TJC Issues Alert in Preparation for New Tubing Connector Standards

Posted August 20, 2014

The Joint Commission (TJC) is urging healthcare organizations to “be vigilant and begin planning” for an upcoming transition to new tubing connector standards, a move prompted by tubing misconnections—instances of which have killed patients.

In a Sentinel Event Alert released Wednesday, the accrediting organization spells out the dangers and types of tubing misconnections, describes the new design standards, and lists specific steps that healthcare organizations can take ahead of a transition period to the new connectors. Enteral connectors will be rolled out first in early 2015.

“Healthcare organizations should begin preparing for changes in connectors and do everything possible during the transitional period to avoid tubing misconnections,” TJC says in its alert. The organization warns that the transition will introduce “new risks to the healthcare environment.”

Specifically, the alert deals with small-bore connectors, which are less than 8.5 mm in diameter and are used in a number of clinical applications, including blood pressure cuffs, breathing systems, and enteral feeding tubes. Because of the compatibility between different medical device delivery systems, clinicians mistakenly can connect unrelated systems to one another, leading to adverse patient events. Authors of a 2011 article published in the journal Nutrition in Clinical Practice found 116 case studies involving the accidental connection of an enteral feeding to an intravenous system. A total of 21 deaths were reported as a result of these misconnections. The case study review covered results from 1972 through 2010.

To minimize this danger, AAMI, International Organization for Standardization (ISO), and other groups have been working on a suite of tubing connector standards. AAMI has adopted ANSI/AAMI/ISO 80369-1, which provides guidance to manufacturers on how to create connectors for their own devices, and the association expects it will approve additional connector-related standards over the coming year. While these standards likely will not be enforced by any state other than California, “in time, healthcare organizations will likely find the new connectors to be the only ones on the market,” according to TJC.

Subsequent connector standards would cover the following applications: intravascular or hypodermic, for which Luer connectors will be maintained; limb cuff inflation; neuraxial, e.g., for local anesthetics placed around the nerves of the central nervous system; and breathing systems and pressurized medical gasses.

What Facilities Can Do

As healthcare delivery organizations prepare to adopt the new connectors, TJC has proposed certain actions, including assessing and managing the current risks of injury. It cites a recommendation from ECRI Institute that calls for an interdisciplinary task force with facility personnel from nursing, pharmacy, healthcare technology management, risk management, and other areas to identify misconnection hazards and devise possible solutions.

In addition, facilities should make themselves aware of the standards and engage in dialogue with suppliers about transitioning to the new connectors. Facilities should be aware of when new connectors become available and commit to not buying equipment with Luer lock connectors for the applications affected by the new standards.  

TJC also lists several processes and procedures facilities should put into place, including tracing tubing from the patient to the point of origin, using tubing and related equipment only as intended, and taking inventory and storing supplies carefully. The latter action is an important step to identifying products that should be discontinued.

Staff training—preferably from the manufacturer—is another area TJC highlights. Ensuring that staff is aware of misconnection issues and has access to easy-to-use reference materials is essential. Staff also is urged to inform patients and visitors that they must get help from a clinician if they detect a need to disconnect a device.

Finally, TJC underlines the need to develop a culture of safety. “Identify, manage, and create awareness of conditions and practices that may contribute to healthcare worker fatigue, inadequate staffing, and interruptions, and take appropriate actions to mitigate those working conditions,” TJC says.

TJC also has provided an infographic that highlights some of the major points in the alert.

AAMI President Mary Logan praised the TJC for its attention to this issue. “This is a great example of the entire healthcare community pulling together to address a crucial patient safety issue,” said Logan. “We appreciate The Joint Commission’s focus on how to manage risk during this transition. We also look forward to working with TJC and other partners throughout healthcare in supporting healthcare delivery organization efforts to make their systems and use of technology even safer.”

Facilities also are advised to learn about the upcoming standards at the website of the Global Enteral Device Supplier Association’s Stay Connected initiative, which is led by a group of clinicians, manufacturers, and regulators that developed the ISO 80369-1 standard.

AAMI also has a number of resources related to small-bore connectors, including a hot topics  page and an FAQ document.