Pacemaker: hardly used, conveniently priced give-away

5. November 2013

They are too expensive to be thrown away after just one use. Many medical devices have been declared disposable items, but work just as reliably as brand new models after cleaning and sterilisation. Many pacemakers now deliver an electrical impulse to people in developing countries.

Underground on the bodies of deceased people there often are not only gold teeth and wedding rings to be found, but in many cases also an expensive high-tech outfit. Not infrequently, the implanted pacemaker had only done its job for a few months before it gets buried with its carrier. Not infrequently it’s still running several years after that. With those who prefer to be cremated, technological heart-aids are usually explanted because of the risk of explosion – and find their way to the wastepile in at least nine out of ten cases.

Reprocessing instead of waste?

The Scottish cardiologist Melissa Walton-Shirley had just fitted one patient with a very expensive pacemaker when the lady died a few days later. Would it not also be in the interest of the deceased to remove the device and to enable it to go to someone’s benefit? Somebody who is reliant on getting one however cannot afford such an expensive piece of medical technology? When Walton-Shirley presented her idea at a congress of the American Heart Association, the subject was not discussed any further at all. The idea of connecting a used unit to the heart of their patients appeared to most of them to be too awkward. By contrast, according to American surveys, almost ninety percent of the carriers of pacemakers advocated the idea of passing on their device after death.

In Europe, medicine using “second heart” devices was already common a few years ago. Cecilia Linde of the Stockholm Karolinska Hospital published a retrospective study in 1998 running over an average two and a half years involving patients with new being compared to used devices. For every hundred patients, among those with used units three infections occurred; in contrast the number was seven among those with the new ones.

Hope for people in developing countries

In the US, the FDA prohibits the use of secondary-life pacemakers, and in Germany also their reuse is a foreign concept to most cardiologists. Meanwhile, there are some – mostly American – initiatives that endeavour to see to it that pacemakers still possessing at least 70 percent battery life make their way to underdeveloped countries like India, Cuba and the Philippines. Approximately 9,000 units have been collected as part of an initiative of the University of Michigan in recent years, even though demand is much greater. Again, the reports here are consistently positive.

Infection rate is not higher than that of new units

Two years ago in the magazine “Circulation: Arrhythmia and Electrophysiology” an overview article appeared reviewing 18 studies on the reuse of pacemakers. The sum 2,300 patients had very close to a two percent rate of infection. The rate was thus about the same as it is for new devices. Malfunction occurred significantly more often with second-use pacemakers, but these rates were still relatively low at 0.7 percent and resulted in no single case of death of the patient. A recent study in “Circulation” also comes to encouraging results. Apart from the slightly shorter battery life of an average six years, complications were not more frequent in comparison to new devices.

Difficult cleaning process

However, it’s not only pacemakers that are actually designed as a “one-off device” and yet achieve good service in their second life. Also implantable cardioverter/defibrillators (ICD) function perfectly normally if the battery can still carry on for a sufficiently long period. Further products in cardiology which create opportunities for second-hand trade include diagnostic and ablation catheters.

So that, for instance, ablation catheters are able to also function perfectly after reprocessing, sophisticated cleaning and sterilisation procedures are necessary. Vanguard, one of the specialists in this field, describes the requirements: “The treatment of ablation catheters using a cooled electrode is, due to the open lumen with very small terminal openings, particularly challenging. In the validated preparation process, an inverse flush, that is a pulsation pressure flushing procedure from distal to proximal using a special adapter, is integrated as a step in the process”. Here sensors monitor the success of the cleaning: “If deviations from experimentally determined and thus previously provided specifications appear, automatic blocking occurs”.

Ablation catheter at half price

Such catheters can be prepared for reuse about four to five times. This way the clinic can save significant costs. Health economist Wilfred von Eiff of the University of Münster created a model calculation for cooled and uncooled ablation catheters: assuming that seven out of ten catheters are reprocessed, the clinic will save around 700 euros per cooled catheter. With 46,000 ablations annually that would for the whole of Germany be around 7 million Euros per annum. For the uncooled devices this means 740 Euros of savings per unit and a total of 16.7 million Euros respectively.

Between 1996 and 2011 the Kerckhoff Clinic in Bad Nauheim used nearly 70,000 reused cardiac catheters and related accessories. Heinz-Friedrich Pitschner of the clinic reported two years ago a cost saving of around 35 percent. His conclusion on safety: “So far there has not been a single incident that would be due to the use of recycled medical device”. A study at the Hospital Munich-Grosshadern involving around 330,000 reworked medical devices employed for electrophysiological purposes revealed over the course of 15 years no increased risk in use and function.

German and EU Directives

Until recently, the EU has still been relatively critical while opposing this recycling. Von Eiff and other experts have been able to demonstrate the economic benefits clearly. According to a new draft regulation, a general reprocessing of “single-use products” should also be possible. Specialised reprocessing firms will herein be treated the same as the manufacturer regarding warranty and will be subject to the same obligations in proof of quality. A list of recyclable single-use devices is being planned.

A rough overview is delivered by guidelines on cleaning and sterilisation of medical equipment, which the Robert Koch Institute and the Federal Institute for Drugs and Medical Devices (BfArM) have produced together. The restoration, for instance, of ECG electrodes presents no problems. Flexible endoscopes require greater diligence though, the reprocessing of ERCP catheters in particular requires time and effort.

Problem case hepatitis viruses

But even if specialised processing companies such as Vanguard or AscaMed have developed sophisticated protocols, some problems do remain which have not yet been resolved, according to experts. It is not yet clearly understood whether the appropriate sterilisation method can also prevent the transmission of hepatitis B and C viruses. HCV in particular appears able to survive in residual blood for several months. A long-term study dealing with reprocessed devices and hepatitis infections however does not as yet exist. Ultimately, things should also not be taken too far by the clinic regarding cost savings. There are a number of disposable products that are indeed quite cheap and do not have the sufficient quality for a second use. Similarly critical is Wilfred von Eiff of any “do-it-yourself” reprocessing in the hospital without the sufficiently validated protocols.

Acceptable residual risk?

Why is our restraint in relation to pacemakers so big? Christian Sticherling of the University of Basel attributes this to the shortened battery life. “With each switchover of the device there is an increased risk of infection, so one would like to minimise changeovers”. Would it not make sense to let the devices benefit patients who due to other conditions have a life expectancy shorter than that of the battery life? In many cases, there are also great fears of liability in the event of a device failure. Manufacturers understandably wish to continue to keep their devices as long as possible as single-use and reject demands for reprocessing. The fear of a failure probably also scares many patients. “Zero-risk”, as discussed by Martin Mielke from the Robert Koch Institute at a conference last year, can nonetheless never exist. An acceptable residual risk must be found in each individual case as part of social consensus.

A heart (pacemaker) for dogs

Unlike the donation of organs shortly after the death, there seems to be no such great restraint in device donation; representative U.S. surveys would also be valid indicators of tendencies in the German population. Especially when, say, the pacemaker could still save lives in developing countries. And for passionate animal lovers, with reprocessed pacemakers there is also a way of at least doing something good for beloved pets even after you die. According to a newspaper article in the American state of Indiana, about 10 percent of the annual 15-20 pacemakers for dogs originate from the local funeral home and assure these pooches a few more happy years.

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Cardiology, Medicine

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