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El. knyga: Healthcare Technology Management - A Systematic Approach

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, , , , (Cardiff University, School of Engineering)
  • Formatas: 569 pages
  • Išleidimo metai: 06-Jan-2017
  • Leidėjas: CRC Press Inc
  • ISBN-13: 9781315354507
Kitos knygos pagal šią temą:
Healthcare Technology Management - A Systematic ApproachDidesnis paveikslėlis
  • Formatas: 569 pages
  • Išleidimo metai: 06-Jan-2017
  • Leidėjas: CRC Press Inc
  • ISBN-13: 9781315354507
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Healthcare Technology Management: A Systematic Approach offers a comprehensive description of a method for providing safe and cost effective healthcare technology management (HTM). The approach is directed to enhancing the value (benefit in relation to cost) of the medical equipment assets of healthcare organizations to best support patients, clinicians and other care providers, as well as financial stakeholders. The authors propose a management model based on interlinked strategic and operational quality cycles which, when fully realized, delivers a comprehensive and transparent methodology for implementing a HTM programme throughout a healthcare organization. The approach proposes that HTM extends beyond managing the technology in isolation to include advancing patient care through supporting the application of the technology. The book shows how to cost effectively manage medical equipment through its full life cycle, from acquisition through operational use to disposal, and to advance care, adding value to the medical equipment assets for the benefit of patients and stakeholders.

This book will be of interest to practicing clinical engineers and to students and lecturers, and includes self-directed learning questions and case studies. Clinicians, Chief Executive Officers, Directors of Finance and other hospital managers with responsibility for the governance of medical equipment will also find this book of interest and value.

For more information about the book, please visit the website.

Recenzijos

"Medical equipment management is a large and diverse area. Therefore, it is perhaps not surprising that books comprehensively covering the topic are few and far between. I was pleased when I heard about the publication of Healthcare Technology Management: A Systematic Approach. Other books I have read which cover medical equipment management have taken a rather hands-off approach to the topicThis book presents a loftier ambition, inviting the reader to apply a systematic approach to the management of healthcare technology At the end of each chapter are self-directed learning points and case studies. These help emphasise that the authors intended this book to be actively engaged with, not just read. In particular, I was impressed with the effort that has clearly gone into putting the case studies together. Evidently written based upon the authors personal experiences within clinical engineering, these painted a colourful picture of how the various topics discussed may apply to real-life situations The standard of writing remains high throughout the book and, combined with a distinct lack of errors for a first edition, make the text a pleasure to read For anyone within this profession, I would not hesitate to recommend itThis book is unique in the guidance it gives to the established clinical engineer to better utilise the medical equipment at their disposal."

Dr Michael Ayers in IPEM Scope Reviews, September and December 2017

"Congratulations to the team of authors...who have given the world of clinical engineering this fantastic resource, which will go on our frequently-accessed shelves...This is a must-have, on-desk reference book for all clinical engineers...This book is a gift because it overviews all aspects of health technology management and then digs deeper, offers tools, and brings all of the relevant and up to date information together in one place. I recommend, a reasonably thorough read of the whole

Preface xvii
Acknowledgements xxi
Author xxiii
Chapter 1 Clinical Engineering in the Healthcare System 1(46)
1.1 Introduction
2(2)
