Reuse Of Pacemakers Research Articles

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

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-defibrillatorshave 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 deviceswill expand in LMICs, until equal access to device technologies be made available to all.

Pacemaker Reuse in Portuguese Speaking Countries: A Clinical Reflection.

There is a gap between high-income countries and others in terms of access to medical cardiac devices, such as pacemakers and implantable cardioverter defibrillators. Costs are one of the main barriers to the use of cardiac devices in these countries. There are international initiatives that aim to reduce the gap. The reuse of pacemakers has been discussed as a possible alternative to this problem. The concept of reusing pacemakers is not new; however, recent studies have proven to be safe, ethical, and effective for those who need cardiac implantable electronic devices and cannot afford them. Part of the Portuguese-speaking countries, especially in Africa, need an immediate response that benefits their countless patients who suffer from treatable arrhythmias.

Cadaveric Donation and Post-mortem Reuse of Pacemakers and Defibrillators in Nepal: Medical, Legal and Ethical Challenges

Cardiovascular diseases (CVDs) are the number one cause of death globally. An estimated 17.5 million people died from CVDs in 2012, representing 31% of all global deaths. Over three quarters of all deaths related CVDs take place in low- and middle-income countries (LMICs). Studies have estimated that 1 to 2 million people worldwide die each year due to lack of access to cardiac rhythm management devices (CRMDs) i.e. implantable cardiac defibrillator (ICD) or a pacemaker. The principal challenge is the high cost of these devices and the resource constraint in LMICs. A growing body of literature, mostly single center, uncontrolled and retrospective studies has suggested reuse of CRMDs from deceased donors as a safe and effective alternative. This paper seeks to propose the concept of post-mortem CRMD donation and reutilization program within Nepal as a life-saving initiative. Though the spirit of the program is in line with the ethical principles of respect for persons, beneficence, justice, and the common good, it is challenged with several logistical barriers and legal concerns. In this paper we have discussed the clinical, legal and ethical perspectives with a literature review on similar programs.

Reuse Of Pacemakers In Ghana And Nigeria: Medical, Legal, Cultural And Ethical Perspectives

According to the World Health Organization (WHO) cardiovascular disease (CVD) is the leading cause of death globally. Over 80% of CVD deaths take place in low- and middle-income countries (LMICs). It is estimated that 1 million to 2 million people worldwide die each year due to lack of access to an implantable cardiac defibrillator (ICD) or a pacemaker. Despite the medical, legal, cultural and ethical controversies surrounding the pacemaker reutilization, studies done so far on the reuse of postmortem pacemakers show it to be safe and effective with an infection rate of 1.97% and device malfunction rate of 0.68%. Pacemaker reutilization can be effectively and safely done and does not pose significant additional risk to the recipient. Heart patients with reused pacemakers have an improved quality of life compared to those without pacemakers. The thesis of this paper is that pacemaker reutilization is a life-saving initiative in LMICs of Nigeria and Ghana. It is cost effective; consistent with the principles of beneficence, nonmaleficence, and justice with a commitment to stewardship of resources and the Common Good. Used pacemakers with adequate battery life can be properly sterilized for use by patients in LMICs who cannot afford the cost of a new pacemaker.

EP News: Clinical

Nava et al (Circulation 2013;127:1177, PMID 2342610) prospectively assessed the reuse of pacemakers in a cohort of consecutive patients and a control group. Six hundred three consecutive patients were evaluated in a noninferiority study, including 307 patients receiving resterilized pacemakers and 296 patients receiving a new pacemaker. A composite end point of unexpected battery depletion, infection, and device dysfunction was analyzed. Eighty-five pacemakers had to be explanted: 31 (10.5%) in the control group and 54 (17.6%) in the study group (hazard ratio [HR] 1.68; P = .02). Forty-three reached the primary end point: 16 (5.5%) in the control group and 27 (7.2%) in the study group (HR 1.3; P = .794). Five (1.7%) new pacemakers and 11 (3.6%) resterilized pacemakers had unexpected battery depletion (HR 2.12; P = .116); 3.7% new pacemakers and 3.2% reused pacemakers had a procedure-related infection (HR 0.87; P = .46). The authors conclude that pacemaker reuse is feasible and safe option. Other than the expected shorter battery life, the reuse of pacemaker generators is not inferior to the use of new devices.

Reuse of pacemakers and defibrillators in developing countries: Logistical, legal, and ethical barriers and solutions

In the wealthy nations of the world, access to implantable cardiac rhythm management devices is widespread. In many underserved low- and middle-income countries (LMIC), where cardiovascular disease is fast becoming a major public health problem, access is often limited. Reuse of pulse generators was practiced regularly in some European nations in the 1990s with good results. It is performed in LMIC, although the rates of device reuse are unknown. The available literature suggests there is no increased risk of morbidity or mortality with the reuse of devices. Donations of pacemaker and defibrillator pulse generators from developed nations constitute an important source of devices for the poor in LMIC. There are opportunities to increase this supply, but logistical barriers and legal and ethical concerns must be addressed. With proper sterilization, meticulous chains of custody, and advance directives for device handling (pacemaker/defibrillator living wills), patients in LMIC who would otherwise lack access to these devices could benefit from their reuse.

