A new global design standard for tubing connectors will improve patient safety by reducing the incidence of medical device tubing misconnections. Stay connected to learn more about the transition to medical devices with new safer connectors.
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Safety Share eNews: Tubing misconnections-update - 11/22/2013
"Stay Connected" FAQs released at Healthcare Supply Chain EXPO
Oct 21, 2013
Enteral Feeding Misconnections: A Consortium Position Statement
IN: The Joint Commission Journal on Quality and Patient Safety, May 2008
Misconnection of tubing used to link patients to medical devices or medical devices to each other, have the potential to result in serious injury or death. and are believed to be under-reported. Although errors involving various types of tubing and catheters have been reported for over 30 years, there has been a recent increase in awareness of this issue and a call for solutions from governmental agencies, professional organizations, and patient safety groups. In April 2006, The Joint Commission (TJC) issued a Sentinel Event Alert entitled "Tubing misconnections - a persistent and potentially deadly occurrence" that offered strategies for healthcare organizations to reduce risk and called upon manufacturers to redesign products to prevent misconnections.
Medical devices used in hospitals must have the ability to connect to related tubing and accessories - the standard "luer" connector makes this possible. However, because the luer connector is a standard size and is used on such a broad range of medical devices and products with totally different functions, the risk for tubing misconnections is great.
A patient, for example, may be connected to several devices used to administer fluids through a vein; deliver feedings via a tube to the stomach; monitor blood pressure; and administer oxygen via mask or cannula. This collection of devices, all of which may include luer connectors, poses a risk of tubing misconnection especially in a busy clinical environment where stress, fatigue and distractions are common.
Examples of tubing misconnections that may lead to severe illness or death include:
- Liquid feedings or formula intended for a feeding tube or nasogastric (NG) tube into the stomach is accidentally connected to an intravenous (IV) line - delivers liquid feeding into the bloodstream.
- A non-invasive blood pressure insufflation tube is accidentally connected to IV line--delivers air under pressure into the bloodstream causing an air embolism.
- IV fluids are accidentally connected to the inflation cuff on a breathing tube (tracheostomy or endotracheal tube) - delivers a large volume of fluid to a fixed volume device designed to be filled with air (the cuff), causing it to burst with fluid leaking into the airway resulting in airway obstruction.
- NG or tube feedings accidentally connected to a peritoneal dialysis catheter - delivers formula intended for the stomach to the abdominal (peritoneal) cavity.
Collaboration to develop standards
Governmental, professional, and trade organizations along with medical device and product manufacturers are collaborating to develop standards that limit the use of luer fittings to specific devices and design other connectors that are incompatible with luer connections for the remaining devices. Experts agree that the best solution to prevent tubing misconnections is to change the design of the connectors so only devices that should be connected are able to be connected and those devices that should not be connected are incompatible. This design incompatibility would make it easy to make the correct connection and difficult or impossible to make the "wrong" connection or a tubing misconnection.
An international effort will be required to develop standards designed to minimize the likelihood of life-threatening tubing misconnections in healthcare facilities. In 2008, such an effort was initiated when 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 International Organization for Standardization (ISO) committee began working together to develop international standards that create engineering "forcing functions" that would physically preclude using mismatched tubing sets. More details about this effort are available in AAMI's press releases from January 2011 and October 2013 or on the AAMI small-bore connectors website.
The first international standard, ISO 80369-1, Small-bore connectors for liquids and gases in healthcare applications: Part 1 General requirements was completed in late 2010. This standard was subsequently adopted and published by AAMI and the American National Standards Institute (ANSI) in early 2011. The standard covers the general requirement of non-interchangeability and outlines the validation procedures for small bore connectors for liquids and gases in healthcare applications. It also provides the framework for parts 2 - 7 of the standard, which will designate a unique connector for each of the following device categories:
- breathing systems and driving gases applications (oxygen and ventilators);
- enteral applications (feeding tubes and formula delivery systems);
- urethral and urinary applications;
- limb cuff inflation applications;
- neuraxial applications (spinal and epidural catheters and infusions);
- and intravascular or hypodermic applications.
The small bore connector - ISO 80369 series of standards (parts 2-7) is nearing completion. When final, these standards will provide design specifications for non-Luer compatible, delivery system-specific connectors for each category. The first new connectors, those for enteral applications are expected to reach the market as early as 4th Quarter 2014. Each additional standard in the series will focus on connectors for a specific device category and will be released as it is completed.
Interim product solutions have been developed by several suppliers (see contracted suppliers offering products to reduce the risk of tubing misconnections). Several government and non-government organizations have also developed resources to assist healthcare providers in assessing the risk of tubing misconnections and providing education in their facilities.
Color coding has been used by some suppliers in the U.S. and in Europe as a visual cue, particularly related to the prevention of enteral misconnections. The color orange has been used by some suppliers and hospitals in the U.S. to designate oral/enteral connections to differentiate them from IV connections. Purple has been used by some suppliers in Europe and this has added to the confusion as some international suppliers have begun using purple worldwide.
To date, there are no standards in the U.S. or Europe related to color for oral/enteral feeding devices. Color coding is not included in the 80369 standards. The standards address connector shape and size with a goal of designed incompatability. These newly developed engineering controls (forcing functions) are designed to make it highly unlikely to bring two unintended connectors together, making the wrong connection impossible.
A California law prohibiting the use of intravenous, epidural or enteral feeding devices with connectors that fit into connection ports other than the type for which they were intended was passed in 2008. Recently, the implementation date was extended to January 1, 2016 to allow time for the development and publication of international standards and the subsequent redesign and implementation of products that comply with the new standards.
Centers for Medicare and Medicaid (CMS) issues memo to surveyors
In March, 2013 CMS posted a memo requiring all surveyors to be alert to the issue of "Luer" misconnections, particularly when investigating adverse events that involve delivery of an incorrect substance or utilization of an incorrect delivery route. The memo offers some resources for surveyors and encourages reporting of problems with Luer misconnections to the FDA, even if no adverse event occurred.
Stay connected: FAQs about small bore connectors and tubing misconnections
AAMI, ISO and an international joint working group are making great advances toward eliminating the potential for tubing misconnections and increasing patient safety-the focus of the small-bore connectors initiative. These advances may reach the market as early as 4th Quarter 2014. FAQs, developed by a consortium of organizations, including the Premier Safety Institute are intended to be used as a tool for understanding all aspects of the small-bore connectors initiative.
Visit our Resource section that provides references, international guidelines, tools and case studies. A list of Premier contracted suppliers offering products to reduce the risk of tubing misconnections, is available in our Contracted suppliers section.