BILL ANALYSIS Ó
AB 444
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CONCURRENCE IN SENATE AMENDMENTS
AB
444 (Gipson)
As Amended June 1, 2015
Majority vote
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|ASSEMBLY: |78-0 |(April 23, |SENATE: |38-0 |July 2, 2015 |
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Original Committee Reference: HEALTH
SUMMARY: Delays, until July 1, 2016, the deadline prohibiting
general acute care, acute psychiatric, special hospitals, and
skilled nursing facilities (SNFs) from using certain enteral
connector devices. Delays, until January 1, 2017, the deadline
prohibiting general acute care, acute psychiatric, special
hospitals, and SNFs from using certain epidural connector
devices.
The Senate amendments added the delay, until July 1, 2016, of
the deadline prohibiting general acute care, acute psychiatric,
special hospitals, and SNFs from using certain enteral connector
devices.
Although the deadline was met for developing Intravenous Therapy
(IV) and enteral designs, complications between manufacturers
and distributers have delayed the ability of the industry to
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adequately fill the supply chain with the syringes needed for
the enteral systems. Accordingly, the industry has also
requested a six month delay in implementation of standardized
enteral systems.
FISCAL EFFECT: According to the Senate Appropriations
Committee, pursuant to Senate Rule 28.8, negligible state costs.
COMMENTS: According to the author, that while worldwide experts
participating in the development of the new international
standards for IV connectors are highly committed to solving the
problem of tubing misconnections, the process is, and should be,
rigorous enough to ensure that the work is done correctly the
first time. The wrong outcome, the author maintains, would lead
to a far more dangerous healthcare environment than what
currently exists by possibly creating new risks, or creating a
solution that cannot be manufactured cost effectively or is too
complicated for users. The author notes that this bill will
ultimately improve patient safety.
Adverse events related to misconnections of devices and lines.
Hospitals and other health care facilities depend on a variety
of catheters, tubing, and syringes to deliver medications and
other substances to patients through vascular, enteral,
respiratory, and epidural (spinal) delivery systems. These
delivery systems frequently employ fittings called Luer
connectors to link various system components. 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. Today Luer connectors are used worldwide to
connect a variety of medical devices, components, and
accessories.
Unfortunately, the ubiquitous nature of the Luer connector
design allows for connection between unrelated delivery systems.
Because Luer connecters are easy-to-use and compatible between
different delivery systems, patient care staff can inadvertently
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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.
SB 158 (Florez), Chapter 294, Statutes of 2008, addressed a
number of issues designed to improve patient safety, including a
requirement that, as of January 1, 2011, certain health
facilities must use separate, unique connectors for IV, enteral
feeding, and epidural connections to prevent adverse events
associated with misconnections. AB 818 (Hernandez), Chapter
476, Statutes of 2009, delayed the effective dates in SB 158 and
established a new deadline - January 1, 2013, for enteral
feeding and IV connections and January 1, 2014, for epidural
connections. AB 818 also required certain health facilities to
include in their patient safety plans measures to prevent
adverse events associated with misconnections and required the
Advanced Medical Technology Association (AdvaMed), to report
annually to the Legislature regarding the progress of the
International Organization for Standardization (ISO) in
developing new design standards. AB 1867 (Pan), Chapter 194,
Statutes of 2012, delayed the deadline for implementing the ban
on compatible IV, epidural, and enteral feeding systems until
January 1, 2016.
AdvaMed report on ISO progress. On December 15, 2014, AdvaMed
provided the Assembly and Senate Health Committees with their
statutorily required report on the progress of the ISO in
solving the problem of tubing misconnections. According to the
report, the 2016 deadline will be met for IV and enteral feeding
lines; however, the epidural connector design was recently found
to still have the ability to allow for misconnection with an IV
and requires more time for redesign and testing. The AdvaMed
report notes that, "?without a delay of the 2016 deadline to
allow completion of the epidural effort, there could be a
proliferation of proprietary new connectors that will add to the
list of possible misconnections and create a cost burden for
California hospitals."
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The International Organization for Standardization. The ISO is
an international standard-setting body composed of
representatives from various national standards organizations.
The organization promotes worldwide proprietary, industrial, and
commercial standards. ISO launches the development of new
standards in response to stakeholders that express a clearly
established need for them. ISO standards are developed by
technical committees comprising of experts from the industrial,
technical, and business sectors which have asked for the
standards.
The ISO has been working on an international standard for IV
connectors since 2008. The work group is comprised of
participants from 31 countries headed by a nurse from the
federal Food and Drug Administration. The workgroup discovered
the Luers in use were more complicated than previously thought.
Nine different dimensions of the Luer had to be taken into
consideration (for example, the length, the circumference at
various points, etc.) It took until December of 2011 to develop
what is called the Masa Cone, which allows for different size
tubing dimensions to be attached to various points on the Luer.
After that, the ISO moved forward designs for each type of
tubing that connect to the Luer, which have taken roughly three
years to get through the ISO process. At each phase of the
process designs must be sent out for feasibility testing and
member comment before draft international standards can be
released. It was during this process that the working group
discovered a design problem with the epidural connector after
feasibility testing. The epidural connector was then
re-designed and sent back out for comment, adding a year to the
process.
Analysis Prepared by:
Lara Flynn / HEALTH / (916) 319-2097 FN:
0001129
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