Reuse of Pacemakers‐The FDA's Viewpoint

Rahmoeller, Glenn A.

doi:10.1111/j.1540-8167.1985.tb01686.x

Cited by 2 publications

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“…The FDA which regulates medical devices and the manufacturers of those devices, not medical practice, did not discuss reuse of pacemakers in the United States. 27 Rather, it provided guidance for exporting refurbished or reprocessed devices for charitable use in underdeveloped countries. The FDA issued eight recommendations to physicians wanting to export pacemakers for reuse.…”

Section: New Cieds Near or Passed Due Date Of Implantationmentioning

confidence: 99%

“…Technical concerns arose 26 because there was little data about methods of sterilization, of assurances of integrity of the pacemaker power source, and properly conducted cost–benefit analysis studies. The FDA which regulates medical devices and the manufacturers of those devices, not medical practice, did not discuss reuse of pacemakers in the United States 27 . Rather, it provided guidance for exporting refurbished or reprocessed devices for charitable use in underdeveloped countries.…”

Section: Reuse Of Cardiac Pacemakersmentioning

confidence: 99%

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The reuse of cardiac pacemakers and defibrillators: A convoluted history in an era of global health

Lemery

2023

Cardiovasc electrophysiol

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Following the development of permanent transvenous cardiac pacing in the 1960s, the costs of pacemakers quickly led to their reuse in both developed countries and in low‐and middle‐income countries (LMIC). Legal, ethical, and industrial factors gradually resulted in the termination of reuse in developed countries. Without health care budgets to pay for costly pacemaker technologies, nongovernmental organizations (NGOs), and other groups have provided support to physicians and hospitals treating patients with heart block in LMICs. Multiple other academic and private groups have also assisted such patients in LMICs. Pacemaker companies have provided physicians and hospitals with new devices (that have an expired package date or through charitable donations). Greater care of preparing and cleaning refurbished devices have demonstrated overwhelmingly the safety and effectiveness of reused devices. More recently, cardiac resynchronization therapy and implantable cardioverter‐defibrillators have also been reused in patients in LMICs. While the globalization of noncommunicable diseases continues, patients with rhythm disorders in LMICs can no longer be left behind. While patients in developed countries only receive new devices to treat rhythm disorders, the practice of reused cardiac implantable electronic devices will expand in LMICs, until equal access to device technologies be made available to all.

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Section: New Cieds Near or Passed Due Date Of Implantationmentioning

confidence: 99%

Section: Reuse Of Cardiac Pacemakersmentioning

confidence: 99%

The reuse of cardiac pacemakers and defibrillators: A convoluted history in an era of global health

Lemery

2023

Cardiovasc electrophysiol

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“…Countries like Canada, Sweden, Switzerland, India, Israel and France allow pacemakers to be reused. In some countries, like the United States, re-use of pacemakers is not permitted although export of refurbished pulse generators may be allowed (Rahmoeller 1985; Conseil d'évaluation des technologies de la santé 1991). In other countries, like Australia, there has been little awareness of the practice and thus little discussion of the issues.…”

Section: Infectionmentioning

confidence: 99%

Issues affecting refurbishment and re-use of pacemakers

Jackson¹

1996

Aust. Health Review

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This paper discusses the problems associated with the refurbishing and re-use of medical devices which are sold by manufacturers as 'single use items' by focusing in particular on the re-use of pacemakers. Re-use of single-use devices such as pacemakers does occur in Australia, and in many other parts of the world, but there has been little public awareness of this fact. The paper explains and discloses medical, legal and ethical issues which arise through the re-use of pacemakers. It also discusses the recommendations of the 1995 'Draft report of the NHMRC Expert Panel on Re-Use of Medical Devices Labelled as Single Use'.

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Reuse of Pacemakers‐The FDA's Viewpoint

Cited by 2 publications

References 0 publications

The reuse of cardiac pacemakers and defibrillators: A convoluted history in an era of global health

The reuse of cardiac pacemakers and defibrillators: A convoluted history in an era of global health

Issues affecting refurbishment and re-use of pacemakers

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