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E-grāmata: Medical Equipment Management [Taylor & Francis e-book]

, , (King's College Hospital, London, UK)
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Based on materials developed for a postgraduate course on clinical engineering and medical physics at King's College London, this volume provides guidance on the theory and practice of medical equipment management. Introductory chapters provide an overview of the medical equipment life cycle and explore the implications of governance, quality, safety, and risk concepts for medical equipment management and clinical engineering. The remaining chapters are devoted to more specialized equipment management topics, including structures and systems of equipment management; purchase and replacement; procurement, specification, and evaluation; equipment training for clinical and technical users; assessing maintenance and support needs; maintenance contract management; adverse incidents, investigations, control, and monitoring; supporting research and development; disposal; sources of information for equipment management professionals; and quality, indicators, benchmarking, and audits. Annotation ©2014 Ringgold, Inc., Portland, OR (protoview.com)

Know What to Expect When Managing Medical Equipment and Healthcare Technology in Your Organization

As medical technology in clinical care becomes more complex, clinical professionals and support staff must know how to keep patients safe and equipment working in the clinical environment. Accessible to all healthcare professionals and managers, Medical Equipment Management presents an integrated approach to managing medical equipment in healthcare organizations. The book explains the underlying principles and requirements and raises awareness of what needs to be done and what questions to ask. It also provides practical advice and refers readers to appropriate legislation and guidelines.

Starting from the medical equipment lifecycle, the book takes a risk-based approach to improving the way in which medical devices are acquired and managed in a clinical context. Drawing on their extensive managerial and teaching experiences, the authors explain how organizational structures and policies are set up, how funding is allocated, how people and equipment are supported, and what to do when things go wrong.

