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J Vasc Access 2011; 12 ( 4): 273-279 REVIEW


DOI: 10.5301/JVA.2011.7745

Central venous catheters: legal issues


Maurizio Gallieni1,2, Valentina Martina1,2, Maria Antonietta Rizzo1,2, Luciana Gravellone1,2,
Francesca Mobilia3, Antonino Giordano1, Daniele Cusi2, Umberto Genovese3
1
Nephrology and Dialysis Unit, Hospital San Carlo Borromeo, Milan - Italy
Nephrology and Dialysis Unit, Hospital San Carlo Borromeo, Milan - Italy and Specialist School of Nephrology, DMCO Hospital San Paolo, University of Milan, Milan - Italy
Nephrology and Dialysis Unit, Hospital San Carlo Borromeo, Milan - Italy and Specialist School of Nephrology, DMCO Hospital San Paolo, University of Milan, Milan - Italy
Nephrology and Dialysis Unit, Hospital San Carlo Borromeo, Milan
Nephrology and Dialysis Unit, Hospital San Carlo Borromeo, Milan - Italy and Specialist School of Nephrology, DMCO Hospital San Paolo, University of Milan, Milan - Italy

2
Specialist School of Nephrology, DMCO Hospital San Paolo, University of Milan, Milan - Italy
3
Institute of Forensic Medicine, University of Milan, Milan - Italy
Institute of Forensic Medicine, University of Milan, Milan - Italy

ABSTRACT
In dialysis patients, both central venous catheter (CVC) insertion and CVC use during the dialysis procedure pose important
legal issues, because of potentially severe, even fatal, complications. The first issue is the decision of the kind of vascular ac-
cess that should be proposed to patients: an arteriovenous (AV) fistula, a graft, or a CVC. The second issue, when choosing
the CVC option, is the choice of CVC: nontunneled versus tunneled. Leaving a temporary nontunneled CVC for a prolonged
time increases the risk of complications and could raise a liability issue. Even when choosing a long-term tunneled CVC,
nephrologists should systematically explain its potential harms, presenting them as “unsafe for long-term use” unless there
is a clear contraindication to an AV native or prosthetic access. Another critical issue is the preparation of a complete, infor-
mative, and easy-to-understand consent form. The CVC insertion procedure has many aspects of legal interest, including the
choice of CVC, the use of ECG monitoring, the use of ultrasound guidance for cannulation, and the use of fluoroscopy for
checking the position of the metal guidewire during the procedure as well as the CVC tip before the end of the procedure.
Use of insertion devices and techniques that can prevent complications should obviously be encouraged. Complications of
CVC use are mainly thrombosis and infection. These are theoretically expected as pure complications (and not as malpractice
effects), but legal issues might relate to inappropriate catheter care (in both the inpatient and outpatient settings) rather than
to the event per se. Thus, in the individual case it is indeed very difficult to establish malpractice and liability with a catheter-
related infection or thrombosis. In conclusion, we cannot avoid complications completely when using CVCs, but reducing
them to a minimum and adopting safe approaches to their insertion and use will reduce legal liability.

Key words: Catheter, Complications, Dialysis, Hemodialysis, Liability

Accepted: December 27, 2010

INTRODUCTION their use may be necessary but there is an increased risk


of severe complications) may raise legal issues in the indi-
A well-functioning vascular access is the cornerstone vidual patient having a CVC access who suffers a relevant
of hemodialysis therapy, and timely planning of access complication, such as septicemia or death.
creation is of utmost importance in the care of patients In this article we analyze the main aspects of legal is-
with chronic kidney disease. Clinical practice guidelines sues of tCVC use. In particular, we concentrate on 4 sub-
recommend an arteriovenous fistula (AVF) as the best per- jects: choice of vascular access, the written consent form,
manent vascular access (1-3). In contrast, the prevalence the insertion procedure, and complications of CVC use.
of tunneled central venous catheters (tCVCs) is rising in
most countries (4).
Recently, it has been suggested that nephrologists Choice Of Vascular Access
have an ethical and legal obligation to avoid the use of
tCVCs as a long-term vascular access in patients who are The first issue is the decision of the kind of vascular
JVA_10_1109_Gallieni

