Microbiological Contamination

Risk Prevention in Infusion Therapy

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Microbiological Contamination

Definition
Definition: Microbiological contamination
Microbiological contamination refers to the nonintended or accidental introduction of infectious
material like bacteria, yeast, mould, fungi, virus, prions, protozoa or their toxins and by-products [1, 2].

A nosocomial infection also called

hospital-acquired infection is defined as:
An infection occurring in a patient in a hospital or
other healthcare facility in whom the infection was
not present or incubating at the time of admission.
This includes infections acquired in the hospital
but appearing after discharge, and also occupational infections among staff of the facility. [3]

Types of microbiological pathogens

There is a broad range of microbiological pathogens, which can
cause contamination and thus infections. Within these groups,
several different types of pathogens exist:
1. Bacteria: are microorganisms with a size of up to 5 m and re-
present the most important group of pathogens when discussing
microbiological contamination. According to the constitution of
their cell wall, bacteria can be distinguished into Gram-positive
and Gram-negative bacteria (see Figure 2, Meningococcus Bacteria).
Bacteria can be further distinguished as follows:
1.1 Commensal bacteria: belong to the normal flora of healthy

humans. They are usually harmless to healthy people or even

have a significant protective role by preventing colonization
by pathogenic microorganisms. Some commensal bacteria

may however cause infection, if the natural host is compro-

mised or if they are brought into the hosts tissue.
1.2 Pathogenic bacteria: have greater virulence and cause

infections regardless of the hosts status.
2. Viruses: subcellular biological objects with a size of 20-200 nm.
They exist with and without envelopes (shells mostly derived
from host membranes covering the virus) and can cause serious
infections (see Figure 3, HI-Virus).
3. Prions: infectious protein particles. They are the smallest
pathogens, which are below 5 nm in size.
Both prions and viruses are particles without own metabolism
and are thus not regarded as living organisms. For reproduction,
they depend on the metabolism of a host organism.
4. Fungi, yeasts and protozoa with up to 200 m in diameter are
three further groups of infection sources [3]. A Mycelium, the
vegetative part of a fungus, is shown in Figure 4, Penicillium
digitatum.

Toxic by-products of microorganisms

Endotoxin:
The most common example for endotoxins are the lipopolysaccharides (LPS) found in the outer membrane of the group of
Gram-negative bacteria. If this membrane degenerates, e.g. when
the bacteria dies, LPSs are released. LPS are heat stable and cause
serious fever, chills, sepsis and irreversible shock.
Exotoxin:
Exotoxins are toxic substances, which are actively excreted or released
by a microorganism, like bacteria, fungi, algae, and protozoa. They can
cause major damage to the host by destroying cells or disrupting normal metabolism, but they are mostly destroyed by heat. For example,
Clostridium tetani produces the tetanospasmin which leads to the
symptoms of tetanus; Vibrio cholerae produces the choleratoxin and
leads to the symptoms of cholera.

Under normal circumstances, one single bacterium will not cause any
harm. However, even one bacterium can quickly replicate itself into
millions: Under optimal conditions, bacteria like Escherischia coli can
double their population every 20 minutes.
Time

Quantity of Escherichea coli

20 min.

40 min.

1h

2h

64

3h

512

4h

4.096

5h

32.768

6h

262.144

6 h 40 min.

1.048.576

It is also important to know that several pathogens can survive under

extreme environments, e.g. Hepatitis C virus is still infectious after
7 days on dry surfaces [4].

