Series Preface |
|
xv | |
Preface |
|
xvii | |
Acknowledgements |
|
xix | |
Authors |
|
xxi | |
1 Introduction |
|
1 | (6) |
|
1.1 Scope of Medical Equipment Management |
|
|
1 | (1) |
|
1.2 Who Should Read This Book? |
|
|
2 | (1) |
|
1.3 Approach and Content of This Book |
|
|
3 | (3) |
|
|
6 | (1) |
|
|
6 | (1) |
|
|
6 | (1) |
2 Medical Equipment and Its Life Cycle |
|
7 | (28) |
|
|
7 | (1) |
|
2.2 What Is Medical Equipment? |
|
|
8 | (2) |
|
2.3 Equipment Management Processes |
|
|
10 | (15) |
|
|
11 | (1) |
|
|
12 | (3) |
|
|
15 | (2) |
|
2.3.4 Tendering, Evaluation and Purchase |
|
|
17 | (3) |
|
|
20 | (1) |
|
2.3.6 Delivery, Installation, Acceptance and Commissioning |
|
|
21 | (2) |
|
|
21 | (1) |
|
|
21 | (1) |
|
|
21 | (1) |
|
2.3.6.4 Acceptance and Commissioning |
|
|
22 | (1) |
|
|
23 | (1) |
|
|
23 | (1) |
|
|
24 | (1) |
|
2.3.9 Asset Management and Depreciation |
|
|
25 | (1) |
|
|
25 | (6) |
|
|
25 | (1) |
|
2.4.2 Decontamination: Cleaning, Disinfection and Sterilisation |
|
|
26 | (1) |
|
2.4.3 User Maintenance, Spares and Consumables |
|
|
26 | (1) |
|
2.4.4 Planned Preventative Maintenance and Breakdown Maintenance |
|
|
27 | (2) |
|
2.4.5 Quality Control and Performance Testing |
|
|
29 | (2) |
|
2.4.6 Condemning and Disposal |
|
|
31 | (1) |
|
2.5 What Is Clinical Engineering? |
|
|
31 | (1) |
|
|
32 | (1) |
|
|
32 | (3) |
3 Medical Device Risk, Regulation and Governance: An Overview |
|
35 | (42) |
|
|
35 | (1) |
|
|
36 | (2) |
|
|
36 | (1) |
|
3.2.2 Legal and Financial Consequences |
|
|
37 | (1) |
|
|
38 | (6) |
|
|
38 | (1) |
|
|
39 | (1) |
|
3.3.3 Practical Approaches to Risk Management |
|
|
40 | (2) |
|
3.3.4 Risks in the Hospital Context |
|
|
42 | (2) |
|
3.4 Governance, Standards and Best Practice |
|
|
44 | (5) |
|
|
44 | (1) |
|
3.4.2 Clinical Governance |
|
|
45 | (1) |
|
3.4.3 Quality Systems, Records and Document Control |
|
|
46 | (3) |
|
3.5 Risk Management and Governance in the Equipment Life Cycle |
|
|
49 | (13) |
|
|
49 | (1) |
|
3.5.2 Installation, Acceptance and Commissioning |
|
|
50 | (1) |
|
3.5.3 Risks during Equipment Operation |
|
|
51 | (5) |
|
|
51 | (1) |
|
3.5.3.2 Health and Safety Risks |
|
|
52 | (1) |
|
|
52 | (1) |
|
3.5.3.4 Non-Ionising Radiation |
|
|
52 | (1) |
|
3.5.3.5 Electrical Safety |
|
|
53 | (1) |
|
3.5.3.6 Mechanical Hazards |
|
|
53 | (1) |
|
3.5.3.7 Chemical Contamination |
|
|
54 | (1) |
|
|
55 | (1) |
|
|
55 | (1) |
|
3.5.3.10 Electromagnetic Interference |
|
|
56 | (1) |
|
|
56 | (2) |
|
3.5.5 Hazard and Incident Reporting and Management |
|
|
58 | (1) |
|
3.5.6 Modification, Clinical Trials, Research and Off-Label Use |
|
|
59 | (2) |
|
3.5.7 Condemning and Disposal |
|
|
61 | (1) |
|
