BILL ANALYSIS Ó
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|SENATE RULES COMMITTEE | SB 658|
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THIRD READING
Bill No: SB 658
Author: Hill (D)
Amended: 5/19/15
Vote: 21
SENATE HEALTH COMMITTEE: 9-0, 4/8/15
AYES: Hernandez, Nguyen, Hall, Mitchell, Monning, Nielsen,
Pan, Roth, Wolk
SENATE JUDICIARY COMMITTEE: 7-0, 5/12/15
AYES: Jackson, Moorlach, Anderson, Hertzberg, Leno, Monning,
Wieckowski
SUBJECT: Automated external defibrillators
SOURCE: Author
DIGEST: This bill repeals or reduces various requirements
relating to persons or entities who acquire automated external
defibrillators (AEDs), including repealing requirements that
employees complete training, and reducing the inspection
requirements from once every 30 days to once every 90 days.
ANALYSIS:
Existing law:
1)Provides, in the Civil Code, immunity from civil liability for
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the acts or omissions of any person who, in good faith and not
for compensation, renders emergency care or treatment by the
use of an AED at the scene of an emergency.
2)Provides, in the Civil Code, immunity from civil liability for
any acts or omissions in the rendering of emergency care by
the use of an AED for a person or entity that acquires an AED
for emergency use, if that person or entity has complied with
certain specified requirements in the Health and Safety Code.
3)Provides, in the Civil Code, immunity from civil liability for
a physician who is involved with the placement of an AED, and
any person or entity responsible for the site where an AED is
located, if that physician, person or entity has complied with
all of the requirements in specified provisions of the Health
and Safety Code that apply to that physician, person or
entity.
4)Provides, in the Health and Safety Code, immunity from civil
liability for a person or entity that acquires an AED for any
acts or omissions in the rendering of emergency care if that
person or entity meets various requirements, including:
a) Ensures that the AED is checked for readiness after
each use and at least once every 30 days;
b) Ensures that any person who renders emergency care
or treatment by using an AED activates the emergency
medical services system as soon as possible and reports
the use to the licensed physician and to the local
Emergency Medical Services (EMS) agency;
c) Ensures that for every AED unit acquired up to five
units, no less than one employee per AED unit, and one
employee for every additional five units, complete a
training course in cardiopulmonary resuscitation (CPR)
and AED use, as specified.
d) Ensure that tenants in a building where an AED is
placed receive a brochure describing the proper use of an
AED and are notified once a year of the location of AEDs.
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e) Permits the Emergency Medical Services Authority
(EMSA) to establish minimum standards for the training
and use of AEDs.
This bill:
1)Recasts a provision of law in the Civil Code that provides
immunity from civil liability to a physician who is involved
with the placement of an AED, and any person or entity
responsible for the site where an AED is located, if that
physician, person, or entity has met certain specified
requirements, by narrowing the immunity to only physicians or
other healthcare professionals and by deleting the requirement
that conditions this immunity on meeting certain requirements,
thereby making this civil liability protection unconditional.
2)Repeals a provision in the Health and Safety Code that
provides immunity from civil liability to a person or entity
who acquires an AED if that person or entity meets certain
requirements, and instead revises this provision to require
persons or entities who acquire an AED to meet a reduced set
of requirements (the reductions are described in #3 below).
3)Repeals, or in some cases revises, certain requirements for
persons or entities that acquire AEDs, as follows:
a) Repeals the requirement that for every AED unit
acquired up to five units, no less than one employee per
AED unit, and one employee for every additional five
units, complete a training course in CPR and AED use that
complies with regulations adopted by EMSA.
b) Repeals a requirement that acquirers of AED units
have trained employees who should be available to respond
to an emergency that may involve the use of an AED unit
during normal operating hours, and instead requires the
building owner to offer a demonstration once a year to at
least one person associated with the building.
c) Repeals the requirement that there be a written plan
that describes the procedures to be followed in the event
of an emergency that may involve the use of an AED, and
that this plan include immediate notification of 911 and
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trained office personnel at the start of AED procedures.
d) Repeals the requirement that the AED be checked for
readiness after each use and at least once every 30 days
if the AED has not been used in the preceding 30 days,
and instead requires a visual inspection at least every
90 days for potential issues such as a blinking light or
other obvious defects.
