Inflated risk: Inadvertent drug injections
into inflation port
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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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ISMP Canada | 
ISMP Spain | Pennsylvania Patient Safety Authority