microbiological contamination - safeinfusiontherapy.com

Risk Prevention in Infusion Therapy

Microbiological Contamination

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DefinitionTypes of microbiological pathogensThere 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 μm and represent 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 host’s tissue. 1.2 Pathogenic bacteria: have greater virulence and cause infections regardless of the host’s 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 μm 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.

Definition: Microbiological contamination

Microbiological contamination refers to the non- intended or accidental introduction of infectious material like bacteria, yeast, mould, fungi, virus, pri-ons, 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 occupa-tional infections among staff of the facility.” [3]

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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 coli20 min. 2

40 min. 4

1 h 8

2 h 64

3 h 512

4 h 4.096

5 h 32.768

6 h 262.1446 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].

DefinitionToxic by-products of microorganismsEndotoxin:The most common example for endotoxins are the lipopoly- saccharides (LPS) found in the outer membrane of the group of Gram-negative bacteria. If this membrane degenerates, e.g. when the bacteria dies, LPS’s 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 nor-mal 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.

Fig. 3: Photomicrograph of Penicillium digitatum mold showing conidiophores and spores

Fig. 2: HI-VirusFig. 1: Meningococcus-Bacteria underthe scanning electron microscope (SEM)

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Definition

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 bacte-remia in a patient. They include exit site or tunnel infections and are defined as: nErythema or induration within 2 cm of the catheter exit site, in the absence of concomitant bloodstream infection and without concomitant purulencen 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].

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 defi-nition 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.

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

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

Legend

“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:

n Increasing numbers and crowding of people

nMore frequent impaired immunity (age, illness and treatments)

nNew microorganims

nIncreased bacterial resistance to antibiotics” [5]

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DefinitionIncidence and Prevalence of MRSAMethicillin 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-associ-ated 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 staphy-lococcal infections, approximately 126,000 are related to MRSA [9].

Definition of multidrug resistant bacteriaMultidrug 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 aren Methicillin resistant Staphylococcus aureus (MRSA) n Vancomycin resistant Enterococci (VRE) n Extended spectrum ß-lactamase (ESBLs) producing Gram-negative bacteria n Klebsiella pneumoniae carbapenemase (KPC) producing Gram-negatives n Imipenem resistant Acinetobacter baumanniin Imipenem resistant Pseudomonas aerginosan Multidrug resistant Mycobacterium tuberculosis (MDR-TB) and extremely drug resistant Mycobacterium tuberculosis (XDR-TB)

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Causes


Outpatient clinic/o�ce

Procedure room

Emergency department

Operating room Patient room

Intensive/Critical care unit Others

20%

18%

13%

9%

3%3%

4%

8%

8%

12%

2%

9.4%

4.8%

4.8%

4.0%

31.5%

28.8%

OtherS. aureusStaph. (koagulase-negativ)EnterococciE. coliPseudomonasEnterobacter sppProteus mirabilisKlebsiella pneumoniaeStreptococcusCandida albicans

50.1%

4.5%2.1%

3.3%3.6%

31.3%

5.1%

Staphylococcus aureusStaphylococcus epidermidisCandida albicansPseudomonas aeruginosaCorynebacterium spp.Other Gr. (+) cocciOther Gr. (-) rods

Pathogenic microorganisms in surgical wounds

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 dis-connection 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].

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).

Fig. 5: Pathogenic microorganisms in surgical wounds

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 diseasen Entry portals: Natural body orifices or artificial openings due to injury or diseasen Direct transmission via contact or droplet spreadn Indirect transmission via surfaces or instrumentsn Indirect transmission via vectors, mosquitoes, flies, rats transmitting the infectionn 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.

Fig. 6: Challenging hygienic situation observed in hospital

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Contaminated infusion �uid Open infusion systems allowing un�ltered air entering the IV System

Not maintaining asepsis when inserting additives or using contaminated additives

Not maintaining asepsis when attaching the administration set to the container and manipulating the cannula

Wrong or faulty connections

Inadequately cleaning the skin prior to insertion of the cannula

Leaving soiled dressings unchanged

Not maintaining the integrity of the connections

Not maintaining asepsis when introducingdrugs via the rubber bung or 3-way tap

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

Faulty administration set:n puncture in packaging

Faulty peripheral catheter:n puncture in packaging

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

Fig. 8: Extra- and intraluminal route of contamintation

Potential contamination before use Potential contamination during use

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ConsequencesConsequences for the patientNosocomial infections occur worldwide and affect both developed and resource-poor countries. Infections acquired in health care set-tings are among the major causes of death and increased morbidityamong hospitalized patients. They are a significant burden both for the patient and for public health. A prevalence survey conducted un-der 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.

