New design standards reduce the risk of misconnection

The circumstances during which misconnections occur vary greatly. A room with low lighting may compromise visibility and clarity; a patient in the ICU may have many different lines that could create confusion; the transition of a patient from one area or facility to another might introduce the possibility for complication; and, the sheer fact that the devices are physically compatible means a misconnection may not be instantly recognizable.

The push to reduce tubing misconnections already includes alerts and guidance documents, educational materials, practice standards, and protocols, but industry leaders recognized that it was time for something more comprehensive – a complete design change specified by a series of standards, adopted across the industry.

The first major step came in 2011 when an international group of clinicians, manufacturers, and regulators, in collaboration with AAMI and ISO, completed and adopted a foundational standard (ISO 80369-1) that set general requirements for safer connectors for the highest risk health care applications. The new, safer connectors will be dimensioned differently for each application. The standards also establish 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 fourth quarter 2014 for enteral devices.

The new design standards will answer a legislative mandate from California and an outcry from health care delivery organizations that have had adverse incidents with current, one-size-fits-all connectors. There are no federal mandates around safer connectors, but effective Jan. 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. With increasing patient mobility and portability, a single global solution is required to ensure patient safety and prevent either a misconnection or no connection.

Severity of misconnection

While it is believed they are under-reported, misconnections are rare. Many clinicians go their entire career without experiencing an incident, but when one does, it is damaging and even fatal. When a noninvasive blood pressure inflation tube is 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.
 

Promise of a new design

The new connectors echo the simplicity that the original Luer connector delivered – ensuring compatibility and consistency – but with a much lower risk of misconnection. 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.
 

Phased introduction

Medical manufacturers are committed to launching the new connectors with minimal disruption to supply and clinical practice, and to working through existing inventory. However, this transition is so comprehensive and affects multiple clinical applications – impacting people across the health care industry, from engineers, designers and manufacturers, to hospital CEOs, supply chain managers, caregivers, and clinicians – that knowledge and understanding of the process is crucial.

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.

Beginning in 2015, additional standards in the series will focus on connectors for other clinical applications such as breathing systems and driving gases, limb cuff inflation, neuraxial, and intravascular-hypodermic. Standards will be released as they are completed. The dimensions of each connector application will be different. Once the new connectors are available, the existing Luer connector will be maintained only for intravascular and hypodermic applications.

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.

GEDSA
www.gedsa.org

About the author: Tom Hancock, executive director GEDSA, leads the development, coordination, and execution of the Stay Connected initiative. He can be contacted at tom@gedsa.org or 614.824.589.