Cité Internationale, Lyon, France
August 23-26, 2007.
Abstract—The study aims to define the technical, ethical,
juridical and economic issues involved in the assessment of a
reprocessing policy for single-use interventional cardiac devices
(SUDs). The feasibility of reprocessing was evaluated for
cardiac electrophysiology catheters by comparing the
chemical, physical and functional properties of new and
reprocessed devices. The issue of hygiene was addressed by
developing microbiological tests for the quantification of
bioburden, sterility and pyrogenic load. The results of more
than 1500 tests, conducted on 531 catheters, suggested a
precautionary number of regenerations of five cycles. The
ethical aspects were reviewed and the European juridical
framework was assessed, revealing a need for harmonization.
Applying a specific economic model, potential savings were
calculated for a representative cardiology department and
estimated at national and European level. Potential savings of
41.2% and 32.9% were calculated for diagnostic and ablation
catheters, respectively. Safe and effective reprocessing of SUDs
could be pursued if quality control processes and certified
procedures are met. A reprocessing policy in EP laboratory
could lead to savings of about 27250 euros per 100,000
population, but the economic benefits are strongly dependent
on the maximum number of regenerations and the regeneration
INIMALLY invasive technology based on single-
use devices (SUDs) is of great importance in modern
medicine, but the increasing number of interventions and the
consequent economic burden on health care systems has led
many countries to consider a reprocessing policy. Although
there are conflicting results regarding the safety and
effectiveness of SUD reprocessing and reuse [1-3],
interventional cardiology is an area where such a policy
seems feasible [1,4-8].
In recent years, the clinical approach to percutaneous
treatment of arrhythmias
electrophysiology (EP) catheters have been developed for
mapping, recording from and ablating cardiac muscle. These
proprietary systems need devoted interfaces and specific
catheters that are usually difficult to clean and generally not
reprocessable. Nevertheless, many ablation procedures and
Manuscript received Apil 2, 2007. This work was supported by the SIX-
SICC Project, Safeness in Interventional Cardiology and Cardiac Surgery –
Fondo unico 2001, Provincia Autonoma di Trento.
F. Tessarolo is with the Department of Physics, University of Trento,
38050 Povo, Trento, Italy (e-mail: firstname.lastname@example.org).
M Disertori, I. Caola, G M. Guarrera, C. Favaretti are with the Azienda
Provinciale per i Servizi Sanitari, 38100 Trento, Italy.
G Nollo is with the Department of Physics, University of Trento, and
ITC-irst, Trento, Italy. (e-mail: email@example.com)
has changed. New
EP studies are conducted using simpler ablation and
recording catheters that can be considered for reprocessing.
Since SUD reprocessing represents the introduction of a
new health technology, a Heath Technology Assessment
(HTA) approach is required, whereby stringent criteria of
effectiveness, safety and suitability must be satisfied. The
available literature underlines the need to determine correct
sterilization techniques and relevant quality controls.
Guidelines for defining organizational procedures and
placing responsibilities for the use of reprocessed materials
should also be provided [5-8]. Important HTA reports on
SUD reuse have been delivered by international public
agencies [1,5,6,8]. All of these reviews, based on extensive
analyses of the best available evidence, highlight a
substantial gap in knowledge regarding the safety and
effectiveness of reprocessing. This gap demands original
This study aims to define the fundamental issues involved in
the assessment of a reprocessing policy for interventional
cardiac catheters according to the Health Technology
Assessment (HTA). The quality and safety of reprocessed
devices is addressed by experimental techniques providing
quantitative data on material properties, functionality and
hygiene. Ethical and juridical issues are also considered,
along with the economic implications. The technical data
and legal, bioethical and economic findings are finally
integrated to evaluate the applicability and suitability of
SUD reprocessing on EP catheters.
A. Priority Setting Definition
Following HTA methodologies, priority-setting indicated
a need for safety, ethical, legal and economic investigations
. Accordingly, the study focused on four issues: i)
physicochemical and functional testing of new and
reprocessed devices; ii)
quantification of bioburden and pyrogenic load, and
optimization of protocols for decontamination, cleaning and
sterilization; iii) comparative analysis of the legal and ethical
issues involved in the reprocessing and reuse of devices
labelled for single use; iv) cost analysis for the introduction
of a reprocessing policy.
microbiological tests for
B. Technical Aspects
The feasibility of reprocessing from a technical point of
view was evaluated on non-irrigated EP devices for
Health Technology Assessment on Reprocessing Single-use Catheters
for Cardiac Electrophysiology: Results of a Three-years Study
F. Tessarolo, M. Disertori, I. Caola, G. M. Guarrera, C. Favaretti, and G. Nollo
Proceedings of the 29th Annual International
Conference of the IEEE EMBS
1-4244-0788-5/07/$20.00 ©2007 IEEE1758
diagnostic and ablation, produced by major worldwide
manufacturers. A total of 182 EP devices were subjected to
physicochemical and functional studies.
