Page 272 - Assurance of Sterility for Sensitive Combination Products and Materials

250 Index

Patient risk concepts (Continued) Procedural-related characteristics, HAIs risk
types of benefits, 206 assessment
uncertainty, 205 device-associated infections, 145–146
risk, defined, 168 non-device-associated infections,
statistical calculations 145–146
confidence bounds, 175 risks based on procedure, 145–149
confidence interval example, 171–173 Process challenge device (PCD) definition,
nonparametric analysis, 176–177 29
parametric analysis, 177–179 Product qualification, 28
point estimation, 170–171 Protection and barriers, 155–161
types, 176–179 Protection and barriers, HCF
sterility assurance, 167–169 cleaning, 155
Patient safety and packaging, 95–96 validation, 156
Patient’s immuno-compromised status, 202 disinfection, 156
Penetration, 94 drapes, 155
Peracetic acid, 161 EO sterilization, 160
Performance qualification, 104–105 facial protection, 153–154
Personnel monitoring, 55–56 gloves, 154
Pharmacopeias, 83, 222 gowns, 155
Plastic selection-pharmaceutical and hoods, caps, and shoe covers, 154
medical device packaging, 91–93 immediate use steam sterilization,
Point estimation, 170–171 159–160
Porosity, 98 steam under pressure, 157–158
Power and sample size considerations sterilization at HCF, 157
equivalence testing, 121–122 terminal sterilization, 159
overview, 117–119 Protein stabilization, 16b
for significance testing, 121
Precautions Q
isolation, 149–150 Q-Submission Program (Q-Subs), 223–224
standard, 149–150 Quality risk management and risk-based
Premarket approval (PMA) applications, critical thinking, 74–76
223 Quality target product profile (QTPP), 47
Pre-Submission (Pre-Sub) definition, 224
Primary mode of action (PMOA) R
assignment algorithm, 5–7, 7f Radiation sterilization, 210
determination for drug-eluting beads, history, 24–25
8–21 Recovery rates, microorganisms/colonies,
Probability of non-sterile unit (PNSU) 55
definition, 2 Regenerative medical devices with
and upper confidence bounds, 191f biologics, 16–19
Procedural interventions, HAIs risk Reusable devices, 146–149
assessment Risk acceptability
antimicrobials, 151–152 alternative treatments, 206
postoperative glucose control, 153–154 duration of benefits, 206
postoperative normothermia, 154 health-care professionals (HCPs) and
prevention, 151 caregivers, 206
surgical asepsis, 154 magnitude of benefits, 206
surgical clippers, 152 methods of determination, 205