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Nutrition in Clinical Practice
http://ncp.sagepub.com/
Tubing Misconnections : Normalization of Deviance
Debora Simmons, Lene Symes, Peggi Guenter and Krisanne Graves
Nutr Clin Pract 2011 26: 286
DOI: 10.1177/0884533611406134
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http://ncp.sagepub.com/content/26/3/286
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Invited Review Nutrition in Clinical Practice
Volume 26 Number 3
June 2011 286-293
Tubing Misconnections: Normalization © 2011 American Society for
Parenteral and Enteral Nutrition
10.1177/0884533611406134
of Deviance http://ncp.sagepub.com
hosted at
http://online.sagepub.com
1,2
Debora Simmons, RN, MSN, CCRN, CCNS ;
1 3
Lene Symes, RN, PhD ; Peggi Guenter, RN, PhD, CNSN ;
1
and Krisanne Graves, RN, MSN, CPHQ
Financial disclosure: none declared.
Background: Accidental connection of an enteral system to errors; patient-related threats; patient outcomes; and recom-
an intravenous (IV) system frequently results in the death of mendations. Results: A total of 116 case studies were found
the patient. Misconnections are commonly attributed to the in 34 publications. Each involved misconnections of tubes
presence of universal connectors found in the majority of carrying feedings, intended for enteral routes, to IV lines.
patient care tubing systems. Universal connectors allow for Overwhelmingly, the recommendations were for redesign to
tubing misconnections between physiologically incompatible eliminate universal connectors and prevent misconnections.
systems. Methods: The purpose of this review of case studies Other recommendations were made, but the analysis indi-
of tubing misconnections and of current expert recommen- cates they would not prevent all misconnections. Conclusions:
dations for safe tubing connections was to answer the fol- This review of the published case studies and current expert
lowing questions: In tubing connections that have the recommendations supports a redesign of connectors to
potential for misconnections between enteral and IV tubing, ensure incompatibility between enteral and IV systems.
what are the threats to safety? What are patient outcomes Despite the cumulative evidence, little progress has been
following misconnections between enteral and IV tubing? made to safeguard patients from tubing misconnections.
What are the current recommendations for preventing mis- (Nutr Clin Pract. 2011;26:286-293)
connections between enteral and IV tubing? Following an
extensive literature search and guided by 2 models of threats
and errors, the authors analyzed case studies and expert Keywords: enteral nutrition; nutrition therapy; feeding
opinions to identify technical, organizational, and human methods; equipment safety; nutritional support
ince 1972, several reports on unintentional failures death by embolus or sepsis. The common element in mis-
to connect the correct tubing between intravenous connection of these tubing systems is the presence of a
S(IV), epidural, intracranial, intrathecal, gas, and universally compatible luer connector. Luer connectors
other tubing systems used for patient therapy have been are used widely throughout healthcare in systems that
1-8
published. Inadvertently connecting an enteral system deliver fluids and gases and in drains and inflation cuffs.
(meant to deliver nutrition to the gastrointestinal (GI) The presence of luer connectors throughout these patient
system) to an IV system (meant to deliver fluids and care systems creates a persistent opportunity for any tub-
medications intravenously) has often resulted in patient ing system with luer connectors to be accidently miscon-
nected to virtually any other tubing system with a luer
connector. Because the luer connector is used across the
1 2 continuum of healthcare settings, the potential for a mis-
From Texas Woman’s University, Houston, Texas; National connection is ever-present.
Center for Cognitive Informatics and Decision Making in
Healthcare, School of Health Information Sciences, University The luer tubing connector is commonly called the
of Texas Health Science Center at Houston, and The Patient luer lock, luer slip, luer tip, or small-bore connector. For
Safety Education Project (PSEP), Buehler Center on Aging, the purpose of this article, the connector will be called
Health & Society, Northwestern University; and 3Clinical
Practice, Advocacy, and Research Affairs, American Society for the luer connector. This article explores the published
Parenteral and Enteral Nutrition (A.S.P.E.N.), Silver Spring, evidence of misconnections between enteral and IV sys-
Maryland. tems. Posited causative factors, patient outcomes, and
Address correspondence to: Lene Symes, Texas Woman’s recommendations for prevention gleaned from a review of
University, College of Nursing, 6700 Fannin, Houston, TX published case studies and current expert recommenda-
77030; e-mail: Lsymes@twu.edu. tions are reviewed.