1.1.1 What Do We Mean By 'Medical Devices', 'Medical Equipment' And 'Healthcare Technology'?
3(1)
1.1.2 The Context In Which Clinical Engineering Now Operates
3(1)
1.2 The Health System
4(4)
1.2.1 Home/community Care
5(1)
1.2.2 Primary Care
5(1)
1.2.3 Secondary Care
6(1)
1.2.4 Tertiary Care
6(1)
1.2.5 Healthcare As A Cycle
6(2)
1.3 The Need For Clinical Engineers In The Healthcare System
8(5)
1.4 Value In Healthcare
13(1)
1.5 How Clinical Engineering Adds Value In The Healthcare Delivery Organization
14(6)
1.5.1 Equipment Management
15(2)
1.5.2 Advancing And Supporting Care
17(2)
1.5.3 Healthcare Technology Management: Dual Remit
19(1)
1.6 Clinical Engineering And Biomedical Engineering
20(8)
1.6.1 Research And Development Of New Medical Equipment
22(1)
1.6.2 Innovation
23(2)
1.6.3 Clinical Engineers Contribute To Standards Development
25(1)
1.6.4 Clinical Engineers Contribute To Post-Market Surveillance
26(1)
1.6.5 Knowledge Sharing Between Clinical Engineers And Equipment Manufacturers
27(1)
1.7 Foundations Of A HTM System Within A Healthcare Delivery Organization
28(4)
1.7.1 Clinical Engineering Within The Corporate Structure
28(2)
1.7.2 Clinical Engineering Leadership
30(1)
1.7.3 Clinical Engineering Ethics
31(1)
1.8 Clinical Engineering Advancing Patient Care
32(1)
1.9 Conclusion
33(1)
References
34(1)
Self-Directed Learning
35(2)
Case Studies
37(10)
Chapter 2 Taking A Systems Engineering Approach 47(56)
2.1 Introduction
48(3)
2.2 Introduction To Systems Engineering
51(6)
2.3 Systems Engineering Methodology
57(10)
2.3.1 Step 1: Defining The System's Objective
58(1)
2.3.2 Step 2: Identifying The System's Constituent Elements
59(3)
2.3.3 Step 3: Identifying The Relationships Between Constituent Elements
62(1)
2.3.4 Step 4: Improving The System
63(1)
2.3.5 Step 5: Systems Improvement Methods
64(1)
2.3.6 Measuring The Performance Of Systems
65(2)
2.3.7 Discussion
67(1)
2.4 Systems Engineering And Healthcare Technology Management (HTM)
67(8)
2.4.1 Systems Approach When Managing An Item Of Medical Equipment
67(1)
2.4.2 Systems Approach To The Sociotechnical Aspects Of Equipment Management
68(1)
2.4.3 Systems Approach To Managing A Fleet Of Medical Equipment
69(1)
2.4.4 Systems Approach To The Planned Replacement Of Medical Equipment
70(1)
2.4.5 Clinical Engineers Using Systems Engineering To Improve HTM Processes
71(1)
2.4.6 Clinical Engineers Using The Systems Approach To Investigate Adverse Events
72(2)
2.4.7 Health Technology Assessment
74(1)
2.5 Introduction To Healthcare As A System
75(4)
2.5.1 Models Of Healthcare As A System
75(3)
2.5.2 The Need To Improve Healthcare Systems
78(1)
2.5.3 Quality Improvement Initiatives In Healthcare
79(1)
2.6 Applying Systems Engineering To Healthcare
79(5)
2.6.1 Systems Engineering At Healthcare Organization Level
80(1)
2.6.2 Systems Engineering Within Clinical Departments
81(1)
2.6.3 Exploiting Developments In Technology To Transform Healthcare
82(1)
2.6.4 Systems Approach And Data Flows
83(1)
2.6.5 Clinical Engineers' Contributions To Improving Healthcare Systems
83(1)
2.7 Conclusion
84(1)
References
85(2)
Self-Directed Learning
87(1)
Case Studies
88(15)
Chapter 3 Key Standards, Regulations And Guidelines 103(44)
3.1 Introduction
104(1)
3.2 Standards
104(5)
3.2.1 What Is A Standard?
104(1)
3.2.2 Who Writes National Standards?
105(1)
3.2.3 Who Writes International Standards?
105(1)
3.2.4 Types Of Standard And How They Are Applicable To HTM And Medical Devices
106(3)
3.3 What Is A Regulation?
109(2)
3.3.1 Process From Act To Regulation
109(1)
3.3.2 Relationship Between Standards And Regulations
110(1)
3.4 What Is A Guideline?
111(2)
3.4.1 What Is The Relationship Between Guidelines And Standards?
112(1)
