Few would disagree that organ donation and transplant surgery is a remarkable achievement. It is a selfless gift that unlocks the potential to cure disease or allay symptoms. But if that “gift” was a bone fixation plate, or an implantable cardiac defibrillator, would the perception be the same? The initial “gift” production responsibility is not with the donor, but the board of directors of the company that was involved in the design and manufacture of that implant. If the recipient never had an option of receiving such an implant straight from the factory, but would only ever have the chance of having this “cure” second hand then what would that patient choose? Is the option of a practise forbidden by federal US regulators better than continuing to be at risk or harm from a disease process? Is it taking advantage of the poverty status of a patient by offering a free second hand implant, rather than nothing at all?
Behzad Parvi, a cardiac electro-physiologist from the Thomas Jefferson University Hospital, Philadelphia, has collected implantable cardiac defibrillators from US patients and funeral homes and taken them to Mumbai, where they were re-implanted into 81 patients. These patients were aged between 27 to 79 and would have otherwise been unable to afford such treatment. Within the USA, 434 per million patients receive new devices per year. Mond et al estimate there are approximately 1 per million implantations in most Asian countries per year. India contains a sixth of the world population. It is obvious why a company who “perceives a new market” would not approve of such a venture, or is it?
For pacemakers, reuse is nothing new. There are reports from the 1970s (Havia et al 1976) as well as more up to date data (Balachander 2003, Kantharia et al 2012, Baman et al 2009, Baman et al 2010) on reuse. Implants are reused in the orthopaedic and dental field (Schwartz et al 2000), much more so in Asia (Magetsari et al 2004). Although not in accordance with any laws or implant guidelines it is a practice born out of necessity that some may call risky, but most would say it is not more risky than no treatment at all.
The school of thought that feels it is less than ideal to implant second hand devices into patients and that those patients should receive new ICDs are absolutely right. That is not the question, as these healthcare systems and patients cannot afford the implant in the first place. The issue is, “Is it right to deny patients any treatment, even if sub-optimal?” The reason to withhold implantation is based on an aversion to take responsibility when things go awry. Our laws have problems in this area. If something goes disastrously wrong for a patient with a re-used implant and that patient sought legal advice for compensation, is there enough precision and clarity in the legal system to cope with this? The company who make the implants and doctors who implant them need protection and an absolution of responsibility if this practice is ever made legal and expanded. This is effectively “charity work” in areas of deep deprivation. It is not exposing the patients to more risk than they are under currently, with no treatment at all. Perhaps the biggest risk is not to the patient receiving these second hand devices destined for US “trash cans” but to the relatives at open funeral pyres, standing too close as the implants explode on heat combustion.
It becomes clearer why a company would not approve of implant reuse. Why take the risk in getting sued? The circumstances of “better to let a patient die, than take any responsibility—much less expensive” have sparked workers like Parvi into this action and the Annals of Medicine into publishing this paper. If this was a Randomised Control Trial, the control group is not the patients with a new implant, but no implant at all.
Inappropriate disposal of reusable implants, such as external fixators, is also a problem. In the UK a team from the Royal London Hospital (Timms et al 2010) surveyed 118 technicians working in Human Tissue Authority (HTA) approved mortuaries licensed to perform post-mortems. Of those, nine always discarded the fixators, eight always left them on the body, and two stored them in the mortuary. The authors conclude that, “Many reusable external fixation devices are inappropriately disposed of each year due to a lack of knowledge and communication with orthopaedic departments.” Clear guidance is required on what to do with all medical implants. In other words the answers to when to throw away, when to return and when to recycle, all depend on who is asked. It is the law makers who ought to make clear that there is a greater good that needs protection. This will enable us to evolve our ethics about this practice and expand its use rather than denying patients any care at all.
References:
Balachander J, Anilkumar R, Sampath M, Sethuraman KR, Chamdrasekhar S, Dodinot B. Efficacy and safety of refurbished pacemakers:17 years followup of an international collaborative programme. Stimucoeur. 2003;31:190-3.
Rej Bhumbra is the editorial registrar, BMJ