Just how ethical, safe and legal is it to reuse medical devices taken from deceased patients / It’s up to the legislature to define whether a program for people in need is required
The case of one or more doctors who are accused of reimplanting medical devices (pacemakers or pacemakers and implantable defibrillators) that were recovered from deceased patients is currently circulating in the press. This event brings to the public’s attention not one but several issues that deserve to be clarified:
First, the idea is being floated that the doctors in question may have given bradycardia drugs, which lower the heart rate, in order to simulate the patient’s need for pacemaker implantation. The investigation is ongoing and will determine whether these allegations are true. If the facts are confirmed, it would be a serious breach of the Hippocratic oath and a criminal case, of course.
Secondly, these devices were allegedly paid for by the insurance company, although they are not new devices but reused ones. If the facts are true, there is a suspicion of fraud but also a possible lack of traceability and control within the insurance company. Again, this is a criminal matter, not a medical one, which will be decided by the court.
Thirdly we are talking about the possibility of reimplantation of pacemakers and defibrillators that are recovered from deceased patients. This issue should be disconnected from the rest, as it is an ethical issue, a financial issue and a decision that should be taken at the level of the health system.
In France, 50,000 pacemakers manufactured by five international companies (MEDTRONIC, ABOTT, BOSTON, SORIN, BIOTRONIK) are implanted every year. These devices are considered disposable and have an expiry date (three years in France and five years in the USA).
By analogy, the need in Romania would be 10000-13000 pacemakers and defibrillators, with a unit cost of between 3000 and 6000 euros (up to 15000 euros for an implantable defibrillator), plus the cost of the procedure.
In France the cost of such a device is TOTALLY covered by the insurance company. In most cases, the insurance company also covers 100% of the cost of the procedure in state hospitals, and in private hospitals the insurance company covers a large part of the cost, only a small part is paid by the private supplementary insurance or by the patient if he does not have such insurance.
The natural question is the cost for a patient in Romania and access to such devices.
What happens to these devices when patients die or when during the operation the device is found to be unsuitable? Without the patient’s consent (it is a mandatory procedure) these pacemakers are either withdrawn by the funeral home in the case of a death at home and sent to a special circuit to recover the rare metals from the devices.
In hospitals, the devices are taken back by doctors or nurses and are recovered by the companies that manufactured them, who then analyse the wear of the internal parts before sending them to the metal recycling and recovery circuit.
The reuse of these medical devices removed from deceased patients is not a new procedure, but has existed for decades: thus in a 1989 article in the CMAJ (Canadian Medical Association Journal) author Michael Rosengarten concluded that „It is reasonable to believe that properly resterilised devices are biologically safe” and „the routine use of recovered pacemakers works well and is a sensible way to maintain health standards and save millions of dollars for the health care system”. (CMAJ Vol.140 June 1 1989 1274-76)
In another 2013 article in the medical journal Circulation, the authors compared 300 new pacemakers to 300 reused pacemakers: „Pacemaker reuse is feasible and safe and is a viable option for patients with bradyarrhythmias. Apart from the expected shorter battery life, reuse of pacemaker generators is not inferior to the use of new devices.” (Circulation. 2013 Mar 19;127(11):1177-83.)
Another study published in 2017 in Heart Asia found no higher infection rate in people with reimplanted pacemakers. (Selvaraj RJ, et al. Heart Asia 2017;9:30-33. doi:10.1136/heartasia-2016-010828)
Even in France, an association (Stimdevellopement) has been working on recovering pacemakers from deceased people and reimplanting them between 2014 and 2017 in 114 patients in Africa under a well-established protocol.
Is it ethical? After all, why not? We accept organs taken from deceased people, within well-defined protocols. Is there an additional risk? Studies seem to say that there is no additional risk of infection if sterilisation has been done properly and high-risk donors or those with hepatitis, HIV, etc. have been excluded. And in any case, patient information is essential.
On the other hand, what the World Health Organization tells us about medical donations in a 2012 document: There are three types of devices:
unused
implanted and explanted during the same operation (not the right device)
explanted from deceased people;
„Devices in the last two categories require resterilisation and special preparation for reuse, procedures that may affect the effectiveness of the device. This is why these devices are generally questionable and it is not advisable to donate such devices”.
And finally, what does the law say in Romania? In the Emergency Ordinance No 46 of 9 June 2021 it is clearly written:
„Art. 4 – (1) The reprocessing for reuse in public and private health institutions of disposable devices and materials is prohibited.
(2) The use in public and private health institutions of reprocessed single-use medical devices is prohibited”
So reimplantation of pacemakers after 9 June 2021 is illegal in Romania.
Of course, as we have seen in scholarly articles, reimplantation has been practiced until recently on a scale large enough to allow patients who could not otherwise afford it to benefit from such very expensive devices.
It is up to the legislator to define whether it is necessary to create a programme for people in need who could benefit free of charge from such devices with clearly defined resterilisation procedures, with prior information to patients. Or, we can hope that the Romanian state will decide that all patients in Romania who need pacemakers should benefit from such devices that would be fully paid for by the insurance company, without any additional cost for patients…
For the other aspects of the event, let’s wait for the end of the investigation and the court’s decision.
Note: Doctor Radu Lupescu is the president of the medical community of the Rhéna Clinic in Strasbourg. He participated in the regional coordination of Covid in Alsace. Radu Lupescu was awarded the National Order of Merit by the French Minister of Health Olivier Veran in Paris in October 2021 by President Emmanuel Macron for the fight against the pandemic.
Translated by Ovidiu Harfas
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