3.6 Liability and Indemnity: When Risk Becomes Reality |
|
|
62 | (1) |
|
|
62 | (1) |
|
|
62 | (1) |
|
3.7 Legal Obligations of Healthcare Organisations |
|
|
63 | (9) |
|
|
63 | (1) |
|
|
64 | (1) |
|
3.7.3 Medical Device Law and Regulations |
|
|
64 | (3) |
|
|
65 | (1) |
|
3.7.3.2 CE Marking and Identification |
|
|
66 | (1) |
|
3.7.3.3 Placing on the Market |
|
|
66 | (1) |
|
|
66 | (1) |
|
3.7.4 Consumer Protection Law |
|
|
67 | (1) |
|
3.7.5 Health and Safety Legislation |
|
|
68 | (4) |
|
|
72 | (1) |
|
|
73 | (4) |
4 Approaches to Equipment Management: Structures and Systems |
|
77 | (16) |
|
|
77 | (1) |
|
4.2 Organisational Structures to Support Medical Equipment Management |
|
|
78 | (7) |
|
|
78 | (1) |
|
|
79 | (2) |
|
4.2.3 Operational Executive Management Committee |
|
|
81 | (1) |
|
4.2.4 Risk Management Committee |
|
|
81 | (1) |
|
4.2.5 Capital Programme Committee |
|
|
82 | (1) |
|
4.2.6 Medical Equipment Management Committee |
|
|
82 | (1) |
|
|
83 | (2) |
|
4.2.7.1 New Devices Group |
|
|
83 | (1) |
|
|
83 | (1) |
|
4.2.7.3 Clinical Engineering |
|
|
83 | (1) |
|
|
84 | (1) |
|
4.2.7.5 Organisation-Wide Lead Roles |
|
|
84 | (1) |
|
4.3 Systems for Equipment Management: Balancing In-House and External Provision |
|
|
85 | (6) |
|
4.3.1 Financing and Equipping Major Projects: An Overview |
|
|
85 | (1) |
|
4.3.2 PublicPrivate Partnerships and Equivalent Schemes |
|
|
86 | (3) |
|
4.3.3 Financing and Equipping by the Healthcare Organisation |
|
|
89 | (1) |
|
4.3.4 Managed Equipment Services |
|
|
89 | (2) |
|
|
91 | (1) |
|
|
91 | (2) |
5 Purchase and Replacement: Allocating Priorities and Managing Resources |
|
93 | (22) |
|
|
93 | (1) |
|
5.2 Seeking the Ideal: Matching Needs and Resources |
|
|
94 | (1) |
|
5.3 Funding Routes for More Expensive Equipment |
|
|
95 | (2) |
|
5.3.1 Capital Funding Definition |
|
|
95 | (1) |
|
5.3.2 Charities and Research Funding |
|
|
95 | (1) |
|
|
96 | (1) |
|
|
96 | (1) |
|
5.3.3.2 Consumables Related |
|
|
96 | (1) |
|
|
96 | (1) |
|
|
97 | (1) |
|
5.3.4 Using Capital Funds for Low Cost Items |
|
|
97 | (1) |
|
5.4 Identifying Equipment Needs |
|
|
97 | (3) |
|
5.4.1 Routine Replacement |
|
|
98 | (1) |
|
5.4.2 Replacement due to Unreliability |
|
|
98 | (1) |
|
|
98 | (1) |
|
5.4.4 Technological Development |
|
|
98 | (1) |
|
|
99 | (1) |
|
5.4.6 Risk and Health and Safety Issues |
|
|
99 | (1) |
|
5.4.7 Professional and Policy-Setting Bodies |
|
|
99 | (1) |
|
5.4.8 Service Developments |
|
|
99 | (1) |
|
5.4.9 Funding of Innovation |
|
|
100 | (1) |
|
|
100 | (1) |
|
5.5 Relating Funding to Need |
|
|
100 | (6) |
|
5.5.1 General Characteristics of a System to Allocate Capital to Medical Equipment |
|
|
101 | (1) |
|
