Applications of Polymers and Plastics in Medical Devices: Design, Manufacture, and Performance is a comprehensive guide to plastic materials for medical devices, covering fundamentals, materials, applications, and regulatory requirements. This is an essential resource for engineers, R&D, and other professionals working on plastics for medical devices and those in the plastics industry, medical device manufacturing, pharmaceuticals, packaging, and biotechnology. In an academic setting, this book is of interest to researchers and advanced students in medical plastics, plastics engineering, polymer science, mechanical engineering, chemical engineering, biomedical engineering, and materials science.
The book is comprised of 15 chapters covering wide array of topics. Chapter 1 explores the history of medical devices, basic definitions, importance of plastics in medical devices, and impact of healthcare cost on patients. Classification of medical devices and the role that the Food and Drug Administration plays in regulating them is described in Chapter 2. Chapter 3 provides an overview on materials used in medical devices and their requirements for commercialization.
Materials such as plastics and elastomers play a significant role in revolutionizing healthcare. Selection of plastics and elastomers for medical device as well as identifying plastics and elastomers used in FDA class 1 devices is discussed in Chapter 4. Chapter 5, 6, and 7 explores properties and applications of low, medium, and high performance demand polymers. Information on commercially available medical grades and the supplier for each material is also discussed.
Chapter 8 discusses different plastics machining methods such as CNC machining, Plasma Cutters, Electric Discharge Machining, Turning, and Water Jet Cutting. Additionally, other operations such as bonding, stacking, and molding will also be highlighted. Medical device manufacturing includes all aspects of the fabrication of a medical device, from designing a manufacturing process to scale-up to ongoing process improvements. Chapter 9 discusses extrusion and injection molding processes with respect to medical device manufacturing. In addition, catheter manufacturing process will also be discussed.
Chapter 10 reviews some of the commercially available medical devices with applications in Biosurgery, Cardiovascular and Heart Rhythm,Vascular Surgery, Interventional Cardiology, Thoracic Drainage Systems, Prosthetics Implants, and In Vitro Diagnostics. Chapter 11 discusses applications of bio-based polymers in medical devices focusing on four different areas: (a) implantable medical devices, (b) diagnostic and labware, (c) healthcare electronic devices, and (d) masks and medical tubing.
Every medical device manufacturer is required to comply with regulations of the country devices that are intended for use. Chapter 12 reviews the role of Food and Drug Administration (FDA) and other global agencies in regulating medical devices and ensuring medical devices are safe for patients. Chapter 13 discusses market trends toward safety and quality of medical devices and global sourcing of plastics. Chapter 14 provides FDA guidance on reprocessing, factor affecting quality of reprocessing, and cleaning validation of reusable medical devices. Chapter 15 reviews economics of medical device cost and migration of device manufacturing, validation, and use.

Biography xi

Preface xiii

Acknowledgments xv

1. Introduction to polymers and plastics for medical devices 1

1.1 History of medical devices 2

1.2 What are medical devices 2

1.3 Basic definitions 4

1.4 Material used in medical devices 7

1.5 Importance of plastics in medical devices 11

1.6 General requirements of materials to qualify for medical devices 13

1.7 Global nature of medical devices 15

1.8 Socioeconomic factors 16

References 22

2. Classification of medical devices 27

2.1 Role of Food and Drug Administration 27

2.2 Classification of medical devices 28

2.3 Why are devices classified? 33

2.4 Device classification panels 33

2.5 Exemptions 33

2.6 Emergency use authorization 35

2.7 Premarket notification, 510(k) 36

2.8 Premarket approval 36

2.9 Postapproval market requirements 38

2.10 FDA's Accelerated Approval Program 40

2.11 FDA's Breakthrough Devices Program 41

References 42

3. Selection of materials for construction of medical devices 45

3.1 Overview of materials 45

3.2 Material requirements for medical device qualification 49

References 63

4. Classification of plastics and elastomers used in medical devices 65

4.1 Performance-based selection of plastics and elastomers for medical devices 66

4.2 Plastics and elastomers used in FDA class I devices 70

References 77

5. Low performance demand plastics and elastomers for medical devices 79

5.1 Introduction 79

5.2 Polypropylene 80

5.3 Polyethylene 82

5.4 Polyvinyl chloride (PVC) 85

5.5 Polystyrene 87

References 89

6. Medium-performance demand plastics and elastomers for medical devices 91

6.1 Introduction 91

6.2 Polycarbonate 92

6.3 Polymethyl methacrylate 95

6.4 Polybutylene terephthalate 97

6.5 Polyphenylene oxide 98

6.6 Acrylonitrile butadiene styrene 100

References 102

7. High-performance demand plastics and elastomers for medical devices 105

7.1 Introduction 106

7.2 Acetal copolymer 107

7.3 Polyetheretherketone 109

7.4 Polyphenyl Sulfone 112

7.5 Polysulfone 113

7.6 Polyphenylene sulfide 115

7.7 Polyvinylidene fluoride 117

7.8 Polyetherimide 119

7.9 Polydimethylsiloxane 121

7.10 Thermoplastic polyurethane 122

7.11 Thermoplastic elastomer 124

References 126

8. Plastics fabrication techniques 129

8.1 Machining of plastics 129

8.2 Bonding 139

8.3 Staking 141

8.4 Two-part molding (silicone molding) 143

References 144

9. Plastic medical device manufacturing processes 147

9.1 Introduction 147

9.2 Extrusion 148

9.3 Injection molding process 151

9.4 Catheter manufacturing process 153

9.5 Other secondary operations 158

References 162

10. Therapeutic applications of medical devices 163

10.1 Biosurgery 164

10.2 Cardiovascular heart rhythm 169

10.3 Vascular surgery 178

10.4 Interventional cardiology 185

10.5 Thoracic drainage systems 191

10.6 Prosthetic implants 193

10.7 In vitro diagnostics 197

References 203

11. Applications of biobased polymers in medical devices 209

11.1 Introduction 209

11.2 Implantable medical devices 210

11.3 Diagnostics and labware devices 218

11.4 Healthcare electronic devices 218

11.5 Medical mask and medical tubing 219

References 219

12. Regulatory requirements for medical devices 223

12.1 Overview 223

12.2 The Food and Drug Administration 224

12.3 European Union Commission 233

12.4 Other global agencies 234

12.5 International Medical Device Regulators Forum 238

References 239

13. Market trends and global sourcing of medical devices 241

13.1 Market trends toward increased safety and quality of medical devices 241

13.2 Market trends in the medical device industry 243

13.3 Global sourcing of plastics 245

References 248

14. Reprocessing of reusable medical devices 251

14.1 Overview-reusable medical devices 251

14.2 FDA guidance on reprocessing 252

14.3 Factors affecting quality of reprocessing 253

14.4 Cleaning validation-reusable medical devices 255

14.5 Validation of the final microbicidal process 256

14.6 Reusable medical device labeling 256

14.7 Reprocessing of single-use medical devices 258

References 259

15. Economics and future direction of medical devices 261

15.1 Understanding the economics of medical device cost 261

15.2 Migration of device manufacturing, validation and use 270

References 274

Index 277

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