Fig. 1: Meningococcus-Bacteria under

the scanning electron microscope (SEM)

Fig. 2: HI-Virus

Fig. 3: Photomicrograph of Penicillium

digitatum mold showing conidiophores and
spores
3

Microbiological Contamination

Definition
Nosocomial infections are widespread.
They are important contributors to morbidity and
mortality. They will become even more important
as a public health problem with increasing economic and human impact because of:
Increasing numbers and crowding of people

More frequent impaired immunity

(age, illness and treatments)
n

New microorganims

Increased bacterial resistance to antibiotics [5]

Microbiological contamination is most dangerous for patients

when it affects parenteral therapy and the intravenous catheters
used. In this case, pathogens can directly reach the systemic
circulation and cause catheter-related blood stream infection
(CR-BSI) or travel to various organs and induce organ failure.
Therefore, prevention of CR-BSI is crucial. In the mid-90s the Centers
for Disease Control and Prevention (CDC) published a standard definition for CR-BSI, which is the most widely accepted definition for
CR-BSI [6].
Bacterial infections can mostly be treated with antibiotic drugs.
However, there are cases where this is extremely difficult or even
impossible because the bacteria have become multidrug resistant.
Against most viruses and all prion diseases, there are also no effective
drugs available. Thus, prevention of such infections is crucial.

Definition of Catheter-Related Blood

Stream Infection (CR-BSI)
The definition of CR-BSI helps with the decision
whether a catheter is the primary source of bacteremia in a patient. They include exit site or tunnel
infections and are defined as:
n Erythema or induration within 2 cm of the
catheter exit site, in the absence of concomitant
bloodstream infection and without concomitant
purulence
n For tunnel infections, presence of tenderness,
erythema, or site induration >2 cm from the
catheter site along the subcutaneous tract of a
tunneled catheter in the absence of concomitant
blood stream infection is required [7].

Legend
no data
<1%
1-5%
5 - 10 %
10 - 25 %
25 - 50 %
> 50 %

Fig. 4: Prevalence of MRSA in Europe 2008 [7]

4

Incidence and Prevalence of MRSA

Methicillin resistant Staphylococcus aureus (MRSA) infection is a
serious worldwide health concern. MRSA is defined as any strain of
Staphylococcus aureus that has developed resistance to beta-lactam
antibiotics which include the penicillins (methicillin, dicloxacillin,
nafcillin, oxacillin, etc.) and the cephalosporins.
According to the Centers for Disease Control and Prevention (CDC),
MRSA currently causes about 1 % of all staphylococcus infections
and more than 50 % of health-care associated staphylococcus
infections. After Staphylococcus epidermidis, Staphylococcus aureus
is the second most common pathogen causing health care-associated infections in the United States, and 49 % of those infections
are caused by the highly antibiotic resistant bacteria MRSA.
A strain called USA100 is the most common type of MRSA involved
in health care-associated infections in U.S. hospitals [8]. MRSA is
especially troublesome in hospitals and nursing homes where
patients with open wounds, invasive devices and weakened immune
systems are at greater risk of infection than the general public.
Each year in the United States, more than 290,000 hospitalized
patients are infected with Staphylococcus aureus. Of these staphylococcal infections, approximately 126,000 are related to MRSA [9].

Definition of multidrug resistant bacteria

Multidrug resistance is a condition enabling a
disease-causing organism to resist distinct drugs or
chemicals of a wide variety of structure and function
targeted at eradicating the organism [10].
Important multidrug resistant organisms are
n Methicillin resistant Staphylococcus aureus (MRSA)
n Vancomycin resistant Enterococci (VRE)
n Extended spectrum -lactamase (ESBLs) producing
Gram-negative bacteria
n Klebsiella pneumoniae carbapenemase (KPC)
producing Gram-negatives
n Imipenem resistant Acinetobacter baumannii
n Imipenem resistant Pseudomonas aerginosa
n Multidrug resistant Mycobacterium tuberculosis
(MDR-TB) and extremely drug resistant
Mycobacterium tuberculosis (XDR-TB)

Microbiological Contamination

Causes
How does contamination occur?
Contamination may occur if pathogens are carried unintendedly from
a source to an orifice or an artificial body opening of the host where
they then start growing and exerting their harm. There are several
possible sources, entry routes and ways for transmission.
n Sources: Natural body orifices or artificial openings due to injury
or disease
n Entry portals: Natural body orifices or artificial openings due to
injury or disease
n Direct transmission via contact or droplet spread
n Indirect transmission via surfaces or instruments
n Indirect transmission via vectors, mosquitoes, flies, rats
transmitting the infection
n Indirect transmission via intermediate host [e.g. human, animal
or insect, e.g. transmission of malaria through mosquitoes].
In a health care setting, important ways of contamination are
hands of health care personnel and via droplets in the air.

