TABLE OF CONTENTS

1. INTRODUCTION ................................................................................................................... 1

2. INSPECTION AND MAINTENANCE OF MEDICAL DEVICES ................................... 6

2.1. Essential Medical Equipment ............................................................................................. 6

2.2. Medical Equipment Management ....................................................................................... 9

2.2.1. Life Cycle of Medical Equipment ............................................................................ 9

2.2.2. Joint Commission Standards for Medical Equipment ............................................ 13

2.3. Preventive Maintenance of Medical Equipment .............................................................. 15

2.4. Computerized Maintenance Management Systems .......................................................... 17

2.4.1. CMMS Core Modules ............................................................................................ 18

2.4.2. Scheduled and Non-Scheduled Work Orders ......................................................... 21

2.5. Concluding Remarks ........................................................................................................ 23

3. PRIORITIZATION OF MEDICAL DEVICES ................................................................. 24

3.1. Literature Review ............................................................................................................. 24

3.2. Model for Prioritization of Medical Devices .................................................................... 27

3.2.1. Proposed Criticality Assessment Model for Medical Equipment .......................... 29

x
TABLE OF CONTENTS

3.2.2. Descriptions of Criteria and Sub-criteria ............................................................... 33

3.2.3. Determining Weighting Values for Criteria and Sub-Criteria .............................. 37

3.2.4. Setting Up Grades and Intensities for Each Criterion ........................................... 39

3.2.5. Ranking Medical Devices ..................................................................................... 40

3.2.6. Numerical Example and Discussion ...................................................................... 42

3.2.7. Classification and Maintenance Strategies ........................................................... 53

3.3. Concluding Remarks ........................................................................................................ 58

4. RELIABILITY AND TREND ANALYSIS OF FAILURE DATA .................................. 60

4.1. Literature Review ............................................................................................................. 60

4.2. A Model Proposed for Reliability Analysis of Medical Devices’ Failure Data .............. 63

4.2.1. Preliminary Analysis of Failure Data .................................................................... 63

4.2.2. Hard and Soft Failures ........................................................................................... 67

4.2.3. Proposed Policy for Analyzing Soft and Hard Failures ......................................... 69

4.2.4. Trend Analysis – The Laplace Trend Test ............................................................. 72

4.2.5. Trend Analysis and Distribution Fitting of Failure Data ....................................... 73

4.3. Basic Assumptions for the System Under Study ............................................................. 78

4.4. A Proposed Method for Trend Analysis of Failure Data Subject to Censoring............... 81

4.4.1. Parameter Estimation and Trend Analysis ............................................................. 83

4.4.2. Case Studies ........................................................................................................... 90

4.5. Concluding Remarks ........................................................................................................ 97

5. INSPECTION AND MAINTENANCE OPTIMIZATION MODELS .......................... 100

5.1. Literature Review ........................................................................................................... 100

5.2. Case 1: A System Under Periodic Inspections ............................................................... 107

xi
TABLE OF CONTENTS

5.2.1. Minimal Repair of Soft Failures .......................................................................... 108

5.2.1.1. Model Considering Downtime and Repair of Components....................... 109

5.2.1.2. Model Considering the Number of Failures .............................................. 117

5.2.1.3. The Combined Model ................................................................................ 126

5.2.2. Minimal Repair and Replacement of Soft Failures .............................................. 128

5.2.2.1. Model Over a Finite Time Horizon ........................................................... 128

5.2.2.2. Model Over Infinite Time Horizon ............................................................ 136

5.3. Case 2: A System Under Periodic and Opportunistic Inspections ................................. 141

5.3.1. Minimal Repair of Soft and Hard Failures ................................................... 143

5.3.2. Minimal Repair and Replacement of Soft Failures ...................................... 154

5.3.3. Minimal Repair and Replacement of Soft and Hard Failures ....................... 160

5.3.4. Preventive Replacement of Components with Hard Failures at

Periodic Inspections ..................................................................................... 168
5.4. Concluding Remarks ...................................................................................................... 175

6. CONCLUSION AND FUTURE RESEARCH ................................................................. 178

6.1. Conclusion...................................................................................................................... 178

6.2. Future Research .............................................................................................................. 183

7. REFERENCES .................................................................................................................... 185

8. APPENDICES ..................................................................................................................... 203

APPENDIX A- Qualitative grades and intensities for criteria/sub-criteria ......................... 204

APPENDIX B- Calculating the lower bound for the total score value ................................ 209

APPENDIX C- Soft and hard failures ................................................................................. 211

APPENDIX D- Rules for analyzing failure data at the system level ................................... 213

TABLE OF CONTENTS
xiii
xi i