5.5.2 Examples of Allocation Systems |
|
|
102 | (3) |
|
5.5.3 Creating an Effective System |
|
|
105 | (1) |
|
|
105 | (1) |
|
5.5.3.2 Taking Organisational Politics into Account |
|
|
105 | (1) |
|
5.5.3.3 Setting Realistic Time Scales |
|
|
106 | (1) |
|
|
106 | (1) |
|
5.6 Outline of a Possible Bidding Process |
|
|
106 | (7) |
|
|
108 | (2) |
|
5.6.2 Ranking Service Development Bids |
|
|
110 | (1) |
|
|
111 | (1) |
|
5.6.4 Decision-Making Process |
|
|
112 | (1) |
|
|
112 | (1) |
|
|
112 | (1) |
|
5.6.7 Equipment Replacement outside the Annual Capital Allocation Process |
|
|
113 | (1) |
|
|
113 | (1) |
|
|
114 | (1) |
6 Procurement, Specification and Evaluation |
|
115 | (18) |
|
|
115 | (1) |
|
6.2 Approaching a Replacement Programme and Tender |
|
|
115 | (5) |
|
6.3 Preparing a Specification |
|
|
120 | (4) |
|
6.4 Tender Receipt, Evaluation and Decision |
|
|
124 | (6) |
|
|
124 | (2) |
|
6.4.2 Clinical Evaluation |
|
|
126 | (1) |
|
6.4.3 Technical Evaluation |
|
|
127 | (2) |
|
6.4.4 Post-Tender Negotiations |
|
|
129 | (1) |
|
|
129 | (1) |
|
6.5 Collaborative Procurement |
|
|
130 | (1) |
|
|
131 | (1) |
|
|
131 | (2) |
7 Equipment Training for Clinical and Technical Users |
|
133 | (14) |
|
7.1 Introduction: The Need for Training |
|
|
133 | (1) |
|
7.2 Who to Train and What to Learn |
|
|
134 | (6) |
|
7.2.1 Clinical End User Training |
|
|
134 | (3) |
|
7.2.2 Training Patients and Carers |
|
|
137 | (1) |
|
7.2.3 Specialised Technical Training |
|
|
137 | (2) |
|
7.2.4 Underpinning Scientific and Technical Knowledge for Clinical Engineers |
|
|
139 | (1) |
|
|
140 | (1) |
|
7.4 Organisation and Delivery |
|
|
141 | (1) |
|
|
142 | (1) |
|
7.6 Assessment of Training and Its Effectiveness |
|
|
143 | (2) |
|
|
145 | (1) |
|
|
145 | (2) |
8 Assessing Maintenance and Support Needs |
|
147 | (28) |
|
|
147 | (1) |
|
8.2 Balancing Elements of the Maintenance and Support Process |
|
|
148 | (2) |
|
8.3 What Options Are Available for Preventive Maintenance and Support? |
|
|
150 | (1) |
|
8.4 Assessing Maintenance and Support Requirements for Particular Devices |
|
|
151 | (6) |
|
8.5 Assigning Responsibility for Maintenance and Support |
|
|
157 | (11) |
|
|
157 | (1) |
|
8.5.2 In-House Maintenance Provision |
|
|
158 | (2) |
|
8.5.3 External Maintenance Providers |
|
|
160 | (2) |
|
|
160 | (1) |
|
8.5.3.2 Independent or Third-Party Maintenance Providers |
|
|
161 | (1) |
|
8.5.3.3 Maintenance Contract Management Companies |
|
|
161 | (1) |
|
8.5.3.4 Diversified Service Organisations |
|
|
162 | (1) |
|
8.5.4 Factors Affecting What Maintenance Is Undertaken In-House |
|
|
162 | (4) |
|
|
163 | (1) |
|
8.5.4.2 Restrictions on What Can Be Done |
|
|
163 | (1) |
|
