[Federal Register Volume 60, Number 187 (Wednesday, September 27, 1995)]
[Notices]
[Pages 49978-50006]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-23550]




[[Page 49977]]

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Part II





Department of Health and Human Services





_______________________________________________________________________



Centers for Disease Control and Prevention



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Intravascular Device-Related Infections Prevention; Guideline 
Availability; Notice

  Federal Register / Vol. 60, No. 187 / Wednesday, September 27, 1995 / 
Notices   

[[Page 49978]]


DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention


Draft Guideline for Prevention of Intravascular Device-Related 
Infections: Part 1. ``Intravascular Device-Related Infections: An 
Overview'' and Part 2. Recommendations for Prevention of Intravascular 
Device-Related Infections; Notice of Comment Period

AGENCY: Centers for Disease Control and Prevention (CDC), Public Health 
Service (PHS), Department of Health and Human Services (DHHS).

ACTION: Notice.

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SUMMARY: This notice is a request for review and comment of the draft 
Guideline for Prevention of Intravascular Device-related Infections. 
The Guideline consists of two parts: Part 1. ``Intravascular Device-
related Infections: An Overview'' and Part 2. ``Recommendations for 
Prevention of Intravascular Device-related Infections,'' and was 
prepared by the Hospital Infection Control Practices Advisory Committee 
(HICPAC) and the National Center for Infectious Diseases (NCID), CDC.

DATES: Written comments on the draft document must be received on or 
before October 30, 1995.

ADDRESSES: Comments on this document should be submitted in writing to 
the CDC, Attention: IV Guideline Information Center, Mailstop E-69, 
1600 Clifton Road, NE., Atlanta, Georgia 30333. To order copies of the 
Federal Register containing the document, contact the U.S. Government 
Printing Office, Order and Information Desk, Washington, DC 20402-9329, 
telephone (202) 512-1800. Specify the date of the issue requested and 
stock number 069-001-00089-1. See page II of the Federal Register for 
additional ordering and cost information. In addition, the Federal 
Register containing this draft document may be viewed and photocopied 
at most libraries designated as U.S. Government Depository Libraries 
and at many other public and academic libraries that receive the 
Federal Register throughout the country. The order-desk operator can 
tell you the location of the U.S. Government Depository Library nearest 
you.

FOR FURTHER INFORMATION CONTACT: The IV Guideline Information Center, 
telephone (404) 332-2569.

SUPPLEMENTARY INFORMATION: This 2-part document updates and replaces 
the previously published CDC Guideline for Prevention of Intravascular 
Infections (Am J Infect Control 1983;11:183-199). Part 1, 
``Intravascular Device-related Infections: An Overview,'' reviews 
issues relevant to intravascular device-related infections and serves 
as the background for the consensus recommendations of the Hospital 
Infection Control Practices Advisory Committee (HICPAC) that are 
contained in Part 2, ``Recommendations for Prevention of Intravascular 
Device-related Infection.''
    HICPAC was established in 1991 to provide advice and guidance to 
the Secretary and the Assistant Secretary for Health, DHHS; the 
Director, CDC; and the Director, NCID regarding the practice of 
hospital infection control and strategies for surveillance, prevention, 
and control of nosocomial infections in U.S. hospitals. The committee 
also advises CDC on periodic updating of guidelines and other policy 
statements regarding prevention of nosocomial infections.
    The Guideline for Prevention of Intravascular Device-related 
Infections is the third in a series of CDC guidelines being revised by 
HICPAC and NCID, CDC.

    Dated: September 14, 1995.
Claire V. Broome,
Deputy Director, Centers for Disease Control and Prevention (CDC).

Guideline for Prevention of Intravascular Device-Related Infections

Executive Summary

    The revised guideline is designed to reduce the incidence of 
intravascular device-related infections and provides an overview of the 
evidence for recommendations considered prudent by consensus of HICPAC 
members. A working draft of the guideline was reviewed by experts in 
hospital infection control, internal medicine, pediatrics, and 
intravenous therapy; however, all recommendations contained in the 
guideline may not reflect the opinion of all reviewers.
    This document focuses largely on the epidemiology, pathogenesis and 
diagnosis of, and preventive strategies for, infections associated with 
the intravascular devices most commonly used in health care settings 
and for which there is adequate scientific data on which to base 
recommendations for device use and care. Such devices include 
peripheral venous and arterial catheters, central venous and arterial 
catheters, peripherally inserted central venous catheters, and pressure 
monitoring systems. Newer devices (e.g., antimicrobial-impregnated 
catheters, needleless infusion systems) are also discussed. However, 
intraaortic balloon pumps, cardiac catheters, pacemakers, and 
extracorporeal membrane oxygenators are not addressed in this document 
because there is insufficient scientific data on which to base 
recommendations for use and care.
    The unique circumstances and special considerations related to 
intravascular device-related infections in pediatric patients and 
infections associated with parenteral nutrition and hemodialysis will 
be addressed in separate sections.

Introduction

    Intravascular devices are indispensable in modern-day medical 
practice. However, the use of intravascular devices is frequently 
complicated by a variety of local and/or systemic infectious 
complications. Infections related to the use of intravascular devices, 
particularly catheter-related bloodstream infections, are associated 
with increased morbidity and mortality, prolonged hospitalization, and 
increased medical costs.
    Part 1, ``Intravascular Device-related Infections: An Overview'' 
addresses many of the issues and controversies in intravascular-device 
use and maintenance. These issues include definitions and diagnosis of 
catheter-related infection, barrier precautions during catheter 
insertion, changes of catheters and administration sets, catheter-site 
care, and the use of prophylactic antimicrobials, flush solutions and 
anticoagulants. Part 2, ``Recommendations for Prevention of 
Intravascular Device-related Infections'' provides consensus 
recommendations of the HICPAC for the prevention and control of 
infections related to the use of intravascular devices.
    The Guideline for Prevention of Intravascular Device-related 
Infections is intended for use by personnel who are responsible for 
surveillance and control of infections in the acute-care, hospital-
based setting, but many of the recommendations may be adaptable for use 
in the outpatient or home-care setting.

Part 1. Intravascular Device-Related Infections: An Overview

Contents

I. Background
II. Epidemiology
    Devices Used for Short-term Vascular Access
    Peripheral venous catheters
    Peripheral arterial catheters
    Midline catheters
    Nontunneled central venous catheters (CVCs) 

[[Page 49979]]

    Central arterial catheters
    Pressure monitoring systems
    Peripherally Inserted CVCs
    Devices Used for Long-term Vascular Access
    Tunneled CVCs
    Totally implantable intravascular devices
III. Microbiology
IV. Pathogenesis
V. Definitions and Diagnosis of Catheter-Related Infections
    Infections Associated with Short-term Catheters
    Infections Associated with Long-term Catheters
    Catheter-related Bloodstream Infection
    Infusate-related Bloodstream Infection
VI. Strategies for Prevention of Catheter-Related Infections
    Site of Catheter Insertion
    Type of Catheter Material
    Barrier Precautions during Catheter Insertion
    Changing Catheters and Administration Sets
    Intravenous administration set changes
    Intravenous catheter changes
    Catheter-site Care
    Cutaneous antiseptics and antimicrobial ointments
    Catheter-site dressing regimens
    In-line Filters
    Silver-chelated Collagen Cuffs
    Antimicrobial-Impregnated (Coated) Catheters
    Intravenous Therapy Personnel
    Prophylactic Antimicrobials
    Flush Solutions, Anticoagulants, and Other Intravenous Additives
    Needleless Intravascular Devices
    Multidose Parenteral Medication Vials
VII. Intravascular Device-Related Infections Associated with Total 
Parenteral Nutrition
    Risk Factors
    Surveillance and Diagnosis
    Strategies for Prevention
    Infusate preparation
    Cutaneous antisepsis
    Selection of catheter
    Catheter-site dressings
    Catheter changes
    Specialized personnel
VIII. Intravascular Device-Related Infections Associated with 
Hemodialysis Catheters
    Epidemiology
    Microbiology
    Strategies for Prevention of Hemodialysis Catheter-related 
Infections
    Cutaneous antisepsis
    Catheter changes
    Prophylactic antimicrobials
IX. Intravascular Device-Related Infections in Pediatric Patients
    Microbiology
    Epidemiology
    Peripheral venous catheters
    Peripheral arterial catheters
    Umbilical catheters
    CVCs
Table 1. Definitions for Catheter-related Infection
Table 2. Factors Associated with Infusion-related Phlebitis among 
Patients with Peripheral Venous Catheters
Figure 1. Potential Sources for Contamination of Intravascular 
Devices

I. Background

    Intravascular devices are indispensable in modern-day medical 
practice. They are used to administer intravenous fluids, medications, 
blood products, and parenteral nutrition fluids, and to monitor the 
hemodynamic status of critically ill patients. However, the use of 
intravascular-devices is frequently complicated by a variety of local 
and/or systemic infectious complications (see definitions in Table 1), 
including septic thrombophlebitis, endocarditis, bloodstream infection 
(BSI), and metastatic infection (e.g., osteomyelitis, endophthalmitis, 
arthritis) resulting from hematogenous seeding of another body site by 
a colonized catheter. Catheter-related infections (CRIs), particularly 
catheter-related BSIs (CR-BSIs), are associated with increased 
morbidity; mortality of 10%-20%; prolonged hospitalization (mean of 7 
days); and increased medical costs, in excess of $6,000 (1988 dollars) 
per hospitalization.1-5

II. Epidemiology

    An estimated 200,000 nosocomial BSIs occur each year.6 During 
1980-1989, significant increases were detected in the rates of 
nosocomial BSI reported from the National Nosocomial Infection 
Surveillance (NNIS) System hospitals where hospital-wide surveillance 
was conducted.7 Reported rates increased by 70%-279%, depending on 
hospital size and affiliation.
    Most nosocomial BSIs are related to the use of an intravascular 
device, with BSI rates being substantially higher among patients with 
intravascular devices than among those without such devices.8 As 
with overall rates of nosocomial BSI, rates of device-related BSI vary 
considerably by hospital size, hospital unit/service, and type of 
device. During the years 1986-1990, NNIS hospitals conducting intensive 
care unit (ICU) surveillance reported rates of central catheter-related 
BSI ranging from 2.1 (respiratory ICU) to 30.2 (burn ICU) BSIs per 
1,000 central catheter days. Rates of noncentral catheter-related BSI 
were substantially lower, ranging from 0 (coronary, medical, and 
medical/surgical ICU) to 2.0 (trauma ICU) BSIs per 1,000 noncentral 
catheter-days.8
    The incidence of and potential risk factors for intravascular-
device related infections may vary considerably with the type and 
intended use of the device, and these factors should be considered when 
selecting a device for use.
    In general, intravascular devices can be divided into two broad 
categories, those used for short-term, or temporary, vascular access 
and those used for long-term vascular access. Long-term (indwelling) 
vascular devices usually require surgical insertion, while short-term 
devices can be inserted percutaneously.

Devices Used for Short-Term Vascular Access

    Peripheral venous catheters. Of all intravascular devices, the 
peripheral venous catheter is the most commonly used. Phlebitis, 
largely a physicochemical or mechanical rather than infectious 
phenomenon, remains the most important complication associated with the 
use of peripheral venous catheters. A number of factors, including type 
of infusate and catheter material and size, influence a patient's risk 
for developing phlebitis (Table 2); when phlebitis does occur, the risk 
of local CRI may be increased.9-13 However, peripheral venous 
catheters have rarely been associated with BSI; 9 14-17 this may 
reflect the short duration of catheterization with these devices.
    Peripheral arterial catheters. Peripheral arterial catheters are 
commonly used in acute-care settings to monitor the hemodynamic status 
of critically ill patients. Data suggest that peripheral arterial 
catheters may be associated with a substantially lower risk of local 
CRI and CR-BSI than are peripheral venous catheters left in place for a 
comparable length of time.18 Although the reasons for the 
differences in rates of CRI associated with these two types of 
catheters are not clear, arterial catheters may be less prone to 
colonization than are venous catheters because they are exposed to 
higher vascular pressures.19 Factors shown to predispose patients 
with peripheral arterial catheters to CRI are inflammation at the 
catheter insertion site, catheterization >4 days, or catheter insertion 
by cutdown.20 21 In contrast to peripheral venous catheters, 
peripheral arterial catheters inserted in the lower extremities, 
specifically the femoral area, do not clearly pose a greater risk of 
infection than do peripheral arterial catheters inserted in upper 
extremities or brachial areas.22
    In addition to monitoring hemodynamic status, arterial catheters 
may also be used to administer local intraarterial chemotherapy. 
Although this is a well-established method for treating metastatic or 
unresectable tumors, very little has been published on the infectious 
complications associated with this form of therapy. Maki et al. 
conducted an epidemiologic investigation of endarteritis associated 

[[Page 49980]]
with intraarterial chemotherapy administration and identified several 
risk factors for infection: leukopenia, hypoalbuminemia, prior 
radiation therapy, difficult catheterization, and repeated manipulation 
of the catheter.23
    Midline catheters. Midline catheters are peripherally inserted 
(into antecubital veins), six-inch elastomer catheters that do not 
enter central veins, but have recently been used as an alternative to 
central venous catheterization. Presently, there is little published 
scientific data on which to assess the infectious risks posed by these 
newer devices.
    Nontunneled central venous catheters (CVCs). CVCs account for an 
estimated 90% of all catheter-related bloodstream infections 6 and 
nontunneled (percutaneously-inserted) CVCs are the most commonly used 
central catheters. Among the factors that influence the risk of 
infection associated with the use of CVCs are the number of catheter 
lumens and the site at which the catheter is inserted.
    Multilumen CVCs are often preferred by clinicians, because they 
permit the concurrent administration of various fluids/medications and 
hemodynamic monitoring among critically ill patients. In nonrandomized 
trials, multilumen catheters have been associated with a higher risk of 
infection than have their single-lumen counterparts.24-26 In two 
of three randomized trials multilumen catheters were associated with an 
increased risk of infection.27-29 Multilumen catheter insertion 
sites may be particularly prone to infection because of increased 
trauma at the insertion site and/or because multiple ports increase the 
frequency of CVC manipulation.25 26 Although patients with 
multilumen catheters tend to be more ill, the infection risk found with 
the use of these catheters may be independent of the patient's 
underlying disease severity.28
    In addition to the number of lumens, the site at which a CVC is 
inserted may play a major role in CVC-related infections. Five of six 
studies have shown a significantly higher colonization or infection 
rate with catheters inserted into the internal jugular vein compared 
with those inserted into the subclavian vein, with a risk ratio as high 
as 2.7.30-35 Other risk factors for CVC-related infections include 
repeated catheterization, presence of a septic focus elsewhere in the 
body, exposure of the catheter to bacteremia, absence of systemic 
antimicrobial therapy,31 duration of catheterization, and type of 
dressing.33
    Central arterial catheters. Pulmonary artery catheters (PACs) 
(i.e., Swan Ganz 1 catheters) differ from CVCs in that they are 
inserted through a Teflon introducer and typically remain in place an 
average of only 3 days. However, they carry many of the same risks and 
have similar rates of BSI as do other central catheters. Risk factors 
reported for CRI in patients with PACs include duration of 
catheterization >3 days,36 >5 days,37 or >7 days;21 
colonization of the skin insertion site;36 38 and catheter 
insertion in the operating room using submaximal barrier precautions 
(i.e., gloves, small-fenestrated drape).36 Site of insertion may 
also influence the risk of infection associated with PACs. Two studies 
suggest that PACs inserted into jugular veins have a higher rate of 
infection compared with those inserted into subclavian veins;36, 
39 three other studies found no difference in infection rates 
associated with the two insertion sites.37 38 40

