California Law Affects National Enteral Connectors

Evi Dewhurst


Most people think of California as the sunshine state. They imagine sandy beaches, wave-riding surfers, perpetual mild weather, throngs of celebrities and the occasional rock and rolling earthquake. While those perceptions are not far off, they do miss out on some deeper state values. California has often had opportunity to be a starting point of change, which then carries over to national impact. Healthcare is one of those changes. Or healthcare law, to be exact.

One of these laws directly affects neonatal intensive care by tackling enteral connectors. Give a warm welcome to bill number AB 1867.

But first, a little background:

By now, just about every NICU professional is fully aware of the impending ISO enteral connector recommended standards. These standards state that enteral connectors should not physically be able to connect with other (non-enteral) connectors. ISO is attempting to help regulate for optimal patient safety. Guidelines were established and planning moved forward to make these connectors a reality. The standout in this planning was GEDSA, or Global Enteral Device Supplier Organization. This organization brought enteral medical device manufacturers together to achieve an enteral connector design able to meet ISO recommended standards. The ENFit connector was the result. This connector meets the ISO physical dimension standards and establishes male/female connections for specific products, all in order to provide a device connector that is difficult to misconnect.

The rollout for these devices was anticipated to occur throughout 2015. Early adopter healthcare facilities would implement them within the year and others could follow suit as they acquired the resources and capabilities for the transition. Product change is sometimes difficult in the hospital environment, and it seemed many hospitals could make the move according their own timeline.

There was just one issue: that 31st state of eternal sunshine.

California has, in recent years, been sitting on bill number AB 1867. This bill specifically relates to enteral connectors and misconnection concerns. It “prohibits the use of intravenous, epidural or enteral feeding devices with connectors that fit into connection ports other than the type for which they were intended.” AB 1867 was passed in 2008 and has since been extended a few times. However, the last approved extension date was January 1, 2016. That date is fast approaching. With 2015 underway, it appears more and more that there will be no additional extensions. California facilities must have their new connectors in place by January 1, 2016.

What does this mean for you if you are not in California? These changes will cast ripples across the country, causing product decisions through national healthcare providers in the United States while allowing facilities to share information and refine adoption processes, all while influencing neighboring hospital systems. Fellow states might even be inclined to adopt the same law. Given the above, it’s probably a safe bet that California’s golden reach will touch out-of-staters eventually.

Enteral device manufacturers such as Medela are preparing for the needs of California, and the rest of the United States. Product offerings will include ENFit connectors in order to provide ample opportunity for due diligence by hospital decision-making committees throughout California. If you are not in the state of California, it is your moment to make a difference for your neonatal intensive care unit. Take stock now of enteral connectors in your unit and any plans to convert to ISO standards. Perhaps now is the time for you to ride the wave of change as well and join in with California.


Learn more about Medela’s ENFit connectors: Click here

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