Giving Pacemakers a second life

 

Background

Pacemakers and defibrillators are commonly implanted in France (respectively 75000 and 10000 devices per year) and in developed countries, thus helping to improve cardiovascular morbi-mortality, whereas in developing countries have limited access to life-saving medical technology. There are about 1 million people dying each year in the world due to lack of pacemakers.

Implantable devices are powered by batteries. Pacemakers have an average lifespan of around 8-10 years, and they are regularly explanted before batteries are used:

  • Should any unexpected complications arise, in particular infectious complications, devices may be replaced earlier. They may also be replaced by more efficient devices in order to improve pacemaker / defibrillation systems (upgrading).
  • Pacemakers are currently removed after death. Pacemaker explant is compulsory before cremation due to the risk of implosion and it is recommended as regards environmental impact.

Healthcare settings must collect many explanted Active Implantable Medical Devices (AIMD). Yet waste disposal both represents risk of infection (Infectious Healthcare Waste (IHW)) and risk of toxicity. Thus, explanted devices are currently returned to the manufacturer. The problem is the same for thanatopractitioners and funeral homes who rely on reprocessing companies which are specialized in hazardous waste management. Finally, a large number of non-defective explanted devices are thrown away because there are no organized humanitarian recycling networks.

Reusing explanted pacemakers is not allowed in France and in most of developed countries, whereas it is feasible, safe and efficient. Many studies have shown this technique is relevant as from 30 years. Such works were scientifically proven in 2011 through the first meta-analysis which was carried out on 2270 patients included in 18 essays. Ever since, the Sorin Pescariu team has published a series of retrospective case-control studies on 157 defibrillators and 127 cardiac rhythm management (CRM) devices which could be safely reimplanted.

Most often cooperation could arise from relationships which were woven when cardiologists came in France in order to follow training courses and then organized cardiac rhythm management (CRM) activity in their own country. Of course, we try to make sure that teams requiring devices are going through an honest process; and that patient selection criteria are respected, in both economic (rich or insured patients pay for the new devices they have received) and medical terms. Healthcare has evolved over the last 40 years, and among hospitals receiving donated pacemakers, Pondicherry (India) is the most regular partner thanks to the excellent relationships which have been built with JIPMER hospital physicians who are highly qualified and let us know about patients follow-up. Their newly published literature mentioned above is a vibrant plea for reusing explanted devices (Click here to read the article). Timisoara, Rumania, has long been a “privileged” healthcare center. It was the first hospital reimplanting defibrillators and biventricular pacemakers. Its integration into Europe put an end to reusing explanted medical devices. Vietnam, the Ivory Coast, Chili, Ecuador, Ethiopia…can also be quoted.

We would like to warmly thank our partners, not only cardiologists but also healthcare workers and technicians, who have been shipping donated pacemakers for many years, thus helping to create this solidarity chain and save human lives (link). We are also grateful to thanatopractitioners, mortuaries and funeral homes professionals who recently began to cooperate with STIM développement. This website will make it possible to regularly publish our donor list, in the same way as Stimucœur review used to (See letters to subscribers and activity reports).

 

 

Bibliography

Mugica J, Duconge R, Henry. Survival and mortality in 3,701 pacemaker patients: arguments in favor of pacemaker reuse. Pacing Clin Electrophysiol. 1986; 9: 1282-7.

Linde CL, Bocray A, Jonsson H, Rosenqvist M, Rådegran K, Rydén L. Re-used pacemakers: as safe as new? A retrospective case-control study. Eur Heart J. 1998; 19: 154-7.

Dodinot B. Que faut-il faire des stimulateurs et des défibrillateurs explantés ou périmés ? Stimucœur 2001 ; 29 : 166-8. Click here to read the article

Pescariu S, Stiubel M, Cozma D, Ioanovici T, Branea H, Luca CT, Luca C, Dragulescu STI. La reutilisation des pacemakers, une alternative pour les personnes âgées démunies. Etude rétrospective. Stimucœur 2003 ; 31 : 186-9. Click here to read the article

Balachander J, Anilkumar R, Sethuraman KR, Chandrasekhar S, Dodinot B. Efficacité et sécurité des stimulateurs reconditionnés : 17 ans de suivi d’un programme international de collaboration. Stimucœur 2003 ; 31 : 190-3. Click here to read the article

Baman TS, Romero A, Kirkpatrick JN, Romero J, Lange DC, Sison EO, Tangco RV, et al. Safety and efficacy of pacemaker reuse in underdeveloped nations; a case series. J Am coll Cardiol 2009; 54: 1557-8.

