Essentials of Tissue Banking (eBook)

Preface 4
Contents 6
Contributors 8
Part I Management of 10
1 Live Donors of Tissue 11
The Process of Making a Living Donation 11
Circumstances of Living Donation: How Are Tissues from Live Donors Obtained? 16
Femoral Head Donation 16
Amniotic Membrane Donation 18
Limbal Stem Cell Donation 18
Cord Blood Donation 19
Donor Selection: Evidence Base and General Considerations 20
Exclusion of Living Donors of Bone 21
Other Examples of Selection of Living Tissue Donors to Reduce Risk of Disease Transmission 22
Males Who Have Had Sex with Males (MSM) 23
Selection of Cord Blood Donors 24
Microbiological Screening of the Mother and Cord 24
HIV and Hepatitis B and C 24
Other Types of Potential Disease Transmission by Cord Blood 25
Genetic Disease 26
Travel History 26
Bacterial Risk 26
References 26
2 Deceased Donors of Tissue 30
Introduction 30
Tissue Donor Detection 33
Tissue Donor Selection and Evaluation 36
Review Donor's Medical History 38
General Donor Exclusion Criteria 38
Tissue Absolute Contraindication and Age Criteria 39
Heart Valves 40
Vascular 40
Skin 40
Musculoskeletal 41
Eye Tissues 41
Family Consent Details and Donor's Social History 41
Donor's Physical Examination 44
Blood Sample Collection 44
Biopsy/Autopsy Results 46
Conclusion 46
References 46
3 Banking of Cord Blood 48
Introduction 48
Cord Blood Collection and Banking 50
Cord Blood Banks Development 50
Unrelated Cord Blood Banks 51
Sibling Donor Cord Blood Banks 54
Autologous Cord Blood Banks 55
Netcord Organization: Standards and Guidelines 56
Description of Existing Guidelines 57
Practical Aspects of Cord Blood Banking 57
Informed Consent 57
Collection Techniques 57
Infectious Disease Testing 58
Genetic Disease Testing 58
HLA Typing 58
Cell Processing 58
Cryopreservation and Storage 59
Ethical and Legal Aspects 60
Clinical Experience with Related and Unrelated Umbilical Cord Blood Transplantation 61
Clinical Results of Cord Blood Transplantation from Eurocord Registry 62
Influence of Cell Dose and HLA on Transplantation Outcome 62
Conclusion 64
References 64
4 Banking of Corneas 66
Eye Donation 66
Corneal Transplantation 67
Corneal Storage 69
Hypothermia 69
Organ Culture 70
Limbal Stem Cells 72
References 73
5 Banking of Heart Valves 75
Introduction 75
Selection Criteria 75
Processing and Disinfection of Heart Valves 76
Quality Assurance of Heart Valves 79
Current Issues in Heart Valve Banking 80
Viability and Storage 80
Endothelial Cells 81
Morphology of the Valves 82
Mechanical Properties of Valves 82
Conclusions 83
References 84
6 Banking of Skin 87
Acquisition 89
Retrieval 89
Preservation and Storage 95
Conclusions 97
References 98
Part II Principles of 99
7 Storage, Processing and Preservation 100
Introduction 100
Tissue Replacement 100
Autologous Versus Allogeneic Grafts 101
Immunological Reponses to Tissue Allografts 101
Principles of Tissue Preservation 103
Preservation of Non Viable Tissue Grafts 103
Causes of Degradation 103
Reduction of Water Activity 104
Cell Removal 106
Preservation of Viable Tissue Grafts 106
Principles of Disinfection and Sterilisation 107
Definitions 107
Disinfection Methods 109
Viable Tissues 109
Non-viable Tissues 110
Sterilisation Methods 110
Physical Methods 110
Chemical Methods 111
References 111
8 Cryopreservation 113
Introduction 113
Tissues that Do Not Require Living Cells for Effectiveness 114
Tissues that May Not Require Living Cells 115
Tissues that Do Require Living Cells 115
Cryopreservation 116
Cryopreservation of Multicellular Systems 119
Cryopreservation by Vitrification 122
Conclusions 123
References 124
9 Sterilisation by Irradiation 126
Introduction 126
Specificity of Radiation Sterilisation with Gamma Rays and Electron Beams 128
Dosimetry for Radiation Sterilisation 131
Mechanisms Involved in the Inactivation of Micro-Organisms by Ionising Radiation 136
Radiation Resistance of Micro-Organisms 136