Reuse of Electrode Catheters and Pacemakers

A B S T R A C T Reuse of electrophysiology catheters and pacemaker devices has been practiced safely in several countries with significant cost-savings. Data from the literature evaluating clinical end-points, device-related complications, such as infections, and mechanical performance, suggest that this is a safe practice with no increased risk of complications or mortality. However, there remain practical, legal and ethical concerns which need to be addressed before a more widespread use of such practice is adopted. Also, protocols for validation of cleaning and sterilization, and estimations of the potential risks of infective agent transmission need to be more rigorous.

Reuse of angioplasty catheters and risk of Creutzfeldt-Jakob disease

Background In 1996, the Quebec Ministry of Health and Social Services, concerned that reuse of devices contaminated with blood or blood products could cause the transmission of Creutzfeldt-Jakob disease (CJD), discontinued its practice of reusing angioplasty catheters despite the significant cost savings reuse had afforded the health care system for several years. The objective of this study was to establish whether the medical literature provides documentation of any cases in which CJD was transmitted by reused percutaneous transluminal coronary angioplasty (PTCA) equipment. Methods and Results A Medline search was performed to identify previous studies that examined this issue. Key words for the search included PTCA, CJD, and material and equipment reuse. A substantial amount of effort has been spent on the study of PTCA catheter reuse in relation to the risk of infection, toxicity, and catheter breakage as well as cost. In Québec, studies by the Conseil d’Évaluation des Technologies de la Santé investigated the effectiveness of cleaning and sterilizing PTCA equipment and considered the possibility that reuse of single-use catheters, hemodialyzers, and cardiac pacemakers could spread CJD. A number of other studies found evidence that iatrogenic transmission was responsible for several cases of CJD by direct implantation in or adjacent to the central nervous system during neurosurgery. CJD was also transmitted to human beings by injection of pituitary growth hormone and to mice through cerebral inoculation of contaminated blood and urine. However, there were no documented cases of CJD occurring as a complication of PTCA equipment reuse. Conclusions The current literature indicates that there are no known cases of CJD attributable to the reuse of PTCA devices contaminated by blood or to the transfusion of blood or blood products. This practice is associated with a very low risk of CJD transmission. With the considerable cost savings made possible by reuse of PTCA equipment, reimplementation of this practice should be considered by health delivery systems, provided that stringent methods of cleaning and sterilization are observed. (Am Heart J 1999;137:1173-8.)

Re-used pacemakers--as safe as new? A retrospective case-control study.

Re-use of pacemakers is of interest in an era of declining health care resources if it is proven safe and without risks to the patients. In order to investigate the safety of re-use of pacemakers we performed a retrospective case-control study. One hundred patients, who received a re-used pacemaker, were matched for date of implantation and mode (AAI; VVI; DDD) to 100 others who received a newly manufactured pacemaker and were followed for a mean of 32 +/- 11 months for complications defined as infections and signs of pacemaker malfunction and pacemaker replacement earlier than anticipated due to battery depletion. Patients who received re-used pacemakers were significantly older than those who received new units (79 +/- 9 vs 68 +/- 21 years; P < 0.0001). The number of complications did not differ significantly between groups. There were no early replacements due to battery depletion in either of the two groups. A cost-benefit analysis revealed a substantial economical advantage. The re-use of pacemakers can be carried out without increased risk to the patients provided a proper routine for technical control and sterilization is followed. Re-use means substantial savings which possibly could make advanced pacemaker treatment available to all eligible patients irrespective of age. Whether re-use is feasible with implantable defibrillators remains to be determined.

Issues affecting refurbishment and re-use of pacemakers.

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'.

Reuse of Cardiac Pacemakers: Legal Implications

Clinical Progress in Electrophysiology and PacingVolume 3, Issue 1 p. 48-52 Reuse of Cardiac Pacemakers: Legal Implications MAX DOUGLAS BROWN, MAX DOUGLAS BROWN From the Office of Legal Affairs, Rush-Presbyterian-St. Lukés Medical Center, and Health Systems Management Department, College of Health Sciences, Rush University, Chicago, IllinoisSearch for more papers by this author MAX DOUGLAS BROWN, MAX DOUGLAS BROWN From the Office of Legal Affairs, Rush-Presbyterian-St. Lukés Medical Center, and Health Systems Management Department, College of Health Sciences, Rush University, Chicago, IllinoisSearch for more papers by this author First published: February 1985 https://doi.org/10.1111/j.1540-8167.1985.tb01688.xCitations: 1AboutPDF ToolsRequest permissionExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL Share a linkShare onFacebookTwitterLinkedInRedditWechat Citing Literature Volume3, Issue1February 1985Pages 48-52 RelatedInformation

Proceedings of the Policy Conference of the North American Society of Pacing and Electrophysiology on the Reuse of Cardiac Pacemakers*

Proceedings of the Policy Conference of the North American Society of Pacing and Electrophysiology on the Reuse of Cardiac Pacemakers*

Reasoning about madness

Cardiac pacemakers are part of a growing group of expensive implantable electronic devices; hospitals in which 100 pacemakers are implanted per year must budget over $300 000 for these devices. This cost represents a considerable burden to health care resources. Since the "life-span" of modern pacemakers often exceeds that of the patients who receive them, the recovery and reuse of these devices seems logical. Pacemakers can be resterilized and tested with current hospital procedures. Reuse should be acceptable under Canadian law, but the manner in which the pacemakers are recovered and the patients selected should follow careful guidelines. Every patient should provide written informed consent before receiving a recovered pacemaker. Properly executed, reuse of pacemakers should provide a high level of health care while maintaining or reducing the cost of these devices.