Baman TS, Kirkpatrick JN, Romero J, Gakenheimer L, Romero A, Lange DC, Nosowski R, et al. Pacemaker reuse: an initiative to alleviate the burden of symptomatic bradyarrhythmia in inpoverished nations around the world. Circulation 2010; 122: 1649-56.

Kirkpatrick JN, Papini C, Baman TS, Khota K, Eagle KA, Verdino RJ, Caplan AL. Reuse of pacemaker and defibrillators in developing  countries: logistical, legal, and ethical barriers and solutions. Heart Rhythm 2010; 7: 1623-7.

Romero J, Romero A, Kirkpatrick JN, Lange DC, Eagle KA, Baman TS. Pacemaker reuse in a 65 year old woman in the Philippines with severe medical need. Pace 2010; 33: e8-9.

Baman TS, Meier P, Romero J, Gakenheimer L, Kirkpatrick JN, Sovitch P, Oral H, Eagle KA. Safety of pacemaker reuse: a meta-analysis with implications for underserved nations. Circ Arrhythm Electrophysiol 2011; 4(3): 318-23.

Baman TS, Eagle KA. Cardiac device reutilization: Is it time to “go green” in underserved countries ? Pace 2011; 34: 651-2.

Hasan R, Ghanbari H, Feldman D, Menesses D, Rivas D, Zackhem NC, Duarte C, Machado C. Safety and performance of implanted recycled cardiac rhythm management devices in underpriviledged patients. Pacing Clin Electrophysiol 2011; 34: 653-8.

Gakenheimer L, Lange DC, Romero J, Kirkpatrick JN, Sovitch P, Oral H, Eagle KA, Baman TS. Societal views of pacemaker reutilization for those with untreated symptomatic bradycardia in underserved nations. J Interv Card Electrophysiol 2011; 30: 261-6.

Nouaille Degorce M. De la mort à la vie. Quand thanatopraxie et œuvre humanitaire se rencontrent. Résonance 2013 ; 86 : 38-41. Click here to read the article

Sosdean L, Mornos C, Enache B, Razvan I, Macarie RI, Ianos R, Stefea AM, Pescariu S. Safety and feasibility of biventricular devices reuse in general and elderly population – a single-center retrospective cohort study. Clinical Interventions in Aging 2015 ; 10 : 1311-18. Click here to read the article

Selvaraj RJ, Sakthivel R, Satheesh S, Ananthakrishna Pillai A, Sagnol P, Jouven X, Dodinot B, Balachander J. Reuse of pacemakers, defibrillators and cardiac resynchronisation devices. Heart Asia 2017;9:30–33. doi:10.1136/heartasia-2016-010828 Click here to read the article

Crawford TC, Eagle KA. Reuse of cardiac implantable electronic devices to improve and extend lives: a call to action. Heart Asia 2017;9:34–35. doi:10.1136/heartasia-2016-010835 Click here to read the article

Guidance for recycling of medical devices and frequently asked questions (FAQ)

  • Easy Procedures +

    For your convenience :

  • How to select « reusing » devices ? +

    We arbitrarily determined a time limit of less than 3 years as from implantation and a residual longevity of over 5 years – that is a pacemaker longevity lasting over 2/3 of its theoretical lifespan. A first sorting can be done by eliminating devices which commercialization end date is of over 3 years. We provide a list of Reusable Implantable Devices which is regularly updated by the association and that Funeral Home professionals and especially thanatopractitioners can read online:Reusable Implantable Devices List

    Nowadays, device interrogation makes it possible to obtain reliable information about pacemaker estimated longevity which must be evaluated in case of litigious value by suppressing algorithms that may forecast over-rated energy consumption of the pulse generator. We sometimes tackled the problem of pacemaker “pseudo-wear and tear” when a new device with a correct tension to the terminals of the battery showed a minimal residual longevity because it might have experienced a “cold shock”. Residual longevity finally got fixed by reprogramming the device in “standard” mode.

    Moreover, the examination of retrieved devices includes visual inspection in order to determine any alteration related to extraction, especially as regards connectors and set screws.

