Page 414 - Safety Risk Management for Medical Devices

INDEX

Note: Page numbers followed by “f” and “t” refer to figures and tables, respectively.

A Biocompatibility, 43, 215
Abnormal use, 32 34, 111 Biological evaluation, 41 43, 214 215
Action error, 32 34 Biological hazards of device, 215
Active components, 74 Biological risk, 215
Active Implantable Medical Device Directive analysis, 215
(AIMDD), 4 5 Black triangles, 224 225
Adverse device effect, 204 Boolean algebra, 47, 69, 177
Adverse event (AE), 204 Bottom-up analysis, 80
databases, 61 Boundary of analysis, 73, 106, 133
Advice, 235 236 BRA. See Benefit risk analysis (BRA)
AE. See Adverse event (AE) Brake system, 46
AED. See Automatic External Defibrillator (AED) Business reasons, 5 7
AIMDD. See Active Implantable Medical Device avoiding recalls and field corrective actions, 6
Directive (AIMDD) communications, 6 7
ALAP/AFAP concept, 5 cost efficiency, 5 6
Alarm types, 38 BXM method, 1, 13, 20 21, 36, 45, 47, 49, 56,
Anchoring bias, 234 59, 73, 80 81, 86, 100, 160, 172, 174,
Architectural-level Risk Controls, 129 176, 198, 202, 222 223, 236, 265
ARPN, 86 five-level risk computation method, 160f
“As Far As Possible” criteria. See “As Low As integration, 46 47
Possible” criteria quantitative risk estimation, 47
“As Low As Possible” criteria, 55, 126 risk management process, 50f,51
Assertion density, 148 149 for software risk analysis, 141 142
Attentional error, 37 legacy software, 141 142
Attribute testing, 176 177 new software, 142
C/R and attribute sample sizes, 177t system decomposition, 45 46
sample sizes, 177t
Automatic External Defibrillator (AED), 265 C
Automatic sphygmomanometer, 147, 147f
Cancer therapy, 188 189
Automobile
CAPA. See Corrective and Preventive Actions
manufacturer, 46
(CAPA)
subsystems, 152f
Capture end-effects with safety
Availability bias, 234
impact, 172
Axioms, 227
Cassandras, 229 230
B “Causes/Mechanisms of Failure” column, 105,
Basic events, marking low-likelihood faults as, 75 133
Basic safety, 211 CCFs. See Common cause failures (CCFs)
identifying, 211 CE. See Conformite ´ Europe ´enne (CE)
Benefit risk analysis (BRA), 51, 187, 236 “Cherry picking”, 234
in clinical evaluations, 191 192 CHL. See Clinical Hazards List (CHL)
risk benefit comparison, 190f CIP. See Clinical Investigation Plan (CIP)

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