What are the barriers to reuse of pacemakers? (27/03/2013) Dr Peter Kabunga [email protected] Introduction Globally, the need for cardiac pacemaker (PPM) implantation continues to increase. (1)Unfortunately access to these life-saving therapies is currently limited or inexistent in some countries due to their high cost .One study (2) has reported that 19% of deceased patients possess a cardiac device although 85% of these devices are buried with these patients and about 84% of explanted devices are discarded as medical waste. Previous studies have estimated that $33,000 is saved by reusing a pacemakers compared with using a new device (3) .This therefore represents an opportunity to not only save resources but importantly alleviate suffering and prevent deaths. Several studies have now shown that reuse of pacemakers is feasible and safe. This reviews examines the barriers to implementation of this potentially life-saving strategy Safety A comprehensive meta-analysis by Baman et al (3) highlighted the fact that PPM reuse was previously routinely performed in many developed countries, indeed they point out that as recently as in 1996, reused pacemakers comprised 5% of all devices implanted in some developed European countries .The meta-analysis published in 20120 reviewed evidence from 18 studies involving 2270 patients .All studies used chemical sterilization protocols with ethylene oxide with an average follow up period of 35(range, 2 -76) months .The primary and secondary endpoints were PPM infection or device erosion and device malfunction respectively. 1.97% [1.15% to 3.00%] of patients developed infection following implantation with reused pacemakers with no significant difference when compared to those patients implanted with new devices (odds ratio, 1.31 (0.50 to 3.40], P=0.580) while 0.68% (0.27% to 1.28%) developed device malfunction. The increased risk malfunction in the reuse group was significant (P=0.002) [odds ratio, 5.80 [1.93 to 17.47],). The main cause of device malfunction was difficulties in the screwing mechanisms and other non-specified technical errors. The authors point out that these malfunctions probably resulted from damage during the extraction process and that current devices are more robust and less likely to get damaged. It’s also reasonable to argue that as all pacemakers are currently designed as ‘single use’ devices future designs incorporating a multiuse purpose facility could easily overcome this obstacle without an associated increase in overall device cost. Despite the overall favourable outcome of this meta- analysis it is important to point out (as highlighted by the authors) that only 5 of the 18 trials in meta-analysis had a direct comparison with new devices and analysis was based on non-randomized basis. In another study of 3,701 pacemaker patients by Mugica J et al, patients receiving reused devices had comparable survival to those receiving new ones at 10-year follow-up.(4) They concluded that reutilization of PPM did not appear to be detrimental to patients. Kantharia B, et al examined outcomes in patients in India implanted with 121 PPM donated by funeral homes in the United States. (5) 53 (11 single- and 42 dual-chamber) were deemed acceptable for reuse.37 were implanted in new pacemaker patients and 16 were implanted in patients who needed a replacement pulse generator. The primary indications for pacing were complete heart block (51%), and sick sinus syndrome (49%). None of the recipients of a reused device had a significant complication specifically infection or device malfunction after a mean follow-up of 661 days (range 19-1827). There were 4 deaths due to non-device related causes and the majority (95%) of patients reported symptomatic benefit. Nava S et al have recently published a study of 603 consecutive patients. 307 patients received reused PPMs while a control group of 296 patients received new PPMs. A combined end point of (a) unexpected battery depletion, (b) device infection and (c) device malfunction was analyzed. 85 PPMs had to be explanted, 31 in the control group (10.5%) and 54 in the reused PPM group [17.6%; relative risk (RR), 1.68; 95% confidence interval (CI), 1.1-2.5; P=0.02]. 43 patients reached the primary end point, 16 in the control group (5.5%) and 27 in the reused PPM group (7.2%; RR, 1.3; 95% CI, 0.70-2.45; P=0.794).Not surprisingly reused PPMs were more likely to have unexpected battery depletion (11 reused pacemakers (3.6% compared to 5 new PPMs (1.7%) (RR, 2.12; 95% CI, 0.75-6; P=0.116) while interestingly 3.7% new PPMs and 3.2% reused pacemakers had a procedure-related infection (RR, 0.87; 95% CI, 0.38-2.03; P=0.46) and 1 patient in the reused PPM group had a device malfunction related to the screwing in mechanism (6) Overall, numerous studies therefore report no associated incremental risk of infection if pacemakers are resterilized and re-implanted. Importantly no associated increase in mortality with a long follow up has been demonstrated although close follow up to detect malfunction is required. Device Manufacturers It has been argued that returning used devices manufacturers helps build an accurate performance database which may help improve the reliability, performance and safety of future devices. Reuse would however not prevent this as devices could still be returned to the device companies if and when they malfunction and are deemed unusable. Many modern pacemakers can now be wirelessly monitored without the need for explantation and one study has reported that 19% of deceased patients possess a cardiac device, but 85% of these devices are buried with these