The physicochemical properties of new and reprocessed
devices were assessed using optical microscopy (OM),
electron microscopy (EM), atomic force microscopy (AFM)
and infrared (IR) spectroscopy. To determine changes in
their properties with reprocessing, the devices were assessed
after different numbers of reprocessing cycles (0 to 14
cycles). To estimate the maximum number of sustainable
reuses, synthetic tissue and organ phantoms were used to
simulate clinical use and obtain quantitative and
reproducible functional measurements.
C. Microbiological Analysis
A wide spectrum of microbiological tests was performed
on EP catheters at different steps of the reprocessing
procedure to assess bioburden,
decontamination/cleaning efficiency and device sterility.
Different decontamination/cleaning protocols were tested
to identify their biocidal properties and cleaning
effectiveness. Eighty devices were contaminated with
bacteria-spiked human blood and underwent different pre-
sterilization protocols including use of chlorine-releasing
agents, polyphenolic emulsion and enzymatic detergent .
EM and quantitative culture were used to assess cleaning
and bactericidal effectiveness.
Sterility testing methodologies were developed to
evaluate a total amount of 208 devices  Samples were
collected after clinical use, underwent repeated cycles of
simulated use and regeneration and were cultured for 28
days in trypticase soy broth. Six cycles of regeneration, and
four species of inoculated bacteria were considered.
Pyrogenic risk was specifically addressed and endotoxin
content was assayed by the LAL test . The pyrogenic
status of 61 catheters was monitored before any treatment,
after decontamination/cleaning and after reprocessing.
D. Ethical and Legal Comparative Analysis
The ethical-juridical aspects of reuse policy were assessed
by a comparative analysis of current legislation in European
and other Western countries . HTA reports [2-7] and
systematic reviews [1,8], as well as position papers of
European medical devices associations, were considered.
E. Cost Analysis
The economic analysis considered the cost of new
devices, the cost of regeneration, the average number of
regenerations and the regeneration rate (percentage
probability of successful regeneration) as crucial input
variables for the calculation of cost savings by a specific
model . The economic implications of reducing waste,
packaging and labeling, and the cost of assigning new and
reprocessed device contracts were also taken into account.
The number of reprocessable EP catheters used per year in a
considering the annual report of the Italian society of
Electrophysiology . The maximum number of
regenerations sustainable by the device was determined
according to our technical findings.
An estimate of the potential savings for health care
budgets was calculated at national level and extrapolated to
division was calculated,
A. Technical Characterization of New and Reprocessed
Physicochemical studies of reprocessed materials found
changes related to the number of reprocessing cycles. OM
analysis of EP catheters revealed reprocessing-dependent
scratches on the polyurethane shaft surface . EM and
AFM documented physicochemical etching of polymers due
to plasma sterilization, and increased nano-roughness. IR
spectra suggested that low temperature sterilization did not
modify the bulk characteristics of the polymers. The status
of device materials is highly model dependent and should be
verified after each reprocessing cycle. Functionality tests of
EP catheters found no variations in ablation efficiency,
electrode conductivity, thermometric sensor precision or
accuracy . However, tests of slipperiness showed
worsening lubrication in regenerated EP devices after four
cycles, in accordance with the increase in surface roughness.
B. Microbiological Analysis
decontamination and cleaning showed the need to optimize
both disinfection efficiency and biological burden removal
. It is also mandatory to protect personnel from
of different protocols for
CURRENT ESTIMATED COST AND POTENTIAL SAVINGS FOR EP INTERVENTIONS
Current Catheter cost/100000 inhabitants (€)
Current Catheter cost Italya (M€)
Current Catheter cost Europeb (M€)
Potential saving %
Potential saving/100000 inhabitants (€)
Potential saving Italya (M€)
Potential saving Europeb (M€)
a 58.4M inhabitants. ISTAT 2004.
b 457M inhabitants. EUROSTAT 2004
Policy Ablation (A)
infectious agents as HIV. Automation of cleaning could also
minimizes the risk of
Experimental results showed that clinical use does not
represent a critical source of endotoxins. Use of tap water
and manual cleaning increased the pyrogenic load by
introducing Gram-negative microorganisms . Use of
recommended to avoid the pyrogenic risk.
Investigations of the sterility of EP catheters found no
samples positive for the inoculated strain until the fourth
cycle of reprocessing . These results were in accordance
with surface analysis, which showed changes in the
materials’ properties that might favor persistence of bacteria
and limit the effectiveness of reprocessing after repeated
cycles. Hence, over-reuse of devices could affect both their
safeness and their efficacy. This estimate of the maximum
number of reprocessing cycles is precautionary, as it is
derived from experiments conducted under worst-case
water is therefore
C. Ethical and Legal Comparative Analysis
Unlike the US Food and Drug Administration (FDA),
which has enforced priorities for SUD reprocessing, at
present no European regulatory authority has a documented
policy supporting the reuse of SUDs and there are no
enforced regulations for safe reuse . Some EU states have
no legislation on the matter, and in some other countries
non-binding recommendations or notes have been issued
warning about the reuse of SUDs. Despite this, the practice
continues in the EU. Conversely, in Germany, the Medical
Device Act does not ban the reprocessing of medical devices
labeled for single use, and advises users and institutions to
use their own discretion.
