Preface |
|
xiii | |
About the Author |
|
xv | |
Chapter 1 Introduction |
|
1 | |
|
1.1 Need for Reliability Technology, Human Error Studies, and Quality in Health Care |
|
|
1 | |
|
|
1 | |
|
1.2.1 Reliability Technology |
|
|
1 | |
|
|
2 | |
|
|
2 | |
|
|
2 | |
|
1.4 Terms and Definitions |
|
|
4 | |
|
1.5 Useful Information on Reliability Technology, Human Error, and Quality in Health Care |
|
|
5 | |
|
|
5 | |
|
|
6 | |
|
1.5.3 Conference Proceedings |
|
|
6 | |
|
|
7 | |
|
|
7 | |
|
|
8 | |
Chapter 2 Basic Mathematical Concepts |
|
11 | |
|
|
11 | |
|
2.2 Range, Arithmetic Mean, and Standard Deviation |
|
|
11 | |
|
|
11 | |
|
|
12 | |
|
|
12 | |
|
2.3 Boolean Algebra Laws and Probability Properties |
|
|
13 | |
|
2.4 Basic Probability-Related Definitions |
|
|
16 | |
|
2.4.1 Probability Density Function |
|
|
16 | |
|
2.4.2 Cumulative Distribution Function |
|
|
17 | |
|
|
17 | |
|
|
18 | |
|
2.5 Probability Distributions |
|
|
18 | |
|
2.5.1 Exponential Distribution |
|
|
18 | |
|
2.5.2 Weibull Distribution |
|
|
19 | |
|
2.5.3 Normal Distribution |
|
|
20 | |
|
2.5.4 General Distribution |
|
|
21 | |
|
2.6 Laplace Transform Definition, Common Laplace Transforms, Final-Value Theorem, and Laplace Transforms' Application in Solving First-Order Differential Equations |
|
|
21 | |
|
2.6.1 Laplace Transform: Final-Value Theorem |
|
|
22 | |
|
2.6.2 Laplace Transforms' Application in Solving First-Order Differential Equations |
|
|
23 | |
|
|
24 | |
|
|
25 | |
Chapter 3 Introduction to Reliability Technology, Human Error, and Quality |
|
27 | |
|
|
27 | |
|
3.2 Bathtub Hazard Rate Curve |
|
|
27 | |
|
3.3 Commonly Used Formulas in Reliability Analysis |
|
|
28 | |
|
3.3.1 General Formula for Reliability |
|
|
29 | |
|
3.3.2 General Formula for Hazard Rate |
|
|
29 | |
|
3.3.3 General Formula for Mean Time to Failure |
|
|
30 | |
|
3.4 Reliability Configurations |
|
|
31 | |
|
3.4.1 Series Configuration |
|
|
31 | |
|
3.4.2 Parallel Configuration |
|
|
33 | |
|
3.4.3 m-out-of-K Configuration |
|
|
35 | |
|
|
37 | |
|
3.5 Reliability Analysis Methods |
|
|
38 | |
|
|
38 | |
|
3.5.2 Failure Modes and Effect Analysis |
|
|
40 | |
|
3.5.3 Fault Tree Analysis |
|
|
41 | |
|
3.6 Human Error Facts, Figures, and Causes |
|
|
44 | |
|
3.7 Human Error Classifications |
|
|
44 | |
|
3.8 Human Error Analysis Methods |
|
|
45 | |
|
3.8.1 Root Cause Analysis |
|
|
45 | |
|
3.8.2 Man–Machine Systems Analysis |
|
|
46 | |
|
3.9 Human Error Data Sources |
|
|
46 | |
|
3.10 Factors Affecting Product Quality and Services |
|
|
47 | |
|
3.11 Quality Assurance System Tasks |
|
|
47 | |
|
3.12 Total Quality Management versus Traditional Quality Assurance |
|
|
47 | |
|
3.13 TQM Elements and Obstacles to TQM Implementation |
|
|
48 | |
|
|
49 | |
|
|
50 | |
Chapter 4 Medical Device Safety and Quality Assurance |
|
53 | |
|
|
53 | |
|
4.2 Medical Device Safety versus Reliability and Types of Medical Device Safety |
|
|
53 | |
|
4.3 Medical Device-Related Safety Requirements and Safety in Device Life Cycle |
