Navigating California Law and ENFit Connectors (in all 50 States)

Evi Dewhurst / September 2016

Navigating California Law and ENFit Connectors (in all 50 States)

Improving outcomes and patient safety are top priorities for all hospitals. It’s no surprise that these priorities include using enteral feeding best practices, which reduce the risk of adverse events.  ENFit™ enteral connectors fall solidly within these best practice efforts. This is especially true for the neonatal intensive care unit, where a tiny error can have big consequences.

As a result, ENFit connectors seem to have taken center stage everywhere in healthcare. Wherever enteral feeding is mentioned, ENFit is sure to follow—especially within context of safety improvements (for those of you who have missed the parade, ENFit connectors were developed by leading enteral device manufacturers to address ISO standards for safe enteral connectors).

And yet hospitals have found themselves hesitant to act upon implementing ENFit connectors due to some unanswered questions.

Two of those questions are:

Does my current enteral feeding system meet safety standards?

Do we have the capability to adopt such a change right now?

These questions are big enough on their own. But there is one more consideration to include: California law.

California seems to be the laid-back state, the casual state, the sunshine state. Don’t let that fool you. California is also a very progressive state, and has turned its law enablement attention to healthcare practices. This includes healthcare tubing connector safety.

Let’s talk about this specific law, how it applies to those two questions listed above, and how it can impact your facility even if you hail from another state.

In June 2012, California enacted AB 1867. This bill was to take effect on January 1, 2013. It stated:

Prohibits, beginning 24 months after the publication of a new design standard for connections for intravenous or enteral applications by the ISO, or January 1, 2013, whichever occurs first, general acute care, acute psychiatric, and special hospitals from using an intravenous or enteral feeding connection that would fit into a connection port other than the type for which it was intended, unless an emergency or urgent situation exists and the prohibition would impair the ability to provide health care. 

It also included:

Requires a health facility that is required to develop a patient safety plan, as specified, to include in the patient safety plan measures to prevent adverse events associated with misconnecting intravenous, enteral feeding, and epidural lines.  Requires this provision to become inoperative when the above provisions take effect prohibiting the use of connections that can fit into connections other than those intended. 

The bill warned that “Unfortunately, the ubiquitous nature of the Luer connector design allows for connection between unrelated delivery systems (e.g., vascular, enteral, respiratory, epidural, and intrathecal medical devices, components, and accessories). Because Luer connectors are ubiquitous, easy-to-use and compatible between different delivery systems, patient care staff can inadvertently connect wrong systems together, causing medication or other fluids to be delivered through the wrong route. Numerous such errors have been documented, including many that have caused serious patient injuries and deaths.”

 In summary, AB 1867 addressed two issues:

(1) Healthcare facilities needed a plan, and

(2) healthcare facilities could no longer use connections that would fit into other application connectors, such as IV medication connectors to enteral feeding connectors, after a certain date.

While this bill outlined what every hospital secretly wanted for their patient safety efforts, it also required something that would and could take years of planning. California is a progressive state, but also an understanding one. It granted extensions upon this bill’s deadline in order to allow the work required for all healthcare facilities to enact this herculean effort. The date was set for January 1, 2016.

Stay with me here: we’re about to jump forward.

Assembly Bill No. 444 was then enacted to extend the AB 1867 January 1 date to July 1, 2016:

Commencing July 1, 2016, a health facility (…) is prohibited from using an enteral feeding connector that would fit into a connector other than the type it was intended for, unless an emergency or urgent situation exists and the prohibition would impair the ability to provide health care. 

Sounds familiar, right?

As of today, Bill No. 444 has taken effect. It prohibits California health facilities from using an enteral feeding connector that would fit into a connector other than the type it was intended for (except in an emergency situation).

Let’s look at those questions from above in relation to all this information, whether you are located in California or not:

Does my current enteral feeding system meet safety standards?

California law addresses very specific safety issues around enteral connectors. Those safety issues are common to existing Joint Commission and ASPEN guidelines.

The bottom line is, do your enteral connectors fit into a connector other than the type they were intended for? If so, the answer to this question is basically… no. That means you are in an ideal spot to closely consider ENFit connectors to determine if they are the right fit for your facility.

Do we have the capability to adopt such a change right now?

Many hospitals have to consider the entire hospital for ENFit connectors, and that is a daunting task. However, in the NICU, you need safety-oriented connectors for the most fragile patients. For your corner of the hospital, and for the safety of your patients, it would be beneficial to investigate implementing ENFit as a unit. Start asking questions now if you have not already.

You’d be surprised how simple this change can be. NICUs who have adopted our ENFit enteral feeding system have found it to be a simple training process (with a beneficial outcome).

Now that we’ve addressed those two questions, let’s add one more:

Why does California law impact my healthcare facility when I am not in the state?

There are two answers for this:

(1) Your facility is part of a larger system which runs hospitals in California in addition to your state. This means they will have to adopt California law as it relates to enteral feeding and it may impact your out-of-state facility, and

(2) Other states are preparing to adopt similar initiatives in regards to healthcare application connector safety.

The tides of enteral feeding connector change haven’t finished yet. As healthcare facilities juggle many priorities, inevitably safer enteral connectors will rise to the top, impacting staff and patients in a very positive way. It is a priority we can all agree with, and one that California has already enacted a law for. That said, be encouraged to begin your transition plan now. The answers you seek are out there—all you have to do is ask.

Learn more about the Medela Enteral Feeding System with ENFit connectors.

Email your questions to efinfo@medela.com

About the Author

Evi Dewhurst is a Senior Marketing Manager for Medela, Inc. As a proud mother of two young children, she is passionate about healthcare for youngsters everywhere and has a serious soft spot for babies. She is part of the dedicated team at Medela, who together are committed to designing and manufacturing products to advance human milk healthcare. Have a question? Evi can be reached at evi.dewhurst@medela.com

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