Pacemaker reuse: an initiative to help those in underserved nations in need of life-saving device therapy

Hughey, Andrew B.; Baman, Timir S.; Eagle, Kim A.; Crawford, Thomas

doi:10.1586/17434440.2013.827519

Cited by 6 publications

(4 citation statements)

References 17 publications

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“…Rates of malfunction for reused devices have been found in prior studies to be no higher than that for new devices. The increased rate of malfunction found in the recent meta-analysis while concerning, is a risk believed to be acceptable for patients in dire need of bradyarrhythmia therapy in LMICs[10]. PMHYH is poised to conduct a prospective randomized, non-inferiority, multicenter study to confirm the clinical efficacy and safety of pacemaker reuse, for clinical and legal support.…”

Section: Resultsmentioning

confidence: 99%

Pacemaker recycling: A notion whose time has come

Runge

Baman

Davis

et al. 2017

WJC

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The purpose of this paper is to summarize the need, feasibility, safety, legality, and ethical perspectives of pacemaker reutilization in low- and middle-income countries (LMICs). It will also describe, in-depth, Project My Heart Your Heart (PMHYH) as a model for pacemaker reuse in LMICs. The primary source of the discussion points in this paper is a collection of 14 publications produced by the research team at the University of Michigan and its collaborative partners. The need for pacemaker reutilization in LMICs is evident. Numerous studies show that the concept of pacemaker reutilization in LMICs is feasible. Infection and device malfunction are the main concerns in regard to pacemaker reutilization, yet many studies have shown that pacemaker reuse is not associated with increased infection risk or higher mortality compared with new device implantation. Under the right circumstances, the ethical and legal bases for pacemaker reutilization are supported. PMHYH is a proof of concept pacemaker donation initiative that has allowed funeral home and crematory directors to send explanted devices to an academic center for evaluation and re-sterilization before donation to underserved patients in LMICs. The time is now to pursue large-scale studies and trials of pacemaker reuse for the betterment of society. PMHYH is leading the way in the effort and is poised to conduct a prospective randomized, non-inferiority, multicenter study to confirm the clinical efficacy and safety of pacemaker reuse, for clinical and legal support.

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Section: Resultsmentioning

confidence: 99%

Pacemaker recycling: A notion whose time has come

Runge

Baman

Davis

et al. 2017

WJC

Self Cite

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show abstract

“…14 Mais de sessenta mil aparelhos são explantados por ano nos Estados Unidos, e há uma estimativa de que cerca de 20% destes poderiam ser reutilizados, gerando um total anual de 10 a 12 mil aparelhos-ano. [15][16][17] Embora a doação de geradores de marca-passos seja viável, a reutilização de eletrodos é bem mais difícil. Eletrodos são, em geral, difíceis de serem retirados devido ao processo de fibrose causado ao longo do tempo após o seu implante, e a sua extração é potencialmente danosa a eles.…”

Section: Reutilização De Dispositivos Cardíacosunclassified

Reprocessamento de Marca-Passos em Países de Língua Portuguesa: Uma Reflexão Clínica

Lima¹,

Rocha²,

Damasceno³

et al. 2023

Arquivos Brasileiros De Cardiologia

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“…In fact, the US FDA has labeled pacemakers and defibrillators as "singleuse devices" and describes CIED reuse as an "objectionable practice," and there appears little enthusiasm among US manufacturers for a change in the federal perspective. 18,19 Nevertheless, we believe that a more sustainable approach to CIED reutilization is possible given that a majority of deceased hospital autopsy patients with CIEDs in the United States exhibit normal functionality and a remaining longevity estimate ≥4 years. For such an endeavor to be truly successful in both volume and quality, it would be most helpful for several interested academic medical centers to form a national "CIED donor network."…”

Section: Current Regulatory Climatementioning

confidence: 99%

“…We also agree with recent calls for regulatory exemptions to absolve manufacturers of liability for a product's long-term performance beyond the scope of its original single-use warranty when they endeavor to assist with quality control analysis as part of such humanitarian efforts. [17][18][19][20] …”

Section: Current Regulatory Climatementioning

confidence: 99%