    \1\ 1Use of trade names is for identification only and does not 
imply endorsement by the U.S. Public Health Service or the U.S. 
Department of Health and Human Services.
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    Pressure monitoring systems. Pressure monitoring systems used in 
conjunction with arterial catheters have been associated with both 
epidemic and endemic nosocomial BSIs.41 42 The first outbreak of 
infections due to contamination of pressure monitoring systems was 
reported in 1971;43 subsequently, 26 such outbreaks have been 
reported.44-48 The final common pathway for microorganisms that 
enter the bloodstream of patients and cause bacteremia is the fluid 
column in the tubing between the patient's intravascular catheter and 
the pressure monitoring apparatus. Microorganisms in a fluid filled 
system may move from the pressure monitoring apparatus to the patient 
or from the patient to the pressure monitoring system.42
    The earliest outbreaks related to pressure monitoring were due to 
contaminated infusate 43 or failure to sterilize the fluid pathway 
in reusable transducers, particularly the chamber domes.49, 50 
Because of the difficulties in sterilizing reusable transducers, 
sterile disposable plastic chamber domes were developed. These domes 
have a plastic membrane that makes contact with the sensor diaphragm on 
the head of the transducer and isolates the sterile fluid pathway from 
the transducer. However, systems containing these disposable domes have 
also been associated with outbreaks.45 46 51 52 While 
resterilization of disposable domes may damage the membrane and permit 
ingress of microorganisms into the sterile fluid pathway,53 in 
most outbreaks the membranes in the disposable domes remained 
intact.46, 51 A study in 1979 showed that fluid used to fill the 
space between the transducer head and the membrane of the disposable 
dome frequently contaminated the hands of the operator and that the 
system was inoculated by touch contamination during the subsequent 
assembly of the pressure monitoring system.52 This mode of 
contamination is most likely to occur when glucose solutions are used 
between the transducer head and the chamber dome membrane and when 
transducers are not effectively decontaminated between uses.54 
Most outbreaks that have occurred since the introduction of the 
disposable chamber dome have been due to this type of 
contamination.54
    Other mechanisms by which pressure monitoring systems have been 
contaminated include contamination of infusate, 41 in-use 
contamination of the system by nonsterile calibrating devices,55 
contamination of the system by ice used to chill syringes,56 
introduction of microorganisms into the system by contaminated 
disinfectant 49 and in-use contamination of the system related to 
blind, stagnant columns of fluid between the transducer and infusion 
system.42 The importance of the latter mechanism in contamination 
was shown by a substantial drop in contamination of the system after 
introduction of a continuous flush device that eliminated the stagnant 
column of fluid.57
    To date, no outbreaks have been reported with the use of disposable 
pressure transducers. A prospective study of disposable transducers has 
shown a very low rate of associated infection (one case of bacteremia 
in 157 courses of pressure monitoring).58 This study also showed 
that disposable transducers can be safely used for 4 days.58 
Disposable transducers were used as a control measure in one reported 
outbreak caused by contaminated reusable transducers.45

Peripherally Inserted CVCs

    Peripherally inserted CVCs (PICCs) are inserted into the right 
atrium by way of the cephalic and basilar veins of the antecubital 
space and provide an alternative to subclavian or jugular vein 
catheterization and, because they do not require surgical insertion, 
cost much less to insert than tunneled subclavian catheters or 
subcutaneous ports. PICCs have been used for a variety of purposes, 
including total parenteral nutrition (TPN) administration, and their 
use appears to be associated with a rate of infection similar to that 
reported with other percutaneously inserted CVCs.59 Further 
studies are 

[[Page 49981]]
needed to adequately determine how long PICCs can safely be left in 
place 59 60 and to determine the epidemiology and microbiology of 
associated infections.

Devices Used for Long-Term Vascular Access

    Tunneled central venous catheters. Surgically implanted right 
atrial catheters, including Hickmans, Broviacs, Groshongs, and 
Quintons, are commonly used to provide vascular access to patients 
requiring prolonged intravenous therapy (e.g., chemotherapy or home-
infusion therapy, hemodialysis). In contrast to percutaneously inserted 
(nontunneled) CVCs, these catheters have a tunneled portion exiting the 
skin and a Dacron cuff just inside the exit site. The cuff inhibits 
migration of organisms into the catheter tract by stimulating growth of 
the surrounding tissue, thus sealing the catheter tract and providing a 
natural anchor for the catheter. In general, the rates of infections 
reported with the use of tunneled catheters have been significantly 
lower than those reported with the use of nontunneled CVCs;61-69 
however, two recent studies, one randomized, found no significant 
difference in the rates of infection among tunneled and nontunneled 
catheters.59 70
    Totally implantable intravascular devices (TIDs). TIDs are also 
tunneled beneath the skin, but have a subcutaneous port or reservoir 
with a self-sealing septum that is accessed by needle puncture through 
intact skin. TIDs offer the advantage of improved patient image and 
obviate the need for routine catheter-site care. Among devices used for 
long-term vascular access, TIDs have the lowest reported rates of 
catheter-related BSI,71-81 possibly because they are located 
beneath the skin with no orifice for ingress of microorganisms.
    Recently, several investigators have attempted to compare the 
infectious morbidity associated with TIDs and other tunneled catheters. 
In one randomized study, TIDs and Hickman catheters had comparable 
rates of infection.78 In another randomized study, TIDs had lower 
rates of infection compared with other tunneled catheters.79 
Groeger et al. conducted one of the largest comparisons of the 
infectious complications associated with long-term vascular access 
devices to date. In this prospective examination of 1431 devices in 
patients with cancer, TIDs (0.21 infections per 1,000 device-days) had 
a significantly lower rate of infectious complications compared with 
other tunneled catheters (2.77 infections per 1,000 device days, 
p0.001).80 However, the devices in Groeger's study were 
not randomly assigned, thus the differences observed may be due to 
factors other than those inherent to the devices. Existing data suggest 
that either of the indwelling devices can be safely used with a low 
risk of infection. The selection of a given device depends on the 
intended use, patient population, and patient/practitioner preference.

III. Microbiology

    Over the past two decades, there has been a marked change in the 
distribution of pathogens reported to cause nosocomial BSIs.7 82 
83 Since the mid-1980's, an increasing proportion of nosocomial BSIs 
reported to NNIS have been due to gram-positive, rather than gram-
negative, species. Moreover, a major portion of the overall increase in 
nosocomial BSIs reported to NNIS during the past decade was due to 
significant increases in four pathogens: coagulase-negative 
staphylococci (CoNS), Candida spp., enterococci, and Staphyloccocus 
aureus. The distribution of these pathogens varied by hospital size and 
affiliation (i.e., teaching, nonteaching).7
    CoNS, particularly S. epidermidis, have become the most frequently 
isolated pathogens in CRIs and accounted for an estimated 28% of all 
nosocomial BSIs reported to NNIS during 1986-89.7 84 The emergence 
of CoNS as the primary pathogen causing CRIs can be attributed to 
several factors: (1) increased use of prosthetic/indwelling devices 
(e.g., intravascular catheters);85 (2) improved survival of low 
birthweight neonates and increased use of intralipids in these 
patients;86 and (3) recognition of CoNS as true nosocomial 
pathogens rather than harmless commensals.7 The prevalence of 
these pathogens also shows that the hands of healthcare workers (HCWs) 
and the flora of patients' skin are likely the predominant sources of 
pathogens for most CRIs.
    Prior to 1986, S. aureus was the most frequently reported pathogen 
causing nosocomial BSIs.84 Now, S. aureus accounts for an 
estimated 16% of reported nosocomial BSIs.87 S. aureus BSIs may be 
complicated by metastatic foci of infection (e.g., vertebral 
osteomyelitis) and endocarditis.88-90
    Enterococci, another emerging nosocomial bloodstream pathogen, 
accounted for 8% of nosocomial BSIs reported to NNIS during 1986-
1989.84 More alarming, has been the emergence of vancomycin-
resistant enterococci (VRE). During 1989-1993, 3.8% of the blood 
isolates from BSIs reported to NNIS were vancomycin resistant. Although 
data were not available to adequately assess the attributable mortality 
of either the BSI or the antimicrobial resistance of the isolate, 
mortality was significantly higher among patients whose isolates were 
vancomycin resistant (36.6%) than among those whose isolates were 
vancomycin susceptible (16.4%).91 Risk factors associated with VRE 
BSIs include receipt of antimicrobials (including vancomycin), 
gastrointestinal colonization with VRE, underlying disease severity 
(e.g., in oncology or transplant patients), abdominal or cardiac 
surgical procedures, use of indwelling devices, and prolonged hospital 
stay.92-99 Although enterococcal BSIs may arise from the patients' 
endogenous flora, nosocomial transmission of VRE via the hands of 
HCWs,93 patient-care equipment,100 and contaminated 
environmental surfaces 92 93 has also been suggested by the 
findings of recent outbreak investigations. The emergence of 
enterococci as significant nosocomial bloodstream pathogens is likely 
due, in part, to the increased use of invasive devices and the 
injudicious use of broad-spectrum antimicrobials for treatment and 
prophylaxis of infections.101-105
    Fungal pathogens represent an increasing proportion of nosocomial 
BSIs. During 1980-1990, NNIS hospitals reported a nearly fivefold 
increase in the rate of nosocomial fungal BSIs (1.0 to 4.9/10,000 
discharges) and a nearly twofold increase in the proportion of BSIs due 
to fungal pathogens (5.4 to 9.9%).106 Such increases were detected 
for hospitals of all sizes and affiliations and on all major hospital 
services. Candida spp., particularly C. albicans, accounted for >75% of 
all nosocomial fungal infections reported to NNIS during this period. 
Candidemia has traditionally been thought to arise from the endogenous 
flora of colonized patients,107-109 but recent epidemiologic 
studies, assisted by the use of molecular typing, show that exogenous 
infection due to administration of contaminated fluids,110 111 use 
of contaminated equipment,112 cross-infection,113-117 and the 
colonized hands of HCWs 118-122 are also important contributors to 
candidemia among hospitalized patients.
    Although less commonly implicated than either gram-positive 
bacterial or fungal species as a cause of BSI, gram-negative 
microorganisms account for the majority of CRIs associated with the use 
of arterial catheters. Moreover, it has been suggested that clusters of 
infections caused by certain gram-negative species, such as 
Enterobacter 

[[Page 49982]]
spp., Acinetobacter spp., S. marcescens or non-aeruginosa pseudomonads, 
should automatically raise suspicion of a common source, such as a 
contaminated pressure monitoring device. The predominance of gram-
negative microorganisms in infections associated with pressure 
monitoring devices may be due to concomitant receipt of broad-spectrum 
antimicrobials by patients undergoing hemodynamic monitoring.

IV. Pathogenesis

    The pathogenesis of CRIs is multifactorial and complex (Figure 1), 
but available scientific data show most CRIs appear to result from 
migration of skin organisms at the insertion site into the cutaneous 
catheter tract with eventual colonization of the catheter tip.123-
126 However, there is a smaller, but growing, body of data to suggest 
that hub contamination can be an important contributor to intraluminal 
colonization of catheters, particularly long-term catheters.127-
130
    The relative importance of these two mechanisms of catheter 
contamination is the source of continuing debate. Recent findings 
suggest that duration of catheterization influences which of the two 
mechanisms predominates. Using electron microscopy, Raad demonstrated 
that hub contamination was the more likely mechanism of infection for 
long-term catheters (i.e., in place >30 days), while skin contamination 
was the more likely mechanism for short-term catheters (i.e., <10 
days).130 Although much less common than either of these two 
mechanisms, hematogenous seeding of the catheter tip from a distant 
focus of infection or administration of contaminated infusate may also 
cause CRIs.128 131-134
    Two other important pathogenic determinants of CRI are (1) the 
material of which the device is made, and (2) the intrinsic properties 
of the infecting organism. In vitro studies show that catheters made of 
polyvinyl chloride or polyethylene appear to be less resistant to the 
adherence of microorganisms than are newer catheters made of Teflon, 
silicone elastomer, or polyurethane.135-137 Some catheter 
materials also have surface irregularities that may further enhance the 
microbial adherence of certain species (e.g., CoNS, Acinetobacter 
calcoaceticus, and Pseudomonas aeruginosa).138 139 Thus, catheters 
made of certain materials may be more prone to microbial colonization 
and subsequent infection. Additionally, certain catheter materials are 
more thrombogenic than others, a characteristic that also may 
predispose to catheter colonization and catheter-related 
infection.140
    The adherence properties of a given microorganism are also 
important in the pathogenesis of CRI. For example, S. aureus can adhere 
to host proteins (e.g., fibronectin) commonly present on 
catheters,141 142 and CoNS, the most frequent etiologic agents in 
CRIs, adhere to polymer surfaces more readily than do other common 
nosocomial pathogens such as E. coli or S. aureus.143 
Additionally, certain strains of CoNS produce an extracellular 
polysaccharide often referred to as ``slime.'' In the presence of 
catheters, this slime potentiates the pathogenicity of CoNS by allowing 
them to withstand host defense mechanisms 144 145 (e.g., acting as 
a barrier to engulfment and killing by polymorphonuclear leukocytes) or 
by making them less susceptible to antimicrobial agents 146 (e.g., 
forming a matrix that binds antimicrobials before their contact with 
the organism cell wall). More recent studies suggest that certain 
Candida spp., in the presence of glucose-containing fluids, may produce 
``slime'' similar to that of their bacterial counterparts, potentially 
explaining the increased proportion of BSIs due to fungal pathogens 
among patients receiving parenteral nutrition fluids.147

V. Definitions and Diagnosis of Catheter-Related Infections

    Establishing a clinical diagnosis of CRI, especially catheter-
related BSI, is often difficult. Diagnosis is typically based on 
clinical and/or laboratory criteria, with each having significant 
diagnostic limitations. The introduction of semiquantitative methods 
for culturing catheters has greatly enhanced our ability to diagnose 
CRIs. Both semiquantitative and quantitative methods have greater 
specificity in identifying CRI than do traditional broth cultures, 
where a clinically insignificant inocula of microorganisms can result 
in a positive catheter culture.31 148
    However, interpretation of the results of these culture methods may 
vary depending on the type and location of the catheter and the culture 
methodology used. The use of varying definitions in studies of CRI have 
made it difficult to compare existing studies of these infections.
    The predictive values of semiquantitative and quantitative methods 
may vary, depending on the source of catheter colonization.\130\ For 
example, if the skin is the primary source of catheter colonization, 
methods that culture the external surface of the catheter may be 
preferable. Conversely, if hub contamination is the primary mechanism 
for catheter colonization, methods that culture both the external and 
internal surfaces may have greater yield.\130\ As the use of 
antimicrobial-coated catheters becomes more prevalent, existing 
definitions of catheter colonization and CRI may need to be modified.

