Preventing catheter/tubing misconnections: Much needed help is on the way
From the July 15, 2010 issue
Catheter/tubing misconnections remain a serious problem in healthcare. Just a few weeks ago we learned of another fatal event. Over Memorial Day weekend, a 19-month-old child, who was receiving treatment for a chronic gastrointestinal disorder, died at a pediatric care center. A suspension of QUESTRAN (cholestyramine) was accidentally given via a central line intravenous catheter instead of through an enteral feeding tube.
In May 2010, another report was published about barium sulfate being administered via the superior vena cava during an upper gastrointestinal study (Soghoian S, Hoffman RS, Nelson L. Unintentional IV injection of barium sulfate in a child. Am J Health-Syst Pharm. 2010;67:734-36). The patient, a 17-month-old child, had a central venous catheter (CVC) in place for antibiotic therapy. As the procedure began, approximately 3 mL of barium sulfate was injected into the CVC, which was mistaken as the child’s gastrostomy tube. Fortunately, no respiratory distress developed and the child was discharged 4 days later.
Luer connector systems, common to many healthcare catheters, tubes, administration sets, extension sets, and syringes, have been at the heart of many catheter/tubing misconnections. At the center of one of the most commonly reported problems is the fact that some manufactured enteral catheters still have ports that only accept parenteral administration sets and syringes. So, even if a liquid medication is prepared in an oral syringe, the medication must be transferred to a parenteral syringe for administration via this type of enteral catheter port, risking the accidental administration of the drug via a parenteral line.
Below are examples of the type of reports we have received associated with catheter/tubing misconnections, all of which we’ve described in this newsletter since publication began in 1996:
- IV infusions connected to epidural lines, and epidural solutions connected to IV lines
- Syringe containing IV medication given via an intrathecal catheter
- IV tubing connected to inflation balloon port of endotracheal tube or tracheostomy tube
- Sequential compression device tubing or pneumatic blood pressure cuff tubing attached to port of IV administration set
- Oxygen tubing connected to port of IV administration set
- Breast milk intravenously infused into neonates
- Bladder irrigation solutions given IV, or TPN solutions administered via foley catheter port
- IV administration set spiked into enteral nutrition container, resulting in enteral nutrition administered IV.
Help to avoid catheter/tubing misconnections is on the way. The International Organization for Standardization (ISO) has been working on a standard (ISO/IEC/ FDIS 80369-1, “Small-bore connectors for liquids and gases in healthcare applications”) that will result in making various healthcare catheter fittings and associated tubing sets or syringes incompatible with one another. The standards will include connectors for the flow of gases, enteral feedings, liquid medications via a gastric tube, limb cuffs (e.g., sequential compression devices, pneumatic tubes to blood pressure cuffs), urological access (e.g., bladder irrigation), and neuraxial access (epidural, intrathecal, intracranial). In addition, the current Luer connector standard (ISO 594) will be updated.
Designs for the connectors for enteral tubes and catheters, as well as containers, administration sets, and syringes, are expected to be finalized by the end of this year or early 2011, with clinical testing by manufacturers accomplished during the standards development process. A final set of the standards should be completed by 2013. Although these will be voluntary, product vendors should have revised devices available soon after that.
As part of the new enteral standard, a female Luer connector will not be present on feeding tubes, except for the inflation balloon that anchors some long-term use feeding devices. In the past, such connectors on feeding tubes forced nurses to administer enteral feedings and liquid medications with a parenteral syringe or administration set. This, of course, made it possible for enteral substances to be accidentally connected to a Luer connector on an IV system or other systems with Luer connectors. Soon, only a compatible oral/enteral syringe will be able to be used to administer oral liquid medications via an enteral tube.
Until the standards are finalized, though, there is work to be done. It’s important for organizations to perform a risk assessment to identify the various types of catheters and fittings now in use, identify the possibility for misconnections, assess the potential severity of misconnections, and address process changes that need to be made. For example, to start with, two easy-to-implement risk-reduction strategies common to most types of catheter/tubing misconnections include: 1) always trace the port and tubing back to its insertion site to verify the correct access/route of administration, and 2) never attempt to force or jury-rig a connection that does not fit easily and securely into an access port. For additional recommendations to avoid catheter/tubing misconnections, please review the articles we have compiled from prior newsletters at: www.ismp.org/sc?k=enteraladminsafety. Each article deals with one or more types of tubing/administration set/syringe misconnections.
On July 9, 2010, FDA sent a letter to product manufacturers, healthcare practitioners, and hospital purchasing departments (www.fda.gov/downloads/MedicalDevices/ResourcesforYou/Industry/UCM218631.pdf) that offered advice regarding the prevention of catheter/tubing misconnections, which are similar to recommendations you will find in the compilation of ISMP newsletter articles we gathered in the link at the top of this column. FDA encourages manufacturers to assess the risk of misconnections associated with these devices, consider temporary and long-term options to mitigate risk, and to validate solutions they deem most appropriate. The FDA letter advises hospital purchasing departments to consider the safety of various systems and connections when purchasing new inventory.
FDA also mentioned that the agency is considering recognizing the ISO/IEC/FDIS 80369-1 standard when it is published, due to the significant impact it will likely have on the safety of these devices. If FDA recognizes the forthcoming standard, the agency will provide guidance to manufacturers regarding issues such as whether there will be a set period of time for currently marketed devices to come into compliance and the effect of the standard on new devices.
The standards will be a much-welcomed addition to improve patient safety. Coupled with additional safety measures, we are optimistic that patient harm from tubing misconnections will be greatly reduced.