No more tragedies: an introduction to ISO 80369

No more tragedies: an introduction to ISO 80369

by Laura Dowling

A hospital patient should never be injured, or worse, because a hospital employee accidentally connects a small tube carrying medicine or nutrients to the wrong tube outside the patient's body.

That's what happened to Robin Rogers in 2006.

According to the New York Times, a hospital nurse caring for Rogers during her final weeks of pregnancy inadvertently connected a feeding tube with liquid nutrients to an IV in Rogers' arm. The Times noted, "Putting such food directly into the bloodstream is like pouring concrete down a drain." She died shortly after.

Today, a new industry-wide standard defined as ISO 80369 is under development to help eliminate these heartbreaking tragedies. Once completed in the coming years, the international ISO 80369 standard will provide strict guidelines for manufacturers to produce non-interchangeable connectors that only can be used between devices intended for the same clinical application. As the Times noted, the non-interchangeable connectors will be made incompatible "just as different nozzles at gas stations prevent drivers from using the wrong fuel."

The products at the core of ISO 80369 are small-bore luer connectors (less than 8.5 mm in diameter) that hospital personnel use to link, for example, a medicine bag to an IV. The male and female components of luer connectors join together to create secure, yet detachable, leak-proof connections. Multiple connections between medical devices and tubing are common in patient care. Although tiny, these inexpensive connectors play an extremely critical role in any medical device.

ISO 80369 is a package consisting of seven sections of standards. The first section, titled "General Requirements" is the initial governing document that was finalized in April this year. Six additional sections--each meticulously focusing on tube connectors for a specific clinical application and market--must be in place in the coming years.