BILL ANALYSIS
AB 818
Page A
Date of Hearing: April 21, 2009
ASSEMBLY COMMITTEE ON HEALTH
Dave Jones, Chair
AB 818 (Hernandez) - As Introduced: February 26, 2009
SUBJECT : Health facilities: connection ports.
SUMMARY : Delays, from January 1, 2011 to January 1, 2014, the
prohibition on a hospital using an intravenous, enteral, or
epidural connection that would fit into a connection port other
than the type for which it was intended.
EXISTING LAW prohibits, beginning January 1, 2011, a health
facility from using an intravenous connection, epidural
connection, or enteral feeding connection that would fit into a
connection port other than the type it was intended for, except
in an emergency or urgent situation, as specified.
FISCAL EFFECT : This bill has not been analyzed by a fiscal
committee.
COMMENTS :
1)PURPOSE OF THIS BILL : According to the author, health
facilities depend on a variety of catheters, tubing, and
syringes to deliver medications and other substances to
patients through vascular, enteral, respiratory, epidural
(outer part of the spinal canal), and intrathecal (spinal
canal or fluid) delivery systems. These delivery systems
frequently employ fittings called Luer connectors to link
various system components. The author states thousands of
these connections are used in hospital environments in
California daily and are critical to the daily care of
patients in all parts of the hospital environment. The author
states that changing an industry standard for very commonly
used enteral and epidural connections will not be accomplished
within the next two years, as required by SB 158 (Florez),
Chapter 294, Statutes of 2008, and this bill is needed to
allow the industry to meet this important mandate through a
common design format. The author makes several arguments for
allowing time for the development of a common design format.
First, the author contends that without a common design format
or industry standard, hospitals will have to purchase
proprietary products and accessories at high cost. The author
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states these devices currently have low cost because of
volume, and creating a standardized design for these types of
regularly used connectors is important to keeping the costs
down. Second, the author argues that without a common design
format, each hospital might use different equipment, leading
to confusion and possibly risking patient safety.
Additionally, the author argues that this bill will give the
International Standards Organization (ISO) and the federal
Food and Drug Administration (FDA) time to harmonize their
efforts to create a global standard, as well as give industry
time to ramp up manufacturing of the products.
According to the author, the ISO committee review takes
approximately 24 months. After standards are adopted,
industry must complete several additional processes, such as
assessing the standards and identifying specifications and
changes required to create a mold, developing specifications
to create new molds and tools; changing manufacturing
processes; testing new products for interconnectability and
shelf life; developing regulatory documents for submission to
FDA; and, market introduction and customer education. The
author states the FDA review time is three to six months.
After FDA approval, the author states a manufacturer is likely
to need another three to six months to manufacturer enough
product to meet hospital needs.
2)CONNECTORS . According to Hayes, Inc., a medical research
consulting firm, Luer connectors have male and female
components which join together to create secure yet detachable
leak-proof connections. Multiple connections between medical
devices and tubing are common in patient care, and because
Luer connectors are ubiquitous, easy-to-use, and compatible
between different delivery systems, clinicians can
inadvertently connect wrong systems together, causing
medication or other fluids to be delivered through the wrong
route. Such errors have caused serious patient injuries and
deaths. A November 2008 FDA Webcast states that Luer
connector misconnections are underrecognized but common and
potentially dangerous events. Hayes reports that despite the
efforts of FDA and other organizations to reduce
misconnections through education, protocol, and monitoring,
dangerous misconnections continue to occur.
3)STANDARDS . ISO is the global entity focused on creating
standards for commonly used materials including medical and
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other devices. An ISO committee was created to bring together
international health departments, industry experts and
manufacturers to develop standards for global application.
According to an industry representative who is a member of the
ISO committee, the committee has been working on connections
for enteral lines, but will begin the review of connections
for epidural lines in May 2009. The ISO committee also
intends to review the existing standard for intravenous
connectors. In February 2009, FDA issued a letter stating it
is working with ISO and the International Electrotechnical
Commission and plans to publicize standards for connectors
used in intravascular breathing systems and enteral, epidural,
and other applications, but it did not provide a timeline.
4)SUPPORT . Abbott Nutrition writes in support of this bill that
the effective date of January 1, 2011 precedes the completion
of an international effort of regulatory agencies, medical
standards and instrumentation bodies and health care
associations to develop a worldwide technical standard for
non-interchangeable connections. Abbott Nutrition writes it
is not feasible for hospitals and manufacturers to comply with
the law without industry standards, and the absence of
standards would result in a myriad of connection interfaces
for each application, limiting compatibility among
manufacturers. Abbott Nutrition states it would be difficult
for a facility to use enteral formulas from different
manufacturers, and this bill will ensure the standard setting
process is complete, give manufacturers time to make compliant
products, and allow hospital staff to be trained in their use.
The Advanced Medical Technology Association (AdvaMed) and
Hospira, Inc. write in support that FDA, the Joint Commission
(formerly Joint Commission on Accreditation of Healthcare
Organizations, a private, non-profit health care accreditation
and certification organization), the American Hospital
Association, the American Society for Parenteral and Enteral
Nutrition, the Association for the Advancement of Medical
Instrumentation, and ISO are addressing inappropriate
connections of medical tubing, and that FDA is working with
ISO to develop standards for non-interchangeable connectors.
AdvaMed writes the development and implementation of these
standards is expected to take approximately three years.
AdvaMed and Hospira, Inc. also note that in the interim, the
following steps can be taken to mitigate the risk of
misconnections: labeling catheters; educating health care
workers on the importance of tracing lines to the point of
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origin before making connections; and, color coding of tubing
and connectors.
5)PREVIOUS LEGISLATION . SB 158, in addition to provisions
described above, establishes an infection surveillance,
prevention, and control program to provide oversight of
hospital efforts to address hospital-associated infections,
expands the responsibilities of the existing Healthcare
Associated Infection Advisory Committee, and requires all
hospitals to institute a plan to improve the health and safety
of patients.
6)POLICY QUESTION . Given that international efforts to address
standards for connectors are underway but likely to be
complete at different times for the three types of connections
this bill addresses, instead of delaying the effective date of
this requirement for three years, should this bill require
health facilities to comply with the ISO standards for each
type of connector within a specified time period of the
implementation of each standard?
7)AMENDMENTS . The author plans to amend this bill as follows:
a) Timelines . Change the effective date of the prohibition
to the earlier of January 1, 2014, or three years after ISO
adopts standards for each of the connectors referenced in
this bill.
b) Standards Progress . Require AdvaMed to annually provide
a report to the Legislature on the status of the ISO
process for developing each standard.
c) Adverse Events Reports . Require DPH to annually provide
to the Legislature a report on adverse events associated
with tubing misconnections in health facilities (unless
this amendment adds significant cost).
REGISTERED SUPPORT / OPPOSITION :
Support
Hospira, Inc. (sponsor)
Abbott Nutrition
Advanced Medical Technology Association (AdvaMed)
Baxter Healthcare
AB 818
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Opposition
None on file.
Analysis Prepared by : Allegra Kim / HEALTH / (916) 319-2097