3.4.2 What Is The Relationship Between Guidelines And Regulations?
112(1)
3.5 Key Standards That Inform The Practice Of Healthcare Technology Management
113(13)
3.5.1 Introduction
113(1)
3.5.2 The ISO 55000 Suite Of Standards
113(6)
3.5.3 The ISO 9000 Suite Of Standards
119(5)
3.5.3.1 Customer Focus
120(1)
3.5.3.2 Leadership
121(1)
3.5.3.3 Engagement Of People
121(1)
3.5.3.4 Process Approach
122(1)
3.5.3.5 Improvement
122(1)
3.5.3.6 Evidence-Based Decision-Making
123(1)
3.5.3.7 Relationship Management
123(1)
3.5.4 The IEC 60601 Suite Of Standards
124(2)
3.5.5 Other Standards Which Impact Significantly On HTM Work
126(1)
3.6 Key Regulations In HTM
126(3)
3.6.1 Introduction
126(1)
3.6.2 Medical Devices Regulations
126(1)
3.6.3 Health And Safety Regulations
127(1)
3.6.4 Other Health And Safety Regulations And The Responsibility Of Clinical Engineers
128(1)
3.7 Key Guidelines In HTM
129(2)
3.7.1 Introduction
129(1)
3.7.2 Relevant Professional Bodies
129(1)
3.7.3 Not-For-Profit Organizations
130(1)
3.7.4 Sources
130(1)
3.8 Conclusion
131
Appendix: What Is The Process For Generating Standards?
13(122)
References
135(1)
Standards Cited
136(1)
Web Links
137(1)
Self-Directed Learning
138(1)
Case Studies
139(8)
Chapter 4 Life Cycle Management Of Medical Equipment 147(52)
4.1 Introduction
148(1)
4.2 Managing Medical Equipment Over Its Life Cycle
149(8)
4.2.1 Life Cycle Management
149(1)
4.2.2 Life Cycle Medical Equipment Costs
150(3)
4.2.3 Reviewing Maintenance Costs
153(1)
4.2.4 Maintenance Cost Data Can Support Replacement Decision- Making
154(1)
4.2.5 Replacement Planning
154(2)
4.2.6 Lost Opportunity Cost Of Medical Equipment Awaiting Repair
156(1)
4.2.7 Medical Equipment Management System For Life Cycle Management
156(1)
4.3 Approaches To Financing The Life Cycle Of Medical Equipment
157(9)
4.3.1 Traditional Capital-Funded Acquisition With Revenue-Funded Support
157(1)
4.3.2 Funding Equipment Through Consumable Purchases
158(2)
4.3.3 Renting Medical Equipment
160(1)
4.3.4 Leasing Medical Equipment
161(1)
4.3.5 Managed Equipment Service
162(4)
4.4 Extracting Optimal Benefit From Medical Equipment Over Its Life Cycle
166(8)
4.4.1 Asset Management: Equipping And Procurement - 'Buy It Right'
166(2)
4.4.1.1 Will The Technology Add Value, Will It Benefit The Organization?
166(1)
4.4.1.2 Selecting The Right Product
167(1)
4.4.1.3 Installing, Deploying And Commissioning The Equipment
167(1)
4.4.2 Asset Management: Operation And User Support - 'Use It Right'
168(3)
4.4.2.1 End-User Training
168(1)
4.4.2.2 Responding To Changing Clinical Applications
169(1)
4.4.2.3 Auditing The Application Of Equipment
169(1)
4.4.2.4 Responding To Adverse Events Involving Medical Equipment
170(1)
4.4.3 Asset Management: Maintenance - 'Keep It Right'
171(2)
4.4.3.1 Elements Of Maintenance Activities And Tailored Equipment Support Plans
171(1)
4.4.3.2 Medical Equipment Software Management And Upgrades
172(1)
4.4.4 Asset Management: Decommissioning - 'Dispose Of It Right'
173(1)
4.4.4.1 Residual Value
174(1)
4.4.4.2 Disposal Compliant With Environmental Regulations
174(1)
4.5 HTM Principles
174(9)
4.5.1 Introduction To HTM In Practice
177(4)
4.5.2 Definition 1: The Medical Device Policy
181(1)
4.5.3 Definition 2: The Medical Device Committee
181(1)
4.5.4 Definition 3: The Strategic HTM Plan
182(1)
