Due to their potential to cause death or devastating injury, tubing and catheter misconnections have long been a serious issue for the healthcare industry. While most connection errors are caught and corrected before any harm occurs, nine cases of errors had been reported to the Joint Commission's Sentinel Event Database by early 2006, eight of which resulted in patient deaths and one that led to permanent loss of function. Errors involving such connections are believed to be widely underreported.

The Joint Commission (then the Joint Commission on Accreditation of Healthcare Organizations) issued a Sentinel Event Alert in April 2006 to draw the health-care community's attention to the gravity of this issue. The alert provides risk reduction strategies for hospitals and challenges manufacturers to create or redesign connectors that will greatly reduce error. Changes in design are a long-term fix, but the urgency of the issue demanded that healthcare facilities take interim steps to ensure patient safety. Now nearly three years after the alert, several experts weigh in regarding its impact on healthcare facilities.

Peter Angood is the first chief patient safety officer and a vice president for the Joint Commission. Angood acknowledges that tubing connection errors are unfortunately all too common. “Tubing and catheter misconnections are a global problem. Misconnections are often revealed when a patient experiences a complication,” he says. “As a surgeon, I have operated on patients with complications from these misconnections and the attendant problems are often complex.”

Izabella Gieras is the director of technology management for Beaumont Services Company, a subsidiary of Beaumont Hospitals in Royal Oak, MI, which among other projects conducts human factors testing on medical devices. She says the alert has brought the problem to the foreground. “Here at Beaumont, we've been involved [in tubing misconnection initiatives] since 2004, so it was old news to us,” she says. “Prior to the 2006 alert there was a guidance article from ECRI Institute issued that February. Those two things made it a hot topic. I think people probably became more aware of misconnections or the potential for them.”

“Some people have been aware of the problem for a while, but weren't sure what to do about it,” says Matt Baretich, president of Baretich Engineering, which provides medical device-related incident investigation services. “Many hospitals have been working on solutions to the problem of misconnecting non-invasive blood pressure monitors to IV lines. But there haven't been good solutions available for some of the other misconnection problems.” He adds that because so few solutions are available, the Joint Commission recommendations rely heavily on the vigilance of clinicians. “Unfortunately, as we know from human factors engineering, solutions of this type have only limited effectiveness.”

Manufacturing's Role

Gieras notes that some hospitals are assessing connectors with increased awareness and taking appropriate steps to examine equipment for potential misconnections before purchase. But, she adds, “hospitals can't do much about design changes. We all are using pretty much a standard connector. The idea is to try to have unique physical dimensions for the connectors for different applications. So if something uses only air, it will need a different connector so it doesn't mix with a device that uses fluids. The idea is to make them different enough and physically incompatible with others so you can't make misconnections.”

New Standards to Address Tubing Misconnections

As part of the response to the issue of tubing and catheter misconnections, AAMI and other standards development organizations are developing guidelines. The first piece of this effort, ISO/CD 80369-1, Smallbore connectors for liquids and gases in healthcare applications — Part 1: General requirements is scheduled for publication in 2010. Subsequent work under development or consideration in this area includes:

  • Part 2: Connectors for breathing systems and driving gases applications

  • Part 3: Connectors for enteral applications

  • Part 4: Connectors for urethral and urinary applications

  • Part 5: Connectors for limb cuff inflation applications

  • Part 6: Connectors for neuraxial applications

Baretich agrees that the ultimate solution is in the redesign of the connectors to make each unique to a particular device, and mentions that the prevalence of luer fittings—small devices often used in the connection of a number of medical components and accessories—is a major part of the problem. “The solution is to make it impossible or very difficult to make misconnections,” he says. “Electrical connections and medical gas connections are designed so that misconnections are unlikely. The widespread use of more-or-less compatible luer fittings makes tubing misconnections easy and likely.”

While color coding connectors can help, many feel this solution causes caregivers to rely on color coding instead of employing a thorough understanding of the devices and their connectors. Gieras also points out that this is not always the best method simply because “some people are color blind. The most important thing is to educate people about misconnections—how they can happen and what they can do to be diligent about connecting lines. In a busy intensive care unit, we have a multitude of lines, so we try to trace and separate them and even label them if possible to eliminate mistakes.”

Controlling Use Error

Human factors issues come into play as well, Gieras says, especially when new equipment is evaluated before being accepted by a facility. Hospitals should “employ different types of usability testing during pre-purchase. So when looking at new tubing for a catheter, make sure you do the testing first. Look at the design, make sure it's efficient and easy to work with and that you know when it's connected and working properly.” Another important aspect is to assess the actual physical space for ways to eliminate error. “Look at how hectic your clinical environment is and how that plays a part,” she suggests. “When a nurse is busy trying to connect a line with lots of noises occurring, or maybe lighting that's not so good, even excessive temperature and humidity, it can distract him or her and lead to a misconnection. Those are things to consider as well.”

The cost of acquiring new devices, identifying risky conditions and practices, and implementing training and testing will no doubt impact hospitals. “Certainly there are added costs for hospitals and manufacturers too,” says Gieras. “But it's an investment that needs to be made for good reasons. It's all about ensuring you have a safe and effective healthcare environment for everyone.”

The cost of not making such changes could, of course, be much greater in terms of lives lost. “Erroneous connections between tubes and catheters can create catastrophic outcomes—even death,” says Angood. “This is a difficult area in healthcare to get under control because the issues cut across several sectors within the industry. It will take time before a coordinated approach occurs to address these issues. In the interim, organizations and all practitioners must be highly vigilant about preventing misconnections.”

For more information, the Sentinel Event Alert is available at www.jointcommission.org/SentinelEvents/SentinelEven-tAlert/sea_36.htm.

Author notes

Cathy Cruise is a freelance writer based in Fairfax, VA.