Dr. Andrew von Eschenbach, acting FDA commissioner, said it is essential that the agency monitor the performance of medical products after they are approved to make sure it can quickly discover any potential problems that might arise.

The FDA said that UID systems could, for example, help clinicians determine whether different devices are safe to operate together -- deciding, for example, whether to use a magnetic resonance imaging system to examine a patient who has a pacemaker.

The FDA, in a notice published Aug. 11, said it wants comments from the public, the health care industry and medical device manufacturers on whether UIDs can help improve patient safety and whether to use bar codes or RFID tags.

In March, the FDA enacted a regulation requiring drug manufacturers to use bar codes on medications, saying it will allow health care professionals 'to use bar code scanning equipment to verify that the right drug'is given to the right patient at the right time.'

This June the FDA said it plans to require drug manufacturers to use RFID tags by the end of 2007 to establish an electronic pedigree to prevent counterfeiting.


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