Legal & Ethical Issues in Vascular Access Minimizing Risk and Liability of Venous Catheter Access

Maurizio Gallieni, MDOspedale San Carlo Borromeo – Milano, Italy

President, the Vascular Access Society

NO DISCLOSURES

INTRODUCTION

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 main questions in many CVC malpractice

cases are:

• “Was the right CVC inserted into the (right)

patient?”

• “How the insertion technique compares to the

standard, state of the art methodology?”

• Establishing a link between CVC complications and

malpractice

Cost of medical malpractice associated with vascular access complications

American Society of Anesthesiology Closed Claims Project

Domino et al. Anesthesiology 2004; 100:1411‐8.

OPEN ACCESS

OUTLINE OF PRESENTATION

• Choice of vascular access

• Written consent form

• The insertion procedure

• Complications of CVC use

Non‐tunnelled catheters (ntCVC) can be more easily inserted when urgent dialysis is needed

ntCVC are more easily complicated by infections

Long‐term use of a ntCVC increases the risk of complications and it could determine a liability issue.  

CHOICE OF VASCULAR ACCESS Issues related to “temporary” CVCs:

CHOICE OF VASCULAR ACCESS

No RCT of AVF vs tCVC are available.However, in observational studies long-term

dialysis with tCVC has been associated with:

a) 2 to 3-fold increased risk of death

b) 5 to 10-fold increased risk of serious infection

c) increased hospitalization

d) decreased likelihood of adequate dialysis

e) increased number of vascular access procedures

Clin JASN 2009; 4: 456–460.

• Is long-term use of tCVCs ethically problematic?

• Does use of tCVCs potentially exposes nephrologists to legal liability? YES

YES

CHOICE OF VASCULAR ACCESS

Rehman et al suggest that to adequately inform patients

about access options, nephrologists are ethically

obligated to systematically explain to patients the harms

of tunnelled cuffed catheters. If catheters must be used to

initiate dialysis, nephrologists should present catheters

only as "temporary" measures and "unsafe for long-term

use”.

Clin JASN 2009;4:456

OUTLINE OF PRESENTATION

• Choice of vascular access

• Written consent form

• The insertion procedure

• Complications of CVC use

WRITTEN CONSENT FORM

• Complete and informative

• May also be a “refusal” form (e.g. refusal of a suitable AVF,

staying with a CVC)

• Should be ideally explained and signed by the doctor

performing the procedure or surgical intervention

• Another physician of the vascular access or dialysis team

could also explain the procedure and obtain the informed

consent.

OUTLINE OF PRESENTATION

• Choice of vascular access

• Written consent form

• The insertion procedure

• Complications of CVC use

THE INSERTION PROCEDURE

Use of insertion devices and techniques that can prevent accidents amenable of legal liability should be encouraged.• Aspects of legal interest:

• Use of maximal sterile barriers• Use of ECG monitoring• Use of ultrasound guidance for cannulation • Use of fluoroscopy (position of the metal guide-wire;

final position of the CVC tip) • Air embolism (over the wire insertion and valved

insertion devices)

Ultrasound guidance reduces risks and liability

Karakitsos D et al. Real‐time ultrasound‐guided catheterisation of the internal jugular vein: a prospective comparison with the landmark technique in critical care patients. Critical Care 2006;10:R162. 

RCT, 900 ICU patients

OUTLINE OF PRESENTATION

• Choice of vascular access

• Written consent form

• The insertion procedure

• Complications of CVC use

Complications of CVC use

The rate of CVC complications may vary greatly, depending on quality of the insertion procedure and on catheter maintenance.

CVCs have the highest complication and fatality rate when not properly inserted and monitored.

Complications of CVC use Most common complications:

–Thrombosis

– Infections

Is it possible to establish liability with a catheter related infection and/or thrombosis?

Complications of CVC use Liability with a CVC related complication

– Was any deviation from best practice guidelines justified and documented?

– Was the CVC inserted in an appropriate room, with sterile technique?

– Was catheter management in the dialysis setting correct?– How long has the CVC been in place (especially for

ntCVC)?– Is an access coordinator taking care of access problems in

the dialysis unit? (prompt recognition and treatment)– Was the response to adverse events adequate?

http://www.risknomicsllc.com/insurance-risk-new-emerging-risks-0-0

What You Need to Do

• Carefully adhere to best evidenced based practice with respect to intervention components, following industry accepted guidelines

• Education and training must result in competency ensuring that appropriate standards are being followed and that polices and practice comport with those standards

• Catheter risk must be managed at critical exposure points including catheter selection, site selection, insertion, maintenance, and responding to adverse events

• Be aware of new guidelines which have changed the recommendations for catheter replacement/maintenance

APOLOGY LAWS (U.S.A)

• Apologies made by physicians for adverse medical events have been identified as a mitigating factor in whether patients decide to litigate. 

• However, apologies may indirectly admit guilt and invite lawsuits. • An apology law, which specifies that a physician’s apology is inadmissible in court, is written to encourage patient‐physician communication. 

• Apology laws have may reduce the average payment size and settlement time, especially in cases involving more severe patient outcomes. 

McDonnell WM, Guenther E. Ann Intern Med. 2008;149(11):811‐815

• There are very distinct variations by state with respect to what can be stated, who it can be stated to, when it needs to be stated, and even how it is stated. Thus, it is critical that before any apologies are made (or not), a careful review of state law is performed

• In most states with apology laws, it is important to distinguish between an expression of regret and an admission of fault because the latter will be admissible in a minority of states.

APOLOGY LAWS (U.S.A)

Types of apology laws, by state.

McDonnell WM, Guenther E. Ann Intern Med. 2008;149(11):811‐815

CONCLUSIONS

• We can not avoid using CVCs, but reducing them at

the minimum and adopting safe approaches to their

insertion and use will reduce legal liability.

• Patient-physician communication is key at mitigating

litigation. Apology laws may help in establishing such

communication regarding errors.

VAS meeting – April 15-18, 2015