4.5.5 Definition 4: The MDC Action Plan
182(1)
4.5.6 Definition 5: Healthcare Technology Management Programmes
182(1)
4.5.7 Definition 6: The Equipment Support Plan
182(1)
4.5.8 Summary
182(1)
4.6 Mapping The HTM System Proposed In This Book To Iso 55000
183(1)
4.7 Conclusion
184(2)
References
186(1)
Self-Directed Learning
186(1)
Case Studies
187(12)
Chapter 5 The Healthcare Technology Management System: Strategic 199(72)
5.1 Introduction
201(1)
5.2 The Medical Device Committee
201(1)
5.3 The Medical Device Policy
202(7)
5.3.1 Overview
203(1)
5.3.2 Structure And Content Of The Policy
204(5)
5.3.2.1 HTM Organizational Arrangements
205(1)
5.3.2.2 A Life Cycle Approach To Equipment Management
206(1)
5.3.2.3 Inventory And Records
207(1)
5.3.2.4 Acquiring New Devices And Systems, Developing New Services
207(1)
5.3.2.5 Putting New Equipment And Systems Into Use
207(1)
5.3.2.6 Training
207(1)
5.3.2.7 Appropriate Prescription And Use Of Devices
207(1)
5.3.2.8 Cleaning And Decontamination
207(1)
5.3.2.9 Maintenance And Repair
207(1)
5.3.2.10 Removal From Service
208(1)
5.3.2.11 Disposal Of Withdrawn Equipment
208(1)
5.3.2.12 Managing Adverse Events
208(1)
5.3.2.13 Dealing With Safety Alerts And Field Safety Notices
209(1)
5.3.3 Communicating The Policy
209(1)
5.4 Following On From The MD Policy: The Strategic HTM Plan
209(8)
5.4.1 Developing The Strategic HTM Plan As A Quality Cycle: Increasing Value
209(8)
5.4.1.1 Plan
210(5)
5.4.1.2 Do
215(1)
5.4.1.3 Check
216(1)
5.4.1.4 Act
216(1)
5.5 Leadership Of And From The MDC
217(1)
5.5.1 Leadership Of The MDC
217(1)
5.5.2 Membership Of The MDC
217(1)
5.5.3 Leadership From The MDC
217(1)
5.5.4 Actions For The MDC To Lead On
218(1)
5.6 Actions To Address Risk
218(10)
5.6.1 Fundamental Corporate Decisions
218(2)
5.6.2 Organizational Arrangements By The MDC To Address Risk
220(1)
5.6.3 Planned Replacement List
221(3)
5.6.4 Acquisition
224(3)
5.6.5 Internally Identified Hazards, Risk Management And Mitigation
227(1)
5.6.6 Externally Identified Hazards, Risk Management And Mitigation
227(1)
5.7 Actions To Realize Opportunities
228(4)
5.7.1 Flexible Deployment Of Assets
229(1)
5.7.2 Identifying Opportunities For Promoting Quality
229(1)
5.7.3 Identifying Opportunities For Promoting Safety
230(1)
5.7.4 Identifying Opportunities For Promoting Effectiveness
230(2)
5.8 Communication And Documentation Requirements Of The MDC
232(2)
5.8.1 Overview
232(1)
5.8.2 Awareness
232(1)
5.8.3 Communication
233(1)
5.8.4 Information Requirements
233(1)
5.8.5 Documentation
234(1)
5.9 Performance Evaluation
234(3)
5.9.1 Review The Performance Of HTM Programmes
234(1)
5.9.2 Reviewing Quality And Safety Programmes
235(1)
5.9.3 Risk Register
236(1)
5.10 Continual Improvement
237(1)
5.11 Conclusion
237(1)
References
238(1)
Self-Directed Learning
239(1)
Case Studies
239(32)
Chapter 6 Developing Equipment Support Plans In The Context Of The HTM Programme 271(86)
6.1 Introduction
272(4)
6.2 Esp
276(22)
6.2.1 Holistic ESP Planning Which Is Patient Focused
276(2)
6.2.2 ESP Planning Principles
278(1)
6.2.3 ESP As A Process That Is Structured As A Quality Cycle
279(8)
6.2.3.1 Developing The Esp
280(2)
6.2.3.2 Adherence To Manufacturers' Instructions
282(2)
6.2.3.3 Implementing The Esp
284(2)
6.2.3.4 Mems
286(1)
6.2.3.5 Auditing The ESP And The Quality Cycle
287(1)
