International Journal of Hygiene and Environmental Health 213 (2010) 302–307

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International Journal of Hygiene and

Environmental Health
journal homepage: www.elsevier.de/ijheh

What is the use? An international look at reuse of single-use medical devices

Walter Popp a,∗ , Ossama Rasslan b , Akeau Unahalekhaka c , Pola Brenner d , Edith Fischnaller e ,
Maha Fathy b , Carol Goldman f , Elizabeth Gillespie g
a
Hospital Hygiene, University Clinics of Essen, Hufelandstr. 55, 45122 Essen, Germany
b
Infectious Diseases Research and Infection Control Unit, Ain Shams Faculty of Medicine, Cairo, Egypt
c
Faculty of Nursing, Chiang Mai University, Thailand
d
Universidad de Valparaiso, Valparaiso, Chile
e
Institute of Hygiene and Public Health, WHO CC of University Bonn, Germany
f
Consultant, Toronto, Ontario, Canada
g
Sterilisation and Infection Control Co-Director, Southern Health, Australia

a r t i c l e i n f o a b s t r a c t

Article history: Reuse of single-use devices is common in most countries worldwide. We provide an overview of the issue
Received 27 July 2009 from an international perspective.
Received in revised form 13 April 2010 In many developing and transitional countries reuse of cheap single-use devices (needles, syringes,
Accepted 13 April 2010
surgical gloves) is common leading to large numbers of unsafe interventions, specifically injections and, as
a consequence, infection with hepatitis B, C or HIV. There are various reasons for reuse: limited resources,
Keywords:
insufficient knowledge of healthcare workers and the belief of patients that injection is more beneficial
Single-use
than oral medication. Reuse of cheap single-use devices should cease and both medical staff and the
Medical devides
Reprocessing
public should be informed about potential safety risks associated with injection.
Safety In developed countries, reuse of single-use items is less common but may include expensive technical
Quality management products. Reuse is regulated in many countries (e.g. US, Canada, some European countries) demanding
ethical and legal considerations, high standards of reprocessing and training of staff, risk assessment,
management and validation of reprocessing. Well regulated reprocessing can decrease the number of
single-use devices reprocessed.
In developing as well as developed countries, a decision to reprocess single-use devices should only be
made after a critical reflection of advantages and disadvantages.
© 2010 Elsevier GmbH. All rights reserved.

Introduction • Patient beliefs that

Reuse of single-use medical devices (SUMED) is very common in
many countries worldwide. The World Health Organisation (WHO)
estimates that 40% of the 16 billions injections administered world-
wide each year are given with syringes and needles that are reused
without sterilization. Thus, each year unsafe injections cause 1.3
million deaths and almost 26 million years of life lost, mainly
because of transmission of hepatitis B and C, or HIV (WHO, 2008).
Typical examples of cheap medical devices often reused in
developing and transitional countries are gloves, urinary catheters,
tubes (e.g. stomach or rectal tube), drains, syringes, needles, lancets
and indwelling venous cannulae.
There are many reasons for reusing SUMEDs, specifically
syringes and needles in developing and transitional countries
(WHO, 2007), these include:
∗ Corresponding author. Tel.: +49 201 723 4577; fax: +49 201 723 5664.
E-mail address: Walter.popp@uk-essen.de (W. Popp).
◦ injections may help more than oral medication; therefore the
annual rate of injections per person may be up to 11 in some
countries (Hutin and Hauri, 2003; Janjua et al., 2005);
◦ needle sharing within a family causes no harm,
◦ needle sharing may be a good neighbourly practice;
• Healthcare workers (HCW) beliefs that:
◦ Patients do not comply in taking oral medications and prefer
injections.
◦ Insufficient knowledge and non-compliance to safe injection
standards. WHO estimates that the majority of therapeutic
injections in developing and transitional countries are given
unnecessarily (Ahmad, 2004).
• Limited resources (equipment and financial) increases the reuse
of SUMEDs (WHO, 2007).
In developed countries, reprocessing of single-use devices is
restricted to more expensive and technical products and the main
reason is cost savings and consideration of sustainable develop-
ment (Table 1) (Jacobs et al., 2008; Horwitz et al., 2007).

