While most people seem to understand that nobody’s perfect, we refuse to accept imperfection from those who hold the lives of our loved ones in their hands. But human error is an unfortunate fact of life in healthcare settings. Mistakes such as tubing misconnections can occur whether a nurse or doctor is acting quickly in an emergency, overworked, or just plain careless. And while it is the responsibility of healthcare workers to be cautious and follow procedures to avoid such missteps, it is the duty of device makers to minimize opportunities for human error through effective product design.

Poor product design paves the way for human error. In the case of tubing misconnections, the inherent problem lies in standardized luers for tubing sets. These connecting components are often the same size for various types of tubes, thus enabling a healthcare worker to inadvertently connect a tube designated for one function to a catheter or line reserved for a different purpose. For example, several reported cases of misconnections have entailed someone connecting an enteric feeding tube to an IV catheter or an IV infusion to an epidural line.

If not quickly identified and corrected, the consequences of a tubing misconnection could be severe, even deadly. Numbers reflecting incidents of misconnections are all over the map, however, because many tracking systems for such adverse events rely on voluntary or anonymous reporting. In its 2006 Sentinel Event Alert on the hazards of tubing misconnections, The Joint Commission stated that nine cases of tubing misconnections had been reported. Estimates from the U.S. Pharmacopeia, on the other hand, exceed 1000 reported cases. Despite disparate reports, most agree that the problem is vastly underreported—and preventable.

Concerned parties such as The Joint Commission and the nonprofit alliance Premier have issued a call to action and pleas for device manufacturers to help prevent this problem.Yet few seem to be taking the initiative. With inconsistent stats and the burden of blame resting on the healthcare workers’ shoulders, where’s the real incentive to change? Well, it may be coming.

Earlier this year, the Association for the Advancement of Medical Instrumentation’s (AAMI) working group on small-bore connectors for liquids and gases in healthcare applications and an ISO committee convened to discuss the issue. As a result, they are drawing up international standards expected to publish in January 2010. “[The aim is] to develop international standards that create engineering ‘forcing functions’ that would physically preclude using mismatched tubing sets,” according to Brad Noe, cochair of the AAMI working group.

If they haven’t already, manufacturers should be putting on their thinking caps to resolve this issue. Soon, reengineered tubing sets won’t be suggested, but rather expected in order to minimize the chance for human error. And enhancing patient care is always a good move. After all, to err is human; to prevent, divine.

Shana Leonard, Editor

Copyright ©2008 Medical Product Manufacturing News