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Inflated risk: Inadvertent drug injections into inflation port

From the September 9, 2004 issue

Our colleagues at ISMP Canada recently heard from a Canadian hospital about the need for safety improvements to medical devices that have a balloon inflation port, such as tracheostomy tubes, endotracheal tubes, gastrostomy tubes, and Foley catheters. The balloon inflation port is used to inflate the cuff portion of a catheter or tube, helping to ensure anchoring and correct catheter positioning during medical treatment. The hospital’s recommendations were spurred by a critical adverse event in which medications were inadvertently delivered into the balloon inflation port of a catheter instead of the catheter itself. During investigation of the incident, ISMP Canada consulted with other healthcare professionals, who in turn reported two additional incidents in which balloon ports had been accessed in error when attempting to administer medications. In each case, the balloon expanded when the medication was injected, causing harm to the patients. Likewise, we published a similar incident in our November 28, 2001, newsletter in which intravenous medications were infused into the balloon of a tracheostomy tube, resulting in hyperinflation of the cuff, constriction of the tube’s lumen, and an airway obstruction that led to respiratory arrest.

Balloon inflation ports are designed to meet ISO (International Organization for Standardization) standards for accommodating connections with parenteral syringes used to inflate the cuff with saline or air. Manufacturers of IV tubing use these same ISO standards to accommodate connection with parenteral syringes. Yet, human factors engineering specialists warn that the use of identical designs raises the inherent risks for error-induced injuries.

ISMP Canada provided photographs of several devices to illustrate that use of the inflation port is not intuitive and that manufacturers seldom label the port (photos appear in the PDF version of the newsletter). In the few instances where the ports are labeled, the information is not prominent. Thus, ISMP and ISMP Canada support the idea of having manufacturers clearly print “balloon port” prominently on the port extension, or to adhere a clear and visible (e.g., fluorescent) non-removable label to the port. Such labeling can be accomplished with minimal cost.

Unfortunately, despite enhanced labeling, the risk of error still exists if one can easily connect a syringe or IV tubing to an inflation port. Ideally, inflation and infusion ports should be incompatible, and interconnectivity should be impossible through product redesign. Of course, any redesign would need to be researched by human factors engineering experts. To that end, the Association for the Advancement of Medical Instrumentation (AAMI) Human Factors Committee will be voting this month on a proposal to initiate a new American standards effort on medical tubing connectors that will specifically address the dangers of compatibility of various healthcare connections. To avoid unintended consequences, any change in the design of non-IV connectors would need to be a comprehensive integrated solution across all manufacturers. For example, since there are frequent emergent situations when an airway device cuff must be inflated or deflated, it would be dangerous for staff to be searching for a special device to accomplish the task, instead of using a common parenteral syringe. Thus, other solutions will likely be sought to help distinguish different female connectors intended for non-IV use, such as color-coding or a mechanical constraint that would require the user to perform an additional task to make the connection to the non-IV port. Unfortunately, new standards may take years to accomplish. In the meantime, clinicians and manufacturers should work collaboratively to identify error potential through failure mode and effects analysis when introducing new tubes and catheters into healthcare systems and, when the risk of injury to patients is high, affix auxiliary labels to the inflation ports.

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