|
|
54 | |
|
4.4 Safety Analysis Tools for Medical Devices and Considerations for Selecting Safety Analysis Methods |
|
|
56 | |
|
4.4.1 Considerations for Selecting Safety Analysis Methods |
|
|
59 | |
|
4.5 Regulatory Compliance of Medical Device Quality Assurance and Program for Assuring Medical Device Design Quality |
|
|
60 | |
|
4.6 Methods for Medical Device Quality Assurance |
|
|
64 | |
|
|
64 | |
|
|
64 | |
|
|
65 | |
|
|
65 | |
|
4.6.5 Cause-and-Effect Diagram |
|
|
65 | |
|
|
66 | |
|
|
66 | |
|
|
67 | |
Chapter 5 Medical Device Software Quality Assurance and Risk Assessment |
|
69 | |
|
|
69 | |
|
5.2 Medical Device Software Failure Examples |
|
|
69 | |
|
5.3 Classifications of Medical Software |
|
|
70 | |
|
5.4 Framework for Defining Software Quality Assurance Programs in Medical Device Manufacturing Organizations |
|
|
71 | |
|
5.5 Software Design, Coding, and Testing |
|
|
72 | |
|
|
72 | |
|
|
74 | |
|
|
74 | |
|
|
76 | |
|
5.6.1 Metric I: McCabe's Complexity |
|
|
76 | |
|
5.6.2 Metric II: Halstead Measures |
|
|
77 | |
|
5.7 Risk Management Definition and Program Steps |
|
|
78 | |
|
5.8 Factors in Medical Device Risk Assessment |
|
|
79 | |
|
5.8.1 Design and Manufacturing |
|
|
79 | |
|
5.8.2 Materials Toxicity and Degradation |
|
|
80 | |
|
|
80 | |
|
5.8.4 Interaction with Other Devices |
|
|
81 | |
|
5.9 Integrating Risk Assessment into Medical Device Design Control |
|
|
81 | |
|
5.10 Medical Device Risk Assessment-Related Data |
|
|
81 | |
|
|
82 | |
|
|
82 | |
Chapter 6 Medical Device Maintenance and Sources for Obtaining Medical Device-Related Failure Data |
|
85 | |
|
|
85 | |
|
6.2 Medical Equipment Classifications |
|
|
85 | |
|
6.3 Medical Equipment Maintenance Indexes |
|
|
86 | |
|
|
86 | |
|
6.3.2 Medical Equipment-Specific Indexes |
|
|
87 | |
|
6.4 Medical Equipment Computerized Maintenance Management Systems |
|
|
89 | |
|
6.5 Mathematical Models for Medical Equipment Maintenance |
|
|
91 | |
|
|
91 | |
|
|
92 | |
|
6.6 Medical Device-Related Failure Data Sources |
|
|
93 | |
|
6.7 Organizations for Obtaining Medical Device-Related Failure Data |
|
|
94 | |
|
6.8 Medical Device Failure-Related Data |
|
|
95 | |
|
|
96 | |
|
|
96 | |
Chapter 7 Human Error in Health Care |
|
99 | |
|
|
99 | |
|
7.2 Human Error in Health Care-Related Facts, Figures, and Examples |
|
|
99 | |
|
7.3 Human Error in Medication |
|
|
100 | |
|
7.3.1 Types of Medication Errors |
|
|
100 | |
|
7.3.2 Common Reasons for Occurrence of Medication Errors |
|
|
101 | |
|
7.3.3 Useful General Guidelines to Reduce Occurrence of Medication Errors |
|
|
101 | |
|
7.4 Human Error in Anesthesia |
|
|
102 | |
|
7.4.1 Common Anesthesia Errors |
|
|
103 | |
|
7.4.2 Common Causes of Anesthesia Errors |
|
|
103 | |
|
7.4.3 Useful Methods to Prevent or Reduce Anesthetic Mishaps Due to Human Error |
|
|
104 | |
|
7.5 Human Error in Medical Devices |
|
|
106 | |
|
7.5.1 Medical Devices with High Incidence of Human Errors |
|
|
106 | |
|
7.5.2 Human Errors Causing User-Interface Design Problems |
