Used Pacemaker – Reuse or dispose?

Can pacemakers be re-used? The answer is yes – used pacemaker is being re-processed and used across the world in many countries for over 3-4 decades now. Implants such as Pacemakers, are considered single-use devices and hence should be disposed-off after one use, as recommended by manufacturers. However, since these are expensive devices, pacemakers are being re-used in many countries since the past 30-40 years. While not recommended by original device manufacturers, there are several international studies suggesting, that it is safe to re-use pacemakers, subject to certain conditions.

Pacemakers are classified as Single Use Medical Devices (SUMDs). However, refurbishment and reuse of pacemakers has been allowed and documented in many countries where access to new medical devices was difficult or unaffordable for some patients. Even though re-processing and re-use has been in practice for the last four decades across the globe, there are no regulations in place on reprocessing and reuse of pacemakers. The US Food and Drug Administration while not allowing such practice in the USA, however has issued guidance on pacemaker reuse, allowing donation out of the country.

What are the components of a pacemaker?

A pacemaker is an integrated electrical system mainly comprising of a pulse generator and a lead, with rest of the circuit being completed by the patient’s living tissue. A pacemaker lead is made of a metal conductor wrapped with an insulator. Most pacemaker leads are implanted via veins and make contact with the inner lining of the right heart. Once the lead has been implanted, it is gradually incorporated into the tissues, making it virtually impossible to remove without extensive damage, particularly to the insulation. Only the pulse generator is suitable for harvesting, cleaning, re-sterilisation and re-use. A refurbished pacemaker is used with fresh leads for the next patient.

What is re-processing or refurbishment of pacemakers?

Refurbishing of pacemaker involves proper re-sterilization, checking of battery life, pacing mode and other performance parameters and re-labelling with the current parameters including predicted battery life. The aim is that the used pacemaker may have reduced battery life, but should meet all other performance parameters as well as the original.

Problems with pacemaker re-use

As mentioned earlier, it is not possible to re-use the leads but the pulse generator can be re-used. The main argument against the re-use of pacemakers is the risks associated with pacemaker implantation. The main risks suspected were

1. Potential System malfunction and
2. Potential Infection to patient

Hence any re-processing must take more than adequate care to ensure the above problems are avoided. Pacemakers are after all devices and hence can malfunction at any stage during their use, even if installed new. Many institutions across the globe have conducted extensive studies to ascertain whether the risks associated with used pacemaker is greater than or comparable to those associated with new pacemakers.

Malfunction

Even new pacemakers can malfunction at any stage during their use. Adjustments and re-calibrations are therefore done if required by the manufacturer’s representative for new pacemakers installed. Records of initial pacemaker use are kept by manufacturers and hospitals.

A used pacemaker will only be considered for re-use by a hospital if it has no record of malfunction and has been in use for less than two years, so that sufficient battery life remains. An estimate is made of the future life of the battery and of the expected working life of the particular pacemaker model. As mentioned before, only pacemakers with at least 3+years (70-80%) original battery life are considered for re-use. Modern new pacemakers may last from between 5 to 15 years.

The battery life of a refurbished pacemaker will be shorter because of its prior use. But there is no evidence to show that a pacemaker which has only functioned for a short time without any problem and which is then re-used, is more or less likely to malfunction because of that re-use.

The institutions which use re-processed pacemakers conduct extensive performance testing before installing again. The quality of the device’s safety features, performance and battery life should be tested and earlier patient related information if any, must be removed.

As per a study conducted in India over a period of 30+ years, the following was reported – “During the study period, 887 patients underwent device implant, including 127 CRT devices or ICDs. Of these, 260 devices (29.3%) were reused and the others were new. At 6 months, there were three device-related infections in implants using a new device. There were no infections among patients receiving a reused device. There were no device malfunctions or device-related deaths in either group.”

Infection

Sterilisation and the complete removal of all protein material are two important problems that relate to the re-use of pacemakers. Improper cleaning or re-sterilisation of previously implanted pulse generators can cause secondary infections. However, new cardiac pacemakers can also in rare instances become infected and have to be removed because they are no longer sterile. In many studies conducted for outcome of re-used pacemaker, the methods of sterilization included professional cleaning with a brush, detergent and water, packaging of the device and sterilization with ethylene oxide etc.

In the above mentioned study – Reuse of pacemakers, defibrillators and cardiac resynchronisation devices

it was reported that

• Reuse of pacemakers is feasible and is not associated with a higher infection rate.
• This study reinforces this knowledge and extends this information to complex devices (implantable cardioverter defibrillators and cardiac resynchronisation therapy devices).

Ethical issues with used pacemaker

Discarding a used pacemaker while it still has a good part of its functional life seems wasteful. Any such wastage is a serious cause for concern if patients may be denied treatment because of lack of adequate funds. The cost of the pulse generator and the leads could constitute more than half the total cost of the treatment. A refurbished pacemaker can reduce costs. Often interventions are delayed by the patient due to lack of adequate funds, potentially leading to serious debility or even death. Sometimes inappropriate device may be chosen due to limited budget for a new device, instead of a more suitable refurbished one for the patient.

The possibility of saving a life due to timely intervention at reduced treatment cost in itself could justify the use of refurbished pacemakers. In such a scenario, supporters of pacemaker re-use argue if it is ethical to throw it away as a single-use device especially if it has been used only for a few months or so. There are organizations working towards accepting donation of pacemakers and refurbishing for charity purposes.

Legal implications

Ethical questions about wasting precious resources aside, there could be legal issues related to pacemaker re-use, especially since the original device manufacturer won’t take responsibility for its performance if re-used. Despite several studies carried out in the last few decades showing no significant difference in results between usage of new vs re-processed pacemakers, concerns continue to be voiced probably for commercial reasons. Concerns about product liability, patient rights, adherence to re-processing standards and maintenance of device registers, are various issues that could lead to legal problems associated with the re-use of single-use items like pacemakers.

As discussed earlier, the risks associated with re-use of pacemakers may involve malfunctions and infections. Since the original device manufacturer would not refurbish the device for re-use, the responsibility for ensuring product performance falls on the hospital or surgeon who is re-processing the pacemaker and performing the surgery. The hospital re-processing the pacemakers and using these devices must strictly ensure stringent standards of sterilization and performance testing to meet original performance specifications. They should also maintain proper records/ registry of their activities, so as to defend themselves from any accusation of negligence.

Last but not the least, patient must be properly informed of the implications and patient consent to the use of a refurbished device must be obtained and documented.

Conclusion – used pacemaker need not be wasted

Pulse generator re-use has been successfully reported in many countries over the last 30-40 years. High standards of cleaning, sterilisation and testing must be followed and a record of each step in the refurbishing maintained. Patient consent must be obtained. Follow-up procedures after implantation, such as monitoring and maintenance of a register, need to be as stringent as for those used for new implants.

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