Infections Associated with Short-Term Catheters

    The most widely used laboratory technique for diagnosis of CRI is 
the roll-plate method described by Maki et al.\148\ This method 
cultures a segment of the catheter after it has been removed from the 
patient by rolling the catheter segment across the surface of an agar 
plate and determining the number of bacterial colonies present after 
overnight incubation. Growth of 15 colony forming units 
(cfus) from a proximal or distal catheter segment by semiquantitative 
culture in the absence of accompanying signs of inflammation at the 
catheter site is considered indicative of catheter colonization. Growth 
of 15 cfus from a catheter by semiquantitative culture with 
accompanying signs of inflammation (e.g., erythema, warmth, swelling, 
or tenderness) at the device site is indicative of local CRI. In the 
absence of semiquantitative culture, CRI may be diagnosed when there is 
purulent drainage from the skin-catheter junction. Limitations of the 
roll plate method are that it requires removal of the catheter and 
overnight incubation before results become available.
    Cooper et al. proposed direct gram-staining of catheters on removal 
as a rapid way to diagnose catheter infection and as a complement to 
semiquantitative culture.\126\ However, this method appears to be 
considerably more time-consuming than semiquantitative culture and, 
thus, may be impractical for routine diagnostic use.
    Acridine-orange staining of catheters has been proposed as a 
modification of the gram-staining technique.\149\ Although similar to 
gram-staining, acridine-orange staining is a single-step procedure that 
uses a fluorescent dye to enhance detection of microorganisms in 
clinical specimens. This procedure avoids many of the technical 
shortcomings encountered with the direct gram-staining technique, but 
confirmatory studies documenting its quantitative test performance are 
needed before it can be recommended.
    The most sensitive technique for diagnosis of CRI is quantitative 
culture. To culture a catheter quantitatively, the catheter segment is 
either flushed with and then immersed in broth \150\ or placed in broth 
and sonicated; 151 152 the 

[[Page 49983]]
broth recovered from these procedures is cultured quantitatively. 
Sonication releases microorganisms from both the luminal and external 
surfaces of the catheter and thus may have greater sensitivity for 
diagnosing CRIs, especially those associated with central venous and 
arterial catheters, than do methods that only culture the external 
surface of the catheter.\152\
    All semiquantitative and quantitative catheter culture methods 
require removal of the implicated catheter, but the venous access site 
can be preserved by removing the catheter over a guidewire and 
inserting a new catheter over the guidewire. The proximal and distal 
segments of the catheter removed over the guidewire are cultured using 
the semiquantitative technique.\153\ If a catheter is removed over a 
guidewire and has a negative culture, the catheter inserted over the 
guidewire may be left in place. If the catheter removed over a 
guidewire has a culture result suggesting colonization/infection, the 
second catheter should be removed, and a new catheter inserted at a new 
site.59 131 153
    Quantitative blood culturing techniques have been developed for 
diagnosis of CR-BSI in patients where catheter removal is undesirable 
because of limited vascular access. These techniques rely on 
quantitative culture of paired blood samples, one obtained through the 
central catheter and the other from a peripheral venipuncture site. In 
most studies, a colony count from the blood obtained from the catheter 
that is five to tenfold greater than the colony count from the blood 
obtained from a peripheral vein has been predictive of CR-BSI.154-
156

Infections Associated With Long-Term Catheters

    The use of these indwelling catheters may be complicated by a 
variety of local infectious complications: exit-site, tunnel, or pocket 
infections, as defined in Table 1.\69\ However, clinical diagnosis of 
CRI involving the intravascular portion of indwelling catheters is 
particularly difficult; thus, laboratory diagnosis is important. The 
utility of the roll-plate method for diagnosis of infection associated 
with long-term vascular access devices has not been evaluated, but 
recovery of 15 cfus on semiquantitative culture of a 
catheter segment may be diagnostic of colonization of the intravascular 
segment. BSI resulting from a colonized intravascular segment may also 
be suspected if 10-fold higher concentration of 
microorganisms on quantitative culture of blood obtained from the 
catheter compared with the concentration of microorganisms in blood 
obtained from a peripheral venous site.157-159

Catheter-Related Bloodstream Infection

    CR-BSI is most stringently defined as isolation of the same 
organism (i.e., identical species, antibiogram) from semiquantitative 
or quantitative cultures of both a catheter segment and the blood 
(preferably drawn from a peripheral vein) of a patient with 
accompanying clinical symptoms of BSI and no other apparent source of 
infection. In the absence of laboratory confirmation, defervescence 
after removal of an implicated catheter from a patient with BSI is also 
considered indirect evidence of CR-BSI.

Infusate-Related Bloodstream Infection

    Since BSI may result from the administration of contaminated 
intravenous fluids, culturing intravenous fluids should be part of an 
investigation of potential sources of infection. Infusate-related BSI 
is usually defined as the isolation of the same organism from both 
infusate and separate percutaneous blood cultures, with no other 
identifiable source of infection.

VI. Strategies for Prevention of Catheter-Related Infections

    Strict adherence to handwashing and aseptic technique remains the 
cornerstone of prevention of CRIs; however, other measures may confer 
additional protection and must be considered when formulating 
preventive strategies. These measures include the selection of an 
appropriate site of catheter insertion, selection of appropriate 
catheter material(s), use of barrier precautions during catheter 
insertion, change of catheters and administration sets at appropriate 
intervals, catheter-site care, and the use of filters, flush solutions, 
prophylactic antimicrobials, and newer intravascular devices (e.g., 
impregnated catheters, needleless infusion systems).

Site of Catheter Insertion

    The site at which a catheter is placed may influence the subsequent 
risk of CRI. For peripheral venous catheters, lower extremity 
insertions pose a greater risk of phlebitis than do those inserted in 
the upper extremity, and upper extremity sites differ in their risk for 
phlebitis.160-164 Peripheral venous catheters inserted into hand 
veins have a lower risk of phlebitis than do those inserted in upper 
arm or wrist veins.\6\
    Among CVCs, catheters inserted into subclavian veins have a lower 
risk for infection than do those inserted in either jugular or femoral 
veins. 31-36 39 Internal jugular insertion sites may pose a 
greater risk for infection because of their proximity to oropharyngeal 
secretions, and because catheters at internal jugular sites are 
difficult to immobilize. However, mechanical complications associated 
with insertion are less common with internal jugular vein insertion 
than with subclavian venous catheterization.

Type of Catheter Material

    The relationship between catheter material and infectious morbidity 
has been largely examined by the study of peripheral venous catheters. 
The majority of peripheral venous catheters in the U.S. are made of 
Teflon or polyurethane, and these catheters appear to be associated 
with fewer infectious complications than are catheters made of 
polyvinyl chloride or polyethylene.17 135 165 In one large, 
randomized prospective study of Teflon and polyurethane catheters, the 
two types of catheters had comparable rates of local infection, 5.4% 
and 6.9%, respectively,\17\ but polyurethane catheters were associated 
with a nearly 30% lower risk of phlebitis when compared with Teflon 
catheters. In this trial, neither the Teflon nor polyurethane catheter 
was associated with BSI.\17\ By contrast, polyvinyl chloride or 
polyethylene catheters have been associated with BSI rates ranging from 
0%-5%.166 167
    Steel needles, used as an alternative to synthetic catheters for 
peripheral venous access, have the same rate of infectious 
complications as do Teflon catheters. 168 169
    However, the use of steel needles is frequently complicated by 
infiltration of intravenous fluids into the subcutaneous tissues, a 
potentially serious complication if the infused fluid is a 
vesicant.\169\ In view of the low rates of BSI seen with newer Teflon 
and polyurethane catheters, the relative risks and benefits of using 
steel needles must be evaluated on an individual patient basis.
    Catheter material seems to also be an important determinant in the 
risk of infection associated with CVCs. Most CVCs used in the U.S. are 
made of polyurethane, polyvinyl chloride, polyethylene, or silicone. In 
one small, prospective trial comparing silicone with polyvinyl TPN 
catheters, silicone catheters had a significantly lower rate of CR-BSI 
than did polyvinyl chloride catheters, 0.83 and 19 per 1,000 catheter 
days, respectively; however, the silicone catheters were tunneled, and 
the polyvinyl chloride catheters were largely nontunneled. The 
polyvinyl 

[[Page 49984]]
chloride catheters also were associated with a higher risk of 
mechanical complications (i.e., breakage, blockage, displacement, and 
thrombosis).\170\ Because of the potential confounding caused by the 
different types of catheters in this comparison (i.e., tunneled vs. 
nontunneled), appropriate conclusions about the contribution of 
catheter material to CVC-related infections can not be drawn.

Barrier Precautions During Catheter Insertion

    It is generally accepted that good handwashing before and attention 
to aseptic technique during insertion of peripheral venous catheters 
provide adequate protection against infection. Central venous 
catheterization, however, carries a significantly greater risk of 
infection, and the level of barrier precautions needed to prevent 
infection during insertion of CVCs has been a source of debate.
    Until recently, it was assumed that catheters inserted in the 
operating room posed a lower risk of infection than did those inserted 
on inpatient wards or other patient-care areas. However, data from two 
recent prospective studies suggest that the difference in risk of 
infection depends largely on the magnitude of barrier protection used 
during catheter insertion, rather than the sterility of the surrounding 
environment (i.e., ward vs. operating room) 36 171; CVCs or PACs 
inserted in the operating room using submaximal barrier precautions 
(i.e., gloves, small fenestrated drape) were more likely to become 
colonized and to be associated with subsequent BSI than were those 
inserted on the ward or in the ICU using maximal barrier precautions 
(i.e., gloves, gown, large drape, masks). These data suggest that if 
maximal barrier precautions are used during CVC insertion, catheter 
contamination and subsequent CVC-related infections can be minimized, 
irrespective of whether the catheter is inserted in the operating room 
or at the patient's bedside.171 172

Changing Catheters and Administration Sets

    Intravenous administration set changes. The optimal interval for 
routinely changing intravenous administration sets used for patient 
care has been examined in three well- controlled studies. Data from 
each of these studies show that changing administration sets 
72-hours after initiation of use is not only safe, but cost-
beneficial.173-175 However, because certain fluids (i.e., blood, 
blood products, TPN, and lipid emulsions) are more likely than other 
parenteral fluids to support microbial growth if contaminated, 132 
176-179 more frequent tubing changes may be required when such fluids 
are administered.
    A common component of intravenous administration sets is the 
stopcock. Stopcocks are used for injection of medications, 
administration of intravenous infusions, or collection of blood samples 
and, thus, represent a potential portal of entry for microorganisms 
into vascular catheters or intravenous fluids. Although stopcock 
contamination is common, ranging between 45% and 50% in most series, 
the relative contribution of stopcock contamination to intravascular 
catheter or intravenous fluid contamination is unclear. Few studies 
have been able to demonstrate that the organism(s) colonizing stopcocks 
is the same one responsible for CRI.180 181 Data suggest that the 
use of a closed-needle sampling system can significantly reduce 
sampling-port and intravenous fluid contamination.182 183
    ``Piggyback'' systems may be used as an alternative to stopcocks. 
However, they also pose a risk for contamination of the intravascular 
fluid if the needle entering the rubber membrane of an injection port 
is partially exposed to air, or comes into direct contact with the tape 
used to fix the needle to the port. A recently described ``piggyback'' 
system appears to prevent contamination at these sites and reduces the 
incidence of CR-BSI sixfold compared with conventional stopcock and 
``piggyback'' systems.182
    Intravenous catheter changes. Routine or scheduled change of 
intravascular catheters has been advocated as a method to reduce CRIs. 
Studies of peripheral venous catheters show that the incidences of 
thrombophlebitis and bacterial colonization of catheters seem to 
increase dramatically when catheters are left in place >72 
hours.12 168 Both phlebitis and catheter colonization have been 
associated with an increased risk of CRI. Because of the increased risk 
of infection, as well as patient discomfort associated with phlebitis, 
peripheral catheter sites are commonly rotated at 48-72 hour intervals 
to reduce the risk of phlebitis.
    In the maintenance of CVCs, decisions regarding the frequency of 
catheter change are substantially more complicated. Some investigators 
have shown duration of catheterization to be a risk factor for 
infection, 33 35 184 185 and routine change of CVCs at specified 
intervals has been advocated as a measure to reduce infection. However, 
more recent data suggest that the daily risk of infection remains 
constant and show that routine changes of CVCs, without a clinical 
indication, do not reduce the rate of catheter colonization or the rate 
of catheter-related BSI. 186, 187
    The method of replacing CVCs has also been a topic of controversy 
and intensive study. CVCs can be changed by placing a new catheter over 
a guidewire at the existing site or by inserting the new catheter at 
another site. Catheter replacement over a guidewire has become an 
accepted technique for changing a malfunctioning catheter or exchanging 
a PAC for a CVC when invasive monitoring is no longer needed. Catheters 
inserted over a guidewire are associated with less discomfort and a 
significantly lower rate of mechanical complications than are those 
percutaneously inserted at a new site.131 186 188 189 Guidewire-
assisted exchange may, however, be accompanied by complications, most 
notably bleeding at the site, hydrothorax, and subsequent infection of 
the newly placed catheter.131 189
    Studies examining the infectious risks associated with guidewire 
insertions have yielded conflicting results. Three prospective studies 
(two randomized) have shown no significant difference in infection 
rates between catheters inserted percutaneously and those inserted over 
a guidewire.153 187 190 One prospective randomized study has shown 
a significantly higher rate of BSIs associated with catheters changed 
over a guidewire compared with catheters inserted 
percutaneously.186 Most investigators agree that if guidewire-
assisted catheter change occurs in the setting of an CRI, the newly 
placed catheter should be removed (131,153,187,188).

