[Title Page] 1

Contents 1

PRELIMINARY INVESTIGATION REPORT : Establishment of Medical Equipment Management and Operating System at Dessie Referral Hospital 1

Contents 2

Chapter 1. Overview 3

1. Overview of the project 3

2. Background and the goal of project 4

2.1. Background 4

2.2. Purpose 5

2.3. Mission and vision in brief 5

2.4. Goal 5

3. Detail work scope 6

3.1. Preliminary investigation 6

3.2. Supporting medical equipment management and operation system 6

3.3. Enhancing the role and awareness of BME unit 6

4. Structure of the project 6

5. Schedule 7

Chapter 2. Contents of activities 8

1. Data analysis 8

2. Preliminary investigation 9

2.1. Purpose of visit 9

2.2. Personnel information 9

2.3. Schedule 9

Chapter 3. Result of preliminary investigation 10

1. Basic status of Dessie Referral hospital 10

2. The current status of BME unit 10

2.1. BME team responsibilities and major tasks they are conducting 10

2.2. Biomedical Engineering structure 11

2.3. Medical Equipment Management Policy 11

2.4. Corrective Maintenance 12

2.5. Installation of medical equipment 13

2.6. User training 13

2.7. Planned Preventive Maintenance and periodic inspection (PPM) 14

2.8. Medical equipment inventory 15

2.9. Medical equipment acquisition system 16

2.10. Medical Equipment Committee 16

2.11. Major challenge of BME unit 17

3. The current status of medical equipment management and operation cycle 18

3.1. Medical equipment management and operation cycle 18

3.2. Discussion 21

4. BME unit field survey 22

4.1. BME workshop 22

4.2. Document management system 23

5. Field survey on medical equipment operation and pilot operation on daily maintenance 26

5.1. Medical Laboratory 26

5.2. Adult Intensive Care Unit 27

5.3. Radiology department: 27

5.4. Operation theatre 27

5.5. Emergency Room 28

5.6. Central sterilisation unit 28

6. The result of the questionnaire survey for awareness of BME unit 29

6.1. Purpose 29

6.2. Targets 29

6.3. Result 29

6.4. Comprehensive analysis 30

7. Statistical data related to medical equipment 31

7.1. Purpose 31

7.2. Components 31

7.3. Result 31

Medical Equipment Management Policy 34

Contents 35

Acronyms/Abbreviations 36

Introduction 37

Definition of a Medical Device/Equipment 37

Medical Equipment Policy 38

The Procedures of the guidelines 39

1. Acquisition 39

1.1. Planning 39

1.2. Generic equipment specifications and technical data 40

1.3. Procurement 43

1.4. Inspection 44

1.5. Commissioning 44

1.6. Site Preparation 45

1.7. Preparing for equipment delivery 45

1.8. Installation 46

1.9. Testing 47

1.10. Training 48

2. . Donation 50

2.1. Donation Principles 50

2.2. Donation General Requirements 50

2.3. Rejection of Donation 52

2.4.Reporting any Donation Fault 52

3. Standard Operating Procedures 52

4. Maintenance 52

4.1. Planned Preventive Maintenance 53

4.2. Corrective Maintenance 53

5. Lease 54

6. Cluster 54

7. Public Private Partnership (PPP) 54

8. Medical Equipment Inventory 55

9. Work Order and Reports 56

10. Outsourcing of Technical Services 57

11. Medical Equipment Incident Reporting 58

12. Biomedical Engineering Department 58

13. Medical Equipment Risk Assessment 59

14. Utilisation 59

Annexes 60

Annex A. Procurement Request Form 61

Annex B. Acceptance testing log sheet 62

Annex C. Simple acceptance inspection report 65

Annex D. Classification of Medical Equipment by Risk Assessment 68

Annex E. Sample Inventory Format 71

Annex F. Equipment History Files 72

Annex G. Sample Bin Record Card for Spare Parts 73

Annex H. Sample Stock Record Card for Spare Parts 74

Annex I. Sample User Training Verification Form 75

Annex J. Sample Planned Preventive Maintenance Log Sheet 76

Annex K. Inspection Label after Planned Preventive Maintenance 77

Annex L. Daily Maintenance Form 78

Annex M. Sample Work Order Form 79

Annex N. Good Practice Checklist for Corrective Maintenance 80

Annex O. Sample Corrective Maintenance Report 83

Annex P. Sample Job Description 84

Annex Q. Sample Contract for the Procurement of Goods 86

General Conditions of Contract 87

Special Conditions of Contract 97

PRELIMINARY INVESTIGATION REPORT : Establishment of Medical Equipment Management and Operating System at Gebre Tsadik Shawo General Hospital 107

