BILL ANALYSIS Ó
SENATE COMMITTEE ON HEALTH
Senator Ed Hernandez, O.D., Chair
BILL NO: AB 444
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|AUTHOR: |Gipson |
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|VERSION: |June 1, 2015 |
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|HEARING DATE: |June 17, 2015 | | |
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|CONSULTANT: |Shannon Muir |
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SUBJECT : Health facilities: epidural connectors and external
feeding connectors.
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.
Existing law:
1)Provides for the licensing and regulation of health
facilities, including general acute care hospitals, acute
psychiatric hospitals, special hospitals, and SNFs by the
Department of Public Health (DPH).
2)Requires the health facilities 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.
3)Prohibits, as of January 1, 2016, the health facilities
reference in 1) from using an IV, epidural, or enteral
connection that would fit into a connection port other than
the type for it was intended, unless an emergency or urgent
situation exists and the prohibition would impair the ability
to provide health care.
AB 444 (Gipson) Page 2 of ?
4)Requires that every year on January 1, until standards are
adopted, the Advanced Medical Technology Association (AdvaMed)
provides the Legislature with a report on the progress of the
International Organization of Standardizations (ISO) in
developing new design standards for connectors for IV,
epidural, or enteral applications.
This bill:
1)Extends the implementation date of the prohibition on the use
of an enteral feeding connection that would fit into a
connection port other than the type for which it was intended,
from January 1, 2016 to July 1, 2016.
2)Extends the implementation date of the prohibition on the use
of an epidural connection that fits into a connection port
other than the type for which it was intended from January 1,
2016 to January 1, 2017.
FISCAL
EFFECT : According to the Assembly Appropriations Committee,
this bill has negligible state fiscal impact.
PRIOR
VOTES :
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|Assembly Floor: |78 - 0 |
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|Assembly Appropriations Committee: |16 - 0 |
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|Assembly Health Committee: |18 - 0 |
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COMMENTS :
1)Author's statement. According to the author, AB 444 seeks to
ensure enhanced patient safety by extending the deadline on
hospital implementation of new standards for epidural and
enteral medical connectors. When patients receive care, they
often require connection to various hospital devices that may
include epidural or enteral medical equipment. Current
standards for medical connectors can lead to device
AB 444 (Gipson) Page 3 of ?
misconnection, where devices that have compatible connectors
are accidentally connected to the wrong device and can lead to
serious medical complications. Current law will make it so
that new standards are put in place that resolve the problem
of misconnection by making it so that certain connectors are
no longer compatible across devices. However, due to
complications in device development and distribution, the
timeline for the epidural and enteral medical equipment
standards need to be extended to ensure that hospitals are
able to effectively implement the new standards in line with
the statutory deadline.
2)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 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.
3)The International Organization for Standardization (ISO). The
ISO is an international standard-setting body composed of
representatives from various national standards organizations,
and 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
AB 444 (Gipson) Page 4 of ?
technical committees comprised of experts from the industrial,
technical, and business sectors which have asked for the
standards.
4)ISO progress and delays. Since beginning work on an
international standard for IV connectors in 2008, the ISO
workgroup discovered the Luers were more complicated than
previously thought. Nine different dimensions of the Luer had
to be taken into consideration (lengths, circumferences, etc.)
These complications prompted the Legislature in 2009 to delay
the implementation of standardization until January 1, 2013
for IV and enteral connectors, and January 1, 2014 for
epidural connectors. Designs for unique types of tubing that
connect to the Luer took 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. The lengthiness
of the ISO process prompted the State Legislature, in 2012, to
again delay implementation for all three connector types until
January 1, 2016.
On December 15, 2014, AdvaMed, the sponsor of this bill,
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 was to be met for IV and enteral
feeding lines; however, the epidural connector design was
found to allow for misconnection with an IV, and required 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."
Although the deadline was met for developing IV and enteral
designs, complications between manufacturers and distributers
have delayed the ability of the industry to 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.
5)Prior legislation. SB 158 (Florez, Chapter 294, Statutes of
2008), among other provisions, required hospitals and SNFs to
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institute a patient safety plan for the purpose of improving
the health and safety of patients and reducing preventable
patient safety events. SB 158 also prohibited, beginning
January 1, 2011, general acute care, acute psychiatric, and
special hospitals, and SNFs 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, with exceptions, as specified.
AB 818 (Hernandez, Chapter 476, Statutes of 2009), delayed the
January 1, 2011, implementation date of the portions of SB 158
related to medical connectors (Section 3) until 36 months
after the publication of a new design standard or January 1,
2014, whichever occurs first, for epidural connections, and to
24 months after the publication of new design standards or
January 1, 2013, whichever occurs first, for intravenous or
enteral connections. AB 818 also required the Advanced Medical
Technology Association to provide the Legislature with an
annual report on the progress of the ISO in developing the new
design standards and required hospitals to include in their
patient safety plan measures to prevent adverse events
associated with misconnecting intravenous, enteral feeding,
and epidural lines.
AB 1867 (Pan, Chapter 194, Statutes of 2012), delayed the
deadline for implementation of the ban on compatible IV,
epidural and enteral feeding systems until January 1, 2016.
6)Support. AdvaMed states that, absent a standard connector
design, industry would have to implement proprietary
connectors, increasing cost to manufacturers, health care
facilities, and ultimately patients, while creating
unacceptable risk to patient safety.
This bill is supported by numerous organizations and medical
technology companies. Halyard states it is imperative that all
manufactures move forward in a coordinated, nation-wide
transition to new, safer connections, and that supply concerns
with syringes require a delayed implementation of new
connections. Halyard, Medtronic, and MedAssets state that
without this bill, there will be an unreasonable risk to
AB 444 (Gipson) Page 6 of ?
patient safety. BD states that requiring healthcare facilities
in California to adhere to non-interconnectibility
requirements before the ISO process is complete could result
in temporary, interim solutions that are complicated for
healthcare providers, expensive to manufacture, and are not in
the best interest of patients.
SUPPORT AND OPPOSITION :
Support: AdvaMed (sponsor)
AAMI
ALCOR Scientific, Inc.
American Society of Health-System Pharmacists
B. Braun Medical, Inc.
Bard Peripheral Vascular
Baxter
BD
Biocom
California Association of Nurse Anesthetists
California Healthcare Institute
California Life Sciences Association
Corpak MedSystems, Inc.
Feeding Tube Awareness Foundation
Halyard Health, Inc.
Institute for Safe Medication Practices
Kentec Medical, Inc.
MedAssets
Medtronic
Pajunk Medical Systems
Premier Healthcare Alliance
Novation
Teleflex Medical
Oppose: None received
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