Causes
Generally speaking, contamination occurs if any part of a system,
product or medicine gets in touch with microbiological pathogens
where it should be sterile. For example, if a surgical instrument is
contaminated with pathogens, the result might be a surgical wound
infection. Typical pathogens of such infections are shown below.
Contamination in infusion settings may occur, when pathogens are
carried inside of the infusion system, mostly happening during
manipulation (see Figures 7, 8).
With regards to infusion-related infections, there are two separate
routes: the extra- and the intraluminal route [12]. Intraluminal contamination is the consequence of improper handling of the infusion
system, e.g. of the catheter hub at the time of connection and disconnection of the administration set. It is the most common origin of
catheter infections after the first week of catheter placement [13, 14].
Extraluminal catheter seeding results from bacterial invasion from
the catheter entry site along the external surface of the catheter
and leads to bacteremia most often during the week following
catheter placement [15, 16].

Pathogenic microorganisms in surgical wounds

4.5%
2.1 %
3.3%

5.1%

3.6%

50.1%

31.3 %

Staphylococcus aureus
Staphylococcus epidermidis
Candida albicans
Pseudomonas aeruginosa
Corynebacterium spp.
Other Gr. (+) cocci
Other Gr. (-) rods

Fig. 5: Pathogenic microorganisms in surgical wounds

6

4%
8%

3%

3% 2%
20%
Other
S. aureus
Staph. (koagulase-negativ)

Fig. 6: Challenging hygienic situation observed in hospital

Potential contamination before use

Potential contamination during use

Contaminated infusion fluid

Open infusion systems allowing unfiltered

air entering the IV System

Faulty container:
n presence of punctures
in bags or cracks in bottles

Not maintaining asepsis when inserting

additives or using contaminated additives

Faulty administration set:

puncture in packaging

Not maintaining asepsis when attaching

the administration set to the container
and manipulating the cannula

Faulty peripheral catheter:

puncture in packaging

Wrong or faulty connections

Not maintaining the integrity

of the connections

Inadequately cleaning the skin

prior to insertion of the cannula

Not maintaining asepsis when introducing

drugs via the rubber bung or 3-way tap
Leaving soiled dressings unchanged

Fig. 7: Potential sources for microbiological contaminations (modified from [17])

Fig. 8: Extra- and intraluminal route of contamintation

7

Microbiological Contamination

Consequences
Consequences for the patient
Nosocomial infections occur worldwide and affect both developed
and resource-poor countries. Infections acquired in health care settings are among the major causes of death and increased morbidity
among hospitalized patients. They are a significant burden both for
the patient and for public health. A prevalence survey conducted under the auspices of WHO in 55 hospitals of 14 countries representing
4 WHO Regions (Europe, Eastern Mediterranean, South-East Asia and
Western Pacific) showed an average of 8.7 % of hospital patients had
nosocomial infections. At any time, over 1.4 million people worldwide
suffer from infectious complications acquired in hospital [18].
The highest frequencies of nosocomial infections were reported from
hospitals in the Eastern Mediterranean and South-East Asia Regions
(11.8 and 10.0 % respectively), with a prevalence of 7.7 and 9.0 %
respectively in the European and Western Pacific Regions [19].
The most frequent nosocomial infections are infections of surgical
wounds, urinary tract infections and lower respiratory tract infections.

Fig. 9: Local infection at catheter entry site

8

The WHO study, and others, have also shown that the highest prevalence of nosocomial infections occurs in intensive care units and
in acute surgical and orthopaedic wards. Infection rates are higher
among patients with increased susceptibility because of old age,
underlying disease, or chemotherapy [3].
Contamination and subsequent infection can occur locally or
systemically.
n In case of a local infection, surgical wound infections, skin irrit-
ations and catheter entry site infections may occur.
n In case of a systemical inflammation with pathogens reaching the
systemic circulation, septicemia, sepsis and septic shock may be
the result, as well as pathogens might be transported to organs
or extremities and cause organ infection and failure as well as
endocarditis or osteomyelitis which might possible result in
amputation [20, 21].