e) Repeals the requirement that the person or entity
who acquired an AED ensure that any person who renders
emergency care or treatment on a person in cardiac arrest
by using an AED activate the emergency medical services
system as soon as possible, and reports any use of the
AED to the licensed physician and to the local EMS
agency.
f) Repeals the requirement that building owners where
an AED is placed ensure that tenants annually receive a
brochure, approved by the American Heart Association or
American Red Cross, which describes the proper use of an
AED, that similar information is posted next to any
installed AED, and that tenants are notified of the
location of AED units at least once a year.
g) Revises the requirement that an agent of the local
EMS agency be notified of the existence, location and
type of AED acquired by requiring this notification to be
done by the person or entity who acquired the AED, rather
than the existing law requirement that this notification
be done by the person or entity that supplied the AED.
h) Only requires the AED to be maintained and annually
tested according to the operation and maintenance
guidelines set forth by the manufacturer, and repeals the
additional requirements that the maintenance and testing
also comply with guidelines set forth by the American
Heart Association, the American Red Cross, and according
to any applicable rules and regulations set forth by the
governmental authority under the federal Food and Drug
Administration (FDA) and any other applicable state and
federal authority.
4)Specifies that a medical director or other physician is not
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required to be involved in the acquisition or placement of an
AED.
5)Specifies that the requirements relating to persons or
entities acquiring AEDs do not apply to licensed hospitals or
skilled nursing facilities.
6)Specifies that a provision of existing law that governs the
placement of AEDs in public or private K-12 schools, which
includes a requirement that the principle designate trained
employees who are to be available to respond to an emergency
involving the use of an AED, does not prohibit a school
employee or other person from rendering aid with an AED.
Comments:
1)Author's statement. According to the author, this bill
increases the likelihood that AEDs will be installed in
buildings throughout the state by reducing outdated
requirements imposed on building owners who voluntarily
install AEDs. Sudden cardiac arrest kills nearly 1,000 people
per day in the US and ends the lives of 350,000 people
annually. It can happen to anyone, anytime, anywhere and at
any age. The single most effective intervention during sudden
cardiac arrest is the use of an AED which can safely restore
the heart's normal rhythm. A study by Johns Hopkins University
found that Good Samaritan access to AEDs doubles survival from
sudden heart attack. Researchers found - in real-life,
emergency situations - that use of AEDs by random bystanders
more than doubled survival rates among victims felled by a
sudden heart stoppage due to a heart attack or errant heart
rhythm.
2)American Heart Association. According to the American Heart
Association (AHA), an AED is a lightweight, portable device
that delivers an electric shock through the chest to the
heart. The shock can stop an irregular rhythm and allow a
normal rhythm to resume in a heart in sudden cardiac arrest.
Sudden cardiac arrest is an abrupt loss of heart function. If
it is not treated within minutes, it quickly leads to death.
The AED has a built-in computer which assesses the patient's
heart rhythm, determines whether the person is in cardiac
arrest, and signals whether to administer the shock. Audible
cues guide the user through the process.
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According to the AHA, each year in the U.S., there are
approximately 359,400 Emergency Medical Services
(EMS)-assessed cardiac arrests outside of a hospital setting
and on average, less than 10 percent of victims survive. Early
defibrillation, along with CPR, is the only way to restore the
victim's heart rhythm to normal in a lot of cases of cardiac
arrest. For every minute that passes without CPR and
defibrillation, however, the chances of survival decrease by 7
to 10 percent. The 2013 Update of AHA's Heart Disease and
Stroke Statistics shows that 23 percent of out-of-hospital
cardiac arrests are "shockable" arrhythmias, or those that
respond to a shock from an AED, making AEDs in public places
highly valuable. Yet, AHA states there are not enough AEDs and
persons trained in using them and performing CPR to provide
this life-saving treatment, resulting in lost opportunities to
save more lives. Communities with comprehensive AED programs
that include CPR and AED training for rescuers have achieved
survival rates of nearly 40 percent for cardiac arrest
victims. AHA states on its website that it supports placing
AEDs in targeted public areas such as sports arenas, gate
communities, office complexes, doctor's offices, shopping
malls, etc. When AEDs are placed in the community or a
business or facility, AHA strongly encourages that they be
part of a defibrillation program which includes notification
to the local EMS office when an AED is acquired, that a
licensed physician or medical authority provides medical
oversight to ensure quality control, and that persons
responsible for using the AED are trained in CPR and how to
use an AED.
