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J’Accuse! Failure to Prevent Epidural and Spinal Catheter Misconnections

Birnbach, David J. MD, MPH; Brull, Sorin J. MD, FCARCSI (Hon); Prielipp, Richard C. MD, MBA, FCCM

doi: 10.1213/XAA.0000000000000260
Editorials: Editorial
Free

From the *Department of Anesthesiology, University of Miami Miller School of Medicine, Miami, Florida; Department of Anesthesiology, Mayo Clinic College of Medicine, Jacksonville, Florida; and Department of Anesthesiology, University of Minnesota School of Medicine, Duluth, Minnesota.

Accepted for publication August 13, 2015.

Funding: None.

The authors declare no conflicts of interest.

Address correspondence to David J. Birnbach, MD, MPH, UM-JMH Center for Patient Safety, University of Miami Miller School of Medicine, 1611 NW 12th Ave., Miami, FL 33136. Address e-mail to dbirnbach@miami.edu.

Figure 1

Figure 1

In 1898, the French writer Emile Zola challenged the government of France to do the right thing in an open letter entitled, J’Accuse.a The letter was printed on the front page of the leading newspaper l’Aurore (Fig. 1) and eventually led to action: in that particular case, the release of a prisoner, Alfred Dreyfus, who was convicted of a crime that he did not commit. Since then, this phrase has become a symbol of outrage and indignation, especially when dealing with a bureaucracy that allows the miscarriage of justice. What, pray tell, does this have to do with anesthesia?

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EVERYTHING!

In this editorial, we accuse the anesthesia community, including manufacturers, practitioners, hospital administrators and medical directors, state and federal agencies, and our national organizations, of turning a blind eye to a problem that has been occurring far too long, has been harming too many patients, and is indeed fixable.

Almost since the start of the use of epidural catheters, misconnections have occurred. Not frequently enough to become a very hot issue, but frequently enough so that large numbers of patients have been harmed, some horribly so. Unintended IV drugs and infusions have been connected to epidural and spinal catheters and have been delivered accidentally to the neuraxis. The results have been seizures, paralysis, deaths, and the list goes on.1

How common is this phenomenon? The literature has many dozens of case reports describing a huge selection of drugs administered unintentionally through an epidural or a spinal catheter, encompassing almost every IV drug used by anesthesiologists. Beckers et al.2 eloquently summarized this issue when they wrote, “One can consider the epidural space as a human dustbin as virtually every drug or solution used in the hospital has been reported to have been injected epidurally.” Drug administration errors include neuraxial administration of almost every neuromuscular-blocking drug: succinylcholine,3 rocuronium,4 cisatracurium,5 atracurium,6 vecuronium,7 and pancuronium8; general anesthetics, including thiopental,9,10 methohexital,11 diazepam,12 and midazolam13; vasopressor agents, including ephedrine14,15 and metaraminol16; antiemetics, including ondansetron17; and a host of other agents such as potassium chloride,18,19 antibiotics,20 magnesium sulfate,21 glucose,22 total parenteral nutrition,23 and labetalol.24 It seems that if the drug is within arm’s reach of the anesthesiologist, we have managed to unwittingly inject it into the neuraxis. Even ether25 and paraldehyde26 have been injected epidurally.

Many of these drugs have been accidentally injected neuraxially on >1 occasion, so we are obviously not learning from our mistakes. Reporting these cases again and again is not correcting the problem. Why bother publishing more reports, because human vigilance alone is an inadequate fail-safe for such accidents? Perhaps this is a bygone era, because many of these reports were published >10 years ago.