Catheter-Site Care

    Cutaneous antiseptics and antimicrobial ointments. Skin cleansing/
antisepsis of the insertion site is regarded as one of the most 
important measures for preventing CRI, but comparative studies of 
cutaneous antisepsis have largely examined its efficacy in eradicating 
bacterial flora from the hands of hospital personnel.191 192 
However, in one trial, the effectiveness of 2% chlorhexidine, 10% 
povidone-iodine, and 70% alcohol 193 as cutaneous antiseptics were 
compared in preventing central venous and arterial CRIs. The rate of 
catheter-related BSI when chlorhexidine was used for catheter site 
preparation was 84% lower than the rates when the other two antiseptic 
regimens were used; however, the 2% chlorhexidine preparation used in 
this trial is not currently available in the U.S. More recently, a 
sustained-release chlorhexidine gluconate patch (250 mu/

[[Page 49985]]
mg dressing) has been introduced as a dressing for catheter insertion 
sites. In one randomized trial of epidural catheters, the use of these 
patches significantly reduced the incidence of catheter 
colonization.194 However, the efficacy of the chlorhexidine patch 
in reducing intravascular device-related infection still needs to be 
determined.
    Tincture of iodine also has been widely used in hospitals for skin 
antisepsis before catheter insertion, but its efficacy in reducing 
catheter colonization and infection have not been thoroughly evaluated. 
Data derived from examining its use as an antiseptic prior to blood 
culturing suggest that it, like 70% alcohol and 10% povidone iodine, 
may be an effective cutaneous antiseptic for preparation of the skin 
prior to insertion of intravascular catheters.195 However, 
tincture of iodine may cause skin irritation.195 
    The application of antimicrobial ointments to the catheter site at 
the time of catheter insertion and/or during routine dressing changes 
has also been used to reduce microbial contamination of catheter-
insertion sites. Studies of the efficacy of this practice in preventing 
CRIs have yielded contradictory findings.30 196-200 Moreover, the 
use of polyantibiotic ointments that are not fungicidal may 
significantly increase the rate of colonization of the catheter by 
Candida spp.198 200 201
    Recently, topical mupirocin, a nonsystemic anti-staphylococcal 
antimicrobial with documented efficacy in reducing nasal staphylococcal 
spp. carriage,202 has been used for cutaneous antisepsis in 
conjunction with 2.5% tincture of iodine prior to catheter insertion. 
Used in this way, mupirocin was reported to reduce the incidence of 
internal jugular catheter colonization among cardiac surgery patients. 
However, the utility of mupirocin in reducing the rate of colonization 
of peripheral or arterial catheters has not been demonstrated 203 
and its use on catheter sites has not been approved. Moreover, 
mupirocin resistance has been reported (204-206). Controlled studies 
are needed to fully evaluate the effectiveness and potential adverse 
effects of mupirocin use for catheter-site maintenance.
    Catheter-site dressing regimens. Transparent, semipermeable, 
polyurethane dressings have become a popular means of dressing 
catheter-insertion sites. These transparent dressings reliably secure 
the device, permit continuous visual inspection of the catheter site, 
permit patients to bathe and shower without saturating the dressing, 
and require less frequent changes than do standard gauze and tape 
dressings, thus saving personnel time. Nevertheless, the use of 
transparent dressings remains one of the most actively researched, and 
controversial, areas of catheter site care. Some studies suggest that 
their use increases both microbial colonization of the catheter site 
and the risk of subsequent CRI,15 207-210 while other studies have 
shown no difference in catheter colonization and infection rates 
between the use of transparent dressings and gauze and tape 
dressings.10 165 211 The potential risk of infection posed by 
transparent dressings appears to vary with the type of catheter 
(peripheral or central venous catheter) they are used to dress and, 
perhaps, with the season of the year.10 15 209
    In the largest controlled trial of dressing regimens to date, Maki 
et al. examined the infectious morbidity associated with the use of 
transparent dressings on >2,000 peripheral catheters.165 Their 
findings suggest that the rate of catheter colonization among catheters 
dressed with transparent dressings (5.7%) is comparable to that of 
those dressed with gauze (4.6%) and that there are no clinically 
important differences in either the incidences of catheter-site 
colonization or phlebitis between the two groups. Further, these data 
suggest that transparent dressings can be safely left on peripheral 
venous catheters for the duration of catheter insertion without 
increasing the risk of thrombophlebitis.165 
    Studies of the use of transparent dressings on CVCs have also 
yielded contradictory findings. Some investigators have found an 
increased risk of CRI among CVCs with a transparent dressing compared 
with those gauze; 209 210 others have found the risk of infection 
posed by these two types of dressings to be comparable.211 212 
Most of the data on the use of transparent dressings on CVCs are 
derived from studies of short-term nontunneled devices and little data 
have been published regarding the use of transparent dressings on long-
term, tunneled CVCs.213 In a metaanalysis of catheter dressing 
regimens, CVCs on which a transparent dressing was used had a 
significantly higher incidence of catheter tip colonization, but a 
nonsignificant increase in the incidence of CR-BSI.214 Preliminary 
data suggest that newer transparent dressings that permit the escape of 
moisture from beneath the dressing may be associated with lower rates 
of skin colonization and CRI,213 215 but the length of time that a 
transparent dressing can be safely left on a CVC catheter site is 
unknown.
    Collodion has also been evaluated for use as a potential dressing 
for catheter sites. One small (n=34), retrospective study of its use on 
CVCs reported a low incidence of CRIs, despite catheters remaining in 
place an average of 16.5 days.216 However, before collodion can be 
recommended for routine use as a catheter site dressing, randomized 
trials comparing collodion to existing dressings should be done.

In-Line Filters

    In-line filters may reduce the incidence of infusion-related 
phlebitis (217-220), but there are no data to support their efficacy in 
preventing infections associated with intravascular devices and 
infusion systems. Proponents of the use of filters cite a number of 
potential benefits: (1) reducing the risk of infection from 
contaminated infusate or proximal contamination (i.e., introduced 
proximal to the filter); (2) reducing the risk of phlebitis in patients 
who require high doses of medication (e.g., antimicrobials) or in those 
in whom infusion-related phlebitis has already occurred; (3) removing 
particulate matter that may contaminate intravenous fluids; 221 
and (4) filtering endotoxin produced by gram-negative organisms in 
contaminated infusates.222 These theoretical advantages must be 
tempered by the knowledge that infusate-related BSI rarely occurs and 
that pre-use filtration in the pharmacy is a more practical, and less 
costly, way to remove particulates from infusates. Furthermore, in-line 
filters may become blocked, especially with certain solutions (dextran, 
lipids, mannitol), and consequently increase line manipulations and/or 
decrease the availability of administered drugs.223 Because of 
these potential untoward effects, the routine use of in-line filters 
may increase cost, personnel time, and possible infections.224

Silver-Chelated Collagen Cuffs

    Since 1987, a silver-chelated, collagen cuff that is attachable to 
percutaneously inserted CVCs has been commercially available. Similar 
to the cuff used on Hickman and Broviac catheters, this cuff is 
designed to form a mechanical barrier to skin microorganisms migrating 
into the cutaneous catheter tract; 201 225 the silver provides an 
additional antimicrobial barrier.201 225 Two randomized controlled 
trials examining the efficacy of silver-chelated collagen cuffs have 
been published. In the first trial, cuffed CVCs were associated with a 
threefold lower risk of catheter colonization and a nearly fourfold 
lower risk of CR-BSI compared with traditional noncuffed CVCs.225 
In the second trial, a 78% reduction in 

[[Page 49986]]
catheter colonization and a 100% reduction in CR-BSI were observed with 
these devices.201 The relative contribution of the cuff versus the 
antimicrobial properties of the silver preventing CRI is uncertain. No 
controlled trials examining the efficacy of cuffs without antiseptic or 
antimicrobial coating have been published.
    The protective effect of these cuffed CVCs appears to be immediate 
and exceeds that seen with the use of antimicrobial ointment 
alone.201 However, cuffs appear to be most beneficial with 
catheters left in place for >4 days.225 Studies on the efficacy of 
these cuffs in preventing infection with longer-term CVCs (i.e., >20 
days) have not been published.

Antimicrobial-Impregnated (Coated) Catheters

    In animal models, antimicrobial or antiseptic impregnation of 
catheters appears to reduce bacterial adherence and biofilm 
formation,226 227 but the utility of these impregnated catheters 
in clinical settings has only recently been evaluated. Kamal et al. 
conducted a large, randomized, prospective trial among SICU patients to 
evaluate a CVC bonded with cefazolin for the entire length of its 
external and luminal surfaces.228 The authors found a sevenfold 
reduction in the incidence of catheter colonization (2% vs 14%), but no 
difference in catheter-site inflammation (i.e., culture-negative 
inflammation of the insertion site). No bacteremias occurred in either 
group. The authors suggest that antimicrobial coating of the luminal 
surfaces of catheters may be particularly beneficial in reducing the 
risk of infection resulting from hub contamination.
    Data supporting the utility of antimicrobial coating for peripheral 
catheters are much less conclusive. Kamal et al. also studied a small 
number of peripheral arterial catheters as part of their evaluation of 
the cefazolin-impregnated catheter.228 Although impregnated 
peripheral arterial catheters had a fivefold lower incidence of CRI 
compared with noncoated catheters (3% vs 15%), this difference was not 
statistically significant. The lack of demonstrable efficacy of 
antimicrobial coating of peripheral arterial catheters in reducing CRI 
may be due, in part, to the inherently low incidence of CRI associated 
with the use of peripheral arterial catheters.
    Of the studies reported to date, antimicrobial-coated catheters do 
not appear to pose any greater risk of adverse effects than do 
noncoated catheters, but additional controlled trials need to be done 
to fully evaluate their efficacy, determine the appropriate situations 
for their use, and assess the risk of emergence of resistant 
bloodstream pathogens.

Intravenous Therapy Personnel

    Because insertion and maintenance of intravascular catheters by 
inexperienced staff may increase the risk of catheter colonization 
153 and CR-BSI, many institutions have established infusion 
therapy teams. Available data suggest that trained personnel designated 
with the responsibility for insertion and maintenance of intravascular 
devices provide a service that effectively reduces CRIs and overall 
costs.229-231

Prophylactic Antimicrobials

    Prophylactic administration of antimicrobials has been used to 
reduce the incidence of CR-BSIs, but scientific studies on the efficacy 
of this practice are inconclusive. Two published studies, one 
randomized 232 and one nonrandomized,233 suggest that 
antimicrobials administered systemically at the time of (or immediately 
after) insertion of a CVC may reduce the incidence of CR-BSI. Two 
randomized trials of systemically administered antibiotics demonstrated 
no benefit of such prophylaxis.234 235 One randomized controlled 
trial showed a significant protective effect of a heparin-vancomycin 
flush solution used daily in immunocompromised patients with tunneled 
CVCs.236 Two other randomized controlled trials have examined the 
effect of continuous low dose (25g) vancomycin, added to TPN 
fluids, in reducing the incidence of CoNS BSI in low birthweight 
infants.237 238 In one of these trials, the incidence of CoNS BSI 
decreased from 34% to 1.4% (P<0.001) among neonates weighing <1500 
gm.237 However, 4/71 (5.6%) treated neonates developed a BSI due 
to gram-positive cocci after vancomycin prophylaxis was completed. The 
other trial studied neonates weighing <1000 gm and found that the use 
of vancomycin was associated with a significantly lower incidence (0% 
vs 15%) of CoNS CR-BSI.238 Although prophylactic administration of 
vancomycin decreased the incidence of CoNS BSI, it did not decrease 
overall mortality among low birth weight infants in either study. 
Further studies are needed to assess the additional benefit afforded by 
prophylactic antimicrobials in reducing CRIs when standard infection 
control measures are adhered to and to assess the concern that such 
prophylaxis may select for resistant microorganisms, particularly those 
resistant to vancomycin.

Flush Solutions, Anticoagulants, and Other Intravenous Additives

    Flush solutions are designed to prevent thrombosis, rather than 
infection, but thrombi and fibrin deposits on catheters may serve as a 
nidus for microbial colonization of the intravascular devices. 
Furthermore, catheter thrombosis appears to be one of the most 
important factors associated with infection of long-term 
catheters.69 239 Thus, the use of anticoagulants (e.g., heparin) 
or thrombolytic agents may have a role in the prevention of CR-BSI. 
However, several recent studies suggest that 0.9% saline is as 
effective as heparin in maintaining catheter patency and reducing 
phlebitis among peripheral catheters.137 240 241 Furthermore, 
recent in vitro studies suggest that the growth of CoNS on catheters 
may be enhanced in the presence of heparin. In contrast, the growth of 
CoNS on catheters can be inhibited by edetic acid (EDTA),242 
suggesting that EDTA, rather than heparin, may decrease the incidence 
of CoNS CR-BSIs. Also, the routine use of heparin to maintain catheter 
patency, even at doses as low as 250-500 units/day, has been associated 
with thrombocytopenia and thromboembolic and hemorrhagic 
complications.243-246 Clinical trials are needed to further assess 
the relative efficacy, risks, and benefits of the routine use of 
various anticoagulants (e.g., EDTA) in preventing CRI.
    The risk of phlebitis associated with the infusion of certain 
fluids (e.g., potassium chloride,247 lidocaine,247 248 
antimicrobials,247 also may be reduced by the use of certain 
intravenous additives, such as hydrocortisone.247 Bassan et al. in 
a prospective, controlled trial of patients being evaluated for 
possible myocardial infarction found that heparin and/or hydrocortisone 
significantly reduced the incidence of phlebitis in veins infused with 
lidocaine.248 In other trials, topical application of 
venodialators such as glycerol trinitate,249 250 or anti-
inflammatory agents such as cortisone near the catheter site,251 
has effectively reduced the incidence of infusion-related 
thrombophlebitis and increased the life span of the catheters.251 
252 Larger, controlled trials are needed to assess the advisability of 
the routine use of these agents to reduce phlebitis.

Needleless Intravascular Devices

    Attempts to reduce the incidence of sharps injuries and the 
resultant risk of transmission of bloodborne infections to 

[[Page 49987]]
HCWs have led to the design and introduction of needleless intravenous 
systems. However, there are limited data by which to assess the 
potential risk of contamination of the catheter and infusate and 
subsequent CRI that may be associated with the use of these devices. In 
one trial where conventional and needleless heparin-lock systems were 
compared, the rates of infection were comparable.\253\ However, in 
another investigation, the combined use of a needleless infusion system 
and TPN was associated with an increased rate of BSIs among patients 
receiving home infusion therapy.\254\ As the use of these systems 
becomes more widespread, the potential infectious risks associated with 
their use can be more fully evaluated.

