What are the barriers to reuse of pacemakers?

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What are the barriers to reuse of pacemakers?
(27/03/2013)
Dr Peter Kabunga
[email protected]
Introduction
Globally, the need for cardiac pacemaker (PPM) implantation continues to
increase. (1)Unfortunately access to these life-saving therapies is currently
limited or inexistent in some countries due to their high cost .One study (2) has
reported that 19% of deceased patients possess a cardiac device although 85%
of these devices are buried with these patients and about 84% of explanted
devices are discarded as medical waste. Previous studies have estimated that
$33,000 is saved by reusing a pacemakers compared with using a new device
(3) .This therefore represents an opportunity to not only save resources but
importantly alleviate suffering and prevent deaths. Several studies have now
shown that reuse of pacemakers is feasible and safe. This reviews examines the
barriers to implementation of this potentially life-saving strategy
Safety
A comprehensive meta-analysis by Baman et al (3) highlighted the fact that PPM
reuse was previously routinely performed in many developed countries, indeed
they point out that as recently as in 1996, reused pacemakers comprised 5% of
all devices implanted in some developed European countries .The meta-analysis
published in 20120 reviewed evidence from 18 studies involving 2270 patients
.All studies used chemical sterilization protocols with ethylene oxide with an
average follow up period of 35(range, 2 -76) months .The primary and secondary
endpoints were PPM infection or device erosion and device malfunction
respectively. 1.97% [1.15% to 3.00%] of patients developed infection following
implantation with reused pacemakers with no significant difference when
compared to those patients implanted with new devices (odds ratio, 1.31 (0.50 to
3.40], P=0.580) while 0.68% (0.27% to 1.28%) developed device malfunction.
The increased risk malfunction in the reuse group was significant (P=0.002)
[odds ratio, 5.80 [1.93 to 17.47],). The main cause of device malfunction was
difficulties in the screwing mechanisms and other non-specified technical errors.
The authors point out that these malfunctions probably resulted from damage
during the extraction process and that current devices are more robust and less
likely to get damaged. It’s also reasonable to argue that as all pacemakers are
currently designed as ‘single use’ devices future designs incorporating a multiuse purpose facility could easily overcome this obstacle without an associated
increase in overall device cost. Despite the overall favourable outcome of this
meta- analysis it is important to point out (as highlighted by the authors) that only
5 of the 18 trials in meta-analysis had a direct comparison with new devices and
analysis was based on non-randomized basis.
In another study of 3,701 pacemaker patients by Mugica J et al, patients
receiving reused devices had comparable survival to those receiving new ones at
10-year follow-up.(4) They concluded that reutilization of PPM did not appear to
be detrimental to patients.
Kantharia B, et al examined outcomes in patients in India implanted with 121
PPM donated by funeral homes in the United States. (5)
53 (11 single- and 42 dual-chamber) were deemed acceptable for reuse.37 were
implanted in new pacemaker patients and 16 were implanted in patients who
needed a replacement pulse generator. The primary indications for pacing were
complete heart block (51%), and sick sinus syndrome (49%). None of the
recipients of a reused device had a significant complication specifically infection
or device malfunction after a mean follow-up of 661 days (range 19-1827). There
were 4 deaths due to non-device related causes and the majority (95%) of
patients reported symptomatic benefit.
Nava S et al have recently published a study of 603 consecutive patients.
307 patients received reused PPMs while a control group of 296 patients
received new PPMs. A combined end point of (a) unexpected battery depletion,
(b) device infection and (c) device malfunction was analyzed. 85 PPMs had to be
explanted, 31 in the control group (10.5%) and 54 in the reused PPM group
[17.6%; relative risk (RR), 1.68; 95% confidence interval (CI), 1.1-2.5; P=0.02].
43 patients reached the primary end point, 16 in the control group (5.5%) and 27
in the reused PPM group (7.2%; RR, 1.3; 95% CI, 0.70-2.45; P=0.794).Not
surprisingly reused PPMs were more likely to have unexpected battery depletion
(11 reused pacemakers (3.6% compared to 5 new PPMs (1.7%) (RR, 2.12; 95%
CI, 0.75-6; P=0.116) while interestingly 3.7% new PPMs and 3.2% reused
pacemakers had a procedure-related infection (RR, 0.87; 95% CI, 0.38-2.03;
P=0.46) and 1 patient in the reused PPM group had a device malfunction related
to the screwing in mechanism (6)
Overall, numerous studies therefore report no associated incremental risk of
infection if pacemakers are resterilized and re-implanted. Importantly no
associated increase in mortality with a long follow up has been demonstrated
although close follow up to detect malfunction is required.
