BILL ANALYSIS �
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|SENATE RULES COMMITTEE | AB 1867|
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THIRD READING
Bill No: AB 1867
Author: Pan (D), et al.
Amended: 3/29/12 in Assembly
Vote: 21
SENATE HEALTH COMMITTEE : 8-0, 6/6/12
AYES: Hernandez, Harman, Anderson, Blakeslee, De Le�n,
DeSaulnier, Rubio, Wolk
NO VOTE RECORDED: Alquist
SENATE APPROPRIATIONS COMMITTEE : Senate Rule 28.8
ASSEMBLY FLOOR : 74-0, 4/26/12 (Consent) - See last page
for vote
SUBJECT : Health facilities: equipment standards
SOURCE : Advanced Medical Technology Association
DIGEST : This bill extends, until January 1, 2016, the
implementation date of a prohibition on the use of an
epidural, intravenous, or enteral feeding connector that
fits into a connection port other than the type for which
it was intended. Under existing law, for intravenous and
enteral feeding connectors, this prohibition is scheduled
to take effect on January 1, 2013, while the prohibition on
these types of epidural connectors is scheduled to take
effect on January 1, 2014.
ANALYSIS :
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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.
2. Requires general acute care, acute psychiatric, and
special hospitals to develop, implement, and comply with
a patient safety plan for the purposes of reducing
preventable patient safety events. Includes, among the
patient safety events that must be included in a
hospital's patient safety plan, patient deaths or
serious disabilities that are associated with the use of
a device, including but not limited to a catheter,
drain, or other specialized tube, infusion pump, or
ventilator, in which the device is used or functions
other than as intended.
3. Prohibits, beginning 36 months after the publication of
a new design standard for connections for epidural
applications by the International Organization for
Standardization (ISO), or January 1, 2014, whichever
occurs first, 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 impairs the ability
to provide health care.
4. Prohibits, beginning 24 months after the publication of
a new design standard for connections for intravenous or
enteral applications by the ISO, or January 1, 2013,
whichever occurs first, general acute care, acute
psychiatric, and special hospitals from using an
intravenous or enteral feeding connection that would fit
into a connection port other than the type for which it
was intended, unless an emergency or urgent situation
exists and the prohibition would impair the ability to
provide health care.
5. Requires the Advanced Medical Technology Association, on
January 1 of each year until the standards are
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developed, to provide the Legislature with a report on
the progress of the ISO in developing new design
standards for connections for intravenous, epidural, or
enteral applications.
6. Requires a health facility that is required to develop a
patient safety plan, as specified, to include in the
patient safety plan measures to prevent adverse events
associated with misconnecting intravenous, enteral
feeding, and epidural lines. Requires this provision to
become inoperative when the above provisions take effect
prohibiting the use of connections that can fit into
connections other than those intended.
This bill:
1. Extends the implementation date of a 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, 2014, or 36 months after the
publication of a new design standard, whichever occurs
first, and instead prohibits the use of these epidural
connections beginning on January 1, 2016.
2. Extends the implementation date of a prohibition on the
use of an intravenous connection or an enteral feeding
connection that would fit into a connection port other
than the type for which it was intended, from January 1,
2013, or 24 months after the publication of a new design
standard, whichever occurs first, and instead prohibits
the use of these intravenous or enteral connections
beginning on January 1, 2016.
Background
Adverse events related to misconnections of devices and
lines . According to the Food and Drug Administration
(FDA), 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, epidural and intrathecal
(spinal) delivery systems. These delivery systems
frequently employ fittings called Luer connectors to link
various system components. The male and female components
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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 vascular, enteral, respiratory, epidural, and
intrathecal medical devices, components, and accessories.
Unfortunately, the ubiquitous nature of the Luer connector
design allows for connection between unrelated delivery
systems (e.g., vascular, enteral, respiratory, epidural,
and intrathecal medical devices, components, and
accessories). Because Luer connectors are ubiquitous,
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.
ISO standards development process . According to its Web
site, the ISO develops and publishes international
standards and is comprised of a network of the national
standards institutes of 161 countries. ISO launches the
development of new standards in response to sectors and
stakeholders that express a clearly established need for
them. To be accepted for development, a proposed work item
must receive the majority support of the participating
members of the ISO technical committee, which, among other
criteria, verifies the "global relevance" of the proposed
item - this means that it indeed responds to an
international need and will eventually be suitable for
implementation on as broad a basis as possible worldwide.