Multidose Parenteral Medication Vials (MDVs)

    Parenteral medications are commonly dispensed in MDVs that may be 
used for prolonged periods for one or more patients. Although the 
overall risk of extrinsic contamination of MDVs appears to be small, an 
estimated 0.5 per 1,000 vials,\255\ the consequences of contamination 
may be serious. Contamination of MDVs due to breaks in aseptic 
technique have resulted in several nosocomial outbreaks. The implicated 
vehicles in these outbreaks have been lipids infused intravenously from 
multidose containers\177\ and medications used for intra-articular 
injections.256 257 However, when bacteria or yeasts were 
inoculated into some commonly used medications, such as heparin, 
potassium chloride, procainamide, methohexital, succinylcholine 
chloride, and sodium thiopental, and left at room temperature, no 
microorganisms could be cultured from these medications after 96 hours, 
with rare exceptions, irrespective of whether they contained a 
preservative.\258\ Microorganisms could proliferate in lidocaine and 
insulin only if the inocula were prepared in peptone water (with one 
exception), which allowed for transfer of nutrients to the vials. Even 
under these conditions, when vials were kept at 4 deg.C (the 
recommended storage temperature), microorganisms did not proliferate in 
the insulin. There is one report of hepatitis B virus transmission 
related to the use of a contaminated vial of bupivacaine in a 
hemodialysis unit.\259\

VII. Intravascular Device-Related Infections Associated With Total 
Parenteral Nutrition

    Catheter-related BSI remains one of the most important 
complications of TPN therapy and reported rates of infection during TPN 
vary widely depending on the population studied and the definitions 
used. Because TPN solutions commonly contain dextrose, amino acids, 
and/or lipid emulsions, they are more likely than conventional 
intravenous fluids to support microbial growth if contaminated.177 
179 260-263 Lipid emulsions are particularly suited for the growth of 
specific bacteria and yeasts,176 177 with microbial growth 
occurring as early as 6 hours after inoculation of a lipid emulsion and 
reaching clinically significant levels (>10\6\ CFU/ml) within 24 
hours.178 Newer combined TPN solutions (e.g., 3-in-1 system) which 
use glucose, amino acids, lipid emulsion, and additives in one 
multiliter administration bag, may increase the risk of infection 
associated with TPN, but data on which to assess this risk are not 
available.
    Although TPN solutions are particularly suited for microbial 
growth, most infections that occur during the administration of TPN 
result from contamination of the catheter. TPN- related CRI result much 
less commonly from infusion of contaminated fluids or from hematogenous 
seeding of the catheter.
    The microbiology of TPN-related CR-BSIs is similar to that of other 
CR-BSIs, with gram-positive species, particularly CoNS or S. aureus, 
being the predominant pathogens. However, the proportion of BSIs due to 
fungal pathogens, particularly Candida spp., are significantly greater 
in patients receiving TPN.\106\

Risk Factors

    A number of factors have been associated with the development of 
CRI during TPN therapy, including catheter-site colonization,123 
125 155 method and site of catheter insertion, the experience of the 
personnel inserting the catheter,\153\ the use of the TPN line for 
purposes other than administration of parenteral nutrition fluids,\264\ 
breaks in the protocol for aseptic maintenance of the infusion 
systems,167 223 264 265 and the use of triple-lumen 
catheters.24 25 27 28

Surveillance and Diagnosis

    Surveillance for CRI during TPN administration should be the same 
as during the administration of other types of infusion therapy. 
Although culturing the skin adjacent to the catheter insertion site may 
help predict BSI in patients who are receiving TPN,123 125 155 
routine microbiologic surveillance can not be advocated. As with other 
suspected CRIs, semiquantitative and quantitative catheter cultures may 
also be useful for the diagnosis of TPN-related CRIs. Vanhuynegem et 
al. evaluated the efficacy of semiquantitative cultures of blood drawn 
through in place TPN catheters in febrile patients for diagnosing CR-
BSI.\266\ Comparing their methodology to the semiquantitative culture 
technique of Maki, they found that such cultures had a positive 
predictive value of 60%, and a negative predictive value of 100%. 
Moreover, using this technique, they were able to prevent unnecessary 
removal of 87% of the catheters in which infection was suspected.

Strategies for Prevention

    The strategies previously outlined for the prevention of CRIs are 
also effective in reducing the risk of infections associated with TPN, 
and rigorous aseptic nursing care has been shown to greatly reduce the 
incidence for TPN-related infection.265 267 268 Nevertheless, a 
number of supplemental preventive measures that have been proposed to 
reduce the risk for TPN-related CRIs bear discussion, including special 
precautions for infusate preparation, cutaneous antisepsis, and 
catheter selection and care.
    Infusate preparation. Since TPN solutions are prone to microbial 
growth if contaminated, strict attention must be given to asepsis 
during the compounding of TPN solutions. Although controlled trials 
have not been done, centralized preparation of TPN solutions in 
hospital pharmacies, using a laminar flow hood, has generally been 
regarded as the safest method of preparation.
    Cutaneous antisepsis. Findings on the efficacy of various 
antiseptic skin preparations on decreasing the incidence of CRI during 
TPN suggest that tincture of iodine and chlorhexidine in ethyl alcohol 
are superior to povidone-iodine as a skin antiseptic during TPN 
catheter care.\269\ Furthermore, in one prospective randomized study, 
the application of povidone-iodine ointment to the insertion sites of 
subclavian catheters used for TPN was not associated with a decrease in 
CRIs when compared with catheters on which povidone-iodine was not 
used.\268\
    The application of organic solvents, such as acetone or ether, to 
``defat'' (remove skin lipids) the skin prior to catheter insertion and 
during routine dressing changes has been a standard component of many 
hyperalimentation protocols. However, these agents appear neither to 
confer additional protection against skin colonization nor 
significantly decrease the incidence of CRI. Moreover, their use can 
greatly increase local inflammation and patient discomfort.\270\

[[Page 49988]]

    Selection of catheter. Tunnelling of TPN catheters has been 
proposed for three reasons: (1) to prevent dislodgement of the 
catheter; (2) to reduce the incidence of CR-BSI by increasing the 
distance between the sites where the catheter exits the skin and where 
it enters the subclavian vein; and (3) to protect the catheter from 
potentially contaminated sites such as tracheostomies. However, few 
prospective randomized studies have been done to evaluate the efficacy 
of this practice. When Koehane et al. assessed the risk of BSI among 
patients with short-term, noncuffed, tunneled and nontunneled TPN 
catheters, they demonstrated a reduction in the incidence of CR-BSI 
among tunneled catheters as compared with nontunneled catheters.\267\ 
However, this reduction was greatest when a designated nutrition nurse 
was used to maintain the catheter; after improved adherence to the 
infection control protocol, short-term, noncuffed, tunneled and 
nontunneled catheters were associated with a similar rate of BSI. The 
only other controlled trial of short-term, noncuffed, tunneled and 
nontunneled catheters similarly failed to demonstrate a beneficial 
effect of tunnelling after rigorous attention to infection 
control,\127\ suggesting that if strict infection control practices are 
adhered to, short-term, noncuffed, tunneled and nontunneled TPN 
catheters have a similar risk of infection.
    Catheter-site dressings. The use of occlusive dressings on 
catheters used for TPN has been a continuing source of debate. Two 
controlled studies suggest that, with adherence to strict infection 
control protocols, semipermeable, transparent dressings are a safe, 
cost- effective alternative to gauze and tape for dressing TPN 
catheter-insertion sites.212 268 Moreover, data suggest that 
transparent dressings used on TPN catheter sites can be safely changed 
at 7-day intervals.212 268 271
    Catheter changes. Prospective, randomized trials examining the 
frequency of TPN catheter changes have not been published. However, 
data from a study in 1974 suggest that the rate of infection (6.2%) for 
TPN catheters in place for >30 days is similar to the rate of infection 
(7%) for all catheters.\265\
    Specialized personnel. Many institutions have protocols and a 
nutritional support team for insertion and maintenance of catheters 
used for TPN. As with vascular devices used for other purposes, the use 
of specially trained personnel to insert and maintain the catheters 
appears to reduce the rate of infection in patients receiving 
TPN.230, 231, 267

VIII. Intravascular Device-Related Infections Associated With 
Hemodialysis Catheters

Epidemiology

    Each year approximately 150,000 patients undergo maintenance 
hemodialysis for chronic renal failure. Since 1979, when the Uldall 
subclavian catheter was introduced, CVCs have gained popularity as a 
convenient, rapid way of establishing temporary vascular hemodialysis 
access until placement or maturation of a permanent arteriovenous 
fistula or permanent access for patients without alternative vascular 
access.\272\ In 1990, an estimated 73% of centers participating in the 
National Surveillance System for Hemodialysis Associated Diseases had 
1 patients in whom CVCs were used for permanent vascular 
access.\273\ However, only a limited number of controlled trials 
examining the infectious risk associated with the use of CVCs for 
hemodialysis have been published; most data are derived from small 
studies at individual institutions.
    Subclavian hemodialysis catheters have been associated with a rate 
of BSI that exceeds that reported for virtually all other subclavian 
catheters274-283 or for alternative forms of hemodialysis vascular 
access275 284 and their use may be complicated by bacterial 
endocarditis, septic pulmonary emboli,274 275 282 284 and/or 
thrombosis (e.g., venous thrombosis, catheter occlusion). The factors 
contributing to the increased rate of infection experienced with CVCs 
used for hemodialysis have not been fully elucidated,277 278 but 
manipulations and dressing changes of dialysis catheters by 
inadequately trained personnel,\285\ duration of catheterization and 
mean number of hemodialysis runs,\277\ and cutdown insertion of the 
catheter\286\ may increase the risk of CRI among hemodialysis patients.
    More recently, jugular vein catheters have been used for 
hemodialysis access because descriptive studies indicate that they are 
associated with fewer mechanical complications than subclavian 
catheters, including subclavian thrombosis, stenosis, and 
perforation.287-294 These double-lumen, Dacron-cuffed, silicone 
CVCs have been used for exclusive, or prolonged, vascular access in 
chronic hemodialysis patients286 295 and appear to have a longer 
median use-life and fewer insertion complications than do either of 
their single-lumened Teflon or polyurethane counterparts.280 295 
296 Moss et al. recently reviewed the 4-year experience with double-
lumen, cuffed, silicone catheters at their institution. All catheters 
(n=168) had been placed for long-term use (1 month) and were 
the sole vascular access for hemodialysis.\286\ The median life span 
for these catheters was 18.5 months, with 12- and 24-month catheter 
survival being 65% and 30%, respectively. As with subclavian 
hemodialysis catheters, thrombosis (catheter and vein) and infection 
were the most frequent catheter complications. BSI occurred in 16/131 
(12%) patients and exit-site infections in 28/131 (21%); diabetics 
(33%) were significantly more likely to develop exit-site infections 
than were nondiabetics (11%). Based on the duration of catheterization, 
the authors determined the following rates of CRIs associated with the 
use of double-lumen CVCs: 0.25 BSIs per patient-year, 0.36 exit-site 
infections per patient-year (nondiabetics), and 0.87 exit-site 
infections per patient-year (diabetics). The BSI rates reported in this 
review were comparable to those reported for more conventional forms of 
hemodialysis vascular access (0.09-0.20 BSIs per patient-year).284 
297-299
    Two studies have examined the potential impact of tunneled 
hemodialysis catheters on the risk of subsequent CRI. In a 
nonrandomized study, Hickman catheters used for prolonged hemodialysis 
access was associated with a significantly lower rate of BSI (0.08 BSIs 
per 100 catheter-days) than were nontunneled hemodialysis 
catheter.\300\ Schwab et al. prospectively examined the use of cuffed, 
tunneled, double-lumen jugular venous catheters for prolonged 
hemodialysis access. Compared with percutaneously inserted, noncuffed 
subclavian dialysis catheters, double-lumen jugular venous catheters 
had a longer live span, a lower (1.3% vs 3.6%) incidence of associated 
BSIs, but a significantly higher incidence of exit-site infection (29% 
vs 9%).\295\
    Hemodialysis catheters may become contaminated by a variety of 
proposed mechanisms: (1) penetration of organisms from the skin due to 
the pulsatile action of the dialysis pump; (2) manipulation of catheter 
connections by medical personnel with contaminated hands; (3) leakage 
of contaminated hemodialysis fluid into the blood compartment; or (4) 
administration of contaminated blood or other solutions through the 
catheter during the dialysis session.

Microbiology

    CR-BSIs in hemodialysis patients, as in other patient populations, 
are most frequently caused by S. epidermidis.274-276 281-283 285 
However, because of their high rates of 

[[Page 49989]]
colonization with S. aureus,\301\ hemodialysis patients have a greater 
proportion of CR-BSIs due to S. aureus \284\ than among other patient 
populations.

Strategies for Prevention of Hemodialysis Catheter-Related Infections

    Strategies for the prevention of infections associated with the use 
of hemodialysis catheters have not been as rigorously examined as those 
proposed for the prevention of infections associated with CVCs used for 
other purposes. Although there are limited data on infectious 
complications in hemodialysis settings associated with various types of 
catheters, frequency of catheter change, cutaneous antisepsis, and 
prophylactic administration of antimicrobials, no studies examining 
catheter-site dressing regimens, or the utility of newer devices, such 
as antimicrobial-impregnated hemodialysis catheters have been 
published.
    Cutaneous antisepsis. In some series, as many as 50 to 62% of 
hemodialysis patients have been found to be carriers of S. 
aureus.301-304 Therefore, skin antisepsis is a crucial component 
for the prevention of hemodialysis catheter-associated infections. In 
one randomized, controlled study of 129 subclavian dialysis catheters, 
the routine application of povidone-iodine ointment to catheter-
insertion sites was more effective than plain gauze in reducing the 
incidence of exit-site infections (5% vs 18%), catheter-tip 
colonization (17% vs 36%), and BSIs (2% vs 17%);304 duration of 
catheterization was comparable for treated (mean, 38.6 days) and 
nontreated (mean, 36.2 days) catheters, each ranging from 2-210 days. 
The beneficial effect of povidone-iodine ointment was most evident 
among patients with S. aureus nasal carriage where its use reduced the 
incidences of BSI and exit-site infection by 100% and catheter-tip 
colonization by 71%. No adverse effects were detected with the routine 
application of povidone-iodine ointment to subclavian dialysis 
catheter- insertion sites.
    Catheter changes. Since attainment and preservation of vascular 
access in patients with chronic renal failure are often difficult, the 
frequency of catheter change and the role of guidewire catheter 
exchange are of utmost importance. However, to date, there are limited 
data on which to base recommendations for either of these issues in 
hemodialysis patients. One prospective, randomized trial of subclavian 
dialysis catheters using guidewire exchange suggested that the rate of 
BSIs was comparable when catheters were changed weekly or when 
clinically indicated.305 One recent study examined the role of 
guidewire exchange in the treatment of infected jugular vein 
hemodialysis catheters. In this study, a 92% one-year catheter survival 
was observed with the combined use of guidewire exchange and 
administration of antimicrobials 48 hours before and 2 weeks after 
guidewire exchange, when frank pus was not present at the exit 
site.306 These findings, however, are contrary to a large body of 
data suggesting that guidewire exchange should not be done in the 
setting of documented CRI.59 131 153 307 308
    Prophylactic antimicrobials. Hemodialysis patients receiving 
antistaphylococcal antimicrobials at the time of catheter placement 
have been shown to have a lower incidence of CRI.274 276 277 309 
However, the role of prophylactic antimicrobials has not been directly 
studied.
    Whether hemodialysis catheters can be treated in the same way as 
CVCs used for other purposes is unclear. Prospective, controlled trials 
of hemodialysis catheters are needed to determine the epidemiology of 
CRIs associated with their use and to evaluate the role of preventive 
role of different types of catheter materials, appropriate insertion 
sites, intervals for catheter change, guidewire exchange, catheter-site 
dressing regimens, and the use of newer modalities (e.g., such as 
antimicrobial-impregnated hemodialysis catheters).