Contents 108

Chapter 1. Overview 109

1. Overview of the project 109

2. Background and goal of the project 110

2.1. Background 110

2.2. Purpose 111

2.3. Mission and vision in brief 111

2.4. Goal 111

3. Detail work scope 112

3.1. Preliminary investigation 112

3.2. Supporting medical equipment management and operation system 112

3.3. Enhancing the role and awareness of BME unit 112

4. Structure of the project 112

5. Schedule 113

Chapter 2. Contents of activities 114

1. Data analysis 114

2. Preliminary investigation 115

2.1. Purpose of visit 115

2.2. Personnel information 115

2.3. Schedule 115

Chapter 3. Result of preliminary investigation 116

1. Basic status of G/Tsadik shawo general hospital, Bonga Ethiopia 116

2. The current status of the BME unit 117

2.1. BME team responsibilities in the hospital 117

2.2. Biomedical Engineering structure 117

2.3. Medical Equipment Management Policy 118

2.4. Corrective Maintenance 118

2.5. Installation of medical equipment 120

2.6. User training 120

2.7. Planned Preventive Maintenance and periodic inspection (PPM) 120

2.8. Medical equipment inventory 121

2.9. Medical equipment acquisition system: 122

2.10. Medical Equipment Committee 123

2.11. Major challenge of BME unit 124

2.12. Strong side 124

3. The current status of medical equipment management and operation 125

3.1. Medical equipment management and operation cycle 125

3.2. Discussion 127

4. BME unit field survey 128

4.1. BME workshop 128

4.2. Document management system 129

5. Field survey on medical equipment operation and pilot operation on daily maintenance 132

5.1. Medical Laboratory 132

5.2. Adult Intensive Care Unit 133

5.3. Neonatal Intensive Care Unit 133

5.4. Radiology department: 133

5.5. Operation theatre 134

5.6. Emergency Room 134

5.7. Central sterilisation unit 134

6. The result of the questionnaire survey for awareness of BME unit 136

6.1. Purpose 136

6.2. Targets 136

6.3. Result 136

6.4. Comprehensive analysis 137

7. Statistical data related to medical equipment 138

7.1. Purpose 138

7.2. Components 138

7.3. Result 138

Medical Equipment Management Policy : G/Tsadik Shawo General Hospital 141

Contents 142

Acronyms/Abbreviations 143

Introduction 144

Definition of a Medical Device/Equipment 144

Medical Equipment Policy 145

The Procedures of the guidelines 145

1. Acquisition 146

1.1. Planning 146

1.2. Generic equipment Specifications and technincal data 146

1.3. Procurement 150

1.4. Inspection 150

1.5. Commissioning 151

1.6. Site Preparation 151

1.7. Preparing for equipment delivery 152

1.8. Installation 153

1.9. Testing 153

1.10. Training 155

2 . Donation 156

2.1. Donation Principles 157

2.2. Donation General Requirements 157

2.3. Rejection of Donation 158

2.4. Reporting any Donation fault 159

3. Standard Operating Procedures 159

4. Maintenance 159

4.1. Planned Preventive Maintenance 159

4.2. Corrective Maintenance 160

5. Lease 160

6. Cluster 161

7. Public Private Partnership (PPP) 161

8. Medical Equipment Inventory 162

9. Work Order and Report 163

10. Outsourcing of Technical Services 164

11. Medical Equipment Incident Reporting 165

12. Biomedical Engineering Department 165

13. Medical Equipment Risk Assessment 166

14. Utilisation 166

Annexes 167

Annex A. Procurement Request Form 168

Annex B. Acceptance testing log sheet 169

Annex C. Simple acceptance inspection report 172

Annex D. Classification of Medical Equipment by Risk Assessment 175

Annex E. Sample Inventory Format 178

Annex F. Equipment History Files 179

Annex G. Sample Bin Record Card for Spare Parts 180

Annex H. Sample Stock Record Card for Spare Parts 181

Annex I. Sample User Training Verification Form 182

Annex J. Sample Planned Preventive Maintenance Log Sheet 183

Annex K. Inspection Label after Planned Preventive Maintenance 184

Annex L. Daily Maintenance Form 185

Annex M. Sample Work Order Form 186

Annex N. Good Practice Checklist for Corrective Maintenance 187

Annex O. Sample Corrective Maintenance Report 190

Annex P. Sample Job Description 191

Annex Q. Sample Contract for the Procurement of Goods 193

General Conditions of Contract 194

Special Conditions of Contract 204

Copyringht 214