possible candidates for AVFs (5). access that should be proposed to patients: an AVF, a graft,
Recommendations for a limited tCVC use in hemodi- or a CVC (either nontunneled or tunneled). The creation
alysis are based on medical evidence and clinical practice of the vascular access should ideally be planned in ad-
guidelines, suggesting that tCVCs are related to an increased vance of the start of dialysis. In cases where the patient
risk of mortality and morbidity (1, 2). Although it is widely is not a candidate for peritoneal dialysis, an AVF should
accepted that central venous catheters (CVCs) are not the be considered first. An AVF is the optimal vascular access
best type of long-term vascular access, their availability is because it has the longest survival and the lowest infec-
essential for many patients (6), and this contradiction (i.e., tion and thrombosis rates (1, 2, 7). Sometimes, the AVF is

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Central venous catheters: legal issues

not a possible option: there are situations which require a specific informed consent (5). The informed consent
an emergency vascular access, such as acute renal failure should be complete, informative, and easy to under-
and acute obstruction of a previous arteriovenous (AV) ac- stand. The consent form by itself is not sufficient for ei-
cess. Even in stable patients, some increasingly frequent ther the patient (needing clinical and practical informa-
conditions, such as the aging of the chronic kidney disease tion) or the physician (aiming at good clinical practice):
population and the presence of cardiovascular comorbidi- the nephrologist should talk to the patient, should give
ties, can determine an inability to create an autogenous the patient the chance of expressing doubts and asking
permanent vascular access. questions, and then should clearly inform the patient in
The second issue right after choosing the CVC option a step-by-step manner of the different medical aspects
regards the kind of the CVC to use: nontunneled CVC ver- regarding the use of CVCs for hemodialysis, as com-
sus tunneled CVC. Nontunneled catheters (ntCVCs) can pared with AVFs (Tab. I).
easily be inserted when urgent dialysis is needed and al- Physicians should not use the principle of patient’s
low a fully functional vascular access. However, using a autonomy as a justification for leaving a CVC inserted
temporary ntCVC for a prolonged time increases the risk in a central vein for a prolonged time. A doctor has the
of complications, thus raising a liability issue. obligation to offer the best available treatment to patients
The correct clinical indication for a tCVC is their and to carefully discuss with them its features and even-
use as a bridge until AV access maturation, but the tually its alternatives. To do so, sometimes it may be re-
prevalence of permanent tCVCs is rising in patients with quired that doctors have to learn to say no (12, 13), when
congestive heart failure and severe peripheral vascular this avoids a “bad medicine” approach to a disease. Bad
disease, in the very elderly, in those with inadequate medicine and also clinical malpractice involves, for ex-
vascular anatomy, in those with limited life expectancy, ample, choosing a treatment when there is an evidence-
