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Transitioning to New ISO Connector Standards

A typical patient can be connected to several devices to receive medications, fluids and nutrients. Unfortunately, these tubes can be misconnected. One example of a dangerous misconnection is when a patient received enteral feeding formula intravenously because the tubing intended for the feeding tube was connected to the IV instead. Organizations have tried different strategies to reduce the risk of these misconnections.

  • Trace tubing or catheter from the patient to point of origin (line reconciliation)
    • Before connecting or reconnecting any device or infusion
    • At any transition, such as to a new setting or service
    • As part of the hand-off process
  • Route tubes and catheters having different purposes in different, standardized directions (e.g., IV lines routed toward the head; enteric lines toward the feet). This is especially important in the care of neonates and small children.

The State of California made a commitment to significantly address this patient safety issue by adopting legislation (AB 1867). The purpose of the bill is to 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 was intended, starting in January 1, 2016. Although not mandated in other states, medical device manufacturers/ suppliers are expected to comply with the new California law.

To address this problem, new ISO (International Organization for Standardization) tubing connector standards are being developed for manufacturers. The intention is to create a mechanical barrier to prevent misconnections. The enteral feeding tubing, for example, simply cannot be attached to an IV because the ends will not connect together.

As with any significant change in process, there are safety risks associated with the implementation of new connectors. GEDSA (Global Enteral Device Supplier Association) developed Stay Connected as a communication platform to help introduce new enteral connectors with the help of leading experts, such as AAMI, ASPEN, ISMP and the Joint Commission.  The Stay Connected website (stayconnected2014.org) has valuable resources to assist you with your preparations.

Preparing for the changes

It is anticipated that the new connectors will begin to reach the market as early as fourth quarter 2014. Enteral connectors will be introduced first through a slow, deliberate and careful transition. On August 20, 2014, the Joint Commission (TJC) introduced Sentinel Event Alert #53: Managing risk during the transition to new ISO tubing connector standards. Along with this publication, they issued a user guide/poster for reference that can be downloaded and shared throughout your organization.

Below is a summary of steps health care providers are encouraged to take to prepare for the new connectors:

Aware
  • Generate awareness of upcoming changes across the organization to all impacted clinicians, administrators, supply chain, health technology management and other support staff
  • Identify a leader within the organization to stay informed as plans progress and communicate updates to others in the organization early and often
Prepare
  • Form teams 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
  • Train clinicians and materials/inventory management staff for impending changes
Adopt
  • Introduce new connectors into work stream to reduce tubing misconnections and improve patient safety
  • Remind the organization of the long-term benefits vs. the short-term hassles of transitioning to new connectors
Measure
  • Quantify the organization’s ability to adopt changes.
  • Leverage metrics and formal feedback loops to identify ways to improve the organization’s ability to transition for the next phase of connector introductions

Commands