BILL ANALYSIS Ó
AB 1867
Page 1
Date of Hearing: April 10, 2012
ASSEMBLY COMMITTEE ON HEALTH
William W. Monning, Chair
AB 1867 (Pan) - As Amended: March 29, 2012
SUBJECT : Health facilities: equipment standards.
SUMMARY : Delays, until January 1, 2016, the current deadlines
for implementation of a prohibition against general acute care,
acute psychiatric, and special hospitals from using certain
connector devices for intravenous (IV), epidural, and enteral
feeding systems.
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.
3)Requires general acute care, acute psychiatric, and special
hospitals to include in their patient safety plans measures to
prevent adverse events associated with misconnecting IV,
enteral feeding, and epidural lines.
4)Prohibits general acute care, acute psychiatric, and special
hospitals from using an epidural connection that would fit
into a connection port other than the type for which it was
intended, beginning January 1, 2014 or 36 months after
specified prescribed standards are developed by the
International Organization for Standardization (ISO),
whichever comes first. Prohibits 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 beginning
January 1, 2013 or 24 months after specified prescribed
standards are developed by the ISO, whichever occurs first.
Requires the Advanced Medical Technology Association, on
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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.
5)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.
FISCAL EFFECT : This bill has not yet been heard by a fiscal
committee.
COMMENTS :
1)PURPOSE OF THIS BILL . According to the author, hospitals and
other healthcare facilities depend on a variety of catheters,
tubing, and syringes to deliver medications and other
substances to patients through vascular, enteral feeding,
respiratory, and epidural delivery systems. The author
maintains that these delivery systems frequently employ
fittings called Luer connectors to link various system
components and that multiple connections between medical
devices and tubings are common in patient care. The author
asserts that thousands of these connectors are used in
hospital environments in California daily, with millions sold
annually.
According to the author, the Food and Drug Administration (FDA)
is and has been actively participating in an international
effort with the ISO to develop and implement standards for
non-interchangeable connectors used in IV, breathing systems,
enteral feeding, urethral/urinary, cuff inflation, and
epidural applications. Once the ISO process is complete,
according to the author, international standards will be
established to facilitate correct connections and eliminate
incompatible tubing misconnections. The author asserts that
while worldwide experts participating in the development of
the new international standards are highly committed to
solving the problem of tubing misconnections, the process is,
and should be, rigorous enough to ensure that the work is done
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correctly the first time. The wrong outcome, the author
maintains, would lead to a far more dangerous healthcare
environment than what currently exists by fostering unintended
consequences, possibly creating new risks, or creating a
solution that cannot be manufactured cost effectively or is
too complicated for users. The author asserts, however, that
the ISO process to change the industry standard will not be
completed in time to be meet current deadlines required by AB
818 (Hernandez), Chapter 476, Statutes of 2009 and this bill
is needed to allow the industry to meet this important mandate
through a common design format. According to the sponsor, the
Advanced Medical Technology Association (AdvaMed), the ISO
committee review is estimated to be completed mid-year 2014.
The AdvaMed maintains that approximately 18 months is needed
for FDA approval and to bring the new standardized products to
market. The goal of this proposal, according to the author,
is to promote patient safety by allowing the appropriate
amount of time for the ISO to thoughtfully and correctly
create publicly available designs for each unique connection
through globally designed and recognized standards.
2)BACKGROUND . Luer connector systems are common to almost all
healthcare catheters, tubes, and syringes, making it easy to
connect one system to another. According to the FDA, 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
universal, 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.
SB 158 (Florez), Chapter 294, Statutes of 2008, was signed into
law and addressed a number of issues designed to improve
patient safety and decrease infections in a variety of
healthcare environments. Included in SB 158 was a requirement
that, as of January 1, 2011, certain health facilities must
use separate unique connectors for IV, enteral feeding and
epidural connections to prevent adverse events associated with
misconnections. In 2009, AB 818 (Hernandez) was passed into
law to delay the effective dates in SB 158 (Florez) and
established new deadlines - January 1, 2013 for enteral
feeding and IV connections and January 1, 2014 for epidural
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connections or by a period of time following the publication
of new ISO design standards. AB 818 (Hernandez) also required
certain health facilities to include in their patient safety
plans measures to prevent adverse events associated with
misconnections and required the AdvaMed, a trade association
representing medical device manufacturers, to report annually
to the Legislature regarding the progress of the ISO in
developing new design standards.
According to DPH, licensed health facilities are required to
report adverse events, as defined by law, that have occurred
in the facility within five days after the event has been
detected or, no later than 24 hours after the event has been
detected if the event is an ongoing urgent or emergent threat.
