Pacemaker Reutilization for Those in Underserved Nations
Pacemaker Reutilization for Those in Underserved Nations
The reuse of pacemakers was initially supported by the National Association for Sport and Physical Education with a conclusion in 1985 stating that pacemaker reuse is reasonably safe. Moreover, the American College of Cardiology/American Heart Association/National Association for Sport and Physical Education later acknowledged that pacemaker reuse "may eventually add significantly to the cost–effectiveness of cardiac pacing".
However, the current FDA regulations prohibit device reutilization as it is regulated as a class III device that is not to undergo resterilization with subsequent distribution. Proposed methods to address the regulatory concerns included shipping the device 'unprocessed' as a hazardous material with no intention of human use, thus leaving the onus of sterilization, testing and manufacturing for the overseas recipient institutions. This approach may place a heavy burden on the less-able and underfinanced party. Another approach is to file for FDA approval for potential exportation of resterilized devices only to those in need in undeserved nations. Currently, PMHYH is working with the FDA in order to provide a legal framework in the form of an investigational device exemption for those interested in providing this valuable resource to those in underserved nations.
Legal & Regulatory Aspects
The reuse of pacemakers was initially supported by the National Association for Sport and Physical Education with a conclusion in 1985 stating that pacemaker reuse is reasonably safe. Moreover, the American College of Cardiology/American Heart Association/National Association for Sport and Physical Education later acknowledged that pacemaker reuse "may eventually add significantly to the cost–effectiveness of cardiac pacing".
However, the current FDA regulations prohibit device reutilization as it is regulated as a class III device that is not to undergo resterilization with subsequent distribution. Proposed methods to address the regulatory concerns included shipping the device 'unprocessed' as a hazardous material with no intention of human use, thus leaving the onus of sterilization, testing and manufacturing for the overseas recipient institutions. This approach may place a heavy burden on the less-able and underfinanced party. Another approach is to file for FDA approval for potential exportation of resterilized devices only to those in need in undeserved nations. Currently, PMHYH is working with the FDA in order to provide a legal framework in the form of an investigational device exemption for those interested in providing this valuable resource to those in underserved nations.
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