Fig. 10: Ecchymosis, cutaneous

manifestation of sepsis

Fig. 11: Septic shock

In all cases, additional diagnostic investigation and treatment will

be necessary, leading to discomfort, emotional stress for the patient
and potential side effects and pain. In some cases, they might even
lead to disabling conditions that reduce the quality of life.
Along with this, the hospital stay might be prolonged. One study [12]
showed that the overall increase in the duration of hospitalization
for patients with surgical wound infections was 8.2 days, ranging
from 3 days for gynaecology to 9.9 days for general surgery and
19.8 days for orthopaedic surgery.

In ICU patients, MRSA infection is therefore independently

associated with an almost 50 % higher likelihood of hospital
death compared with MSSA infection [22]. Others have found
the mortality rate for blood-stream-infections to be 10-25 %,
that of septic shock was even higher with 40-60 % [23].
Thus, nosocomial infections are one of the leading causes
of death [24].

The EPIC II point-prevalence study of infection in critically ill

patients performed on 8th May 2007 assessed the role of methicillin
resistance in survival of patients with Staphylococcus aureus
infection. On the study day, 7,087 (51 %) of the 13,796 patients
were classified as infected. There were 494 patients with MRSA
infections and 505 patients with MSSA (Methicillin-susceptible
Staphylococcus aureus) infections. ICU mortality rates were 29.1 %
and 20.5 %, respectively (P<0.01) and corresponding hospital
mortality rates were 36.4 % and 27.0 % (P<0.01). Multivariate
analysis of hospital mortality for MRSA infection showed an
adjusted OR* of 1.46 (95 % CI 1.03-2.06) (P=0.03).

*Odds Ratio

Microbiological Contamination

Consequences
Economical consequences
Impact of nosocomial infections
Uslusoy et al. [17] have estimated more than two million cases
of nosocomial infections every year (5.7 infections per 100 admissions) with an average cost of $ 13,973. They state that in case of
MRSA this can be up to 35,367.
Nosocomial infections occur in more than two million hospitalizations each year [25]. The economic costs of nosocomial infections
are considerable [26, 16]. The increased length of stay for infected
patients is the greatest contributor to cost [6, 27, 13]. Additionally,
increased morbidity and increased total cost per patient who survived
is approximately $ 40,000 [27, 28].
In their study evaluating the outcome of intravenous catheter
related infections in critically ill patients, Rello et al. [29] found
that among the survivors, the hospital stay was increased by 19.6
days. This added cost of 3,124 per episode of catheter related
infection based on the additional days only, not taking diagnostic
and treatment expenses into account.
Vandijck et al. [30] investigated the daily cost of antimicrobial
therapy in patients with ICU-aquired bloodstream infection. The
mean overall daily antimicrobial cost was 114.25 per patient.
As the average duration of antimicrobial therapy for infected
patients ranges from 7 to 14 days, the total cost of antimicrobial
therapy per patient ranged between 800 & 1,200. In special
cases of infections from bacteria resistant to comon antibiotics,
it has been identified a potential extra cost of $ 8,480/patient
(approx. 5,000) [31].

10

A systematic literature review covering 1990-2000 calculated the

following average attributable costs (costs calculated with a control
group of patients and including only costs directly resultant from
nosocomial infestion) to the hospital for nosocomial infections
(see Figure 12):
Average nosocomial infection, mean cost = $ 13,973
Bloodstream infection, mean cost = $ 36,441
n Methicillin resistant Staphylococcus aureus infections (MSRA),
mean cost = $ 35,367
n Surgical site infection, mean cost = $ 25,546
n Pneumonia, mean cost = $ 9,969
n
n

For the following infections, no studies were done to determine

attributable costs but treatment costs are known (see Figure 13):
Urinary tract infection, mean cost = $ 1,008
Varicella zoster virus, mean cost = $ 27,377
n Tuberculosis, mean cost = $ 61,446
n Measles, mean cost = $ 41,087
n
n

Since the literature review, Roberts et al. [33] created an economic

model based upon a sample of patients at Rush University Hospital
that controlled for severity of illness and intensive care unit to
calculate the average attributable cost of an average nosocomial
infection at $ 15,275 [28]. Another recent study utilized national
data and a case-control matching method to control DRG, sex, race,
age, and comorbidity to calculate that the average excess costs
attributable to the national indicator selected infection due to
medical care are $ 38,656 [29].

