Page 270 - Assurance of Sterility for Sensitive Combination Products and Materials

248 Index

Hoods, caps, and shoe covers, 154 L
Hospital Infection Control Practices Labeling products as sterile
Advisory committee (HICPAC), regulatory authorities, communication
148–149 with, 222–223
Hospital infection rates vs. medical device, SAL, 222
204f Leachable, 104
Humanitarian device exemption (HDE) Leakage, 97
applications, 223 Line of sight (LOS) approach, 44–46
Humidity, 81 Lower confidence bound (LCB), 184
Hydrogen peroxide, 160
Hydrogen peroxide/ozone, 161 M
Hypochlorite-based product (bleach), 139 Market authorization as medicinal product,
226–227
I Material qualifications, chemical, and
Immediate use steam sterilization, 159–160 biological compatibility, 103
Immuno-compromised status, 202 Medical device
Indirect person to person spread of associated infections, 146
microbes, 144 vs. pharmaceutical packaging, 83–87
Industrial single-use devices, 146 Medicinal products
Industry sectors vs. real-world infection EMA guidance, 222
rates evaluation, terminal sterilization,
bioburden control, in manufacturing 235–236
environment, 202–203 market authorization, EU submission
hospital infection rates vs. medical device, process, 226–227
204f Medtronic Infuse Bone Graft/LT-CAGE
infection probabilities estimation, 196–201 lumbar tapered fusion device, 18, 19f
OC curve, 189f Methicillin resistant Staphylococcus aureus
patient’s immuno-compromised status, (MRSA), 141
202 Microbial barrier
PNSU* and upper confidence bounds, properties, 103
191f test methods, 99–100
representative risk graph, 168f Microbial contamination case study, 64–66
sterilization validation methodology, 203 Microorganisms, sources, 141–145
Infection probabilities estimation, 196–201 Microspheres, 7–8
P1, 197 Moist sterilization history, 26–27
P2, 197–200 Multidrug-resistant organisms (MDROs), 141
P3, 200
P4, 200–201 N
International Standards (ISO), 222 Non-device-associated infections, 145–146
guidance, 233–234 Non-device-associated infections, 145–146
ISO 11607, 103 Nonparametric analysis, 176–177
ISO 14971 Nonsurgical setting attire, 151–152
core concept, 169 Normothermia, postoperative, 154
risk management process, 168t
13408 series, 234–235 O
Investigational device exemption (IDE) Overkill method. See also BI approach
applications, 223 point estimates and confidence bounds,
Isolators/barrier isolators, 59–60 191–194