BILL ANALYSIS Ó
SENATE COMMITTEE ON HEALTH
Senator Ed Hernandez, O.D., Chair
BILL NO: AB 1867
AUTHOR: Pan
AMENDED: March 29, 2012
HEARING DATE: June 6, 2012
CONSULTANT: Marchand
SUBJECT : Health facilities: equipment standards.
SUMMARY : 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 current 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.
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 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.
Continued---
AB 1867 | Page 2
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 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.
FISCAL EFFECT : According to the Assembly Appropriations
Committee, this bill has negligible state fiscal impact.
AB 1867 | Page
3
PRIOR VOTES :
Assembly Health: 17- 0
Assembly Appropriations:17- 0
Assembly Floor: 74- 0
COMMENTS :
1.Author's statement. According to the author, SB 158 (Florez),
Chapter 294, Statutes of 2008, became law as a multi-pronged
bill that addressed a number of issues designed to improve
patient safety and decrease infections in a variety of health
care environments. Included in SB 158 was a requirement that,
as of January1, 2011, all hospitals must use separate unique
connectors for intravenous, enteral (feeding tube) and
epidural connections. The intent was to address past mistakes
in hospital environments where an employee switched one type
of line with another, causing serious injury or death.
The author states that 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
delivery systems. The delivery systems listed above (vascular,
enteral, etc.) 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. Thousands of these connections are used in
hospital environments in California daily, with millions sold
annually. These products are critical to the daily care of
patients in all parts of a hospital environment. The process
of creating a unique connector that can be adopted by all
manufacturers and interchangeable among pumps for that
specific medication can take over two years to develop the
design alone.
According to the author, the Food and Drug Administration
(FDA) has been actively participating in an international
effort with the ISO to develop and implement standards for
non-interchangeable connectors for small-bore medical
connectors used in intravascular, breathing systems, enteral,
urethral/urinary, cuff inflation, and neuraxial applications.
Once implemented, these connectors will facilitate correct
connections and eliminate incompatible tubing misconnections.
AB 1867 | Page 4
The author states that unless there is an industry standard
for connections, hospitals will have to purchase proprietary
products and accessories at incredible cost. Additionally,
each hospital may have different equipment for one of the most
common functions in medical care. This could create confusion
and possibly risk patient safety.
According to the author, there is no way to develop
international standards in time to meet the deadlines in
California law, and therefore, a delay is critically needed.
Extending the deadline will allow the ISO to complete its work
and allow the industry to meet this important mandate through
a common design format.
The goal of this proposal is to promote patient safety through
the creation of publicly available designs for each unique
connection, but to do it thoughtfully and correctly.
2.Adverse events related to misconnections of devices and lines.
According to the 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 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.
3.ISO standards development process. According to its website,
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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.
4.Prior legislation. SB 158 (Florez), Chapter 294, Statutes of
2008, among other provisions, requires hospitals to institute
a patient safety plan for the purpose of improving the health
and safety of patients and reducing preventable patient safety
events. Prohibits, beginning January 1, 2011, general acute
care, acute psychiatric, and special hospitals 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 SB 158 to 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.
5.Support. This bill is sponsored by the Advanced Medical
Technology Association (AdvaMed), which states that this bill
AB 1867 | Page 6
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 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.
6.Opposition. The California Nurses Association (CNA) is
opposed to this bill, stating that it would needlessly prolong
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.
SUPPORT AND OPPOSITION :
Support: AdvaMed (sponsor)
Abbott Laboratories
American Society for Parenteral and Enteral Nutrition
Baxter
BayBio
AB 1867 | Page
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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
Oppose: California Nurses Association
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