286
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Tubing Misconnections / Simmons et al 287
Healthcare Industry Actions The U.S. Food and Drug Administration (FDA) has
alerted the public to the hazards of luer connectors
The healthcare device manufacturing industry classifies in several publications and webcasts.18,19 In January
luer connectors as small-bore connectors, which are 2007, the FDA met with concerned stakeholders and
defined by industry standards for production of medical developed a consensus paper asking for a redesign of
devices, as published by the Association for the connectors.20 The United States Pharmacopeia, the
9 standard-setting organization for pharmaceutical prod-
Advancement of Medical Instrumentation (AAMI). In
1996, the Infusion Device Committee of AAMI passed ucts, has issued error avoidance recommendations that
American National Standard ANSI/AAMI ID54:1996, ask for a redesign of connectors as well.21 Although the
prohibiting the use of luer connectors on feeding sets AAMI standard was passed in 1996 and 2004, the FDA
(which by definition included feeding tubes). This spe- continues to publish alerts and cautions regarding luer
cially convened expert group at AAMI had concluded that connectors.
the universal connecting properties of luer connectors
found on feeding sets and adaptors carried a high risk of
patient harm. In 2004, the standard was revisited by the Frequency of Tubing Misconnections
AAMI in response to a query by the United States
Pharmacopoeia, and the standard was officially recog- Understanding and preventing tubing misconnections
10 has been affected by the same barriers as other patient
nized as being “in force.” AAMI continues to participate
in the International Standards Organization efforts to safety issues. Classic research and epidemiological
coordinate a change to safer connectors across healthcare methods used to research healthcare issues have not
tubing systems, including epidural, respiratory, and been successfully applied to healthcare safety.22,23
enteral tubing, but this laborious process will yield a vol- Healthcare safety experts maintain that underreporting
untary standard in 2013 at the earliest. To date, there is and nondetection of errors in healthcare, on both a
no enforcement of the AAMI standard for luer connectors national and an institutional level, are barriers to recog-
in feeding sets with manufacturers in the United States, nizing threats to patient safety, learning how to avoid
and tubes are connected and reconnected an untold num- errors, and quantifying errors.22,23 Medical error rates
10 have been established on a population level by only 2
ber of times during the day.
Common luer connectors were considered a hazard studies, the Harvard Practice Study and the Australian
to safety by expert organizations as early as 1986 when study.24-27 Acquiring safety data is problematic on many
the ECRI Institute published the Medical Device Safety levels, requiring substantial efforts in retrospective data
Reports describing the connection of enteral feeding tub- collection, aggressive case finding, complicated data
11 mining from technology sources, or costly observational
ing to a tracheostomy cuff. ECRI followed in 2006 with
another alert regarding safe use recommendations for studies to uncover representational data.23 Medical mal-
12 practice claims data are not fully representative of error
feeding tubes. Consistently, ECRI publications have
acknowledged that the existing universal intercompatibil- rates.27 Epidemiological data are not available across
ity of the connectors in tubing systems in healthcare care settings, and the findings of the published studies
presents a safety hazard. The Institute for Safe Medication that focus on 1 specialty or procedure are not generaliz-
Practices (ISMP) has published multiple warnings and able.24
alerts, including a case report of a neonate accidently The healthcare industry continues to rely on report-
infused with breast milk.6,13-15 ing systems to acquire safety data but barriers to report-
The Joint Commission (JC, formerly the Joint ing, such as cultural norms, preclude real progress.
Commission on Accreditation of Healthcare Organiza- Cultural disincentives to reporting errors are often attrib-
tions) has also recognized the danger of tubing miscon- uted to long-standing punitive healthcare traditions and
nections and, in April 2006, issued Sentinel Event Alert include threats of legal and regulatory action coupled
22,28,29
#36. The Sentinel Event Alert cited 9 cases reported to with disciplinary action at the institutional level.
