CHA News Article

CMS Memo Highlights Luer Device Problems and Investigations

CMS has posted a Survey and Certification Memo related to adverse events with Luer device misconnections. In the memo, CMS outlines the survey process for a complaint investigation and directs surveyors to determine if 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 the adverse event. In addition, surveyors should encourage health care facilities to report problems with Luer misconnections to the FDA, even if no adverse event occurred. To read the complete CMS memo, visit