Upon review of 28 adverse events listed in current law, also
known as "never events," DPH determined that there are two
categories most likely to encompass occurrences of
misconnecting IV, enteral feeding or epidural lines. These
categories include "death or serious disability associated
with the use of a device other than intended" or "death or
disability due to medication error." DPH has confirmed
through manual review of each adverse event intake form in
these two categories during 2009-10 and 2010-11 that none of
the substantiated adverse events reported were the result of
IV, enteral feeding or epidural misconnections. DPH asserts
that, because of the serious implications of events of this
type, it is unlikely to go unnoticed.
3)ISO STANDARD DEVELOPMENT . The ISO is a global entity focused
on creating standards for commonly used materials including
medical and other devices. The development of international
standards involves regulatory agencies such as the FDA, large
and small medical device manufacturers, and representatives
from the US, Canada, multiple European countries, and Japan.
According to the Association for the Advancement of Medical
Information (AAMI), an alliance of healthcare professionals
with an interest in medical devices, in late 2010, an umbrella
standard was approved and published and the FDA officially
recognized it in 2011. This umbrella standard provides the
foundation for all of the more product-specific standards
currently under parallel development. These more
product-specific device standards are in various stages of
development and must be measured and evaluated against the
umbrella standard for the Luer connector. Initially, it was
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originally thought that the Luer connector was offered in two
well-established designs. But based on the work done to date
by the ISO, it has been found that the Luer connector has at
least nine disparate dimensional features that require
clarification to reduce misconnection events. If the ISO
fails to define all of the baseline critical dimensions, then
it will not be possible to ensure that connectors designed to
the new international standard will not interconnect with
another connector. According to AAMI, final standards are not
expected to be published until the first half of 2014 and it
will take industry a minimum of 18 months to convert to the
new product, a process that cannot begin until there is strong
certainty that the final standard will be adopted as proposed.
4)SUPPORT . A number of organizations representing medical
device manufacturers, biotechnology, life sciences, academic
research institutions, and medical professionals write in
support that, while AB 818 (Hernandez) acknowledged the
international nature of the ISO process, the legislation
greatly understated the complexity and timing of the process.
Supporters maintain that it is clear today that the relevant
ISO standards will not be issued before the current
legislative deadlines. Supporters argue that there are valid
reasons for this delay that largely relate to full
participation by key stakeholders in the health care system
and through standardization that is more likely to be
achievable and lasting. Supporters maintain that without a
standard design for connectors, industry would have to
implement proprietary connectors which would increase cost to
manufacturers, health care facilities, and ultimately
patients, and create an unacceptable risk to patient safety.
Supporters describe the risks and increased costs to include:
a) Proprietary connectors from each manufacturer would
create situations where devices that are intended to be
used together can no longer be connected. For example,
infusion pumps must be able to connect to a variety of
other medical devices such as catheters, filling extension
sets, and syringes;
b) Health facilities would have to purchase devices from
many different medical device manufacturers. Therefore,
patients that go from one facility to another may have
medical devices that could not be connected to a new
facility's device;
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c) Health care providers would have to be trained on
hundreds or perhaps thousands of different types of
connectors; and,
d) Health care facilities would have increased costs in
their supply chain in order to accommodate proprietary
connectors. For example, a hospital may need to purchase
epidural syringes from several different manufacturers in
order to connect to each of the proprietary epidural
connectors.
Supporters applaud California's effort to keep misconnections
from occurring and support this bill's January 1, 2016 delayed
implementation date.
5) PREVIOUS LEGISLATION .
a) AB 818 delays the January 1, 2011 date for
implementation of a prohibition against certain health
facilities 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 ISO, or January 1, 2014, whichever occurs first.
Requires AdvaMed, 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.
b) SB 158 among other provisions, requires certain health
facilities 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.
c) SB 541 (Alquist), Chapter 605, Statutes of 2008 and SB
1312 (Alquist), Chapter 895, Statutes of 2006, among other
provisions, authorizes 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
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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.
REGISTERED SUPPORT / OPPOSITION :
Support
Advanced Medical Technology Association (sponsor)
Abbott Laboratories
American Society for Parenteral and Enteral Nutrition
BayBio
Baxter
BIOCOM
Boston Scientific
California Association of Nurse Anesthetists, Inc.
California Healthcare Institute
California Society of Anesthesiologists
Covidien
Hospira
I-Flow LLC
Institute for Safe Medication Practices
Kimberly-Clark Corporation
National Patient Safety Foundation
Phillips Electronics North America
The Oley Foundation
Opposition
None on file.
Analysis Prepared by : Tanya Robinson-Taylor / HEALTH / (916)
319-2097