Luer Misconnections Leading to Adverse Events Identified by CMS

 CMS issued Survey & Certification Memorandum, S&C: 13-14-ALL, highlighting the continuing risk of Luer misconnections in health care settings, suggesting actions providers can take to reduce the likelihood of these events; and actions surveyors should take when investigating these events.  To read the memo, see https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/Downloads/Survey-and-Cert-Letter-13-14.pdf.

Summary:

• Luer Misconnections continue to result in adverse events and deaths – Luer connectors easily link many medical components, accessories, and delivery systems. Clinicians, in any type of provider or supplier setting, can mistakenly connect the wrong devices and deliver substances through the wrong route. Despite numerous alerts and warnings, a patient’s blood pressure tubing was recently misconnected to an intravenous (IV) line in an ambulatory surgery center (ASC) resulting in a patient death.

• Adverse Event Complaint Investigation: During a complaint investigation for an adverse event involving delivery of an incorrect substance or utilization of an incorrect delivery route, surveyors must be alert to whether the event involved misconnection of a Luer device. If so, surveyors must determine whether the facility has taken actions to ensure systems are in place to prevent recurrence of this type of adverse event.

• Facility Reporting to Food & Drug Administration (FDA): Surveyors should encourage health care facilities to report problems with Luer misconnections to the FDA, even if no adverse event occurred.
Examples of actions providers and suppliers can take to reduce the likelihood of Luer misconnections include, but are not limited to (1) changing to devices already on the market with alternative connector designs which reduce the likelihood of misconnections of incompatible lines;  (2) tracing lines back to their origins when reconnecting devices; (3) positioning catheters and tubes that have different purposes on different sides of the patient’s body or in unique and standardized directions; and (4) implementing a multidisciplinary facility approach to address Luer misconnections.