The WHO study, and others, have also shown that the highest prev-alence 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. 9: Local infection at catheter entry site Fig. 10: Ecchymosis, cutaneous manifestation of sepsis

Fig. 11: Septic shock

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ConsequencesIn 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.

The EPIC II point-prevalence study of infection in critically illpatients performed on 8th May 2007 assessed the role of methicillinresistance 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).

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].

*Odds Ratio

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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 admis-sions) 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 hospitaliza-tions 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] foundthat among the survivors, the hospital stay was increased by 19.6days. 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].

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): n Average nosocomial infection, mean cost = $ 13,973n 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

For the following infections, no studies were done to determine attributable costs but treatment costs are known (see Figure 13): n Urinary tract infection, mean cost = $ 1,008 n Varicella zoster virus, mean cost = $ 27,377 n Tuberculosis, mean cost = $ 61,446 n Measles, mean cost = $ 41,087


Consequences

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Consequences

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]. The costs of a nosocomial infection outbreak can easily reach millions of dollars [34].

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.

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].

40

30

20

10

0

Cost

s in

thsd

. $

50

40

60

70

30

20

10

0

Cost

s in

thsd

. $

Fig. 12: Costs caused by infections, proven by studies Fig. 13: Costs caused by infections, not proven

Average nosocomial infectionBloodstream infection Methicillin resistant Staphylococcus aureus infections (MSRA) Surgical site infectionPneumonia

Urinary tract infection Varicella zoster virus Tuberculosis Measles

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ConsequencesRisk 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, cate-cholamines) 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 cost- of-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 20–30 % of the cost of illness of severe sepsis. Indirect costs associated with severe sepsis account for 70–80 % of costs and arise mainly from productivity losses due to mortality [39].

Type of infection 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

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

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

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Consequences

I Opportunity costs to health service

Hospital Service Inpatient stay (inpatient days, investigations, treatments) Outpatient consultations (consultations, investigations, treatment)

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

A schematic representation of the costs associated with Nosocomial Infections [40]

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.

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Consequences

High

MediumHigh

Medium

MediumLow

Low


ICU / Intermediate care treatment(Observation / Monitoring / Treatment)

Extension of clinical treatment(Observation / Monitoring)

Local treatment(No additional Monitoring)

No complication for patient

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

0 d RICU*+ 1-3 d Normal Ward

0 d ICU+ 0-1 d Normal Ward

0 d ICU0 d Normal Ward

€ 1,136 - € 7,952

€ 382 - € 1,146

€ 0 - € 382

€ 0 Contamintation without infection, known conta-

mination and dis-card of product

before use

Catheter entry-site infection, phlebitis, local wound infection,

urinary tract infection

Severe wound infection, thromboembolism,complicated urinary tract infection

Sepsis, Organ failure, Embolism

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

Examples of complications resulting from Microbiological Contamination Clinical Treatment Length of Stay Additional CostsSeverity

Full ICU treatment(Treating / Monitoring / Feeding etc.)

4-30 d ICU+ 4-30 d Normal Ward € 7,556 - € 56,670

*RICU: Respiratory intermediate care unit

Costs for the hospital

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].

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Consequences

High

MediumHigh

Medium

MediumLow

Low


ICU / Intermediate care treatment(Observation / Monitoring / Treatment)

Extension of clinical treatment(Observation / Monitoring)

Local treatment(No additional Monitoring)

No complication for patient

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

0 d RICU*+ 1-3 d Normal Ward

0 d ICU+ 0-1 d Normal Ward

0 d ICU0 d Normal Ward

€ 1,136 - € 7,952

€ 382 - € 1,146

€ 0 - € 382

€ 0 Contamintation without infection, known conta-

mination and dis-card of product

before use

Catheter entry-site infection, phlebitis, local wound infection,

urinary tract infection

Severe wound infection, thromboembolism,complicated urinary tract infection

Sepsis, Organ failure, Embolism

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

Examples of complications resulting from Microbiological Contamination Clinical Treatment Length of Stay Additional CostsSeverity

Full ICU treatment(Treating / Monitoring / Feeding etc.)

4-30 d ICU+ 4-30 d Normal Ward € 7,556 - € 56,670

*RICU: Respiratory intermediate care unit

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Fig. 15: Hands disinfection – soap and water, drying.

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 trainingProper 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].

Preventivestrategies

Fig. 16: Hands disinfection – disinfection fluid.

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Fig. 17: Using sterile disposables.


Monitoring and surveillanceThe 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 issuesn 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.

Fig. 18: Routine replacement of IV administration sets according to CDC or local hospital / institutional guideline.

Engineerial and technical solutionsn Use of sterile disposables (see Figure 17)n Use of closed systems and devices n Use of transparent dressings to secure the cannula / cathetern 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]

Preventivestrategies

Definition of a Closed System “A device that does not exchange unfiltered air or contaminants with the adjacent environment.” [54]

Fig. 16: Hands disinfection – disinfection fluid.