1438-4639/$ – see front matter © 2010 Elsevier GmbH. All rights reserved.
doi:10.1016/j.ijheh.2010.04.003
 W. Popp et al. / International Journal of Hygiene and Environmental Health 213 (2010) 302–307
Table 1
Reprocessing of single-use medical devices. Examples in developed countries.
Anesthesiology Endotracheal tubes, pulse oximeter devices,
tracheobronchial suction catheters, masks
Gastroenterology, Biopsy forceps, electrohemostatis catheters,
bronchoscopy gastrointestinal guidewire, colonoscopy snares,
laparoscopic equipment, ERCP equipment, clip appliers,
dissectors, retractors, scissors, trocars, verres needles, laser
fibers
Ophthalmology Keratome blade and knives, gauge diamond dusted
membrane scraper
Orthopedics Blades and drills, osteosynthesis plates and screws, burrs,
drill bits, needle holder, reamers, ronguer, scissors,
trephine, external fixation frames, arthroscopic rasps
Urology Electrode rollerball, stone baskets, Foley catheters,
transurethral prostatectomy loops
Cardiology Pacing electrodes, balloon catheters, pacemakers,
guidewires, electrophysiology catheters
Vascular Angiography catheters, angioplasty balloons, Fogarty
catheters, guidewires, stent introducers, vein strippers
Surgery Electrosurgery cautery pencil, diathermy penoils, MIC
instruments, Ultrascission scissors, clip instruments
Others Breast pump kits, bone marrow trephine sets, dental
appliances, skin staplers
Polisena et al. (2008), Collignon et al. (1996), Magetsari et al. (2006), Sikka et al.
(2005), Dunn (2002, 2002a), Christensen et al. (1999) and United States Government
Accountability Office (2008).
While there is a perception that reprocessing is less expensive
than single use, the health, ethical and liability risks for reuse can
be very high. Manufacturers of single-use devices benefit greatly as
SUMEDs do not require the same degree of documentation and val-
idation. Also, there is no requirement for a manufacturer to prove
that a device cannot be reprocessed.
Methods
At a workshop held during the 9th Congress of the Interna-
tional Federation of Infection Control (IFIC) in Santiago de Chile
in October 2008 delegates were surveyed about the reuse of
SUMEDs in their respective countries. The survey asked about legal
requirements and recommendations regarding reprocessing of
SUMEDs. Information about national data or studies, management
of reprocessing, personal experience with reprocessing SUMEDs
was gathered through a written questionnaire. The questionnaires
were distributed to the 26 participants of the workshop, filled in
there and collected.
A review of the literature available through MEDLINE using
the keywords “single-use” from 2000 to 2009 was conducted to
develop a worldwide perspective.
Results
Survey during IFIC congress and situation in South America
During the IFIC congress there were 22 respondents of 26 dis-
tributed. Brazil (n = 3), Chile (n = 12), Columbia (n = 2), Ecuador
(n = 2), Sweden (n = 1), The Netherlands (n = 1) and US (n = 1).
National legislation on reprocessing single-use devices and also
recommendations for reprocessing is available in Brazil. National
law and reprocessing recommendations also exist for Chile,
and reprocessing of single-use devices occurs in most hospi-
tals. There are no regulations or recommendations in Ecuador.
Those SUMEDs that are reprocessed in Brazil, Columbia, Ecuador,
and Chile are expensive technical devices such as balloon and
angiography catheters, pacemakers, ultracission scissors, sur-
gical knives, arthroscopic rasps and verres needles. In Chile,
the national regulations state that the reprocessing of nee-
dles and devices used for IV therapy is forbidden. Hospitals
303
can reprocess medical devices only in the following situa-
tions:
• A new device was open but not used in a patient.
• A critical device is life supporting and there is no other choice in
the hospital.
• A device can be cleaned assuring elimination of organic matter
and is not intented to be used in blood and tissue.
• A hemodialysis filter is used in the same patient.
Some authors report that up to 97% of hospitals in Brazil
(1999–2001) reuse single-use devices such as angiography and
cardiac catheters (Amaranta et al., 2008). Presence of pathogenic
bacteria has been reported on some reprocessed single-use
