Webinar: New standards for tubing connectors: Are you ready?
Wed Aug 20, 2014 2-3:30 ET
Visit Stay Connected to learn more about the transition to medical devices with new safer connectors.
California legislation effective January 1, 2016 will prohibit 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. Learn more.
Centers for Medicare and Medicaid Services (CMS) issued a memo requiring surveyors to be alert to "Luer" misconnections. Read more.
Misconnection of tubing used to link patients to medical devices or medical devices to each other is an underreported medical error, which has the potential to result in serious injury or death. Although errors involving various types of tubing and catheters have been reported for over 40 years, a recent increase in awareness of this issue has led to 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.
In 2008, an international initiative led by the Association for the Advancement of Medical Instrumentation (AAMI) and the International Organization for Standardization (ISO) began to develop standards designed to minimize the likelihood of life-threatening tubing misconnections in healthcare. The international standards require unique connectors for each device category and 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 published by AAMI and the American National Standards Institute (ANSI) in early 2011. The standard covers the general requirement of non-interchangeability and provides the framework for parts 2 – 7 of the standard, designating 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.
Stay connected: FAQs and resources about new small bore connectors to prevent tubing misconnections
The AAMI, ISO international joint working group is making great advances toward eliminating the potential for tubing misconnections and increasing patient safety-the focus of the small-bore connector initiative. The first new products 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 connector initiative. Additional information and materials developed to assist healthcare organizations with the transition to new products are available on the Stay Connected website.
Visit our Resource section that provides references, international guidelines, tools and case studies.