8.5.4.3 Pressures to Maintain Equipment In-House |
|
|
164 | (1) |
|
8.5.4.4 Nature of the In-House Service |
|
|
164 | (1) |
|
8.5.4.5 User Buy In: Internal Politics and Culture |
|
|
165 | (1) |
|
8.5.4.6 Willingness to Change Existing Maintenance and Support Regimes |
|
|
166 | (1) |
|
8.5.5 Changing Maintenance Regimes |
|
|
166 | (10) |
|
|
167 | (1) |
|
|
167 | (1) |
|
|
167 | (1) |
|
8.5.5.4 Liability Concerns |
|
|
167 | (1) |
|
8.6 Final Review and Decision Making: Deciding Who Performs Maintenance |
|
|
168 | (4) |
|
|
172 | (1) |
|
|
173 | (2) |
9 Maintenance Contract Management |
|
175 | (18) |
|
|
175 | (1) |
|
9.2 Maintenance Contract Management Life Cycle |
|
|
176 | (14) |
|
9.2.1 Setting Up the Contract |
|
|
176 | (9) |
|
9.2.1.1 Establishing the Need for a Contract |
|
|
177 | (1) |
|
9.2.1.2 Identifying Funding |
|
|
177 | (1) |
|
9.2.1.3 Allocating Funding |
|
|
177 | (1) |
|
9.2.1.4 Deciding on the Provider |
|
|
178 | (1) |
|
9.2.1.5 Reviewing Options for Contract Type and Scope |
|
|
179 | (1) |
|
9.2.1.6 Factors Affecting the Level of Cover Required |
|
|
179 | (1) |
|
9.2.1.7 Cooperative Contracts |
|
|
180 | (1) |
|
9.2.1.8 Breakdown Response Time and Hours of Support |
|
|
180 | (1) |
|
|
181 | (1) |
|
9.2.1.10 Replacement of Expensive Parts |
|
|
182 | (1) |
|
9.2.1.11 Agreeing Operational Responsibilities |
|
|
182 | (1) |
|
9.2.1.12 Check Details before Signing |
|
|
183 | (1) |
|
|
184 | (1) |
|
9.2.1.14 Monitoring Measures for Quality of Service |
|
|
184 | (1) |
|
9.2.1.15 Variations to Contract |
|
|
185 | (1) |
|
9.2.2 Tenders and Negotiation |
|
|
185 | (1) |
|
9.2.3 Operational Support |
|
|
186 | (3) |
|
9.2.3.1 In-House Technical Staff |
|
|
186 | (1) |
|
9.2.3.2 Clinical User Involvement |
|
|
187 | (1) |
|
9.2.3.3 Arranging Service Visits |
|
|
187 | (1) |
|
9.2.3.4 Labelling Equipment |
|
|
188 | (1) |
|
|
188 | (1) |
|
9.2.4 Contract Performance Monitoring |
|
|
189 | (1) |
|
9.3 Contract Review and Renewal |
|
|
190 | (2) |
|
|
192 | (1) |
|
|
192 | (1) |
10 Adverse Incidents, Investigations, Control and Monitoring |
|
193 | (24) |
|
|
193 | (1) |
|
10.2 Definitions and Categories |
|
|
193 | (1) |
|
10.3 Why Report Adverse Incidents? |
|
|
194 | (1) |
|
10.4 Initial Incident Handling |
|
|
195 | (2) |
|
10.5 Incident Investigation |
|
|
197 | (3) |
|
10.5.1 Investigation Process |
|
|
197 | (1) |
|
10.5.2 Establishing the Facts |
|
|
198 | (1) |
|
10.5.3 Investigating the Medical Device and Associated Equipment |
|
|
199 | (1) |
|
|
200 | (12) |
|
10.6.1 Investigation Techniques |
|
|
201 | (1) |
|
10.6.2 Human Error versus System Failure |
|
|
202 | (1) |
|
10.6.3 Categories of Human Error and Associated Remedies |
|
|
203 | (3) |
|
|
203 | (1) |
