As of August 2013, there were no federal mandates for manufacturers or healthcare organizations.
Effective Jan. 11, 2016, a California law (HB 1867) will prohibit general acute care, acute psychiatric, and special hospitals from using an epidural, intravenous, or enteral feeding connector that fits into a connection port other than the type for which it was intended. It is expected that all medical device manufacturers/suppliers will comply with the new California law. In doing so, they will develop modified products that incorporate the new connectors and phase out products with old connectors. The changes and requirements will need to be communicated to clinicians who use the products and to those responsible for product conversions in the organizations.
Also, the FDA issued a letter to manufacturers, healthcare professionals, and hospital purchasing departments in July 2010 that outlines what each group can do to reduce the risk of tubing misconnections. The agency noted they are participating in the development of the ISO standards that will help prevent these misconnections through use of function design and usability testing. The FDA stated it is considering recognizing the ISO standards, and if it does, it will provide guidance to manufacturers regarding the timeline for devices on the market to come into compliance, as well as explain the effect of the standards on new devices.