FEATURE


demic professionals and government regulators, is working to develop a se- ries of standards for incompatible con- nectors. The new connectors are being designed to be used in intravascular, breathing system, enteral, urethral/uri- nary, cuff inflation and neuraxial ap- plications. They are expected to be in- compatible with the ever-present Luer and with each other, as well. Thirty-one countries are participat- ing in the development of the interna- tional standards. Twenty-six of the ex- perts, working in a technical advisory group accredited by the American Na- tional Standards Institute, are from the US. AAMI, a standards development organization and a delegation arm for ISO, created the group. A nurse who is on the FDA staff and directs the Center for Devices and Radiological Health standards program convenes both the domestic and international multi-dis- ciplinary groups. “We’re working through solutions


to prevent small bore misconnections,” Noé says. “The parent document ISO 80369-1 is an approved ISO stan- dard. All the standards have been put through the first round of committee drafts.”


The ISO process has different and distinct phases for identification and development of the standard. “It’s a very democratic process,” Noé says. The Luer standard is now ready for usability testing of the new connector designs and analysis of the comments on the committee drafts, he says. Once those phases are over, a draft interna- tional standard will be written before the standard can be ready for final implementation. The FDA has indicated that it will


likely recognize the standard “offi- cially” as soon as it becomes viable and ready, because of the urgency, Noé says. And California has already passed a law that requires the state’s acute care medical facilities to transi- tion to non-Luer connector devices for


Avoiding Tubing Misconnections


1. Do not purchase non-intravenous equipment that is equipped with con- nectors that can physically mate with a female Luer IV line connector.


2. Conduct acceptance testing (for performance, safety and usability) and, as appropriate, risk assessment (e.g., failure mode and effect analysis) on new tubing and catheter purchases to identify the potential for mis- connections and take appropriate preventive measures.


3. Always trace a tube or catheter from the patient to the point of origin before connecting any new device or infusion.


4. Recheck connections and trace all patient tubes and catheters to their sources upon the patient’s arrival to a new setting or service as part of the hand-off process. Standardize this “line reconciliation” process.


5. Route tubes and catheters having different purposes in different, stan- dardized directions (e.g., IV lines routed toward the head; enteric lines toward the feet). This is especially important in the care of neonates.


6. Inform non-clinical staff, patients and their families that they must get help from clinical staff whenever there is a real or perceived need to connect or disconnect devices or infusions.


7. For certain high-risk catheters (e.g., epidural, intrathecal, arterial), label the catheter and do not use catheters that have injection ports.


8. Never use a standard Luer syringe for oral medications or enteric feedings.


9. Emphasize the risk of tubing misconnections in orientation and training curricula.


10. Identify and manage conditions and practices that may contribute to health care worker fatigue, and take appropriate action.


In addition, The Joint Commission urges product manufacturers to imple- ment “designed incompatibility,” as appropriate, to prevent dangerous mis- connections of tubes and catheters.


Source: Sentinel Event Alert, April 3, 2006, The Joint Commission


enteral feeding and epidurals by 2013. This law is now being amended to fur- ther align with the ongoing work of the ISO committee and extended until the standards are released. “The development process is com-


plicated, given the five different com- peting connector families, and there’s still design work being done,” Noé says. “We are applying the principles of ‘Do no harm’ and trying not to dis- rupt those clinical practices developed over years of experience. This involves


a significant amount of technically re- fined engineering. It’s not trauma sur- gery; it’s fine micro-surgery.” The new standards are expected to be ready in 2014, according to Noé. “Until the standards are formally ad-


opted, health care centers can implement the recommendations from The Joint Commission’s 2006 Sentinel Event Alert, ‘Tubing misconnections—a persistent and potentially deadly occurrence’ (see the box above) to reduce the risks with current devices,” Schyve says.


ASC FOCUS NOVEMBER/DECEMBER 2012 19


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