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HARDLY

This decade we have seen many more, including the report of unintended intrathecal injection of labetalol.24 Last year, there were reports in the literature involving intrathecal injection of IV magnesium.27 In 2012, it was chlorhexidine,28 which tragically resulted in both horrific outcome (paraplegia) and very negative press coverage. Subsequent follow-up of the chlorhexidine injection suggested that the response to those cases was “swift but failed to produce uniform protocols…”28 Because anesthesiologists are involved in patient safety, we believe that the response to all of these drug administration errors has been untimely, frustrating, and disheartening. While on the topic of drug administration errors, let us not forget the unintended IV injection of local anesthetics,29,30 essentially, reciprocal errors of wrongly infusing a parenteral drug into the epidural space. Unintended IV infusion errors may produce equally serious or fatal complications, and these mishaps also continue to occur.

To further complicate the issue, epidural catheter misconnection events produce not only direct patient harm, but also occasionally lead to accusations of criminal wrongdoing. We know there were at least 30 cases of criminal prosecution against physicians between 1981 and 2005 based on catheter misconnections. Although nearly universally condemned by patient safety experts, the criminal prosecution of practitioners involved with such incidents, with the potential loss of personal freedom, property, certification and licensure, and loss of livelihood, adds a chilling personal dimension to these tragedies.

Even without such criminal prosecution, the practitioner involved with such incidents inevitably becomes a “second victim,” often wracked with guilt, shame, fear, and a shaken sense of self-worth. Indeed, 1 in 5 anesthesiologists acknowledge never feeling fully recovered after such a patient catastrophe, and perhaps 1 in 10 even considered changing careers in the aftermath of such a tragedy.b Organizational, departmental, and personal support is crucial to facilitate passage to resolution of these events, often including the need for expert professional counseling.

So why do we continue to accidentally administer IV drugs into the neuraxis? Is it simply a lack of vigilance on the part of anesthesiologists? In 1987, Dror and Hendriksen21 eloquently stated, “As epidural catheters and continuous infusions increase in popularity, vigilance remains essential to minimizing the risk of having inappropriate drugs mistakenly injected into the epidural space.” Now almost 30 years and dozens of case reports later, it is clear that vigilance may be essential, but it is not sufficient.

Humans are fallible. We make errors regardless of how conscientious we are and regardless of how well trained we are. That’s what humans do. The American Society of Anesthesiologists’ Anesthesia Quality Institute developed an Anesthesia Incident Reporting System that tracks all reported incidents anonymously. In a recent issue, the Anesthesia Quality Institute’s Anesthesia Incident Reporting System Steering Committee published an educational case report that highlighted 4 different “missed connections.”c Of the 12 errors reported, 3 (25%) involved an epidural catheter. The authors of the article correctly point out, “Despite widespread recognition of the great potential for error, and the obvious and simple solution (different connectors for different routes), most attempted fixes, including many sets of guidelines… involve labeling, retraining, in-services and education with exhortations to ‘be more careful.’ These solutions are only weakly effective in preventing human errors. Mistake-proofing requires system design changes that force correct actions.”c

The fundamental problem is that currently used neuraxial administration systems allow cross-connectivity between epidural (or continuous spinal) catheters and Luer devices (such as syringes and IV infusion tubing). This is a setup for error. Some initial progress was made in 2009, when the British National Health Service and its National Patient Safety Agency proposed, “purchasing for safety initiatives to eliminate the use of Luer universal connectors and IV infusion spikes in spinal (intrathecal), epidural and regional devices.”d As a result, the National Health Service proposed in 2011 a mandate that neuraxial systems have unique connectors. Its implementation was delayed. A recent update in 2013 to “Neuraxial and regional anaesthesia devices with non-Luer connectors” states that implementation of standards has been a failure.e In the United States, a Sentinel Event Alert by The Joint Commission addressed managing risk during transition to new ISO tubing connector standards.f The document states, “Tubing misconnections continue to cause severe patient injury and death, since tubes with different functions can easily be connected using Luer connectors, or connections can be ‘rigged’ (constructed) using adapters, tubing or catheters… The first new ISO connector standard (ANSI/AAMI/ISO 80369-1) has been adopted and others are expected to be introduced and adopted. Health care organizations should begin preparing for changes in connectors and do everything possible during the transitional period to avoid tubing misconnections.” Unfortunately, these engineered solutions are still not implemented, and our patients continue to be hurt.