IX. Intravascular Device-Related Infections in Pediatric Patients

    This section addresses some of the specific issues relevant to 
intravascular access and intravascular device-related infections among 
the pediatric population. However, the epidemiology of intravascular-
device related infections in pediatric patients is less well-described 
than that in adults, and there are limitations to the existing data. 
First, few controlled trials of intravascular devices in children have 
been reported; most published data are derived from uncontrolled 
retrospective or prospective studies. Second, pediatric data that are 
available were derived, largely, from studies in neonatal (NICU) or 
pediatric intensive care units (PICU) where rates of infection are 
usually higher than on general pediatric wards. Finally, 
semiquantitative culture methods have, in large part, not been used in 
the studies of CRIs in children because such cultures require catheter 
removal.

Microbiology

    As in adults, most CR-BSIs in children are caused by staphylococcal 
spp., with S. epidermidis being the predominant species.310 311 
Other species of gram-positive cocci and fungi are the next most 
frequently isolated pathogens, with Malassezia furfur being an 
especially common pathogen in neonates receiving intravenous 
intralipids.311-319
    Bertone et al. performed quantitative skin cultures on 50 neonates 
to determine the microbial flora present at commonly used catheter-
insertion sites.320 Only 33 neonates had an intravascular device 
in place at the time of culturing; 25 had peripheral venous catheters 
and eight had CVCs. The highest mean colony counts were found at 
jugular sites (2.7 x 104 cfus/10cm2) and the lowest at 
subclavian sites (5.2 x 103 cfus/10-cm2). However, femoral 
and jugular sites had similar mean colony counts as did subclavian and 
umbilical sites. Although CoNS was the pathogen most frequently 
cultured from all body sites, other microbial species (e.g., aerobic 
gram-negative bacilli, yeast, and Enterococcus spp.) were more commonly 
cultured from umbilical and femoral sites.320

Epidemiology

    The majority of nosocomial BSIs in children are also related to the 
use of an intravascular device. During 1985-1990, children's hospitals 
participating in NNIS and conducting ICU surveillance reported 
significantly higher rates of BSI among PICU patients with CVCs (11.4 
BSIs per 1,000 central-catheter days) compared with those without CVCs 
(0.4 BSIs per 1,000 noncentral-catheter days).8 Participating 
Level III NICUs reported a median of 5.1 BSIs per 1,000 umbilical or 
central-catheter days for the 1,500 gram birthweight group 
and 14.6 BSIs per 1,000 umbilical or central-catheter days for the 
<1,500 gram birthweight group over the same period.321 Birthweight 
and device utilization were important determinants of a NICU infant's 
risk for acquiring BSI.321 Others have shown receipt of 
intravenous lipids to also be an important risk factor for the 
acquisition of CR-BSI, particularly CoNS BSIs, among neonates.86
    Cronin studied 376 catheters, of varying types, to determine the 
incidence of catheter colonization and CR-BSI among NICU 
patients.322 The incidence of catheter colonization varied by type 
of catheter, site of insertion, and duration of catheterization. 
Consistent with the findings of other investigators, the rate 

[[Page 49990]]
of catheter colonization was significantly lower among patients 
receiving systemic antimicrobials, having birthweight 1500 
gm, and not receiving parenteral nutrition. In general, the 
colonization rates detected in this study were higher than those 
previously reported for catheters in adults and children.17 148 
311 312 However, the authors could not conclusively determine the 
relationship of catheter colonization to BSI.
    Peripheral venous catheters. As in adults, the use of peripheral 
venous catheters in pediatric patients may be complicated by phlebitis, 
extravasation, and catheter colonization. Garland et al. prospectively 
studied 654 peripheral Teflon catheters in PICU patients to determine 
the incidence of and risk factors for each of these 
complications.311 Of the 654 catheters studied, 83 (13%) were 
associated with phlebitis. Catheter location, infusion of 
hyperalimentation fluids with continuous intravenous lipid emulsions, 
and length of ICU stay before catheter insertion were all factors that 
increased a patient's risk for phlebitis. However, contrary to the 
studies among adults, the risk of phlebitis did not increase with the 
duration of cannulation. The overall incidence of phlebitis in this ICU 
population (13%) was comparable to that reported in general pediatric 
patients (10%); for children >10 years of age the incidence of 
phlebitis (21%) was comparable to that reported for adults 169 and 
older children.323
    Of 459 peripheral venous catheters cultured by Garland, 54 (11.8%) 
were colonized. However, only one (1.9%) of these colonized catheters 
was associated with CR-BSI. In an earlier study, comparable rates of 
catheter colonization (10.4%) were found for Teflon peripheral 
catheters (n=115) used in patients on general pediatric wards.312 
Time in place was the single most important predictor of subsequent 
catheter colonization, with the incidence of colonization increasing 
threefold after catheters remained in place >144 hours.311 Between 
48 and 144 hours, the catheter colonization rate was stable at 11%. 
Other factors significantly but less strongly associated with catheter 
colonization were patient age and receipt of lipid emulsions. Catheters 
inserted emergently were no more prone to colonization than were those 
inserted electively.311
    Extravasation, the most frequent complication, occurred with 28% of 
catheters. Several risk factors for extravasation were identified, 
including patient age (1 year), receipt of anticonvulsant, 
and duration of catheterization (72 hours); the risk of 
extravasation decreased significantly after the catheter was in place 
for 72 hours.311
    There are limited data examining the relationship of catheter 
material to the risk of infection among pediatric patients. In one 
study of premature infants, Teflon catheters and steel needles used in 
scalp veins had a comparable risk of infection. However, Teflon 
catheters had a significantly longer survival than did steel 
needles.313
    Peripheral arterial catheters. In a prospective study using 
semiquantitative culture of 340 peripheral arterial catheters, Furfaro 
identified two risk factors for CRI: (1) use of an arterial system of a 
certain design, and (2) duration of catheterization.314 The 
implicated arterial system (system A) contained a stopcock and a 120-cm 
pressure tubing through which blood was drawn back to clear the line of 
heparin before taking a sample. The alternate system (system B), with a 
significantly lower risk of infection, contained a one-way valve that 
did not permit blood backflow into the tubing. The authors noted that 
the implicated arterial system (A) was the design most widely used in 
U.S. hospitals.314
    Although there was a correlation between duration of 
catheterization and risk of catheter colonization, the risk remained 
constant for 2-20 days at 6.2%. Catheters in place 48 hours 
had a zero risk of colonization.314
    Umbilical catheters (UCs). Although the umbilical stump becomes 
heavily colonized soon after birth, umbilical vessel catheterization is 
often used for vascular access in newborn infants because umbilical 
vessels are easily cannulated, allow for delivery of intravenous 
fluids/medications, permit easy collection of blood samples, and permit 
measurement of hemodynamic status. Studies of the infectious 
complications associated with UCs indicate that the incidences of 
catheter colonization and BSI appear to be similar for umbilical vein 
catheters (UVC) and umbilical artery catheters (UAC). The incidences of 
colonization reported among UACs have ranged from 40 to 55%;324 
325 those among UVCs have varied between 22% and 59%.324-326 The 
incidences of BSI detected for the two types of catheters are also 
similar, 5% for UACs and 3%-8% for UVCs.324 326 However, the risk 
factors for infection appear to differ for the two types of catheters.
    Landers et al. found that neonates with very low birthweight and 
prolonged receipt of antimicrobials were at increased risk for UAC-
related BSIs. In contrast, those with higher birthweight and receipt of 
parenteral nutrition fluids were at increased risk for UVC-related BSI; 
duration of catheterization was not an independent risk factor for 
infection either type of umbilical catheter.324
    In addition to the risk of endemic infection, umbilical vessel 
catheterization has been associated with epidemics among critically ill 
NICU infants. Solomon et al. reported an outbreak of C. parapsilosis 
fungemia among NICU infants 41 in which duration of umbilical 
artery catheterization, prolonged receipt of parenteral nutrition, and 
low gestational age were risk factors for fungemia.41
    Several investigators have reported lower rates of UC colonization 
among infants or neonates receiving systemic antimicrobials during 
umbilical catheterization.315 325 326 However, the one prospective 
study of prophylactic antimicrobials in patients with chronic UACs 
found no clear benefit to this therapy.327
    Central venous catheters. The use of indwelling catheters (e.g., 
Hickmans and Broviacs, TIDs) in children has become increasingly 
important over the past decade for the treatment of children with 
chronic medical conditions, especially malignancies. The Broviac, 
rather than the Hickman, catheter is preferentially used in children 
because of its smaller diameter; TIDs may be particularly advantageous 
in younger pediatric patients (73 328 329
    Although data from the Children's Cancer Study Group suggest that 
as many as 18% of all chronic venous access devices in children are 
removed due to infection,330 the use of these devices in children 
have generally been associated with low rates of infections.64 66 
71 73 77 331 332 Several factors have been associated with an increased 
risk of infection among children with indwelling CVCs, including 
younger age (<2 years), underlying malabsorption syndrome, and receipt 
of TPN.333 Although Indwelling CVCs are largely used in 
immunocompromised patients for the administration of chemotherapy, 
neutropenia has not, in children, been shown to increase the risk of 
infection associated with these devices.334
    As with adults, the relative merits and risk associated with the 
use of long-term vascular access devices in children have been the 
source of considerable investigation. In most studies, TIDs had longer 
survival and fewer infectious complications than other tunneled 
catheters. In one study in which the 

[[Page 49991]]
potentially confounding variables of patient age, underlying diagnosis, 
and therapy were controlled for in a matched analysis, Hickmans and 
TIDs were associated with comparable rates of infection. Broviacs still 
had a higher rate of infection than TIDs, but this difference was only 
significant after 400 days of catheterization.335
    Because of the limited vascular sites, the required frequency of 
catheter change in children is particularly important. Stenzel examined 
the frequency of catheter change in PICU patients by using survival 
analysis techniques. In that study of 395 CVCs, catheters remained free 
of infection for a median of 23.7 days. More importantly, there was no 
relationship between duration of catheterization and the daily 
probability of infection (r=0.21, p>0.1), suggesting that routine 
catheter replacement would not be expected to reduce the incidence of 
CRI.336
    Results of prospective randomized trials examining the effect 
dressing regimens, frequency of catheter and administration sets 
changes, or use of newer antimicrobial-coated catheters in reducing the 
incidence of CRI among pediatric patients have not been published.

Table 1

Definitions for Catheter-Related Infection

Colonized catheter: growth of >15 colony forming units from a 
proximal or distal catheter segment in the absence of accompanying 
clinical symptoms.
Exit-site infection: erythema, tenderness induration, and/or 
purulence within 2cm of the skin at the exit site of the catheter.
Pocket infection: erythema and necrosis of the skin over the 
reservoir of a totally implantable device and/or purulent exudate in 
the subcutaneous pocket containing the reservoir.
Tunnel infection: erythema, tenderness, and induration in the 
tissues overlying the catheter and >2cm from the exit site.
Catheter-related bloodstream infection (CR-BSI): isolation of the 
same organism (i.e., identical species, antibiogram) from a 
semiquantitative or quantitative culture of a catheter segment and 
from the blood (preferably drawn from a peripheral vein) of a 
patient with accompanying clinical symptoms of BSI and no other 
apparent source of infection. In the absence of laboratory 
confirmation, defervescence after removal of an implicated catheter 
from a patient with BSI may be considered indirect evidence of CR-
BSI.
Infusate-related bloodstream infection: isolation of the same 
organism from infusate and from separate percutaneous blood 
cultures, with no other identifiable source of infection.