devices (catheter guide units) after reprocessing (Da Silva et al.,
2006)
Europe
The medical product market in Europe is currently worth 64
Billion D with a yearly growth of 5–6% (European Commission,
2008a,b). The number of single-use products is increasing because
of safety concerns when reuseable medical products are repro-
cessed.
The COUNCIL DIRECTIVE 93/42/EEC concerning medical devices
does not distinguish between single-use and multiple-use devices,
does not demand a differentiated classification of single-use and
multiple-use devices and does not define a standard for reprocess-
ing. Thus, the declaration of a product as single-use or multiple
use is based only on the decision of the manufacturer. Products
can be constructed similarly yet classified differently by alternative
manufacturers (e.g. liposuction cannulas).
The DIRECTIVE 2007/47/EC OF THE EUROPEAN PARLIAMENT
AND OF THE COUNCIL demands that “care should be taken to
ensure that the reprocessing of medical devices does not endan-
ger patients’ safety or health.” Therefore, the necessity is seen “to
provide clarification on the definition of the term ‘single use’, as
well as to make provision for uniform labelling and instructions for
use.” According to DIRECTIVE 2007/47/EC the European Commis-
sion shall submit a report to the European Parliament on the issue
of reprocessing of medical devices not later than September 2010.
This report is under preparation now.
In 2008, the European Commission published a Synthesis docu-
ment “Outcome of the first public consultation on the reprocessing
of medical devices”. According to most of the answers reprocess-
ing means the cleaning, disinfection and sterilization of medical
devices, including related procedures, as well as the functional test-
ing and repackaging. In Europe 90% of reprocessing of reusable
devices undertaken in-house, while 10% of devices are reprocessed
in external facilities. According to some respondents, even tra-
ditional multiple-use devices cannot be indefinitely reprocessed.
With respect to reprocessing of single-use devices there was no
data available on the percentage of reprocessing in-house vs.
external. Reprocessing is conducted on the basis of procedures
developed by the user or the reprocessing service provider. It was
estimated that 10–20% of single-use devices are in fact multiple-use
devices, technically reprocessable for a limited number of times.
According to the reprocessing industry, cost savings for reprocess-
ing of single-use devices may be up to 50% for certain devices, e.g.
electrophysiology/ablation catheters; the cost savings may be up to
90% when reprocessing is done in-house (European Commission,
2008a,b).
Reuse of SUMEDs is common in European hospitals, at least for
some devices according to reports from Germany (40% of hospi-
tals) (Ischinger et al., 2002), Spain (80% of hospitals in Madrid) (El
304 W. Popp et al. / International Journal of Hygiene and Environmental Health 213 (2010) 302–307
Picture 1. Example of a modern reprocessing unit for multiple-use devices. View
from dirty to clean section.
Mundo, 2005) and Denmark (37% of hospitals) (Christensen et al.,
1999).
EU countries differ in reprocessing practices depending on
regulations in the countries. In Germany (e.g. Medical Devices
Act, Medical Devices Operator Ordinance, Recommendation of
the Robert Koch Institute), the Netherlands, Denmark, Sweden,
Belgium, Slovakia and Finland high quality standards are either
accepted in practice or are demanded by regulations (Picture 1).
For example, in Germany the legal conditions for reprocessing
of medical devices depend on whether they are reuse or single-
use only – are developed at a very high level (RKI, 2001; Klosz,
2008; Kramer et al., 2006; GMS, 2008). According to a new sur-
vey in Germany (Bundesministerium für Gesundheit, 2008) the
reprocessing of single-use devices has decreased by 90% in the
recent years. Austria, Luxembourg, Czech Republic and Slovenia
are assessing such standards and legislation for the future. There is
no legislation available in Estonia, Latvia, Lithuania, Malta, Cyprus,
Greece and Poland. Reprocessing is forbidden in France; there
is a statement against the practice issued by the UK’s Medical
Devices Agency. There are no recommendations in Ireland, Portu-