3)EMSA Regulations. In 1990, EMSA adopted a package of
regulations entitled "Lay Rescuer Automated External
Defibrillator Regulations." These regulations predate the
civil immunity provisions that this bill revises, which were
first enacted in 1999. Much of the regulations were
incorporated into the later-enacted Health and Safety Code
requirements that are being repealed or revised by this bill,
including the employee training requirements and the
requirement that the AED be checked every 30 days. However,
these regulations also include a requirement that any agency,
business, organization or individual who purchases an AED for
use in a medical emergency (an AED Service Provider) must have
a physician medical director who is required to be involved in
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developing an internal emergency response plan and who is
responsible for ensuring compliance with training,
notification and maintenance requirements. This bill includes
a provision that specifies that a medical director or other
physician is not required to be involved in the acquisition or
placement of an AED.
4)CDC report on public access defibrillation. The Centers for
Disease Control and Prevention (CDC) published an article in
2010 that reviewed state laws on public access defibrillation
(PAD) policies, and the extent to which 13 PAD program
elements, based on AHA recommendations, were mandated in each
state. These 13 elements range from targeted AED site
placement, CPR and AED training of anticipated rescuers,
maintenance and testing, coordination with emergency medical
services and oversight by medical professionals, and liability
protection. The article concluded that PAD programs in many
states are at risk of failure because critical elements such
as maintenance, medical oversight, EMS notification, and
continuous quality improvement are not required. The article
recommended that policy makers consider strengthening PAD
policies by enacting laws that require strategic placement of
AEDs in high-risk locations or mandatory PAD registries that
are coordinated with local EMS and dispatch centers.
California was identified as one of the states with the
highest rate of adoption of the 13 PAD elements, although no
state had mandated all 13 elements. The article stated that
because it only analyzed the extent to which states had
enacted specific PAD elements, it was unable to associate
cardiac arrest survival rates with the strength of a state
policy, and stated that further research is needed to identify
the most effective PAD policies for increasing AED use by lay
persons and improving survival rates.
5)Reliability of AEDs. In January of this year, the FDA
announced that it was going to strengthen its review of AEDs
by requiring AED manufacturers to submit premarket approval
applications, which undergo a more rigorous review that was
required to market these devices in the past. According to
the FDA, there has been a history of malfunction issues. From
January 2005 through September of 2014, the FDA received
approximately 72,000 medical device reports associated with
the failure of these devices, and that since 2005,
manufacturers have conducted 111 recalls, affecting more than
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two million AEDs. The FDA stated that it did not intend to
enforce the premarket approval requirement until August 3,
2016, as long as manufacturers notify the FDA of their intent
to file a premarket approval application by May 4, 2015.
This bill, among other provisions, repeals a requirement that
AEDs be checked for readiness at least once every 30 days,
instead only requiring the AEDs to be maintained and annually
tested according to the operation and maintenance guidelines
set forth by the manufacturer.
Related Legislation:
SB 287 (Hueso, 2015) requires certain specified buildings with
occupancies of 200 or more constructed on or after January 1,
2016, excluding structures owned or operated by the state or any
local government building, to have an AED on the premises, and
provides for civil immunity to the person or entity that
supplies the AED, conditional upon meeting the requirements in
existing law relating to the acquisition of an AED.
Prior Legislation:
AB 939 (Melendez, 2013) proposed to provide qualified immunity
for a school district and its employees who use, attempt to use,
or do not use an AED to render emergency care, and stated the
intent of the Legislature to encourage all public schools to
acquire an AED, and permitted schools to solicit and receive
nonstate funds for that purpose. AB 939 was held on the Senate
Appropriations Committee suspense file.
SB 1436 (Lowenthal, Chapter 71, Statutes of 2012), removed the
sunset date, thereby making permanent, the existing protections
that provide immunity from civil damages in connection with the
use of AEDs.
SB 63 (Price, 2011) would have stated the intent of the
Legislature that all public high schools acquire and maintain at
least one AED and would have required schools that decide to
acquire and maintain an AED, or to continue to use and maintain
an existing AED, to comply with specified requirements. SB 63
was held in the Senate Appropriations Committee.
SB 1281 (Padilla, 2010) was similar to this bill in making the
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civil immunity protection unconditional, but it went farther in
eliminating all requirements relating to the acquisition of
AEDs. SB 1281 failed passaged in Senate Judiciary Committee.
