Page 419 - Safety Risk Management for Medical Devices

398 Index

Mind map, 75 P
analysis, 75 77, 76f P1 column, 173
methodology, 77 P2 column, 173
theory, 76 77 Pacemaker, 104
Minimal cut set, 68 Packaging, 61
Minitab, 178 Parallel work, 83
Minuteman missile system, 67 Parameter Diagrams (P-diagram), 117 119, 118f
Misfeasance, 2 control factors, 118
Mistake, 32 34 error states, 119
Misuse, 12, 32 34, 111 ideal function, 119
Mitigations, 88 input signals, 118
Modularity and reuse, 83 noise factors, 118
Monitoring, 27 system, 118
workflow, 119
N Parkinson’s disease, 188
National product safety standards, 174 Passive components, 74 75
NBRG. See Notified Bodies Recommendation Patient
Group (NBRG) reservation of, 235
NBRG consensus paper, 55, 377 390 risk tolerance, 189 190
Necessary event, 70 71 “Payload”, 94
New software, 131, 142 P-diagram. See Parameter Diagrams (P-diagram)
No gate-to-gate connections, 75 Perception error, 32 34, 37
“No-Safety Impact” column, 133 134 Personal liability, 230
Noise factors, 118 Personal protective equipment, 163
Nonclinical evaluations, 188 PFD. See Process flow diagram (PFD)
Nonclinical methods, 189 Pfizer, 16
Nonconforming products, 195 PFMEA. See Process Failure Modes and Effects
Nonfunctional failure modes, 95 Analysis (PFMEA)
Nonsafety failure modes, 106 PHA. See Preliminary hazard analysis (PHA)
Nonsafety-related failure modes, Physical error, 37
223 224 Physical interface, 94
Normal Use, 32 34, 34f Political changes, 187
NOTE Permanent impairment, 138 Postmarket
“Note”, 167 clinical investigation, 205
Notified Bodies Recommendation Group postmarket-detected issues, 195
(NBRG), 166 risk management, 196 197
surveillance, 197
benefits, 199
O Postproduction information, 193
Observational postmarket study, 205 Postproduction monitoring, 195 196, 198
Occurrence (Occ), 84 86, 134 135 benefits of postmarket surveillance, 199
ranking, 116 feedback to preproduction risk management,
ratings, 100, 173, 175 197 199
Optical illusions, 183 frequency of risk management file review, 197
OR gates, 77 postmarket risk management, 196 197
Organizational procedures, 163 postmarket vs. postproduction, 193f
Over-infusion of insulin, 79 Postrisk, 162, 172
Ownership of FMEA, 87 88 control, 162