patients and about the majority (84%) of explanted devices are simply discarded as medical waste (7). Device companies also have to comply with regulatory authorities that currently stipulate that pacemakers are single use devices and they are manufactured and tested as such. These companies would be liable for device malfunctions for devices that where intended for single use. Would device manufacturers have an obligation to replace devices on a recall with new ones in patients with reused devices? The huge costs involved in bringing these devices to market also dictate that manufacturers will want to maximize returns on their investment. Financial return is potentially higher with single use devices. This is seen in everyday life when consumers are urged to buy the latest mobile phone with a camera, Television (High Definition + (HD +) as opposed to ‘ordinary’ HD) or other gadgets that replace perfectly functioning ones. Reusing medical devices prevents death and by prolonging life increases the number of patients who will need device replacements in the future. These same patients will often have other coexistent disease like coronary artery disease and will spend money, quite apart from a plain need to improve quality of life and prevent unnecessary death. Unanswered questions Many will argue that unlike reused clothes or other technological gadgets, it is fundamentally immoral to reuse medical devices. How many patients in high income countries would if given the choice choose a resterilized pacemaker? But why wouldn’t they if they were given the facts on safety and told that this practice was in fact not unusual in some European countries until about 20 years ago? Unfortunately, for many patients in under-developed nations the choice is one of either no pacemaker at all and certain misery and/or death and one of reusing a functioning cleaned device (which they also don’t have access to!). Could manufacturers be persuaded to make cheaper versions of medical devices which are able to perform basic essential functions of pacing, but could for instance not have the ability communicate wirelessly? Or even better, why can they not make existing devices affordable as is done with drugs such anti-retroviral therapies? A small study reported that up to 71% of the general public and 87% of patients [p<0.01] were willing to donate a PPM to people in need if they were given the chance. (7, 8) PPM procedure consent forms could have a specific question on whether patients would be willing to donate their pacemaker for reuse if they did not require it in the future. However, the performance of reused implantable cardioverter defibrillators (ICDs) has not adequately studied. These are much more expensive put potentially even more lifesaving. Medical devices have been described as the technical equivalent of therapeutic drugs. And as such once implanted, they need optimal programming and continuous monitoring to ensure that they achieve the desired effect. Many communities and countries unable to afford medical devices in the first place also lack this relevant essential infrastructure needed to run a full brady-pacing implantation service. Conclusion Several charities are currently are currently involved on small scale retrieval of used pacemakers for re sterilization and implantation for patients in poor countries unable to afford new devices. The main barriers to a large scale implementation of this practice are legal not technical or indeed ethical. Clinicians, hospitals and device manufacturers should be encouraged not restricted by regulatory authorities to recycle medical devices perhaps through regional ‘device banks’ for sterilization and eventual export to underserved communities who would keep a register of patients. There may even be a role for commercial (for– profit) medical recycling if this is rigorously regulated. It is morally unacceptable that we live in a world where people die of preventable conduction disorders like complete heart block while we continue to dispose of perfectly functioning devices with a large body of evidence showing reused pacemakers are safe. References 1. Mond HG, et al The 11th world survey of cardiac pacing and implantable cardioverter-defibrillators: calendar year 2009--a World Society of Arrhythmia's project Pacing Clin Electrophysiol. 2011 Aug;34(8):1013-27 2. Baman TS, Kirkpatrick JN, et al. Pacemaker reuse: an initiative to alleviate the burden of symptomatic bradyarrhythmia in impoverished nations around the world. Circulation. 2010; 122:1649-1656 3. Rosengarten M, Chiu R, Hoffman R. A prospective trial of new versus refurbished cardiac pacemakers: A Canadian experience. Can J Cardiol 1989; 5:155-160 4. Mugica J, Duconge R, Henry L. Survival and mortality in 3,701 pacemaker patients: arguments in favor of pacemaker reuse. Pacing Clin Electrophysiol. 1986; 9:1282-1287. 5. Kantharia B, Patel S, Kulkarni G, et al. Reuse of explanted permanent pacemakers donated by funeral homes. Am J Cardioll 2011 6. Nava S, Morales JL et al Reuse of Pacemakers: Comparison of Short and Long-term Performance. Circulation. 2013 Mar 19; 127(11):1177-83 7. Baman T, Kirkpatrick JN, Lange DC, et al. Post-mortem cardiac device retrieval for re-use in third world nations: views of funeral directors. Heart Rhythm Society 2009 Scientific Sessions; May 14, 2009; Boston, MA. Abstract AB20-5. 8. Lange DC, Kirkpatrick JN, Hakan O, et al. Post-mortem cardiac device retrieval for re-use in third world nations: views of the general public and patient population. Heart Rhythm Society 2009 Scientific Sessions; May 14, 2009; Boston, MA. Abstract 20-4.