and as a last resort in patients with multiple access fail- based indication for the cost-effectiveness of alternative
ures (1, 2). K/DOQI recommends that use of tunneled- treatments or techniques. In dialysis patients, one simple
cuffed catheters be discouraged as long-term vascular example is the choice of tunneled versus nontunneled
access and that fewer than 10% of patients should be us- CVCs. More challenging is the decision, in the individual
ing them for permanent access (1). Indeed, tCVCs have patient, of insisting on AV vascular access creation rather
been found to be associated with as much as a 2-fold than relying on a CVC. Good clinical practice nowadays
increased mortality compared with AVFs (8), as well as means good communication with patients too, with spe-
with increased risk of serious infection, increased hos- cial efforts at communicating information and giving
pitalization, decreased likelihood of adequate dialysis, explanations, so that the final decision truly reflects the
and an increased number of vascular access procedures choice of the patient.
(5). Conversely, changing from CVC to a fistula or graft Clinical practice guidelines help the physician to es-
is associated with significantly improved survival (9) tablish a standard of care (1, 2) and represent an obliga-
and with significantly lower hospitalization risk relative tory framework for ex post (as seen after the event) medi-
to keeping the catheter (10).
Strategies to minimize the use of hemodialysis CVCs
are, besides early referral of patients to the nephrologist, TABLE I - ELEMENTS TO BE INCLUDED IN AN INFORMED CONSENT
to increase the number of peritoneal dialysis patients; and FOR CENTRAL VENOUS CATHETER INSERTION
to improve vascular access education, preoperative vascu-
lar mapping, and salvage of early failure and thrombosed • Medical indication for the procedure and alternatives to CVC place-
fistulae (11). The best strategies to reduce legal issues re- ment.
• Description of the procedure, specifying that it is ultrasound and/or
garding use of CVCs in the dialysis setting are to practice
radioscopically guided. If no guidance is available, detail the reason
a good predialytic follow-up of the patients, to make a and the higher risk compared with a guided technique.
strict preliminary selection for patients really needing a • Risks related to CVC insertion, including management of potential
CVC access, and to replace CVC access with other recom- complications.
mended options as soon as possible. • Need for repeated access procedures, due to catheter malfunction.
• Inadequate dialysis.
• Increased risk of infection (5- to 10fold), which might determine severe
complications (septicemia, osteomyelitis, septic arthritis, endocarditis,
Written Consent Form And Patient Information or epidural abscess).
• Increased risk of thrombosis of central veins (including the vena cava)
In dialysis patients requiring a CVC access, both and of the right atrium, which in some cases might require major sur-
gery.
CVC insertion and CVC use during the dialysis proce-
• Increased risk of hospitalization, because of catheter complications.
dure pose important legal issues, because of potentially • Increased risk of death (2 to 3-fold).
severe, even fatal, complications. Therefore, placement
of a CVC as vascular access for hemodialysis requires CVC = central venous catheter