gal, Spain, Italy and Hungary. Reprocessing of single-use devices
may be undertaken in nearly all European countries, and mostly
without quality standards (European Commission, 2008a,b; Hailey
et al., 2008; European Association for Medical Device Reprocessing;
SUPROMED, 2007; Universita degli studi di Trento, 2006).
USA
Reuse of single-use medical devices is reported for around 25%
of hospitals in the United States (Quirk, 2002). Most hospitals repro-
cess reusable devices in-house and give single-use devices to third
party reprocessors (Quirk, 2002). Similarly in Europe, the decision
to label a product single or multiple-use is the responsibility of the
manufacturer. Around 70 products can lawfully be reprocessed in
the U.S. (listed by FDA). About 40–50% of US hospitals including
major hospital networks and group purchasing organizations use a
third party for reprocessing their SUMEDs. All reprocessors, includ-
ing hospitals that reuse single-use devices, are required to comply
with the same regulations as original manufacturers (Hailey et al.,
2008; EAMDR; Universita degli studi di Trento, 2006; United States
Government Accountability Office, 2008; Quirk, 2002; Alfa and
Castillo, 2004; AORN Guidance statement 2006). An actual over-
sight of the FDA states that many reprocessed single-use devices –
more than 70 types at the moment – are being used in US hospi-
tals. According to this study no definitive conclusion can be drawn
about the safety of reprocessed single-use devices. In addition,
Picture 2. Sterilisation pot in front of a health center in some Asian country.
there are also no indications of an elevated health risk (United
States Government Accountability Office, 2008).
Canada
Health care in Canada is a matter of provincial jurisdiction.
The federal health care agency states that health care facilities
and health care providers should not reprocess single-use devices
unless the facility has established quality systems for reprocessing.
These should include: (a) a reuse committee to establish policies
and ensure adherence to approved procedures, (b) written proce-
dures for each type of device that is reprocessed, (c) validation of
cleanliness, sterility and function of the reprocessed devices and
(d) continual monitoring of reprocessing procedures to ensure their
quality. Nevertheless, in some Canadian jurisdictions the practice
still occurs with little or no regulation, although many of provinces
and territories have published guidance documents on the reuse of
SUMEDs.
Even though most hospitals do not, 28% of hospitals do reprocess
single-use devices, 85% are reprocessed in-house. Forty percent of
them do not have a written policy and 12% do not have an incident-
reporting mechanism (Polisena et al., 2008; Hailey et al., 2008).
Asia
A survey (response rate around 30%) of hospitals in Japan in 2003
showed that 80–90% of the responding hospitals reused single-use
devices (Koh and Kawahara, 2005).
Unsafe medical injections are believed to occur most frequently
in South Asia, the Eastern Mediterranean, and the Western Pacific
regions (WHO, 2007; Schmidt et al., 2004; Hutin and Hauri, 2003).
In India, the average person is presumed to have three to five
medical injections per year. Around 60–70% of these will be deliv-
ered by unsterile or reused syringes and needles. WHO estimates
that around 300.000 people in India die every year as a result of
dirty syringes. A lot of medical treatment is given by local “doc-
tors” who do not have a MD degree and injections are seen much
more effective than tablets. Additionally, it is considered dishon-
ourable to criticise the medical profession (Sharma, 2004; Turner,
2009; Hutin and Hutin, 2005; Lakshman and Nichter, 2000; Pandit
and Choudhary, 2008). The situation seems to be very similar in
Pakistan where extremely high incidendes of injection per capita
are reported. It has also been reported (Janjua et al., 2005; Khan et
al., 2000) that the reuse of non-sterile syringes and needles occurs
in over 90% of injections. As seen in Picture 2, it is noted that in many
low resourced countries even sterilisation of all medical products
is done improperly.
 W. Popp et al. / International Journal of Hygiene and Environmental Health 213 (2010) 302–307 305