According to European legislation, a disposable device
ends its intended life after the first use, thereby removing the
manufacturer’s responsibility for subsequent reuse. The
certificate of conformity system could be therefore extended
to reprocessing activity .
Differently, in the German case, a manufacturer’s
indication of ‘single use’ is not considered in the notion of
‘intended purpose’. Moreover, reprocessing does not entail
the placing of the device on the market, since after
processing it is returned to the first purchaser and it does not
need to be re-marked with a new CE label .
From an ethical viewpoint, patient safety and distributive
justice in the allocation of available resources must be
considered. Health care professionals have an ethical
obligation to cause no harm to patients, but the issue is
complicated by the appropriate allocation of increasingly
scarce health care resources and by the need to ensure the
widest possible access to new and effective technologies.
Finally, the perception of duplicity in medical care when
informed consent is obtained has to be considered.
D. Economic Analysis: Cost Minimization
According to cost-saving calculations, reuse of EP
catheters is associated with a potential saving of 41.2% and
32.9% for diagnostic and ablation procedures respectively
and a total of 27247.82 € could be saved per 100,000
population (Table I). By considering the current Italian
workload in EP interventions , a potential saving of
15.91 M€ could be achieved with the widespread
implementation of a reprocessing policy. The scaling to a
population amount of European Community gives an
extrapolated potential saving of 124.52 M€ per year from
the introduction of regeneration practices in interventional
The study showed that a preliminary assessment by both
destructive and non-destructive high-performance analytical
techniques should be undertaken for each type of device that
has never before been regenerated. This in-depth screening
is required to exhaustively assess the feasibility of
reprocessing. Once the correct regeneration protocol has
been defined and optimized by successive quality feedbacks,
only essential non-destructive tests need to be established in
routine reprocessing activities. From the technical and
hygiene perspectives, an efficient and safe reprocessing
protocol is a unique and continuous procedure from post-use
collection to re-delivery to the cardiology department. This
workflow, ensure the best performance and hygiene, but
requires devoted infrastructures, trained staff, specific
knowledge, trackability of items, and allocation of
responsibilities. The even more stringent criteria of active
legislation and regulatory policies (e.g. FDA enforcements)
require certified reprocessing procedures with guarantees of
quality the same as those supplied by the original
manufacturer. These requirements are unlikely to be
achieved by small or medium-size hospitals, but could be
affordable by health care institutions or third-party industry
The economic analysis indicated that reuse of SUDs
might be a source of savings to health care systems and
hospitals. However, the scaling down to a single cardiology
laboratory should be done cautiously. Low numbers of
clinical procedures or variations in the cost of new devices
might nullify any savings. It should also be noted that
innovations in devices or reprocessing technology could
affect the final savings by altering the maximum number of
regenerations or the regeneration rate. The potential to
reduce waste and raw material consumption might give
further economic and ecological benefits.
A. Towards Clinical Use
This work was undertaken in laboratory settings and
therefore does not provide outcomes directly related to
patients. Experimental analyses were conducted after the
first clinical use on patients, while subsequent reuses were
simulated in vitro. To provide a definitive answer on the
feasibility of SUD reuse in clinical settings, monitoring of
the efficacy and safeness in patients is mandatory, and
multi-centre clinical studies should be designed to seek any
causal link between reprocessing and adverse outcomes.
However, there are ethical constraints on the use of patients
for clinical studies designed to determine the risks of SUD
B. Study Limitations
Although some papers have reported on the iatrogenic
transmission of viruses, the degree of risk of Creutzfeldt-
Jakob disease (CJD) linked to the reuse of SUDs has not
been adequately documented and needs more investigation
in the light of new findings on CJD disinfection protocols.
Since reprocessing protocols and analytical techniques are
highly device specific, the results of this study cannot be
directly extended to other categories of medical instrument.
However, the methodological approach could be used to
assess the feasibility and safety of reprocessing for various
types of SUD .
Safe and effective SUD reprocessing should be conducted
following standardized and monitored processes, with
guarantees of quality the same as those supplied by the
The maximum number of reuses sustainable by a device is
a fundamental parameter and might be evaluated by
comprehensive analysis of microbiological, chemical,
physical and functional tests. According to our findings, the
precautionary number of regeneration cycles sustainable by
EP catheters were five. However, this number should be
determined specifically according to reprocessing protocol
and device type.
Substantial savings could follow the introduction of a
reprocessing policy of EP devices in cardiology
departments, but differences in the maximum number of
regenerations, regeneration rate and unitary device cost have
to be carefully considered.
The current lack of harmonization on legislation and
standards conflicts with the general objective to conform
European heath care services to the highest standards
available and to guarantee freedom of enterprise, positive
competition in the market and products improvement.
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statement. Reprocessing of