Device Manufacturers
It has been argued that returning used devices manufacturers helps build an
accurate performance database which may help improve the reliability,
performance and safety of future devices. Reuse would however not prevent this
as devices could still be returned to the device companies if and when they
malfunction and are deemed unusable. Many modern pacemakers can now be
wirelessly monitored without the need for explantation and one study has
reported that 19% of deceased patients possess a cardiac device, but 85% of
these devices are buried with these patients and about the majority (84%) of
explanted devices are simply discarded as medical waste (7). Device companies
also have to comply with regulatory authorities that currently stipulate that
pacemakers are single use devices and they are manufactured and tested as
such. These companies would be liable for device malfunctions for devices that
where intended for single use. Would device manufacturers have an obligation to
replace devices on a recall with new ones in patients with reused devices?
The huge costs involved in bringing these devices to market also dictate that
manufacturers will want to maximize returns on their investment. Financial return
is potentially higher with single use devices. This is seen in everyday life when
consumers are urged to buy the latest mobile phone with a camera, Television
(High Definition + (HD +) as opposed to ‘ordinary’ HD) or other gadgets that
replace perfectly functioning ones.
Reusing medical devices prevents death and by prolonging life increases the
number of patients who will need device replacements in the future. These same
patients will often have other coexistent disease like coronary artery disease and
will spend money, quite apart from a plain need to improve quality of life and
prevent unnecessary death.
Unanswered questions
Many will argue that unlike reused clothes or other technological gadgets, it is
fundamentally immoral to reuse medical devices. How many patients in high
income countries would if given the choice choose a resterilized pacemaker? But
why wouldn’t they if they were given the facts on safety and told that this practice
was in fact not unusual in some European countries until about 20 years ago?
Unfortunately, for many patients in under-developed nations the choice is one of
either no pacemaker at all and certain misery and/or death and one of reusing a
functioning cleaned device (which they also don’t have access to!). Could
manufacturers be persuaded to make cheaper versions of medical devices which
are able to perform basic essential functions of pacing, but could for instance not
have the ability communicate wirelessly? Or even better, why can they not make
existing devices affordable as is done with drugs such anti-retroviral therapies?
A small study reported that up to 71% of the general public and 87% of patients
[p<0.01] were willing to donate a PPM to people in need if they were given the
chance. (7, 8) PPM procedure consent forms could have a specific question on
whether patients would be willing to donate their pacemaker for reuse if they did
not require it in the future.
However, the performance of reused implantable cardioverter defibrillators
(ICDs) has not adequately studied. These are much more expensive put
potentially even more lifesaving.
Medical devices have been described as the technical equivalent of therapeutic
drugs. And as such once implanted, they need optimal programming and
continuous monitoring to ensure that they achieve the desired effect. Many
communities and countries unable to afford medical devices in the first place also
lack this relevant essential infrastructure needed to run a full brady-pacing
implantation service.
Conclusion
Several charities are currently are currently involved on small scale retrieval of
used pacemakers for re sterilization and implantation for patients in poor
countries unable to afford new devices. The main barriers to a large scale
implementation of this practice are legal not technical or indeed ethical.
Clinicians, hospitals and device manufacturers should be encouraged not
restricted by regulatory authorities to recycle medical devices perhaps through
regional ‘device banks’ for sterilization and eventual export to underserved
communities who would keep a register of patients. There may even be a role for
commercial (for– profit) medical recycling if this is rigorously regulated. It is
morally unacceptable that we live in a world where people die of preventable
conduction disorders like complete heart block while we continue to dispose of
perfectly functioning devices with a large body of evidence showing reused
pacemakers are safe.
References
1. Mond HG, et al The 11th world survey of cardiac pacing and implantable
cardioverter-defibrillators: calendar year 2009--a World Society of
Arrhythmia's project Pacing Clin Electrophysiol. 2011 Aug;34(8):1013-27
2. Baman TS, Kirkpatrick JN, et al. Pacemaker reuse: an initiative to
alleviate the burden of symptomatic bradyarrhythmia in impoverished
nations around the world. Circulation. 2010; 122:1649-1656
3. Rosengarten M, Chiu R, Hoffman R. A prospective trial of new versus
refurbished cardiac pacemakers: A Canadian experience. Can J Cardiol
1989; 5:155-160
4. Mugica J, Duconge R, Henry L. Survival and mortality in 3,701
pacemaker patients: arguments in favor of pacemaker reuse. Pacing Clin
Electrophysiol. 1986; 9:1282-1287.
5. Kantharia B, Patel S, Kulkarni G, et al. Reuse of explanted permanent
pacemakers donated by funeral homes. Am J Cardioll 2011
6. Nava S, Morales JL et al Reuse of Pacemakers: Comparison of Short and
Long-term Performance. Circulation. 2013 Mar 19; 127(11):1177-83
7. Baman T, Kirkpatrick JN, Lange DC, et al. Post-mortem cardiac device
retrieval for re-use in third world nations: views of funeral directors. Heart
Rhythm Society 2009 Scientific Sessions; May 14, 2009; Boston, MA.
Abstract AB20-5.
8. Lange DC, Kirkpatrick JN, Hakan O, et al. Post-mortem cardiac device
retrieval for re-use in third world nations: views of the general public and
patient population. Heart Rhythm Society 2009 Scientific Sessions; May
14, 2009; Boston, MA. Abstract 20-4.
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