Australia

During the 1980s, about 50% of hospitals in Australia reused

single-use devices (Collignon et al., 1996). In 2001, another survey
revealed that the reprocessing of SUMEDs had decreased but was
still occurring (Collignon et al., 2003).
Today under regulations introduced in 2005 Australia does not
permit the reuse of single-use devices unless all reprocessors,
including hospitals, meet the regulatory requirements for a manu-
facturer of medical devices (Hailey et al., 2008).
The Australian Infection Control Guidelines 2003, (http://
www.health.gov.au/internet/main/publishing.nsf/content/icg-
guidelines-index.htm) recommend that to avoid
cross-contamination between patients, single-use equipment
should be used wherever practical. Instruments or equipment
intended for single use and labelled “single use” by the manu-
facturer should be disposed of after use. This is supported by the
Therapeutics Good Administration (TGA) and the Australian Health
Ministers Advisory Council agreed in July 2001 that any reprocess-
ing of single-use devices should be regulated by the TGA. This came
into effect in 2005 (http://www.tga.gov.au/devices/devices.htm).
For instance, at Southern Health, Victoriaı̌s largest metropolitan
health service, single-use items are not reused. Electrophysiol-
ogy (EP) catheters which are single use, had previously been
reused (under strict internal regulations) but with the change in
TGA requirements in 2005 EP catheters have only been used as
single-use items. It is understood that other health services across
Australia have followed the same initiative as Southern Health
because the cost of complying with the TGA regulations for repro-
cessing of single-use items is prohibitive.

Africa

According to WHO approximately 18% of injections in sub-

Saharan Africa are given with reused syringes or needles that have
not been sterilized (WHO, 2007, Schmidt et al., 2004).
Thus, the situation may be better than in some parts of Asia.
Unfortunately, there are many countries reusing single-use devices
like gloves, needles and syringes (Picture 3).
Some countries do not have facilities for production of medical
devices, centers for distribution or a nation-wide logistic to deliver
devices. This necessitates the reprocessing of single-use devices to
enable the provision of health services.
Some process controlling and validation can be done in larger
hospitals but is not available in provincial hospitals, health centres
and health posts in many African countries.
Some African countries have national standards for reuse and
reprocessing of medical devices with educational support at uni-
versity level and in medical schools. South Africa, for example,
proposes regulatory requirements according to WHO standard
(Good Manufacturing and Management Practice and Practicle
guidelines for infection control in health care facilities) which are
available on the homepage of the Ministry of Health of S.A.
Arab countries
Picture 3. Reprocessing of single-use gloves in a central-west African country.
In emergency departments of some primary health care facili-
ties, the shortage of masks and tubing of nebulizers have prompted
these facilities to reuse them. Proper procedures for their reuse in
national guidelines were formulated (National guidelines for Infec-
tion Control, Ministry of Health, Egypt, 2008), however the work
over load, understaffing and the emergency conditions compromise
the proper application of these procedures.
Discussion and conclusions
The same standard of safety for all medical devices – regardless
whether they are reuse or single-use – is necessary. According to
IFIC (2007), in its document Basic Concepts of Infection Control,
only after the following five questions are answered positively by
every reprocessor, can the safety and then reuse of reprocessed
SUMEDs be considered:

• Is the single-use device undamaged and functional?