Factors Affecting the Effectiveness of Radiation Sterilisation and the Sensitivity of Micro-Organisms to Irradiation 139
References 140
Part III Ensuring Safety by 142
10 Testing the Donor 143
Introduction 143
Range of Infectious Agents 144
Mandatory Screening 147
Discretionary Screening 149
Other Screening 149
Severe Acute Respiratory Syndrome (SARS) 151
Chikungunya 152
Lymphochoriomeningitis Virus (LCMV) 152
Leishmania 153
Screening Strategy 153
Sample Quality 156
Samples from Living Tissue Donors 156
Samples from Cadaveric (Non Heart-Beating) Donors 156
Screening 159
Serological Screening 160
Molecular Screening 161
Residual Risk 163
Window Period 164
Conclusions 165
References 166
11 Testing the Tissue and the Environment 168
Introduction 168
Microbal Testing of Tissues Recovered Prior to Processing 170
Testing Tissue from Deceased Donors 170
Testing of Tissue from Living Donors 171
Postmortem Blood Cultures 172
Environmental Monitoring of Cleanrooms Used for Tissue Processing 172
Cleanroom Classification 173
Sampling of Cleanroom Air for Viable Particulates 174
Passive Air Sampling: Settling Plates 174
Active Air Sampling 174
Sampling of Cleanroom Surfaces for Microbes: Contact Plates 175
Sampling of Cleanroom Surfaces for Microbes: Swabbing 175
Sampling Locations 175
Sampling Timing 176
Trend Analysis and Action Levels 176
Final Microbial Testing of Allografts After Processing 176
Final Allograft Testing 176
Sampling Methods -- Swab Sampling 177
Swab Efficiency Validation 179
Sampling Methods -- Whole Allograft Immersion and Extraction (Bioburden Testing) 181
Sampling Methods -- Destructive Testing 181
Bacteriostasis/Fungistasis (B/F) Testing 182
Final Testing of Sterilized Allografts 182
Process Validation and Sterility Assurance 183
Process Control Testing In Lieu Of Final Tissue Testing 184
Microbial Testing of the Tissue Allograft Immediately Prior to Implantation 184
Summary 185
References 185
Part IV Ensuring Quality by 189
12 Establishing a Quality System 190
Quality Tools 191
A Sequential, Historical Perspective -- Standards and Regulations 193
Significant Quality Projects 202
Practical Applications of QMS and QC for Tissue Establishments 204
General Quality Management Responsibilities 205
Considerations for a Tissue Establishment's QMS 206
Examples of Third-Party Agreements (Written Contracts or Other Arrangements) 206
Tissue Establishment Functions or Practices That Could Be QC'ed (Written Procedures Required for All Functions) 207
Examples of Tissue Establishment QC Programs 207
Measuring Assurance and Expectations 209
Determining Critical Points of Tissue or Cell Processing 209
Future Considerations 211
Conclusion 211
A Note from the Author 212
References 212
13 IT System 215
What Are the Operational Requirements? 215
Why Use an IT System? 216
The Benefits of an IT System 217
Developing the Operational Requirements Document (ORD) 218
Technology Solutions 218
Barcodes 219
Linear Bar Codes 219
2-Dimensional Bar Codes 219
Radio Frequency Identification (RFID) 219
Electronic Data Interchange (EDI) 220
Database Management Technology 220
Selecting an IT System 220
Cost of an IT System 221
Implementing an IT System 222
Money and People 223
Physical Implementation 224
System Validation 224
User Training 224
Managing an IT System 225
Conclusions 225
References 226
Part V Legal and Ethical Environment 227
14 Regulatory and Ethical Issues 228
Introduction 228
Ethical Uses of Human Tissues: Transplantation and Transfusion 229
The Crucial Nature of Consent 229
The Question of Ownership 230
Living donors 231
Consent to Donation 231
Consent to Use 231
Consent to the Consequences of Donation 232
Withdrawal of Consent 232
Deceased Donors 233
Disposal of Tissue Obtained from Deceased Donors 234
The Passage of Information Between Recipient and Donor 234
The Law 235
Presumed Consent 237
References 238
Index 239