Protecting Against Misconnections: Status Update

The April 2010 CHPSO Patient Safety News discussed the risks of using standard Luer fittings for non-intravenous uses. Inappropriate connections can occur, such as intrathecal injection of an intravenous medication (e.g., vincristine). Developing non-interoperable connectors, so that connectors for fundamentally different uses cannot connect with each other, will prevent most of these incidents.

Since that report, some progress has been made. The basic standard (ISO 80369- 1) has just been issued, establishing six classes of fittings that must only connect to fittings within its class: driving gases and breathing system ancillary ports, enteral feeding, urological access, limb cuffs, neuraxial access and vascular access.

Work is progressing on the standards for enteral feeding and neuraxial fittings, but some standards committee members are expressing concern about meeting the California legal requirement for noncompatible fittings by 2013 for enteral devices and 2014 for neuraxial devices. Early availability of these devices might not occur. For example, the proposed neuraxial fittings are not currently produced by anyone.

For additional information:

Nass, R. Making progress on connector standards. Medical Device and Diagnostic Industry News. Dec 2010.

Value Plastics, Inc., ISO 80369 — News Hub.

ISO Technical Committee 210 (Quality management and corresponding general aspects for medical devices) status.