|
|
106 | |
|
7.5.3 Medical Device-Associated Operator Errors |
|
|
107 | |
|
7.5.4 Human Error Analysis Methods for Medical Devices |
|
|
107 | |
|
7.6 Human Error in Miscellaneous Health Care Areas |
|
|
108 | |
|
7.6.1 Human Error in Emergency Medicine |
|
|
108 | |
|
7.6.2 Human Error in Intensive Care Units |
|
|
109 | |
|
7.7 Useful Guidelines to Prevent Occurrence of Human Error in Health Care |
|
|
109 | |
|
|
110 | |
|
|
111 | |
Chapter 8 Health Care Human Error Reporting Systems and Models for Predicting Human Reliability and Error in Health Care |
|
115 | |
|
|
115 | |
|
8.2 Key Points Associated with Current Event Reporting Systems and Methods Practiced in Such Systems |
|
|
115 | |
|
8.3 Health Care Human Error Reporting Systems |
|
|
116 | |
|
8.4 Medical and General Human Error-Related Data |
|
|
117 | |
|
8.5 Model I: Human Reliability in Normal Work Environment |
|
|
117 | |
|
8.6 Model II: Human Reliability in Fluctuating Work Environment |
|
|
120 | |
|
8.7 Model III: Human Reliability with Critical and Non-Critical Human Errors in Normal Work Environment |
|
|
124 | |
|
|
126 | |
|
|
127 | |
Chapter 9 Patient Safety |
|
129 | |
|
|
129 | |
|
|
129 | |
|
|
130 | |
|
9.4 Patient Safety Culture and Its Assessment |
|
|
131 | |
|
9.5 Patient Safety Program |
|
|
132 | |
|
9.6 Patient Safety Measure Selection and Patient Safety Measures and Analysis Methods |
|
|
134 | |
|
9.7 Patient Safety Organizations |
|
|
136 | |
|
|
136 | |
|
|
137 | |
Chapter 10 Introduction to Quality in Health Care |
|
141 | |
|
|
141 | |
|
10.2 Reasons for Escalating Health Care Costs and Quality Dimensions of Today's Health Care Business |
|
|
141 | |
|
10.3 Health Care Quality Goals and Their Associated Strategies |
|
|
143 | |
|
10.4 Health Care and Industrial Quality Comparisons and Quality Improvement versus Quality Assurance in Health Care Institutions |
|
|
144 | |
|
10.5 Common Health Care Administrators' Appeals for Total Quality and Physicians' Reactions |
|
|
145 | |
|
10.6 Steps for Improving Quality in Health Care |
|
|
145 | |
|
10.7 Implementation of Six Sigma Methodology in Hospitals and Its Advantages and Implementation Barriers |
|
|
147 | |
|
10.8 Quality Indicators for Use in Hospital Departments |
|
|
148 | |
|
10.8.1 Department: Nursing, Acute Care |
|
|
149 | |
|
10.8.2 Department: Physiotherapy |
|
|
149 | |
|
10.8.3 Department: Social Work Services |
|
|
149 | |
|
10.8.4 Department: Pharmacy |
|
|
149 | |
|
10.8.5 Department: Food Services Excluding Therapeutic Nutrition |
|
|
149 | |
|
|
150 | |
|
|
150 | |
Chapter 11 Quality Methods for Use in Health Care |
|
153 | |
|
|
153 | |
|
|
153 | |
|
11.3 Cause-and-Effect Diagram |
|
|
154 | |
|
11.4 Quality Function Deployment |
|
|
155 | |
|
11.5 Process Flow Diagram |
|
|
156 | |
|
|
156 | |
|
|
157 | |
|
11.8 Force Field Analysis |
|
|
157 | |
|
|
158 | |
|
|
159 | |
|
|
159 | |
|
|
160 | |
|
|
160 | |
|
|
162 | |
References |
|
163 | |
Bibliography |
|
165 | |
Index |
|
191 | |