Page 425 - Safety Risk Management for Medical Devices

404 Index

Use specification (Continued) of implementation, 184 185
UMFMEA workflow, 113 117 testing, 175 176
analyzing, 113 117 Visual inspections, 183
identify primary and secondary functions, Vivio, 265
113 architecture, 267, 267f
scope setting, 113 Clinical Hazards List, 279 280
UMFMEA DFMEA, 309 317
detectability ratings definitions, 116t Harms Assessment List, 281 285
occurrence ratings definitions, 115t Hazard Analysis Report, 360 368
severity ratings definitions, 115t PFMEA, 318 324
Use-errors, 31 34, 36 PHA, 286 308
Use-Misuse Failure Modes and Effects Analysis product description, 265 266
(UMFMEA), 36, 39, 80 81, 112 113, product requirements, 266 267
124, 265, 325 339. See also Software RACT, 340 359
Failure Modes and Effects Analysis Risk Management Plan, 268 278
(SFMEA) RMR, 369 375
detectability ratings definitions, 116t UMFMEA, 325 339
distinctions, 110 112
occurrence ratings definitions, 115t W
severity ratings definitions, 115t
Water pump, 152 153, 153f
taxonomy of user actions, 112t
failure mode, 154f
template, 255 259
Weibull distribution, 178
workflow, 113 117
Wisdom, 235 236
analyzing, 113 117
Workflow, 119
identify primary and secondary functions,
DFMEA, 93 102
113
analyzing, 95 102
scope setting, 113
identifying primary and secondary functions,
Use scenario, 32 34, 112
95
inventory, 114f
scope setting, 94 95
User PFMEA, 104 108
safety, 235 analyzing, 105 108
user-device interaction model, 34 36 identifying primary and secondary functions,
user-Medical Device interaction, 34 35, 35f
104
User Interface (UI), 31 34, 78, 216
PFD, 104 105
scope setting, 104
V SFMEA, 132 137
Validation testing, 176 UMFMEA, 113 117
Variable testing, 178 analyzing, 113 117
Ventricular fibrillation (VF), 185, 265 identifying primary and secondary functions,
Verification 113
of effectiveness, 185 186 scope setting, 113