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Ecoflac® plusClosed 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 usagen resealing port elements which prevent germs from entering into the containern self-collapsibility of the container during infusion, which does not require venting


Risk prevention

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

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

Ecoflac® ConnectClosed 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.

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Risk prevention

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

Intrafix® SafeSetUnique 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 surfacesn finger stopper ring around the drip chamber, which prevents slipping of the hand towards the spike

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

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

Intrapur® and Sterifix® Infusion FiltersA whole range of filters for safe infusion therapy.nmicrobial contamination is avoided through microrganism retentive filters

Promanum® PureAlcohol 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 pureFoam 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.

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[10] Hebert C, Weber SG. Common approaches to the control of multidrug-resistant organisms other than methicillin-resistant Staphylococcus aureus (MRSA). Infect Dis Clin North Am. 2011 Mar; 25(1): 181-200, HYPERLINK „/pubmed/21316000, Epub 2010 Dec 17

[11] WHO guideline 2002. http://www.who.int/csr/resources/ publications/whocdscsreph200212.pdf

[12] Raad I. Intravascular-catheter-related infections. Lancet 1998; 351: 893-898

[13] Raad I, Costerton W, Sabharwal U, Sacilowski M, Anaissie E, Bodey GP. Ultra-structural analysis of indwelling vascular catheters: a quantitative relationship between luminal colonization and dura-tion of placement. J Infect Dis 1993; 168: 400-407

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[4] Schmidt, Unsicker. Lehrbuch Vorklinik, Teil A Anatomie, Bio-chemie und Physiologie der Zelle. Kap. Medizinische Mikrobiologie, von W. Solbach, Deutscher Ärzte-Verlag GmbH, 2003

[5] Ducel G, Beraud C, Benassouli. Les nouveaux risques infectieux. Revue Futuribles, 1995, 203: 5–32.

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Literature

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[14] Safdar N, Maki DG. The pathogenesis of catheter-related bloodstream infection with noncuffed short-term central venous catheters. Intensive Care Med 2004; 30: 62-67

[15] Raad I, Hanna H. Nosocomial infections related to use of intravascular devices inserted for long-term vascular access. In: Mayhall C, ed. Hospital Epidemiology and Infection Control. Philadelphia, Pa: Lippincott Williams & Wilkins; 1999: 165-172

[16] Hall K, Farr B. Diagnosis and management of long-term central venous catheter infections. J Vasc Interv Radiol 2004; 15: 327-334

[17] Jamieson EM, McCall JM, Whyte LA. Practice 21: Intravenous therapy. In: Jamieson EM, McCall JM, Whyte LA. Clinical nursing practices. 5. Edition, Edinburgh [u.a.]: Elsevier Churchill Livingstone 2007; 169-176

[18] Tikhomirov E. WHO Programme for the Control of Hospital Infections. Chemiotherapia, 1987, 3:148–151

[19] Mayon-White RT et al. An international survey of the prevalence of hospital-acquired infection. J Hosp Infect, 1988, 11 (Supplement A):43–48

[20] Uslusoy E., Mete S.: Predisposing factors to phlebitis in patients with peripheral intravenous catheters: a descriptive study. J Am Acad Nurse Pract. 2008; 20(4): 172-80

[21] Bouchoucha et al. Deep venous thrombosis associated with acute hematogenous osteomyelitis in children. Orthop Traumatol Surg Res. 2010 Dec; 96(8): 890-3., Boucher 2010

[22] Hanberger H, Walther S, Leone M, Barie PS, Rello J, Lipman J, Marshall JC, Anzueto A, Sakr Y, Pickkers P, Felleiter P, Engoren M, Vincent JL; EPIC II Group of Investigators.Increased mortality associated with meticillin-resistant Staphylo-coccus aureus (MRSA) infection in the Intensive Care Unit: results from the EPIC II study. Int J Antimicrob Agents, 2011 Oct; 38(4): 331-5

[23] Rosenthal VD, Maki DG. Prospective study of the impact of open and closed infusion systems on rates of central venous catheter-associated bacteremia. Am J Infect Control 2004 May; 32(3): 135-41

[24] Gastmeier P, Geffers C, Brandt C, Zuschneid I, Sohr D, Schwab F, Behnke M, Daschner F, Rüden H. Effectiveness of a nationwide nosocomial infection surveillance system for reducing nosocomial infections. J Hosp Infect. 2006 Sep; 64(1): 16-22

[25] Haley RW, Culver DH, White JW, Morgan WM, Emori TG. The nationwide nosomical infection rate. A new need for vital statistics. Am J Epidemiol. Feb 1985; 121(2): 159-167

