The following HTML text is provided to enhance online
readability. Many aspects of typography translate only awkwardly to HTML.
Please use the page image
as the authoritative form to ensure accuracy.
Safe Medical Devices for Children
FDA programs, 38 , 114-126 , 164-170 , 173-177 , 229 , 235-236
forms, 114-115 , 154 , 174 , 181
by health professional networks, 153 , 155 , 161-162 , 163 , 171 , 178 , 377-378
home health agencies, 126 , 156 , 157-158 , 166 , 180
home health care and, 4 , 24 , 112 , 123 , 126 , 156-157 , 159 , 162 , 178 , 181-182 , 230
human factors analysis, 127 , 160 , 169
improvement initiatives, 111 , 164-170
inappropriate, 156
and innovation, 163 , 310 , 321
interactive option, 167
international vigilance reports, 111 , 125 , 236
investigating, 112-113 , 120-126 , 151 , 158-160 , 161-162 , 163 , 170-171 , 172 , 173 , 175 , 178 , 180
investigational devices, 91-92
JCAHO program, 171-172
labeling devices, 138 , 149 , 178
liability concerns and, 132 , 155 , 156
limitations of programs, 8 , 113 , 120-121 , 125-126 , 152-165 , 174 , 235-236 , 330 , 338
linkages between programs and databases, 174 , 225
mandatory, 9 , 24 , 37 , 39 , 40 , 86 , 87-92 , 94 , 114 , 115 , 116-120 , 175 , 177-178 , 321
manufacturer response, 86 , 87-92 , 93 , 94 , 98 , 100-101 , 109-110 , 114 , 115 , 116-119 , 120-121 , 125 , 141-142 , 155 , 163 , 171 , 175 , 177-178
MAUDE database, 93 , 115 , 151 , 155 , 163 , 166 , 206 , 342 , 368 , 369-374 , 412-413
MDR program, 87 , 368 , 369-370 , 411
MedSun program, 8-9 , 35 , 76 , 94 , 114 , 152 , 155 n.3, 159 , 165-167 , 171 , 173 , 175-177 , 180 , 182 , 236 , 321 , 336
MedWatch program, 35 , 37 , 92 , 99 n.16, 164 , 171 , 174 , 178 , 181
objectives, 87 , 101 , 113 , 163 , 173 , 232 , 411
online option, 114-115 , 167 , 174 , 181-182
overreporting, 156
oversight responsibility, 74-75 , 112-113 , 237-238
patient privacy, 91 , 93-94 , 104 , 154 , 175
patient safety programs, 154 , 156 , 157 , 165-167 , 168 , 176-177 , 180
private programs, 171-173
problems with, 153-157 , 161-162
public availability of information, 93-94 , 103 , 105 , 120
and recalls, 162 , 174
recommendations, 8-9 , 11-13 , 174-175 , 176 , 177 , 178 , 179 , 180 , 182
and redesign of devices, 113
in research vs. patient care, 33
resources for patients and families, 181-182
responding to problems, 58-59 , 86 , 124 , 161-164 , 174
review processes, 121-124 , 152 , 160 , 169-170 , 172 , 173
root-cause analysis, 170 , 172 , 173
safety advisories and, 124 , 153 , 206-207
shared responsibility for, 173 , 244 , 248-249
state programs, 170-171
statutory authority, 38 , 39-40 , 86 , 368
terminology defined, 88-89
trends, 115 , 116-119
underreporting, 8 , 94 , 131 , 153-156 , 161 , 171 , 174 , 177 , 235 , 331 , 338
by user facilities, 9 , 39-40 , 87 , 88 , 91 , 93 , 94 , 114 , 115 , 116-119 , 120 , 121 , 152-153 , 156 , 157-158 , 165-167 , 171 , 172 , 175 , 180 , 236 , 310 , 412
voluntary, 37 , 39 , 86 , 87 n.10, 91 , 92-93 , 94 , 114-115 , 116-119 , 121 , 126 , 151 , 163 , 168 , 172 , 178-180
Adverse events
“caused or contributed,” 89
to children, 120 , 121 , 151 , 206
close calls or near misses, 32-33 , 91 , 94 , 115 , 127-129 , 162 , 165 , 166
“Code Blue” events, 124
computer-based surveillance, 167-169 , 182
deaths, 91 , 94 , 113 , 115 , 116-119 , 122 , 146-148 , 162
defined, 32-33 , 422
design factors, 127-148 , 149
