BILL ANALYSIS Ó
AB 444
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Date of Hearing: April 7, 2015
ASSEMBLY COMMITTEE ON HEALTH
Rob Bonta, Chair
AB 444
(Gipson) - As Introduced February 23, 2015
SUBJECT: Health facilities: epidural connectors.
SUMMARY: Delays, until January 1, 2017, the deadline
prohibiting general acute care, acute psychiatric, and special
hospitals from using certain epidural (spinal) connector
devices.
EXISTING LAW:
1)Provides for the licensing and regulation of health
facilities, including general acute care hospitals, acute
psychiatric hospitals, and special hospitals by the Department
of Public Health (DPH).
2)Requires the hospitals referenced in 1) above to develop,
implement, and comply with a patient safety plan to reduce
adverse events, and requires the safety plan to include
measures to prevent adverse events associated with
misconnecting intravenous (IV), enteral (intestinal) feeding,
and epidural lines.
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3)Prohibits, as of January 1, 2016, general acute care, acute
psychiatric, and special hospitals from using an epidural
connection that would fit into a connection port 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.
FISCAL EFFECT: This bill has not yet been analyzed by a fiscal
committee.
COMMENTS:
1)PURPOSE OF THE BILL. 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.
2)BACKGROUND.
a) 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
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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 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.
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b) 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."
c) The International Organization for Standardization. The
ISO is an international standard-setting body composed of
representatives from various national standards
organizations. Founded on February 23, 1947, the
organization promotes worldwide proprietary, industrial,
and commercial standards. ISO launches the development of
new standards in response to sectors and 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
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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.
3)SUPPORT. AdvaMed, the sponsor of this bill, states absent
standard connector design, industry would have to implement
proprietary connectors increasing cost to manufacturers, heath
care facilities, and ultimately patients while creating
unacceptable risk to patient safety. Given that risk, AdvaMed
supports delaying implementation to January 1, 2017 to ensure
standards with a common design for all epidural suppliers.
Standardization will allow health care facilities to purchase
compatible epidural devices from multiple suppliers and
minimize costs.
Numerous manufacturers write that they are actively
participating in the efforts of the ISO to develop and
implement standardized solutions for non-interchangeable
connectors, and while the ISO standards setting process has
taken longer than anticipated, the new connector designs that
result from the process will facilitate appropriate
connections across an even broader range of high risk clinical
applications and eliminate incompatible tubing misconnections.
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4)PREVIOUS LEGISLATION.
a) AB 1867 delayed the deadline for implementation of the
ban on compatible IV, epidural and enteral feeding systems
until January 1, 2016.
b) AB 818 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.
c) SB 158, among other provisions, established a deadline
of January 1, 2011, for certain health facilities to use
separate, unique connectors for IV, enteral feeding, and
epidural connections.
REGISTERED SUPPORT / OPPOSITION:
Support
Advancing Safety in Medical Technology
American Society of Health-System Pharmacists
B. Braun Medical, Inc.
Baxter Healthcare
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BD
Biocom
California Healthcare Institute
California Society of Anesthesiologists
Halyard Health
Institute for Safe Medication Practices
MedAssets, Inc.
Novation
PAJUNK Medical Systems
Premier Healthcare Alliance
Teleflex Medical
Opposition
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None on file.
Analysis Prepared by:Lara Flynn / HEALTH / (916) 319-2097