6.2.4 Financial Analysis Of The Esp
287(4)
6.2.4.1 Cost-Effectiveness Measures
289(2)
6.2.5 Analyzing The Benefits Delivered From An Esp
291(2)
6.2.6 Assessing The Value Delivered By An Esp
293(5)
6.3 Examples Of Equipment Support Plans
298(2)
6.4 Developing Concurrent ESPS As Part Of A Complete HTM Programme
300(7)
6.4.1 Step 1: Group Equipment Into Support Groups
304(1)
6.4.2 Step 2: Estimate Impact Of Equipment Failure
305(1)
6.4.3 Step 3: Prioritize Equipment Groups For Review
306(1)
6.4.4 Step 4: Develop The Ideal ESP For Each Equipment Grouping
306(1)
6.4.5 Step 5: Assign Available Resources To ESP Delivery Teams
306(1)
6.4.6 Step 6: Identify And Communicate Any Residual Risk
307(1)
6.5 Implementing And Auditing The ESPS Within The HTM Programme
307(5)
6.5.1 Set ESPS Into Action
307(1)
6.5.2 Continual Management Of The ESP Delivery
308(1)
6.5.3 Kpis: Seeking Assurance That The HTM Programme Is Being Delivered
308(2)
6.5.4 Reviewing The ESPS Within HTM Programme
310(1)
6.5.5 Auditing To Ensure That All Equipment Has Been Checked
311(1)
6.6 Quality Improvement Of The ESPS And HTM Programme
312(4)
6.6.1 Act To Improve The Equipment Process
312(1)
6.6.2 Review And Revise The Estimate Of Impact Of Equipment Failure
313(1)
6.6.3 Develop A Quality Improvement Plan For The HTM Programmed
313(49)
6.6.3.1 Looking Inwards For Improvements
313(1)
6.6.3.2 Looking Outwards For Improvements
314(1)
6.6.3.3 Best Practice
315(1)
6.7 Report On The Status Of The HTM Programme To The MDC
316(1)
6.8 Managing The HTM Programme From A Risk Management Perspective
316(2)
6.9 Conclusion
318(2)
References
320
Self-Directed Learning
32(290)
Case Studies
322(35)
Chapter 7 The Extended Role Of Clinical Engineers: Advancing Healthcare 357(108)
7.1 Introduction
359(3)
7.2 Projects Arising From Or Relating To HTM Processes
362(18)
7.2.1 Applying The Medical Equipment Inventory To Enhance Care
362(1)
7.2.2 The Mems Database Supports Effective Medical Equipment Management
363(1)
7.2.3 Planned Replacement Projects
363(8)
7.2.3.1 Planning
366(1)
7.2.3.2 Tender Specification
366(1)
7.2.3.3 Procurement
367(1)
7.2.3.4 Commissioning
368(2)
7.2.3.5 Discussion
370(1)
7.2.4 Managing Equipment Trials
371(1)
7.2.5 Local Healthcare Technology Assessment
372(2)
7.2.6 Adverse Event Investigations
374(2)
7.2.7 Medical Device Safety Alerts
376(1)
7.2.8 Projects To Improve HTM Processes
377(1)
7.2.9 Support For Capital Build Projects With Medical Equipment Implications
378(2)
7.3 Advancing The Delivery Of Care: Contribution By Clinical Engineers
380(7)
7.3.1 Innovating Care Processes And Quality Improvement
380(2)
7.3.2 Research Projects
382(1)
7.3.3 Innovation Projects
382(1)
7.3.4 Clinical Informatics
383(2)
7.3.5 Telemedicine
385(1)
7.3.6 Major Incident And Business Continuity Planning
385(2)
7.3.6.1 Major Incident Planning
385(1)
7.3.6.2 Business Continuity
386(1)
7.4 Clinical Engineering Experts And Special Advisors
387(11)
7.4.1 Application Of Medical Equipment At The Point Of Care
387(1)
7.4.2 Managing Medical Equipment Alarms
388(1)
7.4.3 Risk Management
389(1)
7.4.4 In-House Manufacture Of Medical Equipment And The Electrical Safety Expert
390(3)
7.4.4.1 Knowledge And Understanding
390(1)
7.4.4.2 Medical Electrical Systems
390(1)
7.4.4.3 Electrical Safety Procedures
391(1)
7.4.4.4 In-House Manufacture Or Modification Of Medical Equipment