The increased demands for cardiac catheterization together
• Can it be cleaned?
with the limited resources in Arab countries have prompted some
• Is it sterile?
health care facilities to reuse cardiac catheters. Reprocessing is
• Is it cost effective?
done locally by different in-house formulated protocols due to
• Is there someone who takes the responsibility if anything goes
absence of third party reprocessors.
Some Arab countries reuse sclerotherapy needles for treating wrong?
oesophageal varices. Although some of the facilities restricted this
reuse for the same patient, the reprocessing may compromise the The consequences are quite different in developed and devel-
structural integrity of the device and/or lead to device failure. oping/transitional countries.
306 W. Popp et al. / International Journal of Hygiene and Environmental Health 213 (2010) 302–307
In developing and transitional countries, reprocessing of single-
use devices is undertaken in most hospitals and healthcare
settings. The main issues are around unsafe medical injection
with reuse of needles and syringes. This is coupled with exces-
sive use of injections versus oral medication. WHO estimates that
over 70% of injections given in developing and transitional coun-
tries are unnecessary or could be given in an oral formulation
(www.who.int/injection safety). These are the main targets of the
“Safe Injection Global Network” (SIGN) of WHO.
Therefore, in developing and transitional countries
• reuse of cheap single-use devices (needles, syringes, surgical
gloves) must cease.
• In parallel, the public as well as the medical staff must be taught
about injection necessities and safety risks.
In developed countries, high quality standards and regulations
exist in many European countries, US, Canada and Australia. In most
cases there is no difference in the regulations for the reprocessing
of single-use versus multiple-use devices. Nevertheless, reprocess-
ing of single-use devices occurs in many well developed countries
worldwide. Third party reprocessors exist. The development of
high quality standards appears to have led to a decreased num-
ber of reprocessed single-use devices. Through the collaboration of
this paper, it has been identified that even traditional multiple-use
devices cannot be indefinitely reprocessed and that some single-
use devices may in fact be multiple-use ones.
In developed countries it seems reasonable to validate repro-
cessing. Clear guidelines and defaults for the reprocessing or
medical devices including appropriate control mechanisms are the
precondition to use medical devices safely and with economic
advantage. Considerations should be made whether reprocessing of
single-use devices is adequate from an ethical and economic point
of view.
Requirements for the proper reprocessing of single-use devices
might include the following steps:
• A preliminary hazard analysis (PHA) – a technique that can be
used at an early stage of the development of a medical device.
• A fault tree analysis (FTA) – helpful when interpreting safety
technology and determining ranking of hazards.
• A failure mode and effect analysis (FMEA) – to support risk assess-
ments and risk measures once the medical devices is completed.
• Hazard and operability studies (HAZOP, similar to FMEA) and the
hazard analyses and critical control points (HACCP, helping in
cause analysis of hazards) which are recommended for the veri-
fication and optimisation of structure designs.
• Risk assessment of reprocessing including risk analysis and risk
management of the reuse of the reprocessed SUMED (considera-
tion of design input and output).
The potential risk of transmission of prions should be assessed.
Consideration should be given to the risk of contact with neural
tissue and replacing reuseable medical devices with single use, if
necessary.
Additional requirements for the proper reprocessing of single-
use medical devices:
• availability of appropriate technology for reprocessing,
• education and training of staff,
• environmental and structural requirements (e.g. centralized
reprocessing area for collecting, cleaning, decontamination and
sterilising, appropriate HVAC and water supply) for reprocessing,
• occupational health and safety requirements,
• policies and procedures,
• certification of quality management system (e.g. according to EN
ISO 13485),
• testing for functionality and safety,
• testing of biocompatibility and exclusion of reactions caused by
pyrogens as well as allergic and toxic reactions,
• responsibility for patients and users of reprocessed products
(insurances),
• validation of procedure.
A validation of reprocessing seems necessary with respect to
different aspects:
• Physical safety (e.g. alteration of device’s dimensions, alteration
of material stiffness and torsion strength, brittleness or cracking,
malfunction or poor performance that delays the procedure, soft-
ening of adhesives, weakening of components). This can be tested
properly.
• Chemical safety (e.g. absorption of cleaning agents, disinfectants,
sterilisation agents, poor rinsing of cleaning agents, toxic or pyro-
genic reactions). There may be problems in testing, e.g. with
respect to the production of monomers from polymers.
• Biological safety (Debris that remains fixed to surface, inadequate
cleaning or disinfection of all surfaces, nosocomial infection).
There may be some problems like testing of channels or with
respect to virus or prion risk (Brown et al., 2002; Dunn, 2002a;
Gärtner et al., 2008; Roth et al., 2002; Kraft et al., 2000; European
Commission, 2008a,b; Luijt et al., 2001; Granados et al., 2001;
Kobayashi et al., 2009; Lester et al., 2009).
Some producers of single-use devices claim that the number of
devices used for validation of the reprocessing procedure of single-
use devices is too small to get valid results (Schröer, 2000).
Some European reprocessors claim that cost savings may
be up to 90% when reprocessing is undertaken in-house.
Reprocessing of complex medical devices requires specific clean-
ing/disinfection technology and cannot be performed in standard
washers/disinfectors. Special test equipment may be needed, i.e.
for electronical functionality testing of electrophysiology/ablation
catheters. This implies a special training of the staff performing the
tests. Low-temperature sterilisation may be needed using ethylene
oxide or hydrogen peroxide processors. Considering usage rate and
costs of this equipment, a saving of 90% would not appear to be
achievable.
Conclusion
The experience of some European reprocessors show that the
frequency of reprocessing of single-use devices is limited (max-
imum 5 for most devices) (Tessarolo et al., 2007), up to 50% of
reprocessed devices do not function even after first reprocessing,
parameters depend on manufacturer and as found in Australian
health services, there may be no economical benefit. Thus, the deci-
sion on reuse of single-use devices should be made after a critical
reflection of advantages and disadvantages.
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