Table 2

Factors Associated With Infusion-Related Phlebitis Among Patients 
With Peripheral Venous Catheters

Catheter material
Catheter size
Site of catheter insertion
Experience of personnel inserting catheter
Duration of catheterization
Composition of infusate
Frequency of dressing change
Catheter-related infection
Skin prep
Host factors
Emergency room insertion

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Part 2. Recommendations for the Prevention of Nosocomial Intravascular 
Device-Related Infections

Contents

I. Introduction
II. General Recommendations for Intravascular-Device Use
    A. Health Care Worker Education and Training
    B. Surveillance
    C. Handwashing
    D. Barrier Precautions during Catheter Insertion and Care
    E. Catheter-site Care
    1. Cutaneous antisepsis and antimicrobial ointments
     2. Catheter-site dressing regimens
    F. Changing Intravenous Catheters and Administration Sets
    G. Preparation and Quality Control of Intravenous Admixtures
    H. ``Hang time'' for Parenteral Fluids
    I. In-line Filters
    J. Intravenous Therapy Personnel
    K. Needleless Intravascular Devices
    L. Prophylactic Antimicrobials
III. Peripheral Venous Catheters
    A. Selection of Catheter
    B. Selection of Catheter-insertion Site
    C. Catheter Changes
    D. Catheter and Catheter-site Care
     1. Flush solutions, anticoagulants and other intravenous 
additives
     2. Cutaneous antiseptics and antimicrobial ointments
IV. Central Venous and Arterial Catheters
    A. Selection of Catheter
    B. Selection of Catheter-insertion Site
    C. Barrier Precautions during Catheter Insertion
    D. Catheter Changes
    E. Catheter and Catheter-site Care
     1. General measures
     2. Flush solutions, anticoagulants, and other intravenous 
additives
     3. Cutaneous antiseptics and antimicrobial ointments
     4. Catheter-site dressing regimens
V. Additional Recommendations for Central Venous Hemodialysis 
Catheters
    A. Selection of Catheter
    B. Selection of Catheter-insertion Site
    C. Catheter Changes
    D. Catheter and Catheter-site Care
     1. General measures
     2. Cutaneous antiseptics and antimicrobial ointments
VI. Peripheral Arterial Catheters and Pressure-Monitoring Devices
    A. Selection of Pressure-monitoring System
    B. Catheter and Pressure-monitoring System Changes
    C. Care of Pressure-monitoring Systems
     1. General measures
     2. Sterilization or disinfection of pressure-monitoring systems
VII. Additional Recommendations for Umbilical Catheters
    A. Catheter Changes
    B. Catheter-site Care
Appendix. Summary of Recommended Procedures for Maintenance of 
Intravascular Catheters, Administration Sets and Parenteral Fluids
References

I. Introduction

    This guideline presents general recommendations for intravascular-
device use in all patients, device-specific recommendations, and 
recommendations for special circumstances, i.e., intravascular-device 
use in pediatric patients, and central venous catheter use for 
parenteral nutrition administration and hemodialysis access.
    As in previous CDC guidelines, each recommendation is categorized 
on the basis of existing scientific data, theoretical rationale, 
applicability, and economic impact. However, the previous CDC system 
for categorizing recommendations has been modified as follows:
    Category IA. Strongly recommended for all hospitals and strongly 
supported by well-designed experimental or epidemiologic studies.
    Category IB. Strongly recommended for all hospitals and viewed as 
effective by experts in the field and a consensus of HICPAC based on 
strong rationale and suggestive evidence, even though definitive 
scientific studies may not have been done.
    Category II. Suggested for implementation in many hospitals. 
Recommendations may be supported by suggestive clinical or 
epidemiologic studies, a strong theoretical rationale, or definitive 
studies applicable to some, but not all, hospitals.
    No Recommendation; Unresolved Issue. Practices for which 
insufficient evidence or consensus regarding efficacy exists.

II. General Recommendations for Intravascular-Device Use

A. Health Care Worker Education and Training

    Conduct ongoing education and training of health care workers 
regarding indications for the use of and procedures for the insertion 
and maintenance of intravascular devices, and appropriate infection 
control measures to prevent intravascular device-related infections. 
285 337 338
Category IA

B. Surveillance

    1. Conduct surveillance for intravascular device-related infections 
to determine device-specific infection rates, monitor trends in those 
rates, and assist in identifying lapses in infection control practices 
within one's own institution. Express data as the number of catheter-
related infections or catheter-related bloodstream infections per 1000 
catheter-days to facilitate comparisons with national trends. 7 
339-341
Category II
    2. Palpate the catheter insertion site for tenderness daily through 
the intact dressing.
Category IB
    3. Visually inspect the catheter site if the patient develops 
tenderness at the insertion site, fever without obvious source, or 
symptoms of local or bloodstream infection.
Category IB
    4. In patients who have large, bulky dressings that prevent 
palpation or direct visualization of the catheter-insertion site, 
remove the dressing and visually inspect the catheter site at least 
daily and apply a new dressing.
Category II
    5. Record the date and time of catheter insertion in a obvious 
location near the catheter-insertion site (e.g., on the dressing or on 
the bed).
Category IB
    6. Do not routinely perform surveillance cultures of patients or of 
devices used for intravascular access.
Category IB

C. Handwashing

    Wash hands using an antiseptic-containing product before palpating, 
inserting, changing, or dressing any intravascular device.
Category II

D. Barrier Precautions During Catheter Insertion and Care

    1. Wear vinyl or latex gloves when inserting an intravascular 
catheter as required by the Occupational Safety and Health 
Administration (OSHA) Bloodborne Pathogens Standard.342
Category IB
    2. Wear vinyl or latex gloves when changing the dressings on 
intravascular catheters.342
Category IB
    3. NO RECOMMENDATION for the use of sterile versus nonsterile 
gloves during dressing changes.
Unresolved Issue

E. Catheter-Site Care

1. Cutaneous Antisepsis and Antimicrobial Ointments
    Cleanse the skin site with an appropriate antiseptic including 70% 
alcohol, 10% povidone-iodine, or 2% tincture of iodine before catheter 
insertion.269 (EXCEPTION: see umbilical catheter section) 

[[Page 49994]]

Category IA
2. Catheter-Site Dressing Regimens
    a. Use either a sterile gauze or transparent dressing to cover the 
catheter site. 10 165 211 268
Category IA
    b. Leave dressings in place until the catheter is removed, or 
changed, or the dressing becomes damp, loosened, or soiled. Change 
dressings more frequently in diaphoretic patients.165
Category IB

F. Changing Intravenous Catheters and Administration Sets

    1. Remove an intravascular device as soon as its use is no longer 
clinically indicated.
Category IA
    2. Change intravenous tubing, including ``piggyback'' tubing no 
more frequently than at 72-hour intervals, unless clinically 
indicated.173-175 (Exception: See F3 Below)
Category IA
    3. No Recommendation for intravenous tubing changes beyond 72- hour 
intervals.
Unresolved Issue
    4. Change tubing used to administer blood, blood products, or lipid 
emulsions within 24 hours of completing the infusion.178 179
Category IB

G. Preparation and Quality Control of Intravenous Admixtures

    1. Admix all parenteral fluids in the pharmacy in a laminar-flow 
hood using aseptic technique.
Category II
    2. Check all containers of parenteral fluid for visible turbidity, 
leaks, cracks, particulate matter, and the manufacturer's expiration 
date before use.
Category IA
    3. Use single-dose vials for parenteral additives or medications 
whenever possible.256 257 259
Category II
4. If Multidose Vials are Used:
    a. Refrigerate multidose vials after they are opened unless 
otherwise specified by the manufacturer.258
Category II
    b. Cleanse the rubber diaphragm of multidose vials with alcohol 
before inserting needle into the vial.343
Category IA
    c. Use a sterile needle and syringe each time a multidose vial is 
accessed and avoid touch contamination of the needle prior to 
penetrating the rubber diaphragm.259 344-346
Category IA
    d. Discard multidose-vials when empty, when suspected or visible 
contamination occurs, or when the manufacturer's stated expiration date 
is reached.256-259
Category IA

H. ``Hang Time'' for Parenteral Fluids

    1. Do not leave parenteral nutrition fluids hanging for longer than 
24 hours.347 348
Category IA
    2. No Recommendation for the ``hang time'' of intravenous fluids 
other than parenteral nutrition fluids.
Unresolved Issue

I. In-Line Filters

    Do not routinely use filters for infection control 
purposes.220 222-224
Category IA

J. Intravenous Therapy Personnel

    Designate trained personnel for the insertion and maintenance of 
intravascular devices.229-231
Category IB

K. Needleless Intravascular Devices

    No Recommendation for use, maintenance, or frequency of change of 
needleless intravenous devices.
Unresolved Issue

L. Prophylactic Antimicrobials

    Do not routinely administer antimicrobials for prophylaxis of 
catheter colonization or bloodstream infection before insertion or 
during use of an intravascular device.69 234 235
Category IB

III. Peripheral Venous Catheters

A. Selection of Catheter

    1. Select catheters based on the intended purpose and duration of 
use, known complications (e.g., phlebitis and infiltration), and 
experience at the institution. Use a Teflon catheter, a polyurethane 
catheter, or a steel needle.12 17 165 168 169
Category IB
    2. Avoid the use of steel needles for the administration of fluids/
medications that may cause tissue necrosis if extravasation 
occurs.\169\
Category IA
    3. No Recommendation for the use of antimicrobial-impregnated 
peripheral venous catheters.
Unresolved Issue

B. Selection of Catheter-Insertion Site

    1. In adults, use an upper extremity site in preference to one on a 
lower extremity for catheter insertion. Transfer a catheter inserted in 
a lower extremity site to an upper extremity site as soon as the latter 
is available.160-164
Category IA
    2. In pediatric patients, insert catheters into a scalp, hand, or 
foot site in preference to a leg, arm, or antecubital fossa site.\311\
Category II

C. Catheter Changes

    1. In adults, change peripheral venous catheters and rotate 
peripheral venous sites every 48-72 hours to minimize the risk of 
phlebitis.12 165 168
Category IB
    2. In adults, remove catheters inserted under emergency conditions, 
where breaks in aseptic technique are likely to have occurred. Insert a 
new catheter at a different site within 24 hours.
Category IB
    3. In pediatric patients, No Recommendation for the frequency of 
change of peripheral venous catheters.
Unresolved Issue
    4. In pediatric patients, No Recommendation for removal of 
catheters inserted under emergency conditions, where breaks in aseptic 
technique are likely to have occurred.
Unresolved Issue
    5. No Recommendation for the frequency of change of midline 
catheters.
Unresolved Issue
    6. Remove peripheral venous catheters when the patient develops 
signs of phlebitis (i.e., warmth, tenderness, erythema, palpable venous 
cord) at the insertion site.11 12 148
Category IA

D. Catheter and Catheter-Site Care

1. Flush Solutions, Anticoagulants and Other Intravenous Additives
    a. Routinely flush peripheral venous heparin locks with normal 
saline unless they are used for obtaining blood specimens in which case 
a dilute heparin (10 units per ml) flush solution should be 
used.241 349 

[[Page 49995]]

Category IB
    b. No Recommendation for the routine application of topical 
nitrates near the insertion site of peripheral venous 
catheters.249 250 252
Unresolved Issue
2. Cutaneous Antiseptics and Antimicrobial Ointments
    No Recommendation for the routine application of topical 
antimicrobial ointment to the insertion site of peripheral venous 
catheters.197 198 200
Unresolved Issue

IV. Central Venous and Arterial Catheters

A. Selection of Catheter

    1. Use a single-lumen central venous catheter unless multiple ports 
are essential for the management of the patient.26-29
Category IB
    2. Use tunneled catheters (e.g., Hickman or Broviac) or implantable 
vascular access devices (i.e., ports) for patients 4 years 
of age in whom long-term vascular access (>30 days) is 
anticipated.61-63, 68, 72, 73, 350 Use totally implantable access 
devices for younger pediatric patients (age <4) who require long-term 
vascular access.71, 73, 332, 351, 352
Category IA
    3. In adults, consider use of a silver-impregnated, collagen-cuffed 
or antimicrobial-impregnated central venous catheter if, after full 
adherence to other catheter infection control measures (e.g., maximal 
barrier precautions), there is still an unacceptably high rate of 
infection.201, 225, 228 Designate trained personnel to insert 
cuffed catheters to ensure maximal efficacy and prevent possible 
extrusion.201, 225
Category II
    4. In pediatric patients, No Recommendation for the use of 
antimicrobial/antiseptic-impregnated central venous catheters.
Unresolved Issue

B. Selection of Catheter-Insertion Site

    1. Use subclavian, rather than jugular or femoral, sites for 
central venous catheter placement unless medically contraindicated 
(e.g., coagulopathy).31-35
Category IB
    2. No Recommendation on preferred site for insertion of pulmonary 
artery (Swan-Ganz) catheters.36-40
Unresolved Issue

C. Barrier Precautions During Catheter Insertion

    Use sterile technique including a sterile gown and gloves, a mask, 
and a large sterile drape for the insertion of central venous 
catheters. Use these precautions even if the catheter is inserted in 
the operating room.36, 203
Category IB

D. Catheter Changes

    1. No Recommendation for the frequency of routine changes of 
dressings used on central venous catheter sites.268
Unresolved Issue
    2. No Recommendation for frequency of change of totally implantable 
devices (i.e., ports) or the needles used to access them.
Unresolved Issue
    3. Change peripherally inserted central venous catheters at least 
every 6 weeks.\59\
Category IB
    4. No Recommendation for the frequency of change of peripherally 
inserted central venous catheters when the duration of therapy is 
expected to exceed 6 weeks.
Unresolved Issue
    5. Change pulmonary artery catheters at least every 5 days.21 
36 37
Category IB
    6. No Recommendation for the removal of central catheters inserted 
under emergency conditions, where breaks in aseptic technique are 
likely to have occurred.
Unresolved Issue
    7. Do not routinely change percutaneously inserted central venous 
catheters by any means as a method to prevent catheter-related 
infections.186 187 357
Category IA
    8. Use guidewire-assisted catheter exchange to replace a 
malfunctioning catheter or to convert an existing catheter if there is 
no evidence of infection at the catheter site.131 153 186-190
Category IB
    9. If catheter-related infection is suspected, but there is no 
evidence of local catheter-related infection (e.g., purulent drainage, 
erythema, tenderness), change the catheter over a guidewire. Send the 
removed catheter for semiquantitative or quantitative culture. Leave 
the newly inserted catheter in place if the catheter culture is 
negative. If the catheter culture indicates colonization/infection, 
remove the newly inserted catheter and insert a new catheter at a 
different site.131 153 187 188
Category IB
    10. Do not use guidewire-assisted catheter exchange whenever 
catheter-related infection is documented. If the patient requires 
continued vascular access, remove the implicated catheter and replace 
it with another catheter at a different insertion site.131, 153, 
187, 188
Category IA

E. Catheter and Catheter-Site Care

1. General Measures
    a. Do not use parenteral nutrition catheters for purposes other 
than hyperalimentation (e.g., administration of fluids, blood/blood 
products).167 224 264 265
Category IA
    b. No Recommendation for obtaining blood samples for culture 
through central venous or central arterial catheters.353-356
Unresolved Issue
2. Flush Solutions, Anticoagulants, and other Intravenous Additives
    Flush indwelling central venous catheters (e.g., Hickman and 
Broviac) routinely with an anticoagulant. Groshongs do not require 
routine flushing with an anticoagulant.62 64-66 69
Category IB
3. Cutaneous Antiseptics and Antimicrobial Ointments
    a. Do not routinely apply antimicrobial ointment to central venous 
catheter-insertion sites.30 200
Category IB
    b. Do not apply organic solvents (e.g., acetone or ether) to the 
skin before insertion of parenteral nutrition catheters.\270\
Category IA
4. Catheter-Site Dressing Regimens
    Change catheter-site dressings when they become damp, soiled, or 
loose or if inspection of the site or catheter change is necessary.
Category IA

