BILL ANALYSIS
SENATE HEALTH
COMMITTEE ANALYSIS
Senator Elaine K Alquist, Chair
BILL NO: AB 818
A
AUTHOR: Hernandez
B
AMENDED: April 28, 2009
HEARING DATE: June 25, 2009
8
CONSULTANT:
1
Hansel/Orr/sh
8
SUBJECT
Health facilities: connection ports
SUMMARY
Delays the January 1, 2011 date for implementation of a
prohibition against hospitals using intravenous, epidural,
and enteral feeding connection devices that fit into
connection ports other than the type they are intended for
to 36 months after the publication of a new design standard
for the connections by the International Organization for
Standardization (ISO), or January 1, 2014, whichever occurs
first. 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 the new design
standards.
CHANGES TO EXISTING LAW
Existing law:
Existing law 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).
Continued---
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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.
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 it was intended for, unless an
emergency or urgent situation exists and the prohibition
impairs the ability to provide health care.
Authorizes DPH to assess administrative penalties of up to
$125,000 against a general acute care, acute psychiatric,
or special hospital for licensing deficiencies that
constitute immediate jeopardy to the health or safety of a
patient, defined as a situation in which the facility's
noncompliance with one or more requirements of licensure
has caused, or is likely to cause, serious injury or death
to the patient.
This bill:
Changes the January 1, 2011 date for implementation of the
prohibition against hospitals using intravenous, epidural,
and enteral feeding connection devices that fit into
connection ports other than the type they are intended for
to 36 months after the publication of a new design standard
for connections for intravenous, epidural, or enteral
applications by the International Organization for
Standardization (ISO), or January 1, 2014, whichever occurs
first.
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 the new design standards.
STAFF ANALYSIS OF ASSEMBLY BILL 818 (Hernandez) Page
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FISCAL IMPACT
According to the Assembly Appropriations Committee analysis
of AB 818:
No direct fiscal impact for hospitals to eventually
comply with the standardization of medical connections
required by this bill.
Once adopted, significant savings to payers,
including Medi-Cal, Healthy Families and CalPERS, may
accrue to the extent the standardization of medical
connections reduces morbidity and mortality in
in-patient settings.
BACKGROUND AND DISCUSSION
According to the author, AB 818 would extend, by up to
three years, the deadline for hospitals to use separate,
unique connectors for intravenous, enteral (feeding), and
epidural lines for administering therapies to patients
(i.e., a separate type of connector for each type of line).
The author states that this will allow sufficient time for
a standardized design for these types of connectors to be
developed. The author argues that unless an industry
standard for these connections is in place, hospitals will
have to purchase multiple different, and incompatible
products to ensure that they don't use interchangeable
connectors to administer these therapies, which would be
costly and inefficient. The author asserts that the lack
of standardization would also impair the movement of
patients among health care settings, if different settings
use different types of equipment.
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
STAFF ANALYSIS OF ASSEMBLY BILL 818 (Hernandez) Page
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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.
ISO standards development process
To further reduce the occurrence of these misconnections,
the FDA is actively participating in an international
effort to develop and implement standards for
non-interchangeable connectors for small bore medical
connectors. A joint working group established by the ISO
and the International Electrotechnical Commission (IEC)
leads this effort. Once implemented, these connectors will
facilitate correct connections and eliminate incompatible
tubing misconnections.
According to information provided by Hospira, the sponsor
of AB 818, the ISO committee charged with developing
standards for small bore medical connectors expects to
publish draft standards for connectors for enteral feeding
applications by January 2010 and final standards by July
2011. Standards for connectors for epidural applications
are expected to be developed by July 2010 (draft standards)
and December 2011 (final standards). As part of this
process, the ISO committee will review existing standards
for intravenous connectors. According to the sponsor, it
will take companies three years beyond the publishing of
final standards for the connectors to develop and test new
STAFF ANALYSIS OF ASSEMBLY BILL 818 (Hernandez) Page
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products incorporating the standards, and obtain FDA
approval of them as new medical devices.
According to its website, 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, amongst 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.
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 it was intended for, with
exceptions, as specified.
SB 541 (Alquist), Chapter 605, Statutes of 2008 and SB 1312
(Alquist), Chapter 895, Statutes of 2006, Among other
provisions, these bills authorize DPH to assess
administrative penalties against general acute care, acute
psychiatric, or special hospitals for licensing
deficiencies that constitute immediate jeopardy to the
health or safety of a patient, defined as a situation in
which the facility's noncompliance with one or more
requirements of licensure has caused, or is likely to
STAFF ANALYSIS OF ASSEMBLY BILL 818 (Hernandez) Page
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cause, serious injury or death to the patient.
Arguments in support
Hospira, Inc., the sponsor of AB 818, states that it is
important for standards for connectors to be in place to
allow the manufacture of low-cost, safe devices for
hospitals. Without standards, there is potential that
emergency health care providers could be faced with
multiple proprietary devices-for example, there is a
potential that the IV connector used by the ambulance will
not be the same as the one used by the emergency room. In
the meantime, important steps can be taken to mitigate the
risk of misconnections, including labeling catheters,
worker training on the importance of tracing lines to the
point of origin prior to making connections, and color
coding of tubing and connectors.
The Advanced Medical Technology Association (AdvaMed), a
trade association representing medical device
manufacturers, states that while it supports efforts to
address the problem of misconnections of intravenous,
epidural, and enteral feeding lines, there must be
appropriate standards in place for manufacturers to follow.
AB 818 would establish a reasonable timeline for those
standards to be developed.
PRIOR ACTIONS
Assembly Appropriations: 16-0
Assembly Health: 19-0
Assembly Floor: 77-0
COMMENTS
1. Timeline for implementation of prohibition on use of
interchangeable connectors. Under the bill, the
prohibition on use of interchangeable connectors for
intravenous, enteral feeding, and epidural lines would
take effect 36 months after the ISO develops standards
for the connectors, or January 1, 2014, whichever occurs
first. However, according to information provided by the
sponsors of AB 818, the ISO is expected to publish
standards for connectors for enteral feeding applications
by July 2011 and for connectors for epidural applications
by December 2011. This would allow manufacturers 2 to
STAFF ANALYSIS OF ASSEMBLY BILL 818 (Hernandez) Page
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2/12 years to develop products to meet the standards,
once the standards are in place. Is it reasonable to
allow device manufacturers this much time to develop
products? Should the bill specify an earlier drop-dead
date to keep up pressure for standards to be developed
and for manufacturers to develop new products?
2. Interim measures to mitigate risk of misconnections.
Hospitals currently use a variety of techniques to
mitigate the risk of misconnecting lines, including
instructing staff to always trace a tube or catheter from
the patient to the point of origin before connecting any
new device, routing tubes and catheters having different
purposes in different directions (e.g. certain types of
lines towards the head or feet), and labeling or color
coding catheters and tubes. A number of these measures
are currently recommended by the FDA and the Joint
Commission, which accredits hospitals. Should the bill
additionally require hospitals to include in their
patient safety plans measures to prevent adverse events
associated with misconnecting intravenous, enteral
feeding, and epidural lines, during the time the
standards and new devices are being developed?
POSITIONS
Support: Hospira, Inc. (sponsor)
Abbott Nutrition
Advanced Medical Technology Association
(AdvaMed)
Baxter Healthcare
California Healthcare Institute
Oppose: None received
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