Medical Devices: Use and Safety Book

Preface     xi
Safety in health care     1
Quality assurance     3
Safe medical devices     3
Device requirements     5
Devices of varying age     5
Initial inspection     10
Maintenance     11
Safe handling and operation     13
Training     14
Read the instructions for use     16
Alarms and indicators     17
Unexpected malfunctions     17
Watch over the patient     18
Believe the patient     20
Reporting     21
Summary     24
Mechanics and safety     25
Bed rails     25
Flawed mechanics     27
Removable parts and packaging     30
Electricity and safety     33
Macroshock and microshock     34
Macroshock     34
Microshock     37
Current, voltage and conductance     37
Conductance     38
Earth and protection classes     42
Earth fault circuit breakers and isolation transformers     46
Leakage currents     46
Biological effects of electromagnetic fields     51
High-frequency electromagnetic fields     51
Low-frequency electromagnetic fields     51
Electrostatic fields     52
Magnetic fields     52
Electromagnetic compatibility     53
Susceptibility to water     54
Gas, fire and heat     57
Gas technology     57
Medical gases     57
Medical gas devices     62
Oxygen concentrators     72
Evacuation of waste anaesthetic gases     73
Patient suction devices     74
Fire     77
Flammable gases and liquids     77
Oxidizing gases     79
Ordinary fires     81
Thermal injuries     83
Impaired states     83
Blood circulation shut off     85
Measurement techniques     87
Accuracy and precision     89
Measurement uncertainty     90
Characteristics of measuring devices     92
Measurement range     92
Sensitivity     92
Frequency-response characteristic     92
Stability     92
Signal-to-noise ratio     93
Electrical isolation      93
Measurement methods and values     95
Temperature     95
Thermometers     96
Incubators     97
Sound     99
Percussion     100
Auscultation     102
Pressure     105
Blood pressure     106
Blood flow     112
Central circulation     112
Peripheral circulation     114
Electrophysiology     116
Electrocardiography     117
Electroencephalography     121
Electromyography     123
Motor conduction velocity     123
Intensive care monitoring     124
Sensors and analytical instruments     125
Monitored functions     126
Fetal monitoring     127
Telemetry monitoring     130
Medical images     133
Types of images     133
Endoscopy     134
Principle     135
Use     137
Endoscopic surgery     139
Special optical methods     143
X-ray diagnostics     144
Principle     145
Computer tomography     150
Interventional radiology     152
Risks     152
Use     154
Bone mineral densitometry     155
Magnetic resonance imaging     156
Principle     156
Use     160
Nuclear medicine imaging     161
Principle     161
Risks     161
Use     161
Ultrasound diagnostics     164
Principle     165
Use     171
Ventilation     173
Ventilators     174
Manual breathing bags     174
Fundamental components of a ventilator     175
Ventilator use     179
Anaesthetic machines     185
Anaesthetic systems     185
Risks during anaesthesia     187
Oxygen treatment     194
Need for oxygen treatment     194
Risks     195
Treatment at home     195
Treatment with nitric oxide     197
Pressure chamber treatment     197
Incubators     198
Monitoring     199
Blood gas analysis     199
Pulse oximetry     199
Transcutaneous blood gas monitoring      201
Capnograpby     201
Monitoring during anaesthesia     202
Parenteral administration of drugs     203
Risk for hospital staff     204
Medical requirements     204
Infusion sets     207
Drop counters     211
Infusion pumps     213
Peristaltic pumps     213
Syringe pumps     216
Safety aspects     217
Risk of interference     217
Delays     220
Effects of various types of infusion solutions     221
Patient-controlled administration     222
Administration of insulin     222
Portable pumps for analgesia     224
Implantable devices     225
Injection ports     226
Catheters     228
Skin absorption     229
Safety hazards     229
Artificial organs and stimulators     231
Biomaterials     231
Orthopaedic prostheses     235
Types of prostheses     235
Fixation of prostheses     235
Cardiovascular prostheses     237
Vascular grafts     237
Valvular prostheses      238
Cardiac pumps     239
Artificial blood     240
Oxygenators     240
Dialysis machines     241
Haemodialysis     242
Haemofiltration     244
Peritoneal dialysis     245
Renal replacement therapy in intensive care     246
Extracorporeal immunoadsorption     248
Hearing aids     248
Types of hearing aids     249
Hearing implants     252
Voice aids     253
Pacemakers     254
Pacemaker types     255
Physiological rate regulation     257
Defibrillators     258
Defibrillator types     259
Defibrillation energies     262
Implantable cardiac defibrillators (ICD)     265
Muscle stimulators     265
Nerve stimulators     266
Functional nerve stimulators     266
Pain relief and peripheral blood flow increase     267
Stimulation in the brain     269
Death certificates     269
Tissues and calculi     271
Surgical diathermy     272
Types of tissue effects     273
The patient return electrode      280
Controls and colour coding     284
Diathermy during endoscopy     285
Diathermy injuries     287
Laser surgery     294
Effects     294
Risks     296
Areas of use     297
Ultrasonic surgical aspiration     299
Lithotripsy     300
Balloon dilatation     301
Cryosurgery     303
Mechanisms     303
Types of cryodevices     304
Risks     304
Area of use     304
Heat treatment     305
Electromagnetic high-frequency energy     305
Ultrasound energy     306
Electroconvulsive therapy     306
Radiotherapy     307
Radiation therapy devices     308
Dose planning     309
Computers in health care     311
The computer     311
Data acquisition     313
Confidentiality     314
Patient data     314
Administrative data     314
Laboratory results     315
Anaesthesia and intensive care     315
Radiation therapy     317
Expert systems      318
Telemedicine     319
Computerized patient records     320
Standardization within health care     322
The internet     322
Home pages and sites     323
Email     323
User groups     323
Limitation of information technology     324
Responsibility     325
Standards     327
Medical devices     328
Quality management     330
Risk management     332
Types of responsibility     333
Legal responsibilities     333
Political responsibilities     333
Administrative management responsibilities     334
Medical and other professional management responsibilities     334
Personal responsibilities     335
Liability     336
Delegating     337
Procurement     338
Statutes and other publications     339
Overall responsibility     340
Checklists     345
Hospital director (or health care director)     346
Purchasing officer     347
Head of department or ward     347
Head nurse     348
Users      349
Index     351