Hospital-acquired infections add to the imbalance between resource

allocation for primary and secondary health care by diverting scarce
funds to the management of potentially preventable conditions.
On October 1st 2008, the Centers for Medicare and Medicaid Services
(CMS) decided to cease paying hospitals for some of the care made
necessary by preventable complications conditions that result
from medical errors or improper care and that can reasonably be
expected to be averted [35].

The costs of a nosocomial infection outbreak can easily reach

millions of dollars [34].

40
30
20
10

Costs in thsd. $

Costs in thsd. $

Prolonged stay not only increases direct costs to patients or payers

but also indirect costs due to lost work. The need for isolation and
the use of additional laboratory and other diagnostic studies also
contributes to the costs.
70
60
50
40
30
20
10
0

Average nosocomial infection

Bloodstream infection
Methicillin resistant Staphylococcus aureus infections (MSRA)
Surgical site infection
Pneumonia
Fig. 12: Costs caused by infections, proven by studies

Urinary tract infection

Varicella zoster virus
Tuberculosis
Measles

Fig. 13: Costs caused by infections, not proven

11

Microbiological Contamination

Consequences
Risk related Costs for the Healthcare Institution
Even non-fatal episodes of microbiological contamination lead to
additional involvement for diagnostic (e.g. blood cultures, laboratory
work, X-ray) and therapeutic interventions (e.g. antibiotics, catecholamines) as well as an increased length of stay and the average
daily cost [36, 37, 38] of the expected clinical treatment.
The table below shows the results of such a calculation for selected
examples of complications.
Patients with severe infections and sepsis are generally treated in
intensive care units (ICUs) where close supervision and intensive
care treatment by a competent team with adequate equipment
can be provided. Staffing costs represent from 40 % to > 60 % of
the total ICU budget. Because of the high proportion of fixed costs
in ICU treatment, the total cost of ICU care is mainly dependent on
the length of ICU stay (ICU-LOS). The average total cost per ICU day
is estimated at approximately 1,200 for countries with a highly
developed healthcare system (based on various studies conducted
between 1989 and 2001 and converted at 2003 currency rates).

Those patients require a prolonged ICU-LOS, resulting in higher

costs of treatment compared with other ICU patients. US costof-illness studies focusing on direct costs per sepsis patient have
yielded estimates of 34,000, whereas European studies have
given lower cost estimates, ranging from 23,000 to 29,000.
Direct costs, however, make up only about 2030 % of the cost
of illness of severe sepsis. Indirect costs associated with severe
sepsis account for 7080 % of costs and arise mainly from
productivity losses due to mortality [39].

Costs of the most common health care-associated infections in the USA*

Attributable costs in US $

Range in US $

Mean

Minimum

Maximum

Bloodstream infection

36,441

1,822

107,156

Surgical site infection

25,546

1,783

134,602

Ventilator-associated pneumonia

9,969

7,904

12,034

Urinary tract infection

1,008

650

1,361

Type of infection

* Reproduced from Cosgrove SE & Perencevich EN with permission from Lippincott Williams & Wilkins.

12

A schematic representation of the costs associated with

Nosocomial Infections [40]
I Opportunity costs to health service
Hospital Service
Inpatient stay (inpatient days, investigations, treatments)
Outpatient consultations (consultations, investigations, treatment)

Conclusion
Prevention of contamination of medical devices and infusion
solutions and thus prevention of severe infection and sepsis is
of paramount importance in the hospital setting and can result
in tangible savings for the health care provider. In the case of
severe sepsis, which requires full ICU treatment, a hospital may
save up to 56,670 per single case.