|
|
204 | (1) |
|
10.6.3.3 Lack of Knowledge |
|
|
204 | (1) |
|
10.6.3.4 Lack of Training and Experience |
|
|
205 | (1) |
|
|
205 | (1) |
|
10.6.3.6 Behavioural Problems |
|
|
205 | (1) |
|
10.6.3.7 Institutional Pressures |
|
|
206 | (1) |
|
|
206 | (2) |
|
10.6.5 Systematic Interpretations and Associated Remedies |
|
|
208 | (10) |
|
|
209 | (1) |
|
10.6.5.2 Environmental Factors |
|
|
209 | (1) |
|
10.6.5.3 Process and Equipment Factors |
|
|
210 | (1) |
|
10.6.5.4 Operator Factors |
|
|
210 | (1) |
|
|
211 | (1) |
|
10.6.5.6 Unexpected Events |
|
|
212 | (1) |
|
10.7 Devising Control Measures |
|
|
212 | (2) |
|
10.8 Outputs from an Incident Investigation |
|
|
214 | (1) |
|
|
215 | (1) |
|
|
215 | (1) |
|
|
215 | (2) |
11 Supporting Research and Development |
|
217 | (18) |
|
|
217 | (1) |
|
11.2 Legitimising and Managing Research Projects |
|
|
218 | (2) |
|
11.2.1 Internal Governance |
|
|
218 | (1) |
|
11.2.2 Ethical Considerations |
|
|
219 | (1) |
|
|
220 | (1) |
|
11.3 How an Organisation Manages Risk Associated with Innovative Equipment |
|
|
220 | (4) |
|
11.3.1 Approved Medical Devices Used for Research Rather than Clinical Applications |
|
|
221 | (1) |
|
11.3.2 Non-Medical-Grade Items Used as, or in Conjunction with, Medical Devices |
|
|
221 | (1) |
|
11.3.3 Constructing or Modifying Medical Devices for Use within the Organisation |
|
|
222 | (1) |
|
11.3.4 Clinical Investigations of New Devices Prior to Placing on the Market |
|
|
223 | (1) |
|
11.3.5 Use Outside the Region of Approval |
|
|
223 | (1) |
|
11.3.6 Equipment for Off-Label Clinical Use |
|
|
224 | (1) |
|
11.4 Practical Aspects of Getting Novel Medical Equipment into Use |
|
|
224 | (3) |
|
11.5 In-House Construction of Novel Devices |
|
|
227 | (2) |
|
11.6 Creating a Novel Device |
|
|
229 | (2) |
|
11.6.1 Evaluating Whether to Buy, Modify or Build |
|
|
229 | (1) |
|
11.6.2 Establish Resources and Funding |
|
|
230 | (1) |
|
11.6.3 Designing for Conformity |
|
|
230 | (1) |
|
11.6.4 Production, Validation and Traceability of Components and Suppliers |
|
|
231 | (1) |
|
11.7 Placing on the Market |
|
|
231 | (2) |
|
|
233 | (1) |
|
|
233 | (2) |
12 Disposal |
|
235 | (12) |
|
|
235 | (1) |
|
12.2 Condemning and Disposal Procedures |
|
|
236 | (1) |
|
12.3 Legislation Relevant to Disposal |
|
|
236 | (3) |
|
12.4 Preparing for Disposal |
|
|
239 | (1) |
|
|
240 | (4) |
|
12.5.1 Return to Manufacturer |
|
|
240 | (1) |
|
12.5.2 Using a Specialist Contractor |
|
|
240 | (1) |
|
|
241 | (1) |
|
12.5.4 Use for Spare Parts |
|
|
241 | (1) |
|
|
242 | (1) |
|
12.5.6 Redeployment for Research and Teaching |
|
|
242 | (1) |
|
12.5.7 Sale or Donation for Reuse |
|
|
243 | (1) |
|