Are we making any progress? In an impassioned plea for change, Birnbach and Vincent31 challenged the anesthesia community to take urgent action and eliminate the proven risks associated with the accidental mismatch of epidural and IV medications. However, that was >3 years ago. Nothing has changed since then. This issue of A & A Case Reports adds 2 more case reports to the voluminous literature describing how we continue to administer toxic and potentially lethal drugs into the neuraxis because of simple human error. Why have the editors of A & A Case Reports decided to accept yet more case reports involving mismatch of epidural and IV medications? The reason is to issue an even stronger call to action in the hopes that all parties involved directly or indirectly will finally wake up from our collective complacency and act.

The first case report in this issue by Townley et al.32 describes the continuous epidural infusion of phenylephrine because of noncompliance with institutional policies and suboptimal education. The second report by Singh et al.33 presents the tragic results of subarachnoid injection of IV contrast. Only 1 of these case reports was associated with a catastrophic outcome. Both demonstrate that nothing has really changed since Birnbach and Vincent cried out for change in 2012.

The inescapable truth is that we, as individuals, as doctors, as anesthesiologists, as a community, and as a profession, are not doing enough. We pride ourselves as leaders in patient safety. Why have we failed to act? Why do we accept the status quo? Why have we continued allowing our patients to be placed in harm’s way as a result of a dangerous design flaw in neuraxial administration? These questions deserve answers and immediate action. Yes, we inherited this problem, but we do not need to accept it. Numerous stopgap steps, as illustrated in Table 1 and discussed in the 2 case reports published in this issue,32,33 can be taken now. However, these are only temporary measures until the root cause of our problem is addressed. We must stop using Luer connections that allow IV and neuraxial tubing misconnections. In the immortal words of Dr. Seuss, “Unless someone like you cares a whole awful lot, nothing is going to get better. It’s not.”g Enough is enough. Too many of our patients been harmed, and we all need to start caring a “whole awful lot.”

Table 1

Table 1

One word says it all: J’Accuse!

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RECUSE NOTE

Dr. Sorin J. Brull is the Section Editor for Patient Safety for Anesthesia & Analgesia. This manuscript was handled by Dr. Steven L. Shafer, Editor-in-Chief of A & A Case Reports, and Dr. Brull was not involved in any way with the editorial process or decision.

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FOOTNOTES

a L’Aurore, 13 January 1898. Letter to the President of the Republic. Available at: http://www.boston.com/bostonglobe/editorial_opinion/oped/articles/2008/03/30/when_zola_wrote_jaccuse/. Accessed June 6, 2015.
Cited Here...

b http://www.physiciansweekly.com/surgical-catastrophes-anesthesiology/#sthash.a2R8gWC2.dpuf. Accessed July 4, 2015.
Cited Here...

c “A Case Report from the Anesthesia Incident Reporting System.” ASA Newsletter Vol 79; No. 1: 42–5, 2015. Available at: http://viewer.zmags.com/publication/6ceb58a6#/6ceb58a6/44. Accessed July 16, 2015.
Cited Here...

d “Introduction of Safer Spinal and Epidural Devices Will Reduce Risk of Wrong Route Errors—England.” Available at: http://www.npsa.nhs.uk/corporate/news/introduction-of-safer-spinal-and-epidural-devices-will-reduce-risk-of-wrong-route-errors-england/. Accessed July 19, 2015.
Cited Here...

e http://www.aagbi.org/sites/default/files/Neuroaxial%20FINAL%2020_02_2013.pdf. Accessed July 19, 2015.
Cited Here...

f http://www.jointcommission.org/assets/1/6/SEA_53_Connectors_8_19_14_final.pdf. Accessed July 19, 2015.
Cited Here...

g Geisel, Theodor Seuss. The Lorax, by Dr. Seuss. New York, Random House, Inc., 1971.
Cited Here...

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