Primary care Service

General Practitioner (consultations, investigations treatment)
District nursing and other (nursing care, investigations, treatment)
II Private costs to patient and informal carers
Out of pocket expenditures (travel, medicines, miscellaneous expense)
Other consequences (death, anxiety, pain / discomfort)
III Other costs to society
Production losses due to morbidity and caring activities

13

Microbiological Contamination

Consequences
Costs for the hospital

Examples of complications resulting from

Microbiological Contamination

Severity

Severe sepsis, septic shock, multi-organ failure, death

High

Sepsis, Organ failure, Embolism

Medium
High

Severe wound infection, thromboembolism,

complicated urinary tract infection

Medium

Catheter entry-site infection,

phlebitis, local wound infection,
urinary tract infection

Medium
Low

Contamintation without
infection, known contamination and discard of product
before use

Microbiological Contamination
Fig. 14: Estimation of possible additional costs as a consequence of complications caused by microbiological contamination.
In order to facilitate the attribution of each complication to the cost calculation, severity levels were introduced [35, 36, 37].
14

Low

Clinical Treatment

Length of Stay

Additional Costs

Full ICU treatment

(Treating / Monitoring / Feeding etc.)

4-30 d ICU
+ 4-30 d Normal Ward

7,556 - 56,670

ICU / Intermediate care treatment

(Observation / Monitoring / Treatment)

1-7 d RICU*
+ 1-7 d Normal Ward

1,136 - 7,952

Extension of clinical treatment

(Observation / Monitoring)

0 d RICU*
+ 1-3 d Normal Ward

382 - 1,146

Local treatment
(No additional Monitoring)

0 d ICU
+ 0-1 d Normal Ward

0 - 382

No complication for patient

0 d ICU
0 d Normal Ward

*RICU: Respiratory intermediate care unit

15

Microbiological Contamination

Preventive
strategies

Fig. 15: Hands disinfection

soap and water, drying.

Fig. 16: Hands disinfection

disinfection fluid.

Prevention of microbiological contamination and thus nosocomial

infection has gained increasing importance and attention throughout
the last years because of the dramatic consequences for health and
economy. Medical societies, hospitals and government agencies
have invested in development of evidence based guidelines for
prevention of nosocomial infections [3, 6, 10, 11, 41, 42, 49].
Education and training
Proper education of health care workers with requisite knowledge,
skills and attitudes for good infection control practices is the most
important measure for infection prevention. Awareness programmes,
in-service education and on-the-job training with periodic re-training
or orientation of staff should be provided [41, 42].
Among all measures, hand hygiene has the biggest impact in
infection prevention and gloves as well as other personal safety
equipment should always be used (see Figure 15, 16). The WHO and
CDC have launched a campaign named Wash your hands, along
with posters, trainings, websites and guidelines on hand hygiene
[43, 44, 45, 46]. Proper hand hygiene cuts MRSA rates by 50 % [47].
It is important to stress that use of gloves does not obviate the need
for hand hygiene [6].
16

Fig. 17: Using sterile disposables.

Fig. 18: Routine replacement of IV

administration sets according to
CDC or local hospital / institutional
guideline.

Monitoring and surveillance

The implementation of surveillance systems on ICUs and for other
patient populations at risk to determine infusion related complication
rates, monitor trends and correct lapses in infection control practice
have been proven to be successful. E.g. the infection surveillance
strategy in the Netherlands were able to reduce MRSA prevalence
below 1 % of all clinical isolates and is thus one of the lowest
worldwide [48, 49, 50].
Handling issues
n All intravenous solution containers must be carefully inspected
for cracks, defects, turbidity, and particulate matter before
preparation and use.
n Intravenous catheters should never be re-inserted.
n Routine replacement of IV administration set (see Figure 18) [41].
n As less manipulations as possible should be done on infusion
systems as every manipulation bears the risk of contamination.
n Maximum sterile barriers should be used whenever possible.

