CMS Warns of Luer Misconnection Dangers

Posted March 18, 2013

Luer misconnections are an ongoing patient safety concern. Despite widespread publicity, adverse events involving these connectors and locks—which are used in many, and potentially incompatible, applications—continue to plague healthcare facilities. As a result, the Centers for Medicare & Medicaid Services (CMS) has asked that state surveyors ensure facilities are taking action to prevent the recurrence of adverse events involving Luer misconnections.

In a March 8 memo to its state survey agency directors, the Center for Clinical Standards and Quality/Survey & Certification Group within the CMS noted that since 1972, more than 100 reports of Luer misconnections had been reported in literature; however, this figure may underestimate the actual number of events. The memo highlighted a recent incident in which a patient’s blood pressure tubing was connected to an intravenous line, resulting in that person’s death.

CMS has asked state surveyors to keep an eye out for adverse events that have resulted from misconnection of devices involving Luer or similarly designed connectors. Surveyors should encourage healthcare facilities to report such incidents to the U.S. Food and Drug Administration (FDA), even if an adverse event didn’t occur, according to the memo. The memo notes that raising healthcare facility awareness of this problem might protect patients until new connectors become available.

AAMI, The Joint Commission, the Institute for Safe Medication Practices, United States Pharmacopeia, ECRI Institute, and other stakeholders have sought ways to reduce the number of adverse events involving Luer misconnections. In January 2011, AAMI adopted ANSI/AAMI/ISO 80369-1:2010, which provides the general requirements for small-bore connectors for liquids and gases.  Additional parts of the series are under development.

Meanwhile, standards organizations are working on the development of uniform connector designs for specific high-risk medical applications to ensure they can’t be interconnected with a device of another application. However, because it may be some time before these designs are introduced, CMS has recommended steps that providers and suppliers can take in the interim to lower the risk of Luer misconnections:

  • Change to already-marketed devices with alternative connector designs.
  • Trace lines back to their origins when reconnecting devices.
  • Position catheters and tubes that have different purposes on opposite sides of the body or in unique, standardized directions.
  • Implement a multidisciplinary facility approach to address Luer misconnections.

In July 2012, the FDA issued draft guidance recommending methods for reducing the likelihood of unintended connections between enteral connectors and nonenteral medical devices. In addition, the agency has updated its Tubing and Luer Misconnections website by adding tips, an image of Luer connectors, and information for providers and manufacturers of medical devices that use small-bore connectors.

To read the CMS memo (PDF), please click here.