BILL ANALYSIS Ó
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|SENATE RULES COMMITTEE | AB 444|
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CONSENT
Bill No: AB 444
Author: Gipson (D), et al.
Amended: 6/1/15 in Senate
Vote: 21
SENATE HEALTH COMMITTEE: 9-0, 6/17/15
AYES: Hernandez, Nguyen, Hall, Mitchell, Monning, Nielsen,
Pan, Roth, Wolk
SENATE APPROPRIATIONS COMMITTEE: Senate Rule 28.8
ASSEMBLY FLOOR: 78-0, 4/23/15 (Consent) - See last page for
vote
SUBJECT: Health facilities: epidural and external feeding
connectors
SOURCE: AdvaMed
DIGEST: This bill 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. This bill delays, until
January 1, 2017, the deadline prohibiting general acute care,
acute psychiatric, special hospitals, and SNFs from using
certain epidural connector devices.
ANALYSIS:
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
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Department of Public Health.
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.
4)Requires that every year on January 1, until standards are
adopted, the AdvaMed (also known as Advanced Medical
Technology Association) 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.
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
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include epidural or enteral medical equipment. Current
standards for medical connectors can lead to device
misconnection, where devices that have compatible connectors
are accidentally connected to the wrong device and can lead to
serious medical complications. Existing 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. The ISO
is an international standard-setting body composed of
representatives from various national standards organizations,
and promotes worldwide proprietary, industrial, and commercial
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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 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 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
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systems. Accordingly, the industry has also requested a six
month delay in implementation of standardized enteral systems.
Prior Legislation
SB 158 (Florez, Chapter 294, Statutes of 2008), among other
provisions, required hospitals and SNFs to 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 IV 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 IV or enteral connections.
AB 818 also required AdvaMed 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 IV, 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.
FISCAL EFFECT: Appropriation: No Fiscal
Com.:YesLocal: No
SUPPORT: (Verified6/30/15)
AdvaMed (source)
ALCOR Scientific, Inc.
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American Society of Health-System Pharmacists
Association for the Advancement of Medical Instrumentation
B. Braun Medical, Inc.
Bard Peripheral Vascular
Baxter
Beckman, Dickinson, and Company
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
Novation
Pajunk Medical Systems
Premier Healthcare Alliance
Teleflex Medical
OPPOSITION: (Verified6/30/15)
None received
ARGUMENTS IN SUPPORT: AdvaMed, this bill's sponsor, 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 Health 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 Health, Medtronic, and MedAssets state that
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without this bill, there will be an unreasonable risk to patient
safety. Beckman, Dickinson, and Company (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.
ASSEMBLY FLOOR: 78-0, 4/23/15
AYES: Achadjian, Alejo, Travis Allen, Baker, Bigelow, Bloom,
Bonilla, Bonta, Brough, Brown, Burke, Calderon, Chang, Chau,
Chávez, Chiu, Chu, Cooley, Cooper, Dababneh, Dahle, Daly,
Dodd, Eggman, Frazier, Beth Gaines, Gallagher, Cristina
Garcia, Eduardo Garcia, Gatto, Gipson, Gomez, Gonzalez,
Gordon, Gray, Grove, Hadley, Harper, Roger Hernández, Holden,
Irwin, Jones, Jones-Sawyer, Kim, Lackey, Levine, Linder,
Lopez, Low, Maienschein, Mathis, Mayes, McCarty, Medina,
Melendez, Mullin, Nazarian, Obernolte, O'Donnell, Olsen,
Patterson, Perea, Quirk, Rendon, Ridley-Thomas, Rodriguez,
Santiago, Steinorth, Mark Stone, Thurmond, Ting, Wagner,
Waldron, Weber, Wilk, Williams, Wood, Atkins
NO VOTE RECORDED: Campos, Salas
Prepared by:Shannon Muir / HEALTH /
7/1/15 14:56:50
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