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Gallieni et al

colegal analysis regarding clinical malpractice. The use of vert a tCVC into an AV access)
tCVCs as a permanent vascular access exposes nephrolo- – the description of all long-term complications related to
gists to malpractice claims and legal liability, because of the presence of an ntCVC or tCVC.
the existing medical evidence of an increased risk of mor- Obtaining an incomplete consent form may be con-
tality related to the presence of the CVC itself. Sometimes sidered clinical malpractice. If the physician feels that the
the patient prefers to continue dialysis using a CVC: in this consent form is incomplete, she/he must first communi-
situation the physician has theoretically different options. cate the patient information orally and then must seek to
In a recent article (5), the possible responses of the neph- improve the consent form itself. When crucial information
rologist were described. In particular, the doctor should is lacking, there is no informed consent from the patient.
feel obliged to clearly explain the risks of long-term CVC In addition, a specific consent form for tCVCs is advis-
use and, if the patient is a candidate for an AVF, the physi- able, as well as a specific document for refusal of an AVF
cian should also require an informed refusal of an AVF, to when the patient is a possible candidate for an AVF.
avoid legal liability. Other possible options proposed by
Rehman et al (5) are that the physician
– refuse to allow the patient to use a CVC and refer him or The Insertion Procedure
her to another physician;
– temporarily yield to the patient’s request, require in- After choosing the CVC option, recognition of risk fac-
formed refusal of an AVF, and continue to explain the tors for difficult catheterization is essential, and all patients
importance of using a CVC only as a temporary vascular should be evaluated for conditions that might increase the
access. difficulty of catheter insertion, such as skeletal deformity,
The authors believe that in such a complicated cir- presence of scars, obesity, previous CVC insertions, vas-
cumstance the crucial points are the careful informing cular abnormalities, or previous surgery at the insertion
of the patient, the presence of a never-ending process of site (15).
clear communication between the patient and the physi- The CVC insertion procedure has many aspects of le-
cian (from the physician to the patient and vice versa), gal interest. There are a few points to remember, to avoid
and also the full respect of the informed patient choice by CVC insertion complications and the consequent liabil-
the physician. The official refusal form should be just the ity (Tab. II). Use of insertion devices and techniques that
final approach in the situation and not the first goal of the can prevent accidents amenable of legal liability must be
physician. After the patient’s informed choice of keeping encouraged (16). Nephrologists should pay attention to
the CVC access working, the option to refer the patient some aspects of legal interest when they insert CVCs:
to another physician means perhaps not to have fully un- – Maximal sterile barriers. For preventing infections, use
derstood the cultural shift from patient curing to patient wide sterile barriers – cap, mask, gown, gloves, and
caring. wide drape – and wash hands first (15, 17).
Physicians should optimize AVF use and propose it – Ultrasound guidance. Ultrasound assisted cannulation
as standard of care, accepting tCVCs only as temporary can be considered the standard approach to dialysis
vascular access in all patients where a fistula or graft is catheter placement in the internal jugular vein (18, 19).
feasible (14). It is then mandatory for the physician deal-
ing with a patient who will receive a CVC access to ex-
plain from the very beginning that the CVC option is just TABLE II - CENTRAL VENOUS CATHETER INSERTION IN DIALYSIS PA-
a temporary procedure and that the final therapeutic goal TIENTS: KEY POINTS
is the shift from CVC access to AVF or graft.
• Always obtain informed consent for elective CVC insertions. Discuss
Most dialysis units propose to their patients a writ-
both the benefits and the risks.
ten form of consent regarding CVC and AVF placement, • A specific consent form is not needed in an emergency. However,
clearly explaining risks and complications related to the the physician must fully document the nature of the emergency in the
procedure itself. However, such forms often lack some progress notes and, if applicable, any attempts to notify the patient’s
crucial information: family to obtain consent.
• Use wide sterile barriers – cap, mask, gown, gloves, wide drape – and
– a list of all of the possible types of vascular access that
wash hands first.
should be proposed to the patient; • Use ultrasound guidance for internal jugular veins. Avoid subclavian
– a statement indicating that the AV fistula is the optimal veins, unless there is no possibility of future AV access in the same
form of vascular access because it has the longest sur- arm.
vival, ensures the lowest infection rates and thrombosis • Use ECG monitoring during the procedure.
• When placing a CVC in chest central veins, obtain an x-ray following
rates, and is better for dialysis;
the procedure and check for line tip placement, pneumothorax, and
– correct terminology avoiding the misunderstanding be- hemothorax.
tween permanent and tunneled CVC (the term perma-
nent should not be used, leaving the possibility to con- AV = arteriovenous; CVC = central venous catheter

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Central venous catheters: legal issues

