(This article was originally published in the Summer 2016 issue of Neonatal Intensive Care)
Most nurses do not envision their career ending in a horrific incident involving the harm or death of one of their patients. In fact, most of us live in fear over whether that day could ever come, asking “What if that happened to me?”
It is the challenging work of the clinician to provide excellent care for their patients while minimizing risk and potential harm, particularly during hospitalization. While the patient and their families are the obvious victims in these situations, there is also another victim: the clinician. In high acuity settings, such as the NICU, these errors pose an even greater threat to the vulnerable neonatal patient and caregiver. Though many excellent strategies have been implemented to mitigate the risk of these errors, they still occur in alarming numbers. This article will review these strategies and look at the next layer of interventions to protect our patients, families, and care providers from the devastating consequences of wrong route errors.
Medical errors occur in the United States every day, according to the Institute of Medicine’s 1999 report “To ERR is Human.” It is estimated that anywhere from 44,000 to 98,000 people die in hospitals every year as a result of preventable medical mistakes costing 17 to 29 billion dollars annually.1 Many of these errors are from medication errors: according the FDA, over 30,000 medication errors have been reported since 1992, but, since these reports are not mandated, the actual estimate is thought to be much higher.2
Nursing practice includes medication management as governed by the 7 “Rights”: right medicine, right dose, right time, right patient and right route, right reason and right documentation.3 A medication error usually occurs when there is a breach in one of these rights.4 A wrong route error, also known as medical misconnection, is when a “seemingly apparent incompatible system that, when inadvertently connected, can result in life threatening events in the clinical arena.”5 An example of a wrong route error is when a nurse unintentionally places an enteral feed into an IV catheter. While not as prevalent in the literature, tubing misconnections are suspected of being underreported, and when they do occur, they tend to impose grave consequences. As of 2009, “nine cases of tubing misconnections have been reported to the Joint Commission Sentinel Event Database. These events resulted in 8 deaths and 1 permanent loss of function,” including two infants.6
Second Victim Syndrome
Most errors occur from intelligent, well-meaning clinicians involved in “complex clinical conditions, poorly designed processes and inadequate communication patterns.”7
Clearly the victim in these situations is the patient and their families. However, due to the severe emotional, personal and professional anguish suffered by the healthcare provider, it is evident that the “second victim” is the clinician. Dr. Albert Wu first identified second victim syndrome in 2000.8 According to one literature review, the prevalence of second victim syndrome varied in prevalence from 10.4 to up to 43.3%.9
Over the past 15 years, support for the healthcare professional dealing with the consequences of these situations has improved greatly. Hospitals are no longer hiding from these mistakes, but instead encouraging reporting and education, thanks to government and regulatory agencies like the A.S.P.E.N, the FDA and ISMP.10 Some institutions now have support systems in place to help caregivers get help to heal from the shame and suffering of having to live with the harm they have unintentionally caused. Patients and clinicians benefit from the honest, open discussion and root cause analysis done to prevent mistakes from being repeated.
Much time and effort has also been put into mitigating the risk of these types of errors from a variety of regulatory agencies such as Joint Commission, Vermont Oxford Network, Institute for Safe Medication Practices, and the World Health Organization.11 Interventions such as tracking, bar coding, line reconciliation, computerized physician order entry, labeling changes and patient and provider education have made great strides in improving the situation. Despite these efforts, according to the WHO: “misconnections errors still occur with significant frequency with deadly consequences.” More can be done to protect both our patients and our nurses, particularly in the Neonatal Intensive Care Unit.
Risk in the NICU
According to the NANN position statement on Medication Safety, medication administration is at increased risk for adversity related to three factors: “vulnerable nature of NICU patients, the complexity of the medications used, and the challenges of the NICU environment.”12 Examples of this include small size, non-verbal status, weight and physical immaturity.13,14 Not only are these patients at greater risk for experiencing a medication error but, because of their fragile condition, they are more likely to have a worse outcome as a result.15 The high acuity setting, with its low lighting and array of tubing, leaves a fatigued and over-worked nurse at greater risk for harming a patient. An example of the risk associated with the NICU population is the Luer-lock or Luer-slip fit syringes which are able to fit into both IV connectors and enteral tubing. In addition, feeding and medications are often infused on similar (if not the same) syringe pumps. Similar to the adult world, efforts have been made to allay these risks. Yet the incidence of medication errors are reported to be as high as 57%, and occur eight times as often than in the adult population.16 Clearly, additional interventions are needed to improve patient safety.
Design change as protection for infant and nurse
One of the earliest medical misconnections documented in the literature was from 1972, when milk was inadvertently administered thru an IV.17 In 1996 the Joint Commission created a Sentinel Event Policy to assist healthcare facilities in taking steps to improve safety.18 That same year, the Association for the Advancement of Medical Instrumentation (AAMI) implemented a standard to make enteral connectors incompatible with IV Luer-lock connectors. However, because it was a voluntary step, manufacturers never developed the alternative designs, and once they did, they were not mandated—thus they were never universally adopted.19 Ten years later in 2006, Sentinel Event Issue 36 was released. In it, the Joint Commission acknowledged the risks which could lead to patient safety issues, such as look-alike multi-purpose tubing, which continued to be a problem despite best efforts.20 The Joint Commission has urged manufactures to implement design change for products that make them unique to their function. An example of this would be enteral feeding tubes and syringes that can no longer be used for anything other than enteral feeding by nature of their design. This is called force function. Enteral feeding equipment will be the first of many product design changes that will finally be brought into the market. More importantly, the same design will be shared by multiple manufactures with the goal of national standardization. As a result, hospitals will receive many benefits, such as not having to change tubes when patients are transported, and from institution to institution. Future areas planned for change include: connectors for flow of gases, limb cuffs, urological access, neuraxial access.21
But as we know from history, voluntary adoption of these products may lead to limited use. Finally, one state has no longer made this a voluntary option. In July 2016, California enacted a legal requirement for health care facilities to adopt enteral connectors which do not misconnect with other clinical applications. Thus putting into effect what A.S.P.E.N and the Joint Commission have long recommended: the physical inability for a nurse to connect enteral feeding into an intravenous line (or any connection other than enteral), regardless of how busy she is or how complex the clinical environment. The effort to create a product design that allows a physical impediment to prevent a medical misconnection has been in the works for over 10 years. Researchers agree that human factors are the most frequent cause contributing to medical errors.22 Having products and equipment that have force function inherent in their design only brings us closer to our common goal: a culture of safety.