the Sentinel Event Database and noted that this type of Poor character judgments rendered among professional
error is often underreported.16 Internationally, tubing peer groups and colleagues can also negatively influence
22,25
misconnections have been recognized as a patient safety reporting behaviors. In addition, errors may simply
29,30
hazard by the World Health Organization (WHO). not be detected. James Reason, the author of Human
Preventing tubing misconnections is a part of the WHO’s Error, describes the poor detection of errors as a barrier
“9 solutions” for patient safety published in 2007.17 to learning from errors and therefore a significant barrier
Although the JC jointly published the WHO patient to preventing recurrence.
safety solutions, the JC has failed to make the resolution Analysis of patient safety data is crucial to inform
of tubing misconnections a national patient safety goal the industry regarding hazards to safe care and to creating
in the United States. proactive approaches to patient safety. The landmark
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288 Nutrition in Clinical Practice / Vol. 26, No. 3, June 2011
Table 1. Data on Enteral Tube Misconnections From Case Studies
Patient Outcome Threats Identified Recommendations From
Case Reports From 116 Cases From 32 Reports 32 Reports
(N =116 in 34 reports) Death (N = 21) • Similar appearance of enteral • Write the order in full
Patients Survival feeds and IV infusion (N = 6) (N = 1)
• Adult (N = 60) • Hypersensitivity and • Compatible (luer) tubing • Redesign connectors to
• Child/infant hypercoagulopathy connectors (N = 15) prevent misconnection
(N = 30) reaction • Enteral pumps and IV pumps (eliminate cross-system–
• Not specified (N = 1) On same IV pole compatible connectors)
º
(N = 26) • Septicemia/sepsis Identical in appearance or (N = 22)
º
(N = 16) used interchangeably • Visual cues
2 with neurologic Tubes running from Label or color to indicate
º º º
damage pumps which look the system and contents
2 with respiratory same (N = 5) Place catheters and tubing
º º
arrest • Inadequate lighting (N = 2) for differing systems on
33 with hypoxia • Lines different sides of patient’s
º
1 with seizure and confused body (N = 7)
º º
hypoglycemia Use of tubes or catheters • Use oral syringes for feedings
º
5 with intracranial for unintended purposes (N = 2)
º
hemorrhage Placing functionally • Modify human factors through
º
• Renal impairment (N = 8) dissimilar tubes in close Training
º
• Respiratory arrest/distress proximity to one another Changes in policies and
º
(not listed above) (N = 2) (N = 5) protocols
• Neurologic damage (not • Using luer lock syringes Routinely trace lines back
º
listed above) (N = 2), 1 instead of oral syringes and to sourceincreased
with blindness and unlabeled syringes (N = 1) vigilance
deafness • Human factors Increased supervision
º
• No harm or outcome not Knowledge deficit Double checks (N = 6)
º º
given (N = 12) Confusion • Other equipment
º
Fatigue modifications
º
Mistake (N = 11) Use an IV–incompatible
º º
• Modified tubing connector NG tube and
(N = 1) administration set
Use different pumps for
º
different purposes, when
possible (N = 1)
IV, intravenous.
publication by the Institute of Medicine (IOM), To Err Is approach was used for this literature search. A case study
22
Human, cited poor familiarity with safe practices in the approach is pertinent for 3 reasons. The first is that case
industry and called for an increase in safe practices. Lack study reports may be the only information published and
of evidence has remained a key barrier to progress. available about specific healthcare errors. Second, case
Further reports from the IOM have repeated the call for study reports offer narrative description of events that
increasing the knowledge base for safety through “sys- may not be found in traditional databases. These narra-
tems” analysis of error events. The IOM repeatedly has tive reports can offer essential information regarding
asked healthcare institutions to become learning organi- safety threats, patient outcomes, and interventions that
zations with increased organizational agility to respond to are crucial to the success of any safety program aimed at
safety threats. Before healthcare providers can agilely error reduction.31,32 The third consideration for a case
respond to safety threats, they must understand how to study approach is the absence of traditional research in
analyze and learn from adverse events and to disseminate the area of human performance and healthcare safety.
the resulting knowledge about safe practices. Because safety research in human performance and error
often relies heavily on retrospective analyses, case stud-
ies may prove the sole informative source.24 This analysis
Case Study Approach of case study reports provided sole source information to
answer the following questions: When completing tubing
In consideration of these barriers to learning about connections with the potential for enteral to IV tubing
tubing misconnections and other errors, a case study misconnections, what are the threats to safety? What are
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