ISO standards are developed by technical committees
comprising experts from the industrial, technical and
business sectors which have asked for the standards. These
experts may be joined by representatives of government
agencies, testing laboratories, consumer associations,
non-governmental organizations and academic circles.
FISCAL EFFECT : Appropriation: No Fiscal Com.: Yes
Local: No
SUPPORT : (Verified 6/26/12)
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Advanced Medical Technology Association (source)
Abbott Laboratories
American Society for Parenteral and Enteral Nutrition
Baxter
BayBio
BD
BIOCOM
Boston Scientific
California Association of Nurse Anesthetists, Inc.
California Healthcare Institute
California Society of Anesthesiologists
Covidien
Hospira
I-Flow LLC
Infusion Nurses Society
Institute for Safe Medication Practices
Kimberly-Clark
Nestle HealthCare Nutrition, Inc.
Oley Foundation
Philips Electronics
OPPOSITION : (Verified 6/26/12)
California Nurses Association
ARGUMENTS IN SUPPORT : This bill is sponsored by the
Advanced Medical Technology Association (AdvaMed), which
states that this bill will promote patient safety by
ensuring that the international standards process begun by
the ISO will have sufficient time to create standardized
designs for the basic Luer and enteral, epidural and IV
connectors. AdvaMed states that the January 1, 2016, date
will allow sufficient time to perform this rigorous and
critical process, while also allowing sufficient time for
device makers to get FDA approval of the new designs and
bring their products to market.
AdvaMed states that according to the Association for the
Advancement of Medical Instrumentation, the secretariat of
the ISO Working Group, final standards are not expected to
be published until the first half of 2014. Because the ISO
drafting process is still underway, there is no way for
anyone to meet the current deadline. Absent an extension
to allow these new design standards to be developed, the
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wrong outcome could lead to a far more dangerous health
care environment than what currently exists today,
fostering unintended consequences, possibly creating new
risks, or creating a solution that could not be
manufactured cost effectively or would be too complicated
for users.
ARGUMENTS IN OPPOSITION : The California Nurses
Association (CNA) is opposed to this bill, stating that it
needlessly prolongs prohibitions against the use of
medically unsafe connectors for epidural, intravenous and
enteral tubing. CNA points to the recent death of a cancer
patient at Alta Bates Summit Hospital when CNA nurses were
locked out by the employer and a replacement nurse hired by
the hospital placed a liquid feeding meant for a feeding
tube in the patient's stomach into the patient's
intravenous line. According to CNA, medical devices that
are currently available can significantly decrease the
likelihood of connection errors and the use of these
protective device requirements should be implemented by the
dates in current law. CNA states that the process of
improvement is an ongoing one but one that should not be
delayed by thinly veiled attempts by the hospital industry
to increase profits in the guise of awaiting international
consensus.
ASSEMBLY FLOOR : 74-0, 4/26/12
AYES: Achadjian, Alejo, Allen, Ammiano, Atkins, Beall,
Bill Berryhill, Block, Blumenfield, Bonilla, Bradford,
Brownley, Buchanan, Butler, Charles Calderon, Campos,
Carter, Chesbro, Conway, Cook, Davis, Dickinson,
Donnelly, Eng, Feuer, Fletcher, Fong, Fuentes, Beth
Gaines, Galgiani, Garrick, Gatto, Gordon, Gorell, Grove,
Hagman, Hall, Hayashi, Roger Hern�ndez, Hill, Huber,
Hueso, Huffman, Jeffries, Knight, Lara, Logue, Bonnie
Lowenthal, Ma, Mansoor, Mendoza, Miller, Mitchell,
Monning, Morrell, Nestande, Nielsen, Norby, Olsen, Pan,
Perea, V. Manuel P�rez, Portantino, Silva, Skinner,
Solorio, Swanson, Torres, Valadao, Wagner, Wieckowski,
Williams, Yamada, John A. P�rez
NO VOTE RECORDED: Cedillo, Furutani, Halderman, Harkey,
Jones, Smyth
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CTW:k 6/26/12 Senate Floor Analyses
SUPPORT/OPPOSITION: SEE ABOVE
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