Medical mistakes happen with frightening frequency in the United States. In the NICU, our patients and clinicians are at even higher risk of an adverse event. Many of our medical institutions, government, and regulatory agencies have worked very hard and continue to discuss and implement strategies to decrease the risk factor that contribute to these devastating outcomes. Patient safety is a complex, multidisciplinary effort with no “one fix” solution. We have come a long way in making improvements in the area of medication safety. But we are now at the next stage when manufacturers are contributing solutions to decrease these horrific events. As hard and costly as change can be, we as care providers and administrators are now ethically obligated to utilize this next layer of protection from misconnection errors, not only for our patients, but also for the people on the front lines of patient care who treat them every day.
Read more on neonatal enteral feeding system safety in
- Institute of Medicine. (1999). To err is human: Building a safer health system (L.T. Kohn, J. M. Corrigan, & M. S. Donaldson, Eds.). Washington, DC: The National Academies Press.
- Smeulers, M., Verweij, L., Maaskant, J. M., de Boer, M., Krediet, C. T. P., Nieveen van Dijkum, E. J. M., & Vermeulen, H. (2015). Quality Indicators for Safe Medication Preparation and Administration: A Systematic Review. PLoS ONE, 10(4), e0122695. http://doi.org/10.1371/journal.pone.0122695
- Wakefield DS, Wakefield BJ, Borders T, Uden-Holman T, Blegen M, Vaughn T. Understanding and comparing differences in reported medication administration error rates. AmJMedQual. 1999; 14(2):73–80. PMID: 10337117
- The Joint Commission: Tubing misconnections—A persistent and potentially deadly occurrence, Sentinel Event Alert, Issue 36, Apr. 3, 2006.
- Guenter, P.A., et al.:Enteral Feeding Misconnections: A Consortium Position Statement. The Joint Commission Journal on Quality and Patient Safety 34: 285-92, May 2008.
- Kumar S. Fatal Care: Survive in the U.S. Health System. Minneapolis, MN: IGI Press; 2008. ISBN: 9780977712113. Wu AW. Medical error: the second victim. The doctor who makes the mistake needs help too. BMJ. 2000;320:726-727
- Wu AW. Medical error: the second victim. The doctor who makes the mistake needs help too. BMJ. 2000;320:726-727
- Seys D, Wu AW, Van Gerven E, Vleugels A, Euwema M, Panella M, Scott SD, Conway J, Sermeus W, Vanhaecht K. Eval. Healthcare professionals as second victims after adverse events: a systematic review.Health Prof. 2013 Jun; 36(2):135-62. Epub 2012 Sep 12.
- Stavroudis TA1, Shore AD, Morlock L, Hicks RW, Bundy D, Miller MR.NICUmedication errors: identifying a risk profile for medication errors in the neonatal intensive care unit.
- J Perinatol. 2010 Jul;30(7):459-68. doi: 10.1038/jp.2009.186. Epub 2009 Dec 31 http://www.who.int/patientsafety/solutions/patientsafety/PS-pdf
- National Association of Neonatal Nurses. Medication Safety in the Neonatal Intensive Care Unit: Position Statement #3060. NANN Board of Directors. June 2014.
- Kozer E, Scolnik D, Keays T, Shi K, Luk T, Koren G. Large errors in the dosing of medications for children. N Engl J Med 2002; 346: 1175
- Gray JE, Goldmann DA. Medication errors in the neonatal intensive care unit: special patients, unique issues. Arch Dis Child Fetal Neonatal Ed 2004; 89: 472–473.
- Sharek, P. J., Horbar, J. D., Mason, W., Bisarya, H., Thurm, C., Suresh, G.,Classen, D. (2006). Adverse events in the neonatal intensive care unit:Development, testing, and findings of a NICU-focused trigger tool to identify harm in North American NICUs. Pediatrics, 118(4), 1332–1340
- Kugelman, A., Inbar-Sanado, E., Shinwell, E. S., Makhoul, R., Leshem, M.,Zangen, S., Bader, D. (2008). Iatrogenesis in neonatal intensive careunits: Observational and interventional, prospective, multicenter study. Pediatrics, 122(3), 550–555.
- Guenter, P.A., et al.:Enteral Feeding Misconnections: A Consortium PositionStatement. He Joint Commission Journal on Quality and Patient Safety 34: 285-92, May 2008.
- http://www.jointcommission.org/Sentinel_Event_Policy_and_ Procedures
- American National Standards Institute (ANSI)/Association for the Advancement of Medical Instrumentation (AAMI): Enteral Feeding Set Adapters and Connectors. Arlington, VA: ANSI/AAMI, 1996.
- http://www.jointcommission.org/SentinelEvents/ SentinelEventAlert/sea_36.htm
- https://www.ismp.org/newsletters/acutecare/ articles/20100715.asp
- Stavroudis, T. A., Miller, M. R., & Lehmann, C. U. (2008). Medication errors in neonates. Clinics in Perinatology, 35(1), 141–161.