Page 273 - Assurance of Sterility for Sensitive Combination Products and Materials

Index 251

patient factors, 206 S
patient impact, 206 Safety and performance requirements, 228
probability of patient benefits, 206 Sealing (closure) and assembly process
product availability, 206 validation, 107–109
types of benefits, 206 Shelf life, 94
uncertainty, 205 Simulation study design, 66
Risk assessment, HAIs Single-used devices
behavior industrial, 146
isolation precautions, 149–150 preliminary sterilization process,
standard precautions, 149–150 210–211
burden/impact of, 138–139 sterilize SAL 10 , 210–212
-6
engineering solutions terminally sterilized product
suite/room design, 152 development, 209
identification, 138 Spinal fusion system sterilization, 18b
patient-related factors, 137–138 Stability issues, 93–94
antibiotics, 143 Stabilizing and protecting solutions (SPS), 16
direct person-to-person spread of Statistical calculations, risk concepts
bacteria, 144 confidence bounds, 175
indirect person to person spread of confidence interval example, 171–173
microbes, 144 nonparametric analysis, 176–177
means of transmission, 142–144 parametric analysis, 177–179
source of microorganisms, 141–145 point estimation, 170–171
susceptible host, 141–142 types, 176–179
procedural interventions Statistical significance and functional
antimicrobials, 151–152 equivalence
postoperative glucose control, power and sample size considerations,
153–154 equivalence testing, 124
postoperative normothermia, 154 sample size, process capability in process
prevention, 151 validation, 124–128
surgical asepsis, 154 Steam sterilization, 212
surgical clippers, 152 Steam under pressure
procedural-related characteristics protection and barriers, HCF, 157–158
device-associated infections, 145–146 Sterility assurance, 239–240
non-device-associated infections, reusable devices, 241
145–146 Sterility assurance level (SAL), 222
risks based on procedure, 145–149 definition, 2
risk factors, 137 probability of survival, definition, 3
transmission-based isolation Sterility assurance professionals, 242–243
precautions Sterilization cycle time
health-care personnel attire, 151 aeration, 160
nonsurgical setting attire, 151–152 hydrogen peroxide, 160
surgical hand scrub, 150–151 hydrogen peroxide/ozone, 161
surgical setting attire, 151 peracetic acid, 161
WHO “Safe Surgery Saves Lives” temperature, 160
initiative, 148 Sterilization validation methodology, 203
Risk classification, CE-marking for medical Surgical asepsis, 154
device, 227 Surgical clippers, 152
Root cause analysis, 99 Surgical hand scrub, 150–151