Legal & Ethical Issues in Vascular Access Minimizing Risk and Liability of Venous Catheter Access Maurizio Gallieni, MD Ospedale San Carlo Borromeo

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1 Legal & Ethical Issues in Vascular Access Minimizing Risk and Liability of Venous Catheter Access Maurizio Gallieni, MD Ospedale San Carlo Borromeo Milano, Italy President, the Vascular Access Society

2 NO DISCLOSURES

3 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.

4 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

5 Cost of medical malpractice associated with vascular access complications American Society of Anesthesiology Closed Claims Project Domino et al. Anesthesiology 2004; 100:

6 OPEN ACCESS

7 OUTLINE OF PRESENTATION Choice of vascular access Written consent form The insertion procedure Complications of CVC use

8 CHOICE OF VASCULAR ACCESS Issues related to temporary CVCs: 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.

9 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

10 Clin JASN 2009; 4: Is long-term use of tcvcs ethically problematic? YES Does use of tcvcs potentially exposes nephrologists to legal liability? YES

11 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

12 OUTLINE OF PRESENTATION Choice of vascular access Written consent form The insertion procedure Complications of CVC use

13 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.

14 OUTLINE OF PRESENTATION Choice of vascular access Written consent form The insertion procedure Complications of CVC use

15 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)

16 Ultrasound guidance reduces risks and liability RCT, 900 ICU patients 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.

17 OUTLINE OF PRESENTATION Choice of vascular access Written consent form The insertion procedure Complications of CVC use

18 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.

19 Complications of CVC use Most common complications: Thrombosis Infections Is it possible to establish liability with a catheter related infection and/or thrombosis?

20 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?

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22 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

23 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.

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

25 APOLOGY LAWS (U.S.A) 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.

26 Types of apology laws, by state. McDonnell WM, Guenther E. Ann Intern Med. 2008;149(11):

27 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.

28 VAS meeting April 15-18, 2015