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       Florida Senate - 2010                      CS for CS for SB 2556
       
       
       
       By the Committees on Community Affairs; and Health Regulation;
       and Senator Altman
       
       
       
       578-05287-10                                          20102556c2
    1                        A bill to be entitled                      
    2         An act relating to medical devices; amending s.
    3         401.2915, F.S.; requiring certain entities to notify
    4         local emergency services medical directors of the
    5         locations of automated external defibrillators;
    6         requiring local emergency medical services medical
    7         directors to maintain registries of certain automated
    8         external defibrillator locations; amending s. 499.01,
    9         F.S.; revising the list of exemptions from the
   10         requirement that certain persons engaged in the
   11         manufacture, repackaging, or assembly of medical
   12         devices hold a device manufacturer permit; amending s.
   13         768.1326, F.S.; directing the State Surgeon General,
   14         with the assistance of the Department of Management
   15         Services, to adopt rules to establish guidelines for
   16         the appropriate placement and deployment of automated
   17         external defibrillators in places of public assembly;
   18         providing a definition; providing exceptions;
   19         providing for construction; providing an effective
   20         date.
   21  
   22  Be It Enacted by the Legislature of the State of Florida:
   23  
   24         Section 1. Section 401.2915, Florida Statutes, is amended
   25  to read:
   26         401.2915 Automated external defibrillators.—It is the
   27  intent of the Legislature that an automated external
   28  defibrillator may be used by any person for the purpose of
   29  saving the life of another person in cardiac arrest. In order to
   30  achieve that goal, the Legislature intends to encourage training
   31  in lifesaving first aid and set standards for and encourage the
   32  use of automated external defibrillators.
   33         (1) As used in this section, the term:
   34         (a) “Automated external defibrillator” means a device as
   35  defined in s. 768.1325(2)(b).
   36         (b) “Defibrillation” means the administration of a
   37  controlled electrical charge to the heart to restore a viable
   38  cardiac rhythm.
   39         (2) In order to promote public health and safety:
   40         (a) All persons who use an automated external defibrillator
   41  are encouraged to obtain appropriate training, to include
   42  completion of a course in cardiopulmonary resuscitation or
   43  successful completion of a basic first aid course that includes
   44  cardiopulmonary resuscitation training, and demonstrated
   45  proficiency in the use of an automated external defibrillator.
   46         (b) Any person or entity in possession of an automated
   47  external defibrillator is encouraged to notify the local
   48  emergency medical services medical director of the location of
   49  the automated external defibrillator. The owner, operator, or
   50  administrator responsible for a place of public assembly, as
   51  defined in s. 768.1326, shall notify the local emergency medical
   52  services medical director of the location of the automated
   53  external defibrillator. The state agency responsible for a
   54  building or portion of a building owned or leased by the state
   55  shall notify the local emergency medical services medical
   56  director of the location of the automated external
   57  defibrillator. The local emergency medical services medical
   58  director shall maintain a registry of these automated external
   59  defibrillator locations.
   60         (c) Any person who uses an automated external defibrillator
   61  shall activate the emergency medical services system as soon as
   62  possible upon use of the automated external defibrillator.
   63         (3) Any person who intentionally or willfully:
   64         (a) Tampers with or otherwise renders an automated external
   65  defibrillator inoperative, except during such time as the
   66  automated external defibrillator is being serviced, tested,
   67  repaired, recharged, or inspected or except pursuant to court
   68  order; or
   69         (b) Obliterates the serial number on an automated external
   70  defibrillator for purposes of falsifying service records,
   71  
   72  commits a misdemeanor of the first degree, punishable as
   73  provided in s. 775.082 or s. 775.083. Paragraph (a) does not
   74  apply to the owner of the automated external defibrillator or
   75  the owner’s authorized representative or agent.
   76         (4) Each local and state law enforcement vehicle may carry
   77  an automated external defibrillator.
   78         Section 2. Paragraph (q) of subsection (2) of section
   79  499.01, Florida Statutes, is amended to read:
