Jerome Sullivan, PhD, RRT, FAARC
A major effort has been underway for some time now to establish new international standards for medical equipment used worldwide to connect various vascular, respiratory, medical gas tubing, enteral, and epidural devices and their accessories to patients. This initiative is driven by the underestimated and underreported number of cases in which caregivers mistakenly connect the wrong tubing or catheter and deliver substances through the wrong route.
These misconnection errors represent a critical patient safety hazard resulting in injury and, in some cases, death. The Association for the Advancement of Medical Instrumentation (AAMI) serves as the Secretariat for a joint international working group developing the new small-bore connectors standards within the International Organization for Standardization and the International Electrotechnical Commission. The working group is developing a series of standards for small-bore (ID < 8.5 mm) connectors that will ultimately make it impossible for misconnection errors. This will be accomplished by designing a line of connectors that are specific to their application, thereby eliminating the “universal” design. AAMI specifically serves as Secretariat to the ISO/TC 210 & IEC/SC 62D JWG4 working group, which is developing what is referred to as the 80369 series, which generally refers to the small-bore connectors for liquids and gases in health care applications. Of particular interest to the respiratory care community is the 80369-2 line of connectors for breathing systems and driving gases. In all instances, to prevent misconnection, the new standards call for design features that make a connector unique and incompatible with any other application. The consequences of a small-bore connector misconnection can be devastating and cannot be overstated. The Food and Drug Administration (FDA) reports a number of examples, including, but not limited to:
Reports of similar adverse events date back many years and indeed, many decades. Through its Collaborating Centre for Patient Safety Solutions, the World Health Organization reported in 2007 that, “Though these errors are highly preventable and can often be easily averted, multiple reports of patient injury and death from such wrong route medication errors indicate that they occur with relative frequency.”
The AAMI is working in conjunction with product manufacturers, the FDA, the American Hospital Association, and other interested parties to prepare the health care marketplace for the impending changes, which are directed at maximizing patient safety. For further information regarding the small-bore connectors committees or standards, please email AAMI Director of Standards Colleen Elliott.