BILL ANALYSIS
AB 818
Page 1
CONCURRENCE IN SENATE AMENDMENTS
AB 818 (Hernandez)
As Amended July 23, 2009
Majority vote
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|ASSEMBLY: |77-0 |(May 21, 2009) |SENATE: |35-1 |(August 31, |
| | | | | |2009) |
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Original Committee Reference: HEALTH
SUMMARY : Delays the prohibition on a health facility using a
tubing connection that would fit into a connection port other
than the type for which it was intended until the earlier of
January 1, 2014 or 36 months after the International
Organization for Standardization (ISO) publishes a new
applicable design standard for epidural connections, and the
earlier of January 1, 2013, or 24 months after ISO publishes an
applicable design standard, for intravenous or enteral
connections.
The Senate amendments change the effective dates for the
prohibitions and require a health facility to include in its
patient safety plan measures to prevent adverse events
associated with tubing misconnections, until the prohibitions on
interchangeable tubing connections become operative.
EXISTING LAW prohibits, beginning January 1, 2011, a health
facility from using an intravenous connection, epidural
connection, or enteral feeding connection that would fit into a
connection port other than the type for which it was intended.
AS PASSED BY THE ASSEMBLY , this bill delayed until the earlier
of January 1, 2014 or 36 months after the publication of a new
applicable design standard by ISO, the prohibition on a health
facility using a tubing connection that would fit into a
connection port other than the type for which it was intended.
FISCAL EFFECT : According to the Senate Appropriations
Committee, pursuant to Senate Rule 28.8, negligible state costs.
COMMENTS : According to the author, health facilities depend on
a variety of catheters, tubing, and syringes to deliver
medications and other substances to patients through vascular,
AB 818
Page 2
enteral, respiratory, epidural (outer part of the spinal canal),
and other delivery systems. These delivery systems frequently
employ fittings to link various system components. Thousands of
these connections are used in hospital environments in
California daily and are critical to the care of patients. The
author states that changing an industry standard for very
commonly used enteral and epidural connections will not be
accomplished within the next two years, as required by SB 158
(Florez), Chapter 294, Statutes of 2008. This bill provides
time for the industry to meet this important mandate through a
common design format, without which hospitals will have to
purchase proprietary products and accessories at high cost. The
author also argues that without a common design format, each
hospital might use different equipment, leading to confusion and
possibly risking patient safety. Finally, the author argues
this bill will give ISO and the federal Food and Drug
Administration (FDA) time to harmonize their efforts to create a
global standard, as well as give industry time to develop
manufacturing processes for the new products.
Analysis Prepared by : Allegra Kim / HEALTH / (916) 319-2097
FN: 0002404