New Epidural/Spinal Law: Not Yet Workable

by
  • Zakowski, Mark, MD
| Jan 10, 2017
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CSA’s got your back!

We are constantly advocating for your safe practice of anesthesiology by monitoring, advising and participating in the various legislative, regulatory and policy arenas in Sacramento and nationally.

A California law passed in 2015 – Assembly Bill 444 authored by Assemblymember Mike Gipson (D-Carson) – took effect on January 1. AB 444 prohibits health facilities from using any epidural 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.” While the bill’s intentions are good, the problem lies in the implementation.

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To reduce frequency and risk of wrong route delivery of medications and fluids (tubing misconnections), the International Organization for Standardization (ISO) changed the standards for neuraxial and enteral connectors to a smaller (diameter) bore for healthcare applications. Ultimately, AB 444 will provide a simple way to reduce the risk of neuraxial and regional anesthesia misconnections, and to improve patient safety.  The problem is that while some of the equipment is ready for use starting in January, not all the required components will be available for purchase until later in 2017.

Patient safety is a prime concern for the California Society of Anesthesiologists and all our members.  The safe delivery of epidural medications is not limited to anesthesiologists. This law requires multiple manufacturers and suppliers to comply with the new standard. Since multiple manufacturers are involved – for epidural catheters, epidural infusion pump tubings, and syringes – implementation of AB 444 today is not a simple task.

To be fully compliant, hospitals will need to stock new epidural catheters along with new connectors, tubing, and multiple size syringes. The new catheters have smaller connectors, and standard syringes won’t work. I’ve spoken with a few manufacturers who are gearing up for this change, but most will not be ready by January. As in so many other issues, California is a leader and we passed legislation before the international implementation required by the new ISO standard.

The CSA has working with the California Department of Public Health to request a delay in enforcement until manufacturers and supply chains for the new equipment can be developed and maintained.  This new law is important, but enforcement timelines should recognize the reality of the equipment supply delays. Patients still need to be able to receive epidurals, and doctors need to be able to provide safe patient care while manufacturers are working to get all the new connectors, tubings and syringes ready for widespread use.

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As we start the New Year, it’s important for members to know that the CSA tracks and engages on a multitude of healthcare policy issues that impact our daily practices. This is just one example of how the CSA is working to make sure good intentions are implemented in a practical and achievable way.

Mahalo – I hope to see you at the CSA Winter Anesthesia Conference on January 23 in Maui!

1 comment

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  1. Virgil Airola | Jan 10, 2017
    get work, Mark! Many thanks to CSA

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