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)
1.4 Clarifications
6(1)
1.5 Values and Value
6(1)
References
6(1)
2 Medical Equipment and Its Life Cycle 7(28)
2.1 Introduction
7(1)
2.2 What Is Medical Equipment?
8(2)
2.3 Equipment Management Processes
10(15)
2.3.1 Establishing Need
11(1)
2.3.2 Funding
12(3)
2.3.3 Specification
15(2)
2.3.4 Tendering, Evaluation and Purchase
17(3)
2.3.5 Preparatory Work
20(1)
2.3.6 Delivery, Installation, Acceptance and Commissioning
21(2)
2.3.6.1 Delivery
21(1)
2.3.6.2 Storage
21(1)
2.3.6.3 Installation
21(1)
2.3.6.4 Acceptance and Commissioning
22(1)
2.3.6.5 Payment
23(1)
2.3.7 User Training
23(1)
2.3.8 Deployment
24(1)
2.3.9 Asset Management and Depreciation
25(1)
2.4 Management in Use
25(6)
2.4.1 Storage
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)
2.6 Summary
32(1)
References
32(3)
3 Medical Device Risk, Regulation and Governance: An Overview 35(42)
3.1 Introduction
35(1)
3.2 Medical Device Risks
36(2)
3.2.1 Frequency
36(1)
3.2.2 Legal and Financial Consequences
37(1)
3.3 Risk Management
38(6)
3.3.1 Risk Categories
38(1)
3.3.2 Perception of Risk
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)
3.4.1 Introduction
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)
3.5.1 Procurement
49(1)
3.5.2 Installation, Acceptance and Commissioning
50(1)
3.5.3 Risks during Equipment Operation
51(5)
3.5.3.1 Operating Risks
51(1)
3.5.3.2 Health and Safety Risks
52(1)
3.5.3.3 Radiation Safety
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)
3.5.3.8 Infection
55(1)
3.5.3.9 Heat Injury
55(1)
3.5.3.10 Electromagnetic Interference
56(1)
3.5.4 Maintenance
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)
3.6.1 Liability
62(1)
3.6.2 Indemnity
62(1)
3.7 Legal Obligations of Healthcare Organisations
63(9)
3.7.1 Introduction
63(1)
3.7.2 Legislation
64(1)
3.7.3 Medical Device Law and Regulations
64(3)
3.7.3.1 Conformity
65(1)
3.7.3.2 CE Marking and Identification
66(1)
3.7.3.3 Placing on the Market
66(1)
3.7.3.4 Exemptions
66(1)
3.7.4 Consumer Protection Law
67(1)
3.7.5 Health and Safety Legislation
68(4)
3.8 Summary
72(1)
References
73(4)
4 Approaches to Equipment Management: Structures and Systems 77(16)
4.1 Introduction
77(1)
4.2 Organisational Structures to Support Medical Equipment Management
78(7)
4.2.1 Introduction
78(1)
4.2.2 Governing Board
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)
4.2.7 Supporting Groups
83(2)
4.2.7.1 New Devices Group
83(1)
4.2.7.2 Project Teams
83(1)
4.2.7.3 Clinical Engineering
83(1)
4.2.7.4 Users
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 Public—Private 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)
4.4 Summary
91(1)
References
91(2)
5 Purchase and Replacement: Allocating Priorities and Managing Resources 93(22)
5.1 Introduction
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)
5.3.3 Revenue Funding
96(1)
5.3.3.1 Managed Service
96(1)
5.3.3.2 Consumables Related
96(1)
5.3.3.3 Leasing
96(1)
5.3.3.4 Loan and Hire
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)
5.4.3 Failure
98(1)
5.4.4 Technological Development
98(1)
5.4.5 Standardisation
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)
5.4.10 Equipment Usage
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)
5.5.3.1 Flexibility
105(1)
5.5.3.2 Taking Organisational Politics into Account
105(1)
5.5.3.3 Setting Realistic Time Scales
106(1)
5.5.3.4 Gaming
106(1)
5.6 Outline of a Possible Bidding Process
106(7)
5.6.1 Writing Bids
108(2)
5.6.2 Ranking Service Development Bids
110(1)
5.6.3 Bid Vetting
111(1)
5.6.4 Decision-Making Process
112(1)
5.6.5 Confirmation
112(1)
5.6.6 Procurement
112(1)
5.6.7 Equipment Replacement outside the Annual Capital Allocation Process
113(1)
5.7 Summary
113(1)
References
114(1)
6 Procurement, Specification and Evaluation 115(18)
6.1 Introduction
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)
6.4.1 Initial Process
124(2)
6.4.2 Clinical Evaluation
126(1)
6.4.3 Technical Evaluation
127(2)
6.4.4 Post-Tender Negotiations
129(1)
6.4.5 Award
129(1)
6.5 Collaborative Procurement
130(1)
6.6 Summary
131(1)
References
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)
7.3 How to Train
140(1)
7.4 Organisation and Delivery
141(1)
7.5 Training Records
142(1)
7.6 Assessment of Training and Its Effectiveness
143(2)
7.7 Summary
145(1)
References
145(2)
8 Assessing Maintenance and Support Needs 147(28)
8.1 Introduction
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)
8.5.1 Introduction
157(1)
8.5.2 In-House Maintenance Provision
158(2)
8.5.3 External Maintenance Providers
160(2)
8.5.3.1 On-Site Services
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)
8.5.4.1 Type of Device
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)
8.5.5.1 Service Risks
167(1)
8.5.5.2 Staffing Risks
167(1)
8.5.5.3 Regulatory Risks
167(1)
8.5.5.4 Liability Concerns
167(1)
8.6 Final Review and Decision Making: Deciding Who Performs Maintenance
168(4)
8.7 Summary
172(1)
References
173(2)
9 Maintenance Contract Management 175(18)
9.1 Introduction
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)
9.2.1.9 Costs
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)
9.2.1.13 Liability
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)
9.2.3.5 Keeping Records
188(1)
9.2.4 Contract Performance Monitoring
189(1)
9.3 Contract Review and Renewal
190(2)
9.4 Summary
192(1)
Reference
192(1)
10 Adverse Incidents, Investigations, Control and Monitoring 193(24)
10.1 Introduction
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)
10.6 Incident Analysis
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)
10.6.3.1 Poor Design
203(1)
10.6.3.2 Basic Mistakes
204(1)
10.6.3.3 Lack of Knowledge
204(1)
10.6.3.4 Lack of Training and Experience
205(1)
10.6.3.5 Malicious Acts
205(1)
10.6.3.6 Behavioural Problems
205(1)
10.6.3.7 Institutional Pressures
206(1)
10.6.4 Equipment Failure
206(2)
10.6.5 Systematic Interpretations and Associated Remedies
208(10)
10.6.5.1 Patient Factors
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)
10.6.5.5 Team Factors
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)
10.9 Monitoring
215(1)
10.10 Summary
215(1)
References
215(2)
11 Supporting Research and Development 217(18)
11.1 Introduction
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)
11.2.3 Confidentiality
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)
11.8 Summary
233(1)
References
233(2)
12 Disposal 235(12)
12.1 Introduction
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)
12.5 Disposal Routes
240(4)
12.5.1 Return to Manufacturer
240(1)
12.5.2 Using a Specialist Contractor
240(1)
12.5.3 Scrapping
241(1)
12.5.4 Use for Spare Parts
241(1)
12.5.5 Remanufacturing
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)
12.8 Summary
245(1)
References
245(2)
13 Sources of Information for Equipment Management Professionals 247(20)
13.1 Introduction
247(1)
13.2 Government Agencies and Medical Device Regulatory Bodies
248(2)
13.2.1 Regulation
248(1)
13.2.2 Regulatory Bodies
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)
13.3.2 Standards Bodies
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)
13.3.3.2 Quality Systems
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)
13.4.1 Introduction
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)
13.4.6 Chartered Status
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)
13.5.2.1 ECRI Institute
262(1)
13.5.2.2 Charitable Bodies
262(1)
13.6 Summary
263(1)
References
264(3)
14 Improving Performance: Quality, Indicators, Benchmarking and Audit 267(16)
14.1 Introduction
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)
14.7 Audit
279(1)
14.8 Summary
280(1)
References
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
Keith Willson, Keith Ison, Slavik Tabakov
Permanent link: https://www.kriso.lv/db/9780429130373_pe.html
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