CHA News Article

Hospitals Encouraged to Transition to New Tubing Connectors, Review Safety Plans

The law prohibiting hospitals from using tubing “connectors that would fit into a connector other than the type it was intended for” goes into effect this year. Hospitals are encouraged to develop a careful and methodical transition to the new connectors, once an evaluation of marketplace availability shows a stable supply. Hospitals should also review their patient safety plans to ensure that the prevention of misconnecting intravenous (IV), enteral and epidural lines is adequately addressed. More details about patient safety plan requirements are available in Chapter 21 of CHA’s Consent Manual.

Currently, all tubing attached to one of three connector types (epidural, IV and enteral) can be interconnected. Until these connectors are reengineered, approved by the International Organization for Standardization (ISO) and the Food & Drug Administration (FDA), and adequately distributed throughout the health care industry, the possibility of human error remains.   

Though updates to the standards for manufacturing these connectors have progressed, all three tubing/connector types can be interconnected until the reengineered products are readily available. Per the Advanced Medical Technology Association’s 2015 annual report to the California Legislature, ISO-compliant IV connectors became available Jan. 1, 2016, and ISO-compliant epidural connectors would be available by Jan. 1, 2017. However, ISO-compliant enteral connectors have been delayed beyond the law’s July 1, 2016, deadline. In addition, although ISO-compliant IV connectors are available now, they will not technically be “non-interconnectable” with epidural/enteral connectors until those connectors are reengineered according to ISO requirements and made fully available in 2017. Hospitals risk technical non-compliance with the law if the products are not available when the legal prohibition(s) take effect.

Hospitals are required to develop, implement and comply with a patient safety plan to improve patients’ health and safety and reduce preventable patient safety events (Health and Safety Code Section 1279.6). Patient safety plans must include measures to prevent adverse events associated with misconnecting IV, enteral feeding and epidural lines (Health and Safety Code Section 1279.7). Hospitals are encouraged to review their patient safety plan to ensure that prevention of adverse events associated with these misconnections is adequately addressed, and perform a risk analysis addressing the connectors’ availability and identifying methods to mitigate risk. The plan may include an assessment of the sustained availability of connectors that meet the legal standard, staff training, etc.