Engineerial and technical solutions

Use of sterile disposables (see Figure 17)
n Use of closed systems and devices
n Use of transparent dressings to secure the cannula / catheter
n Commercially available intravascular solutions are manufactured
and provided sterile. Contamination of infusate solutions rarely
occurs during the manufacturing process [46], but is more likely
during manipulation and contamination in course of manual
preparation [6, 23, 1, 45, 51, 52, 53]
n

Definition of a Closed System

A device that does not exchange unfiltered air or
contaminants with the adjacent environment. [54]

17

Microbiological Contamination

Risk prevention
Ecoflac plus
Closed system IV solution container that offers safe and convenient
application of all IV procedures from drug admixture to drug delivery.
Microbial contamination is prevented through
n 2 separate, ready-to-use, tamper evident ports. No disinfection required
prior to usage
n resealing port elements which prevent germs from entering into the
container
n self-collapsibility of the container during infusion, which does not
require venting

Mini-Plasco connect
Plastic ampoule, which helps preventing microbial contamination by
n a grip plate with integrated finger stopper, which prevents touch
contamination of open areas
n a Luer-Lock-connector, which allows air tight connection of syringes
n a collapsing container for vent-free aspiration of the content

18

Mini-Spike
Vented dispensing pin for safe and convenient transfer of fluids between
containers and syringes. Microbial contamination is prevented through:
n
tight-sealing snap cap, which minimizes the risk of touch contamination
n
integrated air-venting channel which makes over-pressure release
techniques unnecessary
n
a bacteria retentive air filter, which reduces contamination of drug
with environmental air

Ecoflac Connect
Closed system transfer cap for single dose drug admixture.
n the closed system of Ecoflac Connect, ensures that there is no
contact of drugs or IV fluids with environmental air

Vasco Nitril
n single use medical glove for effective protection against micro
organisms and chemical agents according to EN 374, EN 420.

19

Microbiological Contamination

Risk prevention
Intrafix SafeSet
Unique infusion set for safe and convenient infusion.
Microbial contamination is prevented through:
n PrimeStop cap (hydrophobic membrane), which ensures a closed
system until connection of the IV Set to the IV Catheter
n inbuilt air vent with a bacteria proof air filter, which avoids
contamination of the fluid with environmental air for infusions from
glass bottles or non-collapsing plastic containers
n possibility of re-spiking of IV Set into another IV fluid container based
on the Air Stop feature (hydrophilic membrane), which results in less
manipulations at the patient access
n luer hook in the roller clamp, which allows to securely attach the IV
line to protect Luer connector from touching contaminated surfaces
n finger stopper ring around the drip chamber, which prevents slipping
of the hand towards the spike

Safeflow
Capless valves for safe and convenient access to the infusion line.
The valve continuously maintains the closed system.
n closed valve prior to activation
n air tight, leak resistant sealing when Luer cone connects to the valve
n closure of the valve when Luer connection is disconnected
n flat valve surface facilitates effective disinfection (swabbing)

Discofix C
The unique stopcock for premium safety.
n a special material prevents microbial contamination by
preventing from stress cracks
n Discofix C resists all pharmaceutical agents even during
long-term application

20

Intrapur and Sterifix Infusion Filters

A whole range of filters for safe infusion therapy.
n microbial contamination is avoided through microrganism
retentive filters

Softa-Man
Product system for the hygienic and surgical hand desinfection.
The alcohol based formulation effectively eliminates contamination
from bacteria, fungi and viruses.

Promanum Pure
Alcohol based compound for hygienic and surgical hand desinfection.
Protects quickly and effectively (EN 1500 - 15 sec, EN 12791 - 90 sec)
against bacteria (incl. TbB), fungal encapsulated viruses (HIV, HBV, HCV)
and adeno, noro, rota and polio viruses.
Especially suitable for frequent application in high risk areas such as
intensive care.

Meliseptol Foam pure

Foam for the disinfection of medical devices and small surfaces.
Protects quickly and effectively against bacteria (incl. TbB and MSRA),
fungi, rota virus, polioma virus and air borne influenza viruses.
Delimited virucidal effect (incl. HIV, HBV, HCV).
Especially suitable for alcohol sensitive materials.