[26] Guerin K, Wagner J, Rains K, Bessesen M. Reduction in cenral line-associated bloodstream infections by implementation of a post-insertion care bundle. Am J Infect Control 2010 Aug; 38(6):430-3

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[27] Pittet D, Tarara D, Wenzel RP. Nosocomial bloodstream infection in critically ill patients. Excess length of stay, extra costs, and attributable mortality. JAMA 1994 May 25; 271(20): 1598-601

[28] Zhan C, Miller MR. Excess length of stay, charges, and morta-lity attributable to medical injuries during hospitalization. JAMA 2003 Oct; 290(14):1886-1874

[29] Rello J, Ochagavia A, Sabanes E, Roque M, Mariscal D, Reynaga E, Valles J. Evaluation of Outcome of Intravenous Catheter-related Infections in Critically III Patients. Am J Respir Crit Care Med 2000 (162): 1027–1030

[30] Vandijck DM, Depaemelaere M, Labeau SO, Depuydt PO, Annemans L, Buyle FM, Oeyen S, Colpaert KE, Peleman RP, Blot DI, Decruyenaere JM. Daily cost of antimicrobial therapy in patients with Intensive Care Unit-acquired, laboratory-confirmed blood-stream infection. International Journal of Antimicrobial Agents 2008; 31: 161-165

[31] Jang TN, Lee SH, Huang CH, Lee CL, Chen WY. Risk factors and impact of nosocomial Acinetobacter baumannii bloodstream infec-tions in the adult intesive care unit. A case-control study, received 16 January 2009; accepted 10 June 2009

[32] Stone PW, Larson E, Kawar LN. A systematic audit of economic evidicen linking nocosomial infections and infection control inter-ventions:1990-2000. Am J Infect Control 2002; 30:145-52

[33] Roberts RR, Scott RD 2nd, Cordell R, Colomon SL, Steele L, Kampe LM, Trick WE, Weinstein RA. The use of economic modeling to determine the hospital costs associated with nosocomial infections. Clin Infect Dis. 2003 Jun 1;36 (11):1424-32. Epub 2003 May 22

[34] Karchmer TB, Durbin LJ, Simonton BM, Farr BM. Cost-effective-ness of active surveillance cultures and contact/droplet precautions for control of methicillin-resistant Staphylococcus aureus. J Hosp Infect. 2002 Jun; 51(2):126-32

[35] NCSL (National Conference of State Legislatures). Medicare Nonpayment for Medical Errors. Washington D.C. 2008

[36] Gianino MM, Vallino A, Minniti D, Abbona F, Mineccia C, Silva-plana P, Zotti CM. A method to determine hospital costs associated with nosocomial infections (transl). Ann Ig., 2007;19(4): 381-92 [37] Bertolini G, Confalonieri M, Rossi, Simini B, Gorini M, Corrado A. Cost of the COPD. Differences between intensive care unit and respiratory intermediate care unit. Res Med 2005,(99): 894-900

[38] Cohen J, Brun-Buisson C, Torres A, Jorgensen J. Scientific Reviews. Diagnosis of infection in sepsis: An evidence-based review. Critical Care Medicine 2004, (32) 11: 466-494

[39] Burchardi H, Schneider H. Economic Aspects of Severe Sepsis: A Review of Intensive Care Unit Costs, Cost of Illness and Cost Effectiveness of Therapy. Adis International, PharmacoEconomics 2004; 22(12): 793-813(21). http://www.ingentaconnect.com/content/adis/pec/2004/00000022/00000012/art00003

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[41] World Health Organization. Practical Guidelines for Infection Control in Health Care Facilities. SEARO Regional Publication No. 41, WPRO Regional Publication 2004

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[42] Centers for Disease Control and Prevention (CDC).Guideline for the Prevention of Intravascular Catheter-Related Infections. 2011

[43] Royal College of Nursing (RCN). Standards for infusion therapy. Third edition. The RCN IV Therapy Forum. http://www.rcn.org.uk/__data/assets/pdf_file/0005/78593/002179.pdf, January 2010

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26


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 AG34209 MelsungenGermany

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.

Therapeutic Indications:Hygienic and surgical hand disinfection

Contraindications:Hypersensitivity (Allergy) to Ethanol, Isopropyl Alcohol 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: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)

Last Revision:03/2011

Pharmaceutical Entrepreneur:B. Braun Melsungen AG34209 MelsungenGermany

Productdescription

27


Notes

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B. Braun Melsungen AG | Hospital Care | 34209 Melsungen | GermanyTel. +49 5661 71-0 | www.bbraun.com | www.safeinfusiontherapy.com

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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.

microbiological contamination - safeinfusiontherapy.com

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