BILL ANALYSIS Ó
SENATE COMMITTEE ON HEALTH
Senator Ed Hernandez, O.D., Chair
BILL NO: SB 658
---------------------------------------------------------------
|AUTHOR: |Hill |
|---------------+-----------------------------------------------|
|VERSION: |April 6, 2015 |
---------------------------------------------------------------
---------------------------------------------------------------
|HEARING DATE: |April 8, 2015 | | |
---------------------------------------------------------------
---------------------------------------------------------------
|CONSULTANT: |Vince Marchand |
---------------------------------------------------------------
SUBJECT : Automated external defibrillators
SUMMARY : Repeals various requirements relating to persons or entities
who acquire automated external defibrillators (AEDs), including
requirements that employees complete training and that the AEDs
be checked every 30 days, and makes the civil liability immunity
in existing law for persons or entities who acquire an AED no
longer conditional upon meeting specified requirements.
Existing law:
1.Provides, in the Civil Code, immunity from civil liability for
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:
SB 658 (Hill) Page 2 of ?
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 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.
5.Permits the Emergency Medical Services Authority (EMSA) to
establish minimum standards for the training and use of AEDs.
This bill:
1.Repeals the requirement, in the Civil Code, that a person or
entity who acquires an AED for emergency use must comply with
certain specified requirements in order to have immunity from
civil liability resulting from the use of the AED, thereby
making this civil liability protection unconditional.
2.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.
3.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 4) which no
longer would have any effect on civil liability immunity.
SB 658 (Hill) Page 3 of ?
4.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.
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
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
that records of these checks be maintained;
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
SB 658 (Hill) Page 4 of ?
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 and any other applicable state and federal
authority.
5.Specifies that a medical director or other physician is not
required to be involved in the acquisition or placement of an
AED.
6.Specifies that the requirements relating to persons or
entities acquiring AEDs do not apply to licensed hospitals or
skilled nursing facilities.
7.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.
FISCAL
EFFECT : This bill is keyed non-fiscal.
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,
SB 658 (Hill) Page 5 of ?
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.Background. 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.
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
SB 658 (Hill) Page 6 of ?
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
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
SB 658 (Hill) Page 7 of ?
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 U.S. Food
and Drug Administration (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 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.
6.Double referral. This bill is double referred. Should it pass
out of this committee, it will be referred to the Senate
Judiciary Committee.
7.Related legislation. SB 287 (Hueso), would require 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. This bill is scheduled
to be heard in this committee on April 15th.
8.Prior legislation. AB 939 (Melendez) of 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,
SB 658 (Hill) Page 8 of ?
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) of 2011 would have stated the intent of the
Legislature that all public high schools acquire and maintain
at least one AED and would require 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) of 2010 was similar to this bill in making
the 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) of 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
SB 658 (Hill) Page 9 of ?
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.
9.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 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
SB 658 (Hill) Page 10 of ?
quickly.
10.Opposition. This bill is also 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.
11.Oppose unless amended. Consumer Attorneys of California (CAC)
opposes this bill unless it is amended to keep important
training and maintenance protections. According to CAC,
current law provides an AED acquirer with qualified immunity
if specific requirements are complied with, which include
proper maintenance and testing of the AED and assurance that
trained employees are available to respond to an emergency.
CAC asserts that keeping these safeguards intact is necessary
to ensure that AEDs can be as effective as possible in the
event of sudden cardiac arrest. CAC cites a CDC report, which
states that public access defibrillation programs in many
states "are at risk of failure because critical elements such
as maintenance, medical oversight, emergency medical service
notification, and continuous quality improvement are not
required." CAC also states that this bill deletes requirements
that the AED be checked at least once every 30 days, and would
instead only require a check every year. According to CAC, the
most common cause for an AED malfunctioning is a dead battery,
and that the existing requirement to check an AED monthly
ensures that a faulty battery can be caught early and
remedied.
SUPPORT AND OPPOSITION :
Support: American Heart Association
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 Sheriffs' Association
SB 658 (Hill) Page 11 of ?
Civil Justice Association of California
Commercial Real Estate Development Association
El Camino Hospital
International Council of Shopping Centers
Philips
Oppose: Consumer Attorneys of California (unless amended)
Rescue Training Institute
-- END --