Posted September 19, 2007
Funeral Home Transport and Shipping of Pacemakers and Defibrillators
Over the past few months, issues concerning the legality of funeral homes that donate pacemakers and defibrillators removed from dead bodies prior to cremation to charitable organizations have arisen
NFDA representatives have reviewed applicable law regarding the shipping of pacemakers and defibrillators from funeral directors to other organizations within the United States. There are two scenarios in which this may occur: (1) shipping to charitable organizations that then send the device overseas for use or (2) shipping the medical devices back to their respective manufacturers.
Under relevant federal laws, funeral directors may not ship medical devices within the United States. Any person who “furthers the distribution of a device from the original place of manufacture to the person who makes delivery to the ultimate user” is considered a “distributor,” i.e. , any person who moves the device from the original manufacturer to the patient is considered a distributor. Device distributors are subject to many federal and state statutory requirements, not the least of which are licensing and recordkeeping requirements. The statutes do not currently have any “charitable use” exception for distribution requirements; in fact, the relevant statute specifically imposes the same requirements on the charitable distribution of devices. Therefore, funeral directors that ship devices to a charitable organization are violating device distribution laws and are at risk for sanctions.
NFDA representatives confirmed the above analysis with the federal Food and Drug Administration (FDA). Neither the fact that there is no money exchanged nor that the devices are to be used for humanitarian purposes would make this activity legal. FDA stated that, while it has some level of discretion in circumstances involving charitable donations of devices, FDA could not endorse this activity or state there was no risk of enforcement in this area.
In contrast, based on laws and regulations, shipping medical devices back to the manufacturer does not appear to fall within the definition of “distribution.” Returning a used device to it manufacturer appears to “break the chain” of distribution to the ultimate user.
The FDA confirmed that it does not consider the return of a used device to the manufacturer as “distribution.” FDA is concerned with the proper labeling of the device, if funeral directors ship devices. FDA stated that it assumed that if the manufacturer was providing pre-labeled packages for return of the devices, the devices would be labeled pursuant to laws and regulations, as manufacturers are familiar with FDA laws and regulations. However, where the original manufacturer supplies the pre-labeled package for the device, we would recommend that the funeral director receive some type of written assurance from the manufacturer that the package is properly labeled and follows all applicable laws and regulations.
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