  • Must devices be disinfected before being shipped to STIM développement ? +

    Decontamination is necessary and sufficient. Explanted devices are steeped in a Salvanios® detergent/disinfectant bath for 15 minutes according to the requested dilution: 1 bag of 25 ml for 5l of water. Then devices are brushed, rinsed under clear water, dried, packed up and labeled with date of disinfection.

  • How to program devices ? +

    The objective is a “robust” pacemaker programming that can satisfy implanting health care facilities that cannot afford a programmer or bipolar electrodes. Moreover, it is useless programming minimal frequency and tension as anyway power consumption is low when there is no connection. Thus, in any case, we focus on safety by programming standard values: unipolar stimulation mode, 2.5-V output amplitude, neither autocapture nor power consumption algorithm. We make sure to delete the patient’s name from the device memory.

  • How to package devices and where to send them ? +

    Programmed and decontaminated pacemakers must be forwarded using a double-package airtight system with a compartment to put the device labelling away. As regards information provided with the device, disinfection must be mentioned and programmed parameters must be clearly indicated. The report which was edited by the programmer must indicate implant date, programmed parameters values, battery lifetime. Devices should be packed in a padded bag to protect them from external shocks and shipped by parcel post indifferently to:

    • Docteur Bernard DODINOT, STIMdéveloppement - Stimubanque, 1 rue Bel Air, 54520 Laxou - France
    • Docteur Pascal SAGNOL, Service de Cardiologie, Centre Hospitalier William Morey, 4 rue Capitaine Drillien, 71100 Chalon sur Saône - France
  • What about electrodes ? +

    Explanted electrodes can rarely be reusable due to pulling on the insulating material or difficult internal cleaning of the lumen.We mostly use devices that have reached their expiry dates or whose packages have been inadvertently open or accidentally broken.In such a case, thank you for thinking of STIM développement !Manufacturers sometimes provide us with such medical devices. We kindly thank our industry partners for thinking to give us such unselfish gifts without any trade compensation.

  • Does explanted device donation require patient’s consent ? +

    French law considers that patients own their implanted device, then their beneficial owners after patient’s death. Nevertheless, explanted devices cannot be given to their relatives for hygiene reasons and they must be discarded with Infectious Healthcare Waste (IHW).

    Experience shows that patients, or the family members of a deceased patient, do not oppose explanted device donation as long as they are informed about the possibility of reimplantation for humanitarian reuse. ANSM (the French Medicines and Health Products Safety Agency) simply requires there is no opposition to donation, but they do not require collecting written consent.

  • Is a convention necessary between the donating health care settings and STIM développement ? +

    There are no legal obligations imposed, but a convention may be established. This is meant as a reassurance for hospitals concerned with applying the precautionary principle. We keep at your disposal the convention which was signed with Chalon-sur-Saône hospital.

  • How are devices forwarded to implanting health care settings abroad ? +

    Device transportation tends to rely on the pouch service with the Ministry Of Foreign Affairs, where there is no opposition from the corresponding consulate, which makes it possible to avoid delicate situations when it is not easy to pass through the frontier. Without such a legal protection, device transportation is carried out by volunteers in order to pass through customs on the occasion of a trip (French cardiologists or cardiologists from the country concerned, relatives, patients’ families…).

  • How are devices sterilized before reimplantation ? +

    Only ethylene oxide sterilization is possible. Most developing countries implement this technique which is no longer available in France. No single pacemaker manufacturer will accept to re-sterilize pacemakers that would be shipped back to them. For a long time, a laboratory manufacturing pacemaker electrodes accepted to help us and sterilized devices free of charge before shipping them. Now sterilization is carried out over there.

  • What about the risk of transmitting the prion ? +

    Such a risk cannot be fully eliminated by ethylene oxide sterilization. This is a small, very long-term risk that must be compared with the expected short-term benefice for patients who are condemned to certain death of cardiac origin which could be avoided thanks to pacemaker implantation, a life-saving medical technology they would have no access to. The association considers that applying the precautionary principle to pacemaker implantation “for humanitarian reuse” would be extremely harmful and contrary to medical ethics.

  • Do humanitarian associations have similar goals in other developed countries? +

    Heartbeat International has collected pacemakers from manufacturers and hospitals as from 30 years in the United-States, and has shipped them to many disadvantaged countries.

    World Medical Relief established cooperation between Michigan University, funeral homes and hospitals in the Philippines and Vietnam.

    Pace4Life is a young association in Great-Britain collecting pacemakers mostly from funeral homes and forwarding them to Ghana and Pakistan.

    Project Pacer International

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