Use of ultrasound guidance for cannulation allows a through a peel-away sheath (29), but the current avail-
better localization of the vein, an evaluation of its depth ability of valved introducers has greatly reduced the risk
beneath the skin, and identifies vascular abnormalities of air embolization. The use of a sheathless technique
such as anatomical variations or vein thrombosis; it also for tCVCs has been advocated (30), but in our experi-
reduces the time of the insertion procedure, the rates ence, this technique carries some technical challenges
of unsuccessful catheterization, carotid-artery puncture, during catheter insertion, and we prefer the use of a
hematoma formation, and mechanical complications valved introducer.
(20, 21). After the guidewire insertion, its correct po- Interesting data from the anesthesiology setting are
sitioning into the vein can be easily verified by ultra- available, regarding changing patterns of injury and li-
sound, excluding the possibility of carotid artery cannu- ability associated with central venous or pulmonary artery
lation. Ultrasound guidance is also very effective in the catheters (31). These authors analyzed closed malpractice
femoral approach (22, 23), while no clear advantages claims for central catheter injuries in the American Society
have been demonstrated in subclavian vein cannula- of Anesthesiologists Closed Claims database. All claims for
tion. Ultrasound-guided CVC placement has also been which a central catheter was the primary damaging event
proven to be safe and useful in the hands of surgical for the injury were compared with the rest of the claims
trainees (24). in the database. Central catheter complications were de-
– ECG monitoring. Use of ECG monitoring during the pro- fined as being related to vascular access or catheter use
cedure is useful to prevent arrhythmia (25). or maintenance. The database included 110 claims for in-
– Use of fluoroscopy. For tCVC, the use of fluoroscopy juries related to central catheters (1.7% of 6,449 claims).
allows checking the position of the metal guidewire as Claims for central catheter injuries had a higher severity of
well as the catheter tip before the end of the procedure. injury, with an increased proportion of death (47%) com-
This is particularly important for left-side placements. pared with 29% of the other claims in the database. The
ntCVCs are usually inserted without fluoroscopic guid- most common complications were wire/catheter embolus,
ance. cardiac tamponade, carotid artery puncture/cannulation,
– Avoiding pneumothorax. The possibility of causing a hemothorax, and pneumothorax. Cardiac tamponade,
pneumothorax while trying to access a central vein hemothorax, and pulmonary artery rupture had a higher
should always be kept in mind. To prevent this com- proportion of death compared with the rest of the central
plication, it is advisable to use ultrasound guidance. catheter injuries. Important information from this study is
When choosing the site for central vascular access, also the increased proportion of claims for vascular ac-
the internal jugular vein is preferable for the lower cess injury (47% to 84%) and the decreased proportion of
frequency of pneumothorax compared with the sub- use/maintenance injury (53% to 16%) in 1994-1999 com-
clavian site. In symptomatic patients, pneumothorax pared with 1978-1983. The article reports that almost half
can be detected with chest x-ray obtained immediately of the central catheter claims were judged to be possibly
after the procedure. A chest x-ray obtained within 4 preventable by ultrasound guidance, pressure waveform
hours from the procedure can also detect asymptom- monitoring, or chest radiograph.
atic pneumothorax (26).
– Avoiding air embolism. Air embolism is a rare but po-
tentially fatal complication caused by the sudden entry Long-Term Complications Of Central Venous Catheters For
of air through the catheter into the right heart or pul- Hemodialysis
monary artery. Death may occur if a large amount of
air enters the heart and pulmonary arteries, stopping CVC-related complications are important causes of
blood flow in the pulmonary circulation. In the United hospitalization and mortality in dialysis patients (32, 33).
States, the Agency for Healthcare Research and Quality The rate of CVC complications may vary greatly, depend-
of the Department of Health and Human Services has ing on the quality of the insertion procedure and on cath-
identified “patient death or serious disability associated eter maintenance. CVCs have very high complication and
with intravascular air embolism that occurs while being fatality rates when not properly inserted and monitored.
cared for in a health care facility” as one of the pre- The most relevant CVC complications are infections
ventable never events (medical errors that should never and thrombosis. Infectious complications are related to
occur) (27). Accordingly, the Center for Medicare and different mechanisms: infection of the exit site; migra-
Medicaid Services stated that reimbursement for air em- tion of the pathogen along the external catheter surface;
bolism which developed during hospital admission will intraluminal migration, usually due to contamination of
be denied (28). Significant factors contributing to this catheter hub, leading to bacteremia and catheter colo-
adverse event include the patient’s body position and nization. Catheter-related thrombosis may be associated
hydration status (29). It has been shown that air embo- with central vein thrombosis and pulmonary embolism.
lism usually occurs during insertion of a dialysis tCVC Thrombosis is a serious complication because it can lead

