FDA Requires Manufacturers to Track Home Infusion Pumps
The final rule, which appeared in the Feb. 8 Federal Register, is the latest refinement of a Food and Drug Administration (FDA) regulation that originally mandated the tracking of nearly 30 types of medical devices. In its present form, the rule calls for the tracking of 17 types of medical devices, including electromechanical infusion pumpsbut not elastomeric and gravity-flow pumpsthat are used in patients homes, physicians offices, and similar settings outside of health systems.
According to FDA's most recent guidance document (PDF) on the subject, published in 2000, only manufacturers that have received a "tracking order" from the agency must maintain a tracking system. FDA issues tracking orders for "life sustaining or life support" devices used outside of health systems as well as for devices that, if they fail, could cause serious health consequences.
The tracking system must enable the device's manufacturer to supply FDA, within three days of the agency's request, information about the whereabouts of the units still in distributors' possession. Within 10 days of the agency's request for information, the device's manufacturer must provide details on the units that have been distributed to patients. FDA expects home health agencies to keep records on the disposition of infusion pumps that must be tracked and to promptly report this information to the device's manufacturer.
Information that must be given to the manufacturer includes the devices serial number or similar identifier; the name, address, and telephone number of the devices distributor (a home health agency would be considered a distributor); the location of the device; and the name, address, and telephone number of the prescribing physician.
In the guidance document, FDA asked that the tracking information include the patients name, address, telephone number, and Social Security number. But FDA does not require that such personal information be reported back to the manufacturer unless the patients health or safety is at risk.
FDA acknowledged that patients can decline to have their device tracked and refuse to reveal personal information, such as their Social Security number. Such refusals must be documented and do not change the manufacturer's "obligation to account for the tracked device."
According to FDA, patients are not required to consent in writing to the tracking of their device or the release of their identity to the device's manufacturer.
Although the amended regulation was published as a final rule, it will be reviewed by the Office of Management and Budget and could change. FDA noted that it intends to publish in future editions of the Federal Register periodic updates regarding devices that must be tracked through the distribution chain.