391(2)
7.4.5 Advice For The Construction Of New Buildings Or Facilities
393(1)
7.4.6 Wider Professional Involvement Of Clinical Engineers
394(1)
7.4.7 Medical It Network Risk Management Expert
394(1)
7.4.8 Non-Ionizing Radiation Protection Advisors
395(1)
7.4.9 Consultant Clinical Engineer
396(1)
7.4.10 Other Technology Experts
397(1)
7.4.11 Continuing Training Of Clinical Staff
398(1)
7.5 Rehabilitation Engineering
398(1)
7.6 Conclusion
399(1)
References
399(1)
Standards Cited
400(2)
Self-Directed Learning
402(1)
Case Studies
402(63)
Chapter 8 The Clinical Engineering Department: Achieving The Vision 465(4486)
8.1 Introduction
466(1)
8.2 The Mission, Vision And Values Of The Clinical Engineering Department
467(1)
8.2.1 The Mission Statement
467(1)
8.2.2 The Vision Statement
467(1)
8.2.3 The Value Statement
468(1)
8.3 The Clinical Engineering Department's Position Within Healthcare Organizations
468(1)
8.4 The Structure Of A Clinical Engineering Department
469(6)
8.4.1 Illustrative Organizational Structures Of The CED
470(4)
8.4.1.1 Centralized And Decentralized Structures
470(2)
8.4.1.2 Organizational Chart
472(1)
8.4.1.3 Reporting Arrangements
473(1)
8.4.2 The Organizational Design Of The CED
474(1)
8.4.2.1 Quality Management System
474(1)
8.4.3 Some Thoughts On Physical Structures
475(1)
8.5 Staff Roles And Responsibilities
475(5)
8.5.1 Clinical Engineering Technicians
477(1)
8.5.2 Clinical Engineering Technologists
477(1)
8.5.3 Clinical Engineers
478(1)
8.5.4 Clinical Engineering: A Continuum
478(2)
8.5.5 Summary: The Staff Of The CED
480(1)
8.6 Leadership In The Clinical Engineering Department
480(3)
8.6.1 Setting The Strategic Objectives Of The CED
481(1)
8.6.2 Communication Skills
481(1)
8.6.3 Organizational Ability
482(1)
8.6.4 Developing Individuals
482(1)
8.7 The Training Role Of Clinical Engineers
483(4368)
8.7.1 Developing The Workforce
483(1)
8.7.2 Contributing To Academic Programmes
484(4367)
8.8 Communication
4851
8.9 Conclusion
486(1)
References
487(1)
Self-Directed Learning
487(1)
Case Studies
488(4463)
Chapter 9 Medical Device Governance 4951
9.1 Introduction
4951(1)
9.2 The Extended Life Cycle From Design Through Operational Use To End Of Life
4951(20)
9.3 Medical Device Governance, A Patient And Carer Perspective
4971
9.3.1 Medical Device Governance At The Point Of Care (Inner Circle)
4971(20)
9.3.2 Support Systems Within The Healthcare Organization (Middle Circle)
4991(30)
9.3.3 When Things Go Wrong
5021(10)
9.3.4 Industry, Standards And National Agencies (Outer Circle)
5031
9.4 Conclusion
504(1)
References
505(1)
Standards Cited
506(1)
Self-Directed Learning
506(1)
Chapter 10 Healthcare Technology Management Adding Value 507(12)
10.1 Introduction
507(1)
10.2 Overview Of This Book
508(1)
10.3 HTM: Benefitting Stakeholders
509(5)
10.3.1 HTM Benefitting Patients And Carers
509(2)
10.3.2 HTM Benefitting Clinical Staff
511(1)
10.3.3 HTM Benefitting The Healthcare Organization
512(1)
10.3.4 HTM Benefitting The Funding Providers
513(1)
10.3.5 HTM Benefitting The Medical Device Industry And Regulatory Authorities
514(1)
10.4 Discussion
514(3)
10.5 A Call To Arms
517(2)
Glossary 519(10)
Index 529
Francis Hegarty, John Amoore, Paul Blackett, Justin McCarthy, Richard Scott
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