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Gallieni et al

to inefficient dialysis, alter the venous circulation, and fa- and if there are signs of depression and suicidal thoughts,
cilitate infections. In many cases, patients with CVC-related they should be reported to the relatives and to all members
thrombosis are treated with oral anticoagulation. However, of the renal dialysis team, to prevent suicide. However, re-
it should be kept in mind that warfarin substantially in- ports of suicide through incision of an AV fistula have also
creases the risk of bleeding in patients on dialysis (34). It is been reported (41). Therefore, the issue here is not the type of
possible that it may also contribute to accelerated vascular vascular access but rather the identification of the individual
calcification, due to interference with vitamin K dependent patient at risk for depression and suicidal thoughts.
calcification inhibitors, such as matrix GLA protein (35).
Dialysis CVC care is also of paramount importance in
determining outcomes. Poor CVC care can facilitate infec- Patient Negligence
tions and raise nursing liability issues. This has already been
observed in the nondialysis setting (36, 37). Schulmeister If present, patient negligence can be an important as-
(36) suggests that nurses can reduce the likelihood of being pect to consider in case of a medical malpractice lawsuit.
named in a lawsuit, by maintaining clinical competency; Three aspects are particularly relevant to the dialysis set-
communicating effectively; adhering to policies, proce- ting:
dures, and standards of care; and thoroughly documenting 1. The patient refused AV fistula surgery and asked to start
care. or continue dialysis with a CVC. To claim that there was
Clinical policies within the dialysis unit are also im- patient negligence, it is very important to document that
portant, as good clinical care can be the best preventive the patient was correctly and repeatedly informed.
measure to avoid infections (15, 17). A correct clinical 2. The patient carried out inadequate CVC care, in particu-
policy should state that nursing care should follow stan- lar of dressings, which should not be opened in the in-
dard, high-quality procedures. These include hand decon- terdialytic period.
tamination (by washing with an antimicrobial liquid soap 3. The patient failed to disclose important information to
and water or by using an alcohol handrub) and aseptic the doctor.
nontouch techniques for catheter handling (17). In the in-
tensive care setting, wearing sterile gloves and disinfecting
the skin with 2% chlorhexidine–based preparations reduce CONCLUSION
catheter-related infections most effectively. Skin disinfec-
tion before insertion of a CVC should also be performed We can not avoid complications using CVCs, but re-
with 2% chlorhexidine, rather than 10% povidone-iodine ducing them to a minimum and adopting safe approaches
or 70% alcohol, as it can reduce the incidence of device- to their insertion and use will reduce legal liability. Pa-
related infection (38). tients should be adequately informed about the choice
In the dialysis setting, an infection-preventing approach of dialysis (peritoneal vs. hemodialysis), about the choice
should also be adopted, particularly in children (39), al- of vascular access, and about complications related to
though it is not yet clear which measures are truly safe and CVCs. Long-term dialysis with CVC increases the risk
cost-effective. of serious complications and mortality – a good reason
Establishing liability with a catheter infection and/or to present catheters as temporary vascular access only.
thrombosis may be difficult. When investigating if clinical The main questions in many vascular access malpractice
care was appropriate, it should be easy to assess the fol- cases concerning CVCs should be kept in mind: was the
lowing: indication to insert a CVC clinically justified? Were the
– the CVC was inserted in an appropriate room, with sterile informed consent and the whole information communica-
technique; tion process adequate? How did the insertion technique
– established catheter management procedures in the di- compare with the standard, state-of-the-art methodology?
alysis setting were followed; Was catheter management in the dialysis unit correct? A
– how long the CVC has been in place (especially for complete description of what has been done and of the
ntCVC). reasons specific decision were made will help in demon-
The presence of an access coordinator taking care strating good clinical practice, despite the occurrence of
of access problems in the dialysis unit should allow their a complication.
prompt recognition and treatment, reducing the possibility
of adverse outcomes.
A recent case report (40) has raised the issue of the po-
tential use of a CVC as an easily accessible method to com- Abbreviations
mit suicide, by cutting the CVC tube and bleeding to death AVF = arteriovenous fistula
or dying because of air embolism. These authors highlight ntCVC = nontunneled central venous catheter
the requirement to assess carefully the patient’s mental state, tCVC = tunneled central venous catheter

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Central venous catheters: legal issues

ACKNOWLEDGEMENTS Vascular access and all-cause mortality: a propensity score


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