The Refurbished Puise Generator

Abstract

With the advent of long-life lithium pulse generators, normally functioning pulse generators with a potential life of more than five years have been removed from patients and become available for re-implantation. Although pulse generator refurbishing is widely employed, the practice has not been accepted in the United States. At The Royal Melbourne Hospital, all lithium pulse generators removed because of patient death or other causes were washed in a quaternary ammonium compound and soaked in formaldehyde. Pulse generators were than electronically tested and, if within specification, were made available for re-implantation. Pulse generators were then washed under sterile conditions in distilled water and gas-sterilized with ethylene oxide. Between 1975 and 1978 (48 months), 600 pulse generators were implanted and 93 pulse generators removed. There were 56 deaths, 22 cases of pre-erosion, erosion, or infection and 15 elective removals either due to lead problems or impending power source depletion. Eight-three (89%) pulse generators were refurbished (14% of total implants). This included 12 pulse generators refurbished on two occasions. Ten pulse generators were returned to manufacturers, seven because of impending power source depletion, two with suspected electronic faults, and one with a damaged case. Two complications occurred in patients with refurbished pulse generators. An infective process present with the previous pulse generator spread to a new pocket. The other pulse generator was removed 35 months post second implantation because of impending power source depletion. Primary infection or unusual tissue reactions did not occur. Pulse generator refurbishing as described was found to be a safe and economic procedure.

Reuse of pacemakers, defibrillators and cardiac resynchronisation devices

“…This early device infection warranting device explantation was addressed in one study, where mean time period between device implantation and explantation was 52 days 18. Patients over 80 years of age comprise 32% of pacemaker implants in developed countries 19. Although survival rates after implant vary with population characteristics, the 5-year mortality rate for patients with pacemakers can reach 40% 20.…”

Issues affecting refurbishment and re-use of pacemakers

“…As mentioned earlier, while the leads are clearly unable to be re-used, the pulse generator can and has been re-used. It has been argued that there are few risks associated with pacemaker implantations, the main ones being system malfunction and infection (Mond et al 1980; Conseil d'évaluation des technologies de la santé 1991). The question explored below is whether the risks associated with using refurbished pacemakers are greater than those associated with new pacemakers.…”

“…As a result of infection, death from cardiac or non-cardiac causes, or other changes in a patient's cardiac situation, cardiac pacemakers are sometimes removed while they are capable of functioning normally for many more years. For some years, in Australia and overseas, cardiac pacemakers have been harvested, cleaned, sterilised, tested and re-used, a procedure referred to as 'refurbishing' (Mond et al 1980). The purpose of this article is to discuss the issues associated with the re-use of pacemakers.…”

Insights into cardiac pacemaker and defibrillator revision/upgrades

“…In 2005, an estimated 17.5 million people died of cardiovascular disease (CVD), 80% occurring in low and middle-income countries (LMICs) [2]. For over 30 years pacemakers (PMs) have been reprocessed for reuse in countries with limited healthcare resources [3]. Recent studies suggest that reprocessing of pacemakers (PM) and implantable cardioverter-defibrillators (ICDs) can be successful when devices are carefully selected, tested, cleaned, and sterilized [4,5,6,7].…”