12.6 Disposal of Consumables and Batteries |
|
|
244 | (1) |
|
12.7 Disposal of Waste from In-House Repair and Manufacturing Activities |
|
|
245 | (1) |
|
|
245 | (1) |
|
|
245 | (2) |
13 Sources of Information for Equipment Management Professionals |
|
247 | (20) |
|
|
247 | (1) |
|
13.2 Government Agencies and Medical Device Regulatory Bodies |
|
|
248 | (2) |
|
|
248 | (1) |
|
|
249 | (1) |
|
13.2.3 Competent Authorities and Notified, Accredited and Certification Bodies |
|
|
249 | (1) |
|
13.3 Standards and Standards Bodies |
|
|
250 | (4) |
|
13.3.1 Overview of Standards |
|
|
250 | (1) |
|
|
251 | (2) |
|
13.3.3 Key International Standards Relevant to Medical Devices and Their Management |
|
|
253 | (1) |
|
13.3.3.1 Device Construction and Development |
|
|
253 | (1) |
|
|
253 | (1) |
|
13.3.3.3 Medical Equipment Management |
|
|
254 | (1) |
|
13.3.4 Other Functions of Standards Bodies |
|
|
254 | (1) |
|
13.4 Learned Societies and Professional Bodies |
|
|
254 | (6) |
|
|
254 | (2) |
|
13.4.2 Societies Relevant to Equipment Management and Healthcare Technology |
|
|
256 | (1) |
|
13.4.3 Training and Certification in Clinical Engineering |
|
|
257 | (1) |
|
13.4.4 Knowledge Resources |
|
|
258 | (1) |
|
13.4.5 Regional and International Societies |
|
|
258 | (2) |
|
|
260 | (1) |
|
13.5 Sources of External Assistance: Commercial, Non-Profit and Peers |
|
|
260 | (3) |
|
13.5.1 Commercial Equipment Advisors and Equipment Manufacturers |
|
|
260 | (1) |
|
13.5.2 Supranational and Not-for-Profit Agencies |
|
|
261 | (7) |
|
|
262 | (1) |
|
13.5.2.2 Charitable Bodies |
|
|
262 | (1) |
|
|
263 | (1) |
|
|
264 | (3) |
14 Improving Performance: Quality, Indicators, Benchmarking and Audit |
|
267 | (16) |
|
|
267 | (1) |
|
14.2 Why Monitor Performance? |
|
|
268 | (1) |
|
14.3 Internal and External Monitoring |
|
|
268 | (2) |
|
14.3.1 Internal Monitoring |
|
|
268 | (1) |
|
14.3.2 External Monitoring |
|
|
269 | (1) |
|
14.3.3 Monitoring Methods |
|
|
270 | (1) |
|
14.4 Constructing Performance Indicators |
|
|
270 | (2) |
|
14.4.1 Types of Performance Indicators |
|
|
270 | (1) |
|
14.4.2 Quantitative Input and Output Measures and Ratios |
|
|
271 | (1) |
|
14.5 Performance Indicators in Equipment Management |
|
|
272 | (5) |
|
14.5.1 Devising Practical Indicators |
|
|
272 | (2) |
|
14.5.2 Pitfalls of Indicator Design |
|
|
274 | (2) |
|
14.5.3 Selecting and Using Performance Indicators |
|
|
276 | (1) |
|
14.6 Benchmarking in Clinical Engineering |
|
|
277 | (2) |
|
|
279 | (1) |
|
|
280 | (1) |
|
|
281 | (2) |
Appendix A: Practical Issues in Running an In-House Clinical Engineering Service |
|
283 | (12) |
Appendix B: Electrical Safety for Medical Equipment |
|
295 | (16) |
Index |
|
311 | |