21

Microbiological Contamination

Literature
Literature
[1] Gabriel J. Infusion therapy. Part two: Prevention and management of complications. Nurs Stand. 2008; 22(32): 41-8
[2] Dougherty L. Central Venous Access Devices: Care and
Management. Blackwell Publishing, Oxford, 2006
[3] World Health Organization, Department of Communicable
Disease, Surveillance and Response. Prevention of hospital-acquired
infections. A practical guide, 2nd edition, 2002, http://www.who.int/
csr/resources/publications/drugresist/en/whocdscsreph200212.pdf
[4] Schmidt, Unsicker. Lehrbuch Vorklinik, Teil A Anatomie, Biochemie und Physiologie der Zelle. Kap. Medizinische Mikrobiologie,
von W. Solbach, Deutscher rzte-Verlag GmbH, 2003
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25

Microbiological Contamination

Product
description
Softa-Man
Composition:
100 ml solution contain
Active ingredients:
45 g Ethanol (100%), 18 g Propanol.
Excipients:
Purified Water, Diisopropyl Adipate, Macrogol 6 Glycerol Caprylocaprate (Ph. Eur.),
Dexpanthenol, (+/-)alpha-Bisabolol, Perfume (contains Limonene and Linalool),
Allantoin.
Therapeutic Indications:
Hygienic and surgical hand disinfection
Contraindications:
Hypersensitivity (Allergy) to Ethanol, Propanol or any of the other ingredients
Side Effects:
Cases of local alcohol-induced irritation symptoms (e.g. itching, redness) may occur,
especially after frequent application. Moreover, contact allergy is possible.

Warnings:
Flammable.
Keep container tightly closed.
Keep away from sources of ignition - No smoking.
Avoid contact with eyes. Do not apply on injured skin or mucous membranes.
For external use only.
Flash point: 21 to 22 C (DIN 51 755)
Last Revision:
09/2008
Pharmaceutical Entrepreneur:
B. Braun Melsungen AG
34209 Melsungen
Germany

Promanum pure
Composition:
100 g solution contain:
Active ingredients:
73.4 g Ethanol (100%), 10.0 g Isopropyl Alcohol.
Excipients:
Purified Water, Isopropyl Myristate, Cetearyl Ethylhexanoate, Butanone,
Sorbitol, Povidone.

Warnings:
Highly flammable.
Keep container tightly closed.
Keep away from sources of ignition - No smoking.
Avoid contact with eyes. Do not apply on injured skin or mucous membranes.
For external use only.
Flash point: 14 C (DIN 51 755)

Therapeutic Indications:
Hygienic and surgical hand disinfection

Last Revision:
03/2011

Contraindications:
Hypersensitivity (Allergy) to Ethanol, Isopropyl Alcohol or any of the other ingredients

Pharmaceutical Entrepreneur:
B. Braun Melsungen AG
34209 Melsungen
Germany

Side Effects:
Cases of local alcohol-induced irritation symptoms (e.g. itching, redness) may occur,
especially after frequent application. Moreover, contact allergy is possible.

26

Notes

27

Mi
Con crob
ta i
m

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Inj ar
u

ty
ug tibili
a

Air
Embolism

Pa
r
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am

ps

Co

Chemical
mination
e n Conta
at
ul a t i o
in

l
ica
g
n
o
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in

Infusion
Therapy
Risks

ry
Medication
Error

Inc Dr
o
m
p

The summarized scientific information in this document has been prepared for healthcare professionals. It is based on an analysis of
public literature and guidelines. The intention is to give an introduction to the risks commonly associated with infusion therapy and to
increase the awareness of healthcare workers to these kinds of problems. Due to its summary nature, this text is limited to an overview
and does not take into account all types of local conditions. B. Braun does not assume responsibility for any consequences that may
result from therapeutical interventions based on this overview.

B. Braun Melsungen AG | Hospital Care | 34209 Melsungen | Germany

Tel. +49 5661 71-0 | www.bbraun.com | www.safeinfusiontherapy.com

Nr. 606 9094