SB 127 (Calderon, Chapter 500, Statutes of 2010), removed the
July 1, 2012 sunset date for existing requirements that every
health studio acquires and maintains an AED and trains personnel
in its use thereby extending these requirements indefinitely.
AB 1312 (Swanson, 2009) would have made the current requirements
for health studios to purchase, maintain, and train staff in the
use of AEDs applicable to amusement parks and golf courses.
This bill also proposed to extend the sunset date on this
requirement from July 1, 2012 to July 1, 2014. AB 1312 was
vetoed by the Governor.
AB 2083 (Vargas, Chapter 85, Statutes of 2006), extended the
sunset date from 2008 to 2013 on the operative provisions of
existing law which provide immunity from civil damages for
persons or entities that acquire AEDs and comply with
maintenance, testing, and training requirements.
AB 1507 (Pavley, Chapter 431, Statutes of 2005), required all
health studios in the state to have automatic external
defibrillators (AEDs) available with properly trained personnel
until July 1, 2012.
AB 254 (Nakanishi, Chapter 111, Statutes of 2005), required the
principal of a public or private K-12 school to meet certain
requirements in order to be exempt from liability for civil
damages associated with the use of an AED.
AB 2041 (Vargas, Chapter 718, Statutes of 2002), expanded the
immunity protections for the use or purchase of an AED, and
included a sunset date of 2008.
SB 911 (Figueroa, Chapter 163, Statutes of 1999), created
qualified immunity from civil liability for trained persons who
use in good faith and without compensation an AED in rendering
emergency care or treatment at the scene of an emergency.
FISCAL EFFECT: Appropriation: No Fiscal
Com.:NoLocal: No
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SUPPORT: (Verified5/18/15)
American Heart Association
American Red Cross
Association of California Healthcare Districts
Building Owners and Managers Association of California
California Ambulance Association
California Apartment Association
California Business Properties Association
California Chamber of Commerce
California Hospital Association
California Retailers Association
California State Firefighters' Association
California State Sheriffs' Association
Civil Justice Association of California
Commercial Real Estate Development Association, NAIOP of
California
El Camino Hospital
International Council of Shopping Centers
Lucile Packard Children's Hospital
Philips
Pulse Point Foundation
Santa Clara County Board of Supervisors
Santa Clara County Fire Chiefs' Association
Silicon Valley Leadership Group
Stanford Health Care
OPPOSITION: (Verified5/18/15)
Rescue Training Institute
ARGUMENTS IN SUPPORT: Philips, a maker of AEDs, states in
support that California's current AED liability requirements are
onerous, outdated, and do not reflect the current capabilities
of AEDs in the marketplace. Building owners and those
responsible for sites where AEDs are located are therefore
dissuaded from purchasing and placed AEDs, out of fear they will
not be granted immunity from civil liability. The California
State Sheriffs' Association states in support that by
eliminating outdated and burdensome requirements that must be
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met to confer protection from liability, the Legislature could
encourage wider access to AEDs and increase their life-saving
capacity. The California Business Properties Association, the
Building Owners and Managers Association of California, the
Commercial Real Estate Development Association, and the
International Council of Shopping Centers jointly write in
support that existing law may have made sense over a decade ago,
but due to evolving technology and ease of AED use, have since
become an anachronism and are an impediment to installation. The
California Chamber of Commerce notes in support that this bill
still holds a manufacturer, developer, installer, or distributor
liable for potential product defects or performance, and that
this bill continues to mandate that any person or entity that
acquires an AED notify the local EMS agency of its placement as
well as ensure that the AED is regularly maintained and tested.
The American Heart Association states in support that while it
believes that requirements in current law are important, it
knows that sudden cardiac arrest is 100 percent fatal if not
treated quickly.
ARGUMENTS IN OPPOSITION: This bill is opposed by the Rescue
Training Institute, which states that it is not a good approach
to providing CPR and AED in the community by expecting a
non-trained employee or bystander to retrieve, deploy, apply and
utilize the AED to safely defibrillate a patient in sudden
cardiac arrest. Only through approved national training programs
can one learn how to confidently and competently perform CPR and
utilize an AED. The Rescue Training Institute also opposes the
repeal of the monthly inspection requirement and the requirement
that the AED be checked after each use.
Prepared by:Vince Marchand / HEALTH /
5/21/15 12:07:27
**** END ****
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