V. Additional Recommendations for Central Venous Hemodialysis 
Catheters

A. Selection of Catheter

    Use cuffed central venous catheters for hemodialysis if the period 
of 

[[Page 49996]]
temporary access is anticipated to be 1 month.286 295
Category IB

B. Selection of Catheter-Insertion Site

    No Recommendation for the site of insertion of central venous 
hemodialysis catheters.
Unresolved Issue

C. Catheter Changes

    1. No Recommendation for the frequency of routine changes of 
dressings used on hemodialysis catheter sites.
Unresolved Issue
    2. No Recommendation for the removal of hemodialysis catheters when 
a patient develops fever without an obvious source.
Unresolved Issue

D. Catheter and Catheter-Site Care

1. General Measures
    a. Do not use hemodialysis catheters for purposes other than 
hemodialysis (e.g., administration of fluids, blood/blood products, or 
parenteral nutrition).
Category II
    b. Restrict manipulations of the hemodialysis catheter, including 
dressing changes, to trained dialysis personnel.285
Category IB
2. Cutaneous Antiseptics and Antimicrobial Ointments
    Apply povidone-iodine ointment to the catheter insertion site 
before and after hemodialysis.304
Category IB

VI. Peripheral Arterial Catheters and Pressure-Monitoring Devices

A. Selection of Pressure-Monitoring System

    Use disposable, rather than reusable, transducer assemblies when 
possible.45 47 58
Category IA

B. Catheter and Pressure-Monitoring System Changes

    1. In adults, change peripheral arterial catheters and rotate 
catheter-insertion sites every 4 days.20 21
Category IB
    2. In pediatric patients, No Recommendation for the frequency of 
change of peripheral arterial catheters.
Unresolved Issue
    3. Replace disposable or reusable transducers at 96-hour intervals. 
Replace other components of the system, including the tubing, 
continuous-flush device, and flush solution at the time the transducer 
is changed.47 58
Category IB
    4. Replace the arterial catheter and the entire monitoring system 
if the patient develops a bacteremia while the catheter is in place, 
irrespective of the source of bacteremia. The catheter and monitoring 
system should be replaced 24 to 48 hours after antimicrobial therapy 
has been started.42 47
Category IB

C. Care of Pressure-Monitoring Systems

1. General Measures
    a. Keep sterile all devices and fluids that come into contact with 
the fluid of the pressure-monitoring circuit (e.g., calibration 
devices, heparinized saline).43 49 55 56
Category IA
    b. Minimize the number of manipulations and entries into the 
pressure-monitoring system. Use a closed-flush system (i.e., continuous 
flush), rather than an open system (i.e., one that requires a syringe 
and stopcock), to maintain the patency of the pressure-monitoring 
catheters. If stopcocks are used, treat them as a sterile field and 
cover them with a cap or syringe when not in use.47 57
Category IA
    c. When the pressure monitoring system is accessed through a rubber 
diaphragm rather than a stopcock, wipe the diaphragm with an 
appropriate antiseptic before and after accessing the system.183
Category IA
    d. Do not administer dextrose-containing solutions or parenteral 
nutrition fluids through the pressure-monitoring circuit. Use only 
heparinized normal saline.47
Category IA
    e. Do not routinely use pressure-monitoring devices to obtain blood 
cultures.47
Category IB
2. Sterilization or Disinfection of Pressure-Monitoring Systems
    a. Clean reusable transducers first with soap and water and then 
sterilize with ethylene oxide or subject to high-level disinfection 
when: (1) The transducer is used between patients, (2) the transducer 
is reused on a single patient who requires prolonged pressure 
monitoring, or (3) the monitoring circuit (including chamber-dome and 
continuous flow device) is replaced.47 54 Because transducers 
differ in design, consult the manufacturers' instructions for detailed 
reprocessing recommendations.
Category IA
    b. Sterilize and disinfect transducers in a central processing 
area. Reprocess and disinfect reusable transducers in patient care 
areas only in emergency situations.47
Category IB

VII. Additional Recommendations for Umbilical Catheters

A. Catheter Changes

    1. No Recommendation for the frequency of change of umbilical 
catheters.
Unresolved Issue
    2. No Recommendation for the removal or exchange of umbilical vein 
catheters when the patient develops a fever without an obvious source.
Unresolved Issue

B. Catheter-Site Care

    1. Cleanse the umbilical insertion site with an appropriate 
antiseptic, including alcohol or 10% povidone-iodine before catheter 
insertion.322 324 325 Do not use tincture of iodine because of the 
potential effect on the neonatal thyroid.
Category IB
    2. No Recommendation for the routine application of polymicrobial 
ointment to umbilical catheter insertion sites.
Unresolved Issue

                                                                        

[[Page 49997]]
Appendix.--Summary of Recommended Procedures for Maintenance of Intravascular Catheters, Administration Sets and
                                                Parenteral Fluids                                               
----------------------------------------------------------------------------------------------------------------
                                                   Frequency of                                                 
Frequency of catheter/ Frequency of dressing    administration set     ``Hang time'' for    Use of antimicrobial
    device change              change                 change           parenteral fluids          ointments     
----------------------------------------------------------------------------------------------------------------
Peripheral Venous                                                                                               
 Catheters:                                                                                                     
    In adults, change  Leave dressings in     Change intravenous     Do not leave           NO RECOMMENDATION   
     catheter and       place until the        tubing, including      parenteral nutrition   for the routine    
     rotate site        catheter is removed,   ``piggyback'' tubing   fluids hanging >24     application of     
     every 48-72        or changed, or the     no more frequently     hours.                 antimicrobial      
     hours. Replace     dressing becomes       than at 72-hour                               ointments to       
     catheters          damp, loosened, or     intervals.                                    catheter site.     
     inserted under     soiled.                                                                                 
     emergency                                                                                                  
     conditions                                                                                                 
     within 24 hours.                                                                                           
    In pediatric       .....................  NO RECOMMENDATION for  NO RECOMMENDATION for  ....................
     patients, NO                              intravenous tubing     the ``hang time'' of                      
     RECOMMENDATION                            changes beyond 72-     intravenous fluids                        
     for the                                   hour intervals.        other than                                
     frequency of                             Change tubing used to   parenteral nutrition                      
     catheter change                           administer blood,      fluids.                                   
     or for the                                blood products, or                                               
     removal of                                lipid emulsions                                                  
     catheters                                 within 24 hours of                                               
     inserted under                            completing the                                                   
     emergency                                 infusion.                                                        
     conditions.                                                                                                
Peripheral Arterial                                                                                             
 Catheters and                                                                                                  
 Pressure-monitoring                                                                                            
 Devices:                                                                                                       
    In adults, change  Leave dressing in      Change intravenous     Do not administer      NO RECOMMENDATION   
     catheter and       place until the        tubing, including      dextrose-containing    for the routine    
     rotate insertion   catheter is removed,   ``piggyback'' tubing   solutions or           application of     
     sites every 4      or changed, or the     no more frequently     parenteral nutrition   antimicrobial      
     days.              dressing becomes       than at 72-hour        fluids through the     ointments to       
    In pediatric        damp, loosened, or     intervals.             pressure monitoring    catheter site.     
     patients, NO       soiled.                                       circuit. Use only                         
     RECOMMENDATION                                                   heparinized normal                        
     for the                                                          saline.                                   
     frequency of                                                                                               
     catheter change.                                                                                           
    Replace            .....................  NO RECOMMENDATION for  NO RECOMMENDATION for  ....................
     disposable or                             intravenous tubing     the ``hang time'' of                      
     reusable                                  changes beyond 72-     heparinized normal                        
     transducers at                            hour intervals.        saline.                                   
     96-hour                                                                                                    
     intervals.                                                                                                 
     Replace other                                                                                              
     components of                                                                                              
     the system,                                                                                                
     including the                                                                                              
     tubing,                                                                                                    
     continuous-flush                                                                                           
     device and flush                                                                                           
     solution at the                                                                                            
     time the                                                                                                   
     transducer is                                                                                              
     changed.                                                                                                   
Midline Catheters:                                                                                              
    NO RECOMMENDATION  Leave dressing in      Change intravenous     Do not leave           NO RECOMMENDATION   
     for the            place until the        tubing, including      parenteral nutrition   for the routine    
     frequency of       catheter is removed,   ``piggyback'' tubing   fluids hanging >24     application of     
     catheter change.   or changed, or the     no more frequently     hours.                 antimicrobial      
                        dressing becomes       than at 72-hour       NO RECOMMENDATION for   ointments to       
                        damp, loosened, or     intervals.             the ``hang time'' of   catheter site.     
                        soiled.               NO RECOMMENDATION for   intravenous fluids                        
                                               intravenous tubing     other than                                
                                               changes beyond 72-     parenteral nutrition                      
                                               hour intervals.        fluids.                                   
                                              Change tubing used to                                             
                                               administer blood,                                                
                                               blood products, or                                               
                                               lipid emulsions                                                  
                                               within 24 hours of                                               
                                               completing the                                                   
                                               infusion.                                                        

[[Page 49998]]
                                                                                                                
Central Venous                                                                                                  
 Catheters                                                                                                      
 (nontunneled                                                                                                   
 catheters and                                                                                                  
 tunneled catheters                                                                                             
 [Hickmans,                                                                                                     
 Groshongs, Ports]:                                                                                             
    Do not routinely   Leave dressing in      Change intravaneous    Do not leave           Do not routinely    
     change             place until he         tubing, including      parenteral nutrition   apply antimicrobial
     percutaneously     catheter is removed,   ``piggyback tubing''   fluids hanging >24     ointment to        
     inserted           or change, or the      no more frequently     hours.                 catheter insertion 
     (nontunneled)      dressing becomes       than at 72-hour                               site.              
     central venous     damp, loosened, or     intervals.                                                       
     catheters by       soiled.                                                                                 
     either rotating                                                                                            
     insertion sites                                                                                            
     or by guidewire-                                                                                           
     assisted                                                                                                   
     catheter                                                                                                   
     exchange.                                                                                                  
    NO RECOMMENDATION  NO RECOMMENDATION for  NO RECOMMENDATION for  NO RECOMMENDATION for  ....................
     for frequency of   the frequency of       intravenous tubing     the ``hang time'' of                      
     change of          routine changes of     changes beyond 72-     intravenous fluids                        
     tunneled           dressing used on       hour intervals.        other than                                
     catheters,         catheter site.        Change tubing used to   parenteral nutrition                      
     totally                                   administer blood,      fluids.                                   
     implantable                               blood products, or                                               
     devices (i.e.,                            lipid emulsions                                                  
     ports), or the                            within 24 hours of                                               
     needles used to                           completing the                                                   
     access them.                              infusion.                                                        
Peripherally Inserted                                                                                           
 Central Venous                                                                                                 
 Catheters:                                                                                                     
    Change at least    Leave dressing in      Change intravenous     Do not leave           Do not routinely    
     every 6 weeks.     place until the        tubing, including      parenteral nutrition   apply antimicrobial
    NO RECOMMENDATION   catheter is removed,   ``piggyback'' tubing   fluids hanging >24     ointment to        
     for frequency of   or changed, or the     no more frequently     hours.                 catheter insertion 
     change when the    dressing becomes       than at 72 hour       NO RECOMMENDATION for   site.              
     duration of        damp, loosened, or     intervals.             the ``hang time'' of                      
     therapy is         soiled.               NO RECOMMENDATION for   intravenous fluids                        
     expected to       NO RECOMMENDATION for   intravenous tubing     other than                                
     exceed 6 weeks.    the frequency of       changes beyond 72-     parenteral nutrition                      
                        routine changes of     hour intervals.        fluids.                                   
                        dressing used on      Change tubing used to                                             
                        catheter site.         administer blood,                                                
                                               blood products, or                                               
                                               lipid emulsions                                                  
                                               within 24 hours of                                               
                                               completing the                                                   
                                               infusion.                                                        
Central Arterial                                                                                                
 Catheters (pulmonary                                                                                           
 artery catheters):                                                                                             
    Change catheter    Leave dressing in      Change intravenous     NO RECOMMENDATION for  Do not routinely    
     at least every 5   place until the        tubing, including      the ``hang time'' of   apply antimicrobial
     days.              catheter is removed,   ``piggyback'' tubing   intravenous fluids     ointment to        
                        or changed, or the     no more frequently     other than             catheter insertion 
                        dressing becomes       than at 72 hour        parenteral nutrition   site.              
                        damp, loosened, or     intervals.             fluids.                                   
                        soiled.               NO RECOMMENDATION for                                             
                       NO RECOMMENDATION for   intravenous tubing                                               
                        the frequency of       changes beyond 72-                                               
                        routine changes of     hour intervals.                                                  
                        dressing used on                                                                        
                        catheter site.                                                                          
Central Hemodialysis                                                                                            
 Catheters:                                                                                                     
    NO RECOMMENDATION  Leave dressing in      NOT APPLICABLE (Do     NOT APPLICABLE (Do     Apply povidone-     
     for the            place until the        not use hemodialysis   not use hemodialysis   iodine ointment to 
     frequency of       catheter is removed,   catheters for          catheters for          the catheter       
     catheter change.   or changed, or the     purposes other than    purposes other than    insertion site     
                        dressing becomes       hemodialysis [e.g.,    hemodialysis [e.g.,    before and after   
                        damp, loosened, or     administration of      administration of      hemodialysis.      
                        soiled.                fluids, blood/blood    fluids, blood/blood                       
                       NO RECOMMENDATION for   products, or           products, or                              
                        the frequency of       parenteral             parenteral                                
                        dressing change.       nutrition).            nutrition).                               

[[Page 49999]]
                                                                                                                
Umbillical Catheters:                                                                                           
    NO RECOMMENDATION  NOT APPLICABLE.......  Change intravenous     Do not leave           NO RECOMMENDATION   
     for frequency of                          tubing, including      parenteral nutrition   for the routine    
     catheter change.                          ``piggyback tubing''   fluids hanging >24     application of     
                                               no more frequently     hours.                 antimicrobial      
                                               than at 72-hour       NO RECOMMENDATION for   ointments to the   
                                               intervals.             the ``hang time'' of   catheter site.     
                                              NO RECOMMENDATION for   intravenous fluids                        
                                               intravenous tubing     other than                                
                                               changes beyond 72-     parenteral nutrition                      
                                               hour intervals.        fluids.                                   
                                              Change tubing used to                                             
                                               administer blood,                                                
                                               blood products or                                                
                                               lipid emulsions                                                  
                                               within 24 hours of                                               
                                               completing the                                                   
                                               infusion.                                                        
----------------------------------------------------------------------------------------------------------------



References

    1. Smith RL, Meixler SM, Simberkoff MS. Excess mortality in 
critically ill patients with nosocomial bloodstream infections. 
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[FR Doc. 95-23550 Filed 9-26-95; 8:45 am]
BILLING CODE 4163-18-P