   80         499.01 Permits.—
   81         (2) The following permits are established:
   82         (q) Device manufacturer permit.—
   83         1. A device manufacturer permit is required for any person
   84  that engages in the manufacture, repackaging, or assembly of
   85  medical devices for human use in this state, except that a
   86  permit is not required if:
   87         a. The person is engaged only in manufacturing,
   88  repackaging, or assembling a medical device pursuant to a
   89  practitioner’s order for a specific patient; or.
   90         b. The person does not manufacture, repackage, or assemble
   91  any medical devices or components for such devices, except those
   92  devices or components that are exempt from registration pursuant
   93  to s. 499.015(8).
   94         2.1. A manufacturer or repackager of medical devices in
   95  this state must comply with all appropriate state and federal
   96  good manufacturing practices and quality system rules.
   97         3.2. The department shall adopt rules related to storage,
   98  handling, and recordkeeping requirements for manufacturers of
   99  medical devices for human use.
  100         Section 3. Section 768.1326, Florida Statutes, is amended
  101  to read:
  102         768.1326 Placement of automated external defibrillators in
  103  state buildings and places of public assembly; rulemaking
  104  authority.—
  105         (1)No later than January 1, 2003, The State Surgeon
  106  General shall adopt rules to establish guidelines on the
  107  appropriate placement of automated external defibrillator
  108  devices in buildings or portions of buildings owned or leased by
  109  the state and in places of public assembly, and shall establish,
  110  by rule, recommendations on procedures for the deployment of
  111  automated external defibrillator devices in such buildings and
  112  places of public assembly in accordance with the guidelines. The
  113  Secretary of Management Services shall assist the State Surgeon
  114  General in the development of the guidelines. The guidelines for
  115  the placement of the automated external defibrillators shall
  116  take into account the typical number of employees and visitors
  117  in the building or place of public assembly buildings, the
  118  extent of the need for security measures regarding the building
  119  or place of public assembly buildings, special circumstances in
  120  the building or a portion of the building buildings or portions
  121  of buildings such as high electrical voltages or extreme heat or
  122  cold, and such other factors as the State Surgeon General and
  123  Secretary of Management Services determine to be appropriate.
  124  For purposes of this section, the term “place of public
  125  assembly” means a location with a seating capacity of at least
  126  1,000 people and includes, but is not limited to, any stadium,
  127  ballpark, gymnasium, field house, arena, civic center, or
  128  similar facility used for the conduct of sporting events and any
  129  concert hall, recital hall, theater, indoor or outdoor
  130  amphitheatre, or other auditorium used for the presentation of
  131  musical performances or concerts. The term does not include any
  132  church, synagogue, or other not-for-profit religious
  133  organization or any public association or public library. The
  134  State Surgeon General’s recommendations for deployment of
  135  automated external defibrillators in buildings or portions of
  136  buildings owned or leased by the state or in places of public
  137  assembly shall include:
  138         (a)(1) A reference list of appropriate training courses in
  139  the use of such devices, including the role of cardiopulmonary
  140  resuscitation;
  141         (b)(2) The extent to which such devices may be used by
  142  laypersons;
  143         (c)(3) Manufacturer recommended maintenance and testing of
  144  the devices; and
  145         (d)(4) Coordination with local emergency medical services
  146  systems regarding registration of automated external
  147  defibrillators and documentation of the incidents of use of the
  148  devices.
  149  
  150  In formulating these guidelines and recommendations, the State
  151  Surgeon General may consult with all appropriate public and
  152  private entities, including national and local public health
  153  organizations that seek to improve the survival rates of
  154  individuals who experience cardiac arrest.
  155         (2) This section may not be construed to:
  156         (a) Prohibit a county or municipal government from
  157  enacting, implementing, and enforcing any local ordinance that
  158  expands the requirements of this section for the placement of
  159  automated external defibrillators in a place of pubic assembly;
  160  or
  161         (b) Mandate the placement of any automated external
  162  defibrillator in any place of public assembly.
  163         Section 4. This act shall take effect July 1, 2010.

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