Improving Patient Safety:
Collaboration, Innovation, Connection

Organization Provides Information on New Connector ISO Standards

piercing

Manufacturers will begin launching new enteral device
connections in 2014.

When the “Luer” connector was developed more than a century ago, its genius was its simplicity. The universal design of this small-bore connector made it easy to administer medication, oxygen, and fluids, among many other therapeutic uses. However, its universal design also introduced vulnerabilities by allowing connection between devices that were not intended to connect (e.g., feeding tube to a ventilator in-line suction catheter; feeding tube in a tracheotomy tube; blood pressure monitor into an IV line, etc.).

Misconnections are rare—many clinicians go their entire career without experiencing an incident—but when misconnections do occur, they may be damaging and even fatal.

These misconnections may occur for a variety of reasons, such as line confusion when multiple medical devices are being used, difficulty in distinguishing the proper connection in low-light conditions, and even the well-intentioned helper misconnecting lines after unintentional disconnection.

New design standards for connectors that are nearing completion will answer a legislative mandate from California and an outcry from health care delivery organizations that have had adverse incidents. Once the new connectors make their way into the supply chain, the “universality” of the Luer connector will be history. The new, safer connectors will be differently dimensioned for each application, eliminating the universality of the current, one-size-fits-all connectors.

The Current Situation

We don’t know exactly how many misconnections are happening today—because we believe incidents are under-reported—but we do know exactly how dangerous they can be. When a noninvasive blood pressure inflation tube gets connected to an IV line, it delivers air under pressure into the bloodstream and causes an air embolus. When nutritional formula intended to go to the stomach through a feeding tube is connected to an IV line, it delivers the formula into the bloodstream causing embolus and sepsis. When IV fluids are connected to the inflation cuff on a breathing tube and deliver a large volume of fluid to a fixed volume device designed to be filled with air, it creates an airway obstruction.

The push to reduce tubing misconnections already includes alerts and guidance documents, educational materials, practice standards, and protocols, such as tracing a line back to its origin, putting tubes with different purposes on different sides of the body, color-coding connectors, or developing alternate connectors. But eliminating the risk of misconnection required something more comprehensive—a complete design change specified by a series of standards, adopted across the industry.

Success of such a feat has required a shift—both in thinking and operating—from competition to collaboration. The first major sign of success came in December 2010, when an international group of clinicians, manufacturers, and regulators, in collaboration with AAMI and ISO, completed and published a foundational standard (ISO 80369-1) that sets general requirements for safer connectors for the highest risk health care applications. It also establishes a framework for testing connectors to ensure non-interconnectability of unrelated delivery systems (e.g., vascular and enteral). Standards for system-specific applications are still in development, but new connectors are expected to reach the market as early as 4th Quarter 2014 for enteral devices.

Beginning in 2015, additional standards in the series will focus on connectors for specific clinical applications—such as breathing systems and driving gases, limb cuff inflation, neuraxial, and intravascular-hypodermic—and will be released as they are completed. The key point here is that the dimensions of each connector application will be different. Once the new connectors are available, the existing Luer connector will be maintained only for the intravascular and hypodermic applications. All other tubing connectors will be designed to make sure they are not compatible with the intravascular (Luer) connector, or any of the other new connector designs for other delivery systems.

The Promise of a New Design

The beauty of the new connectors is that they echo the simplicity that the original Luer connector delivered—ensuring compatibility and consistency—but with a much lower risk of misconnections. New connectors will provide greater ability for different manufacturers’ devices to integrate, while making it much more difficult, if not impossible, for unrelated delivery systems to be connected. Standardized connections across health care settings will lessen the likelihood of therapy interruption due to connector incompatibility or unavailability.

A Phased Introduction

Manufacturers are committed to launching the new connectors with minimal disruption to supply and clinical practice and to working through existing inventory. There will definitely be “pain points” through the supply chain for health care delivery organizations, though. Change is always hard, and this will be a change as “big,” or bigger than, as when single-use needles were introduced. The better you and your organizations understand the process, the easier the transition will be.

A phased approach will start with enteral devices in 2014. The enteral devices that will be impacted include feeding tubes, administration sets, and syringes. Manufacturers will incorporate the new connectors into their existing offerings where applicable. By working closely with their suppliers, health care facilities or providers should be able to convert on a timeline that best suits their needs and those of their patients.

The introduction will include guiding health care providers through a careful transition plan; developing and executing a coordinated joint communications plan; and identifying each unique connector with a common name to be used by all suppliers of devices for each respective delivery system.

While there are no federal mandates around safer connectors, effective January 1, 2016, California law will prohibit general acute care, acute psychiatric, and special hospitals from using an epidural, intravenous, or enteral feeding connector that fits into a connection port other than the type for which it is intended.

You Can Help: Aware, Prepare, Adopt

The Global Enteral Device Supplier Association (GEDSA), a nonprofit trade association, was formed to introduce the new standards. Partnering with experts from leading industry organizations, GEDSA developed “Stay Connected,” a 3-phased communications program—Aware, Prepare, and Adopt—to ensure a successful transition to safer connectors. Just as the development of the new design standards was a coordinated effort, so too is the market adoption of the safer connectors. You are the key to a successful transition.

The first step is to generate awareness of the impending changes across your organization. The new connectors will impact clinicians and administrators, risk management, materials management, quality and safety, health care technology management (i.e., clinical engineering), and other support staff. Choose a team within the organization to stay informed as plans progress, use that team to develop your implementation plan, and communicate updates to the rest of the organization as often as possible.

Preparation will smooth the way for the transition, so clinical teams need to assess existing systems, processes, and protocols that may need to change, focusing on areas of highest risk that have the most immediate need to convert to the new connectors. Work with supplier representatives and adopt their product-specific transition plan. Train clinicians and materials/inventory management staff for impending changes.

Successful adoption requires, when the new connectors enter the work stream, that you reinforce to your organization the long-term benefits over the short-term inconvenience of the transition process itself. Transitions can increase or introduce new risk, so awareness of and preparation for what’s coming are key to strong adoption strategies.

Working together and taking careful steps to make sure we do it the right way, we will be on our way toward reducing risk and improving patient safety by eliminating the potential for misconnections.

For more information:

http://www.aami.org/hottopics/connectors/index.html (see especially the new FAQs)

About AAMI

The Association for the Advancement of Medical Instrumentation (AAMI), is a nonprofit organization founded in 1967. It is a diverse community of nearly 7,000 health care technology professionals united by one important mission—supporting the health care community in the development, management, and use of safe and effective medical technology.

About GEDSA

The Global Enteral Device Supplier Association (GEDSA) is a nonprofit trade association formed to introduce international standards for health care tubing connectors. Comprised of manufacturers, distributors, and suppliers worldwide, GEDSA facilitates information flow about the initiative, which is designed to increase patient safety and optimal delivery of enteral feeding by reducing the risk of tubing misconnections. GEDSA partners with leading experts from The Joint Commission, AAMI, American Society of Parenteral and Enteral Nutrition, The Institute for Safe Medication Practices, Premier Safety Institute, Novation, and more to develop and execute a communication plan. Led by GEDSA, this group helps organizations, clinicians, administrators, supply chain, and others transition to new ISO standard connectors. GEDSA invites everyone to “Stay Connected” as the tubing connectors are introduced to ensure a successful transition to safer connections.


The authors are grateful for the work of Colleen Elliott, standards director at AAMI, for her work with the standards committee and input on this article.

Mary Logan, JD, CAE is President of AAMI and Thomas Hancock is Executive Director of GEDSA..