Bill Text: FL S2556 | 2010 | Regular Session | Engrossed

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Bill Title: Medical Devices [SPSC]

Spectrum: Partisan Bill (Republican 1-0)

Status: (Failed) 2010-04-30 - Died in Messages, companion bill(s) passed, see HB 5311 (Ch. 2010-161) [S2556 Detail]

Download: Florida-2010-S2556-Engrossed.html

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CS for CS for SB 2556                      First Engrossed (ntc) 
20102556e1 
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 an educational facility used as an emergency 
126  shelter or a location that has a seating capacity of at least 
127  1,000 people and includes, but is not limited to, any stadium, 
128  ballpark, gymnasium, field house, arena, civic center, or 
129  similar facility used for the conduct of sporting events and any 
130  concert hall, recital hall, theater, indoor or outdoor 
131  amphitheatre, or other auditorium used for the presentation of 
132  musical performances or concerts. The term does not include any 
133  church, synagogue, or other not-for-profit religious 
134  organization or any public association or public library. The 
135  State Surgeon General’s recommendations for deployment of 
136  automated external defibrillators in buildings or portions of 
137  buildings owned or leased by the state or in places of public 
138  assembly shall include: 
139         (a)(1) A reference list of appropriate training courses in 
140  the use of such devices, including the role of cardiopulmonary 
141  resuscitation; 
142         (b)(2) The extent to which such devices may be used by 
143  laypersons; 
144         (c)(3) Manufacturer recommended maintenance and testing of 
145  the devices; and 
146         (d)(4) Coordination with local emergency medical services 
147  systems regarding registration of automated external 
148  defibrillators and documentation of the incidents of use of the 
149  devices. 
150 
151  In formulating these guidelines and recommendations, the State 
152  Surgeon General may consult with all appropriate public and 
153  private entities, including national and local public health 
154  organizations that seek to improve the survival rates of 
155  individuals who experience cardiac arrest. 
156         (2) This section may not be construed to: 
157         (a) Prohibit a county or municipal government from 
158  enacting, implementing, and enforcing any local ordinance that 
159  expands the requirements of this section for the placement of 
160  automated external defibrillators in a place of public assembly; 
161         (b) Mandate the placement of any automated external 
162  defibrillator in any place of public assembly; or 
163         (c) Authorize the adoption of rules, guidelines, or 
164  recommendations that would establish any legal standard of care 
165  in civil actions. 
166         Section 4. This act shall take effect July 1, 2010.