Clinical Engineering Handbook (2nd Edition)

Download Clinical Engineering Handbook (2nd Edition) written by Ernesto Iadanza in PDF format. This book is under the category Engineering and bearing the isbn/isbn13 number 128134674/9780128134672. You may reffer the table below for additional details of the book.

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Specifications

book-author

Ernesto Iadanza

publisher

Academic Press; 2nd edition

file-type

PDF

pages

958 pages

language

English

asin

B082G1ZPX2

isbn10

128134674

isbn13

9780128134672


Book Description

Clinical Engineering Handbook; 2nd Edition; (PDF) includes modern clinical engineering topics; providing experienced professionals the essential skills and knowledge for this fast-evolving field. Including insights from leading international experts; this ebook presents traditional practices; such as medical device service; healthcare technology management; and technology application. In addition; readers will find beneficial information on the newest research and revolutionary developments in clinical engineering; such as health technology assessment; ; decision support systems; mobile medicine; disaster preparedness and prospects and guidelines on the future of clinical engineering.

As the biomedical engineering field increases throughout the world; clinical engineers play an increasingly significant role as translators between the engineering; medical and business professions. In addition; they inspire procedures and policies at research facilities; universities; and in government and private agencies. This ebook explores their current and continuing reach and its importance.

  • Features a definitive; complete; and up-to-date resource on clinical engineering
  • Written by worldwide experts with ties to IFMBE; IUPESM; IEEE; ACCE Global CE Advisory Board; and more
  • Includes coverage of new topics; like Health Technology Assessment (HTA); Success Stories in Clinical Engineering; Decision Support Systems (DSS); Mobile Apps; and Human Factors Engineering

NOTE: The product includes the ebook; Clinical Engineering Handbook; 2nd Edition in PDF. No access codes are included.

Table of contents


Table of contents :
Cover……Page 1
Clinical Engineering
Handbook
……Page 3
Copyright……Page 4
Dedication……Page 5
Section Editors……Page 6
Contributors……Page 7
Foreword……Page 13
Acknowledgments……Page 15
Information technology and mobile apps……Page 16
Introduction to human factors……Page 17
Section 1
Clinical engineering……Page 18
What is clinical engineering?……Page 20
Fields of knowledge……Page 21
References……Page 22
Further reading……Page 23
Increasing the access to medical devices: The need for alternative strategies for innovation……Page 24
Medical device……Page 25
Enabling tools and technologies……Page 26
Virtual platforms……Page 27
The importance of human capital in OSMDs……Page 28
References……Page 29
Further reading……Page 31
Rationale……Page 32
Results……Page 33
Conclusions……Page 34
Appendix……Page 35
Links……Page 48
A brief history of RFID……Page 50
RFID technology……Page 51
RFID applications……Page 52
Patient safety……Page 53
Internet of things……Page 54
Near-field communication……Page 55
Hospital supply chain……Page 56
References……Page 57
Further reading……Page 58
5
Computer-aided facilities management in health care……Page 59
Web viewer……Page 60
Search engine……Page 62
Sanitation management……Page 63
Energy management……Page 64
Bed management……Page 66
Further reading……Page 68
Corneal graft……Page 69
National and regional background in public procurement……Page 70
Tender project……Page 71
Drafting of technical specifications……Page 72
Bidding assessment criterion and drafting of the evaluation table/grid……Page 74
Tenders assessment……Page 75
Conclusions……Page 76
Further reading……Page 77
Section 2
Worldwide clinical engineering practice……Page 78
What is in a name?……Page 80
Clinical engineering services in the UK……Page 81
Healthcare technology management……Page 82
Rehabilitation engineering……Page 83
Quality systems……Page 84
Career and training pathways……Page 85
Clinical engineering technologists……Page 86
The register of clinical technologists (RCT)……Page 87
References……Page 88
The Canadian medical and biological engineering society……Page 89
Clinical engineering standards of practice for Canada……Page 90
References……Page 91
Administrative organization of the Colombian health and social security system……Page 92
Colombian universities that offer biomedical engineering programs……Page 95
Maintenance……Page 96
Accreditation of health institutions……Page 97
Further reading……Page 98
Biomedical/clinical engineering in Mexican hospitals……Page 99
BME associations in Mexico……Page 101
References……Page 103
Introduction……Page 104
HCT policy……Page 105
Telemedicine……Page 106
Human resource development……Page 107
Conclusion……Page 109
References……Page 110
Peruvian healthcare system……Page 111
Situational status of infrastructure and equipment in hospitals……Page 112
Review about health technology……Page 113
Public-Private Partnerships (PPP) in the Peruvian health system……Page 114
Main processes of a healthcare technology management system……Page 115
Further reading……Page 117
Historical perspective……Page 118
Programs and their management……Page 120
References……Page 121
National Certification (License) System……Page 122
Business scope……Page 123
References……Page 124
The beginning……Page 125
Clinical engineering today……Page 126
References……Page 127
Jordan……Page 128
Common challenges……Page 129
Further reading……Page 130
The main development stages of clinical engineering in China……Page 131
The development of clinical engineering chapters of the Medical Association in various provinces and cities in recent years……Page 132
Chinese translation of nine books of the WHO Medical Device Technical Series released in November 2015……Page 134
Co-organized “Flying Over the Hump” Health Technology Management (HTM) training series……Page 135
CCE certification program……Page 136
Joint training courses for EMBA, HTM, and hospital operation management in conjunction with Peking University and Tongji Un ………Page 137
The awarding for the national key clinical engineering disciplines in 2011……Page 138
After-sales service satisfaction survey……Page 139
Participated in the AAMI and ACCE conferences in the United States in 2017……Page 140
Further reading……Page 141
Regulations……Page 142
Societies……Page 143
References……Page 144
The up-to-date situation of the Clinical Engineering in Italy……Page 145
Further reading……Page 148
Concerns regarding current state of healthcare technology management……Page 149
International Clinical Engineering Workshop (ICEW—India, 2011)……Page 150
Training of clinical engineers: Barriers and opportunities……Page 151
Conclusion……Page 152
References……Page 153
Education……Page 154
CE authorities……Page 155
Further reading……Page 156
The environment……Page 157
The workforce……Page 158
The future……Page 159
The previous situation……Page 160
Hospital safety training……Page 161
Type of CE structure in the country (centralized or individual CE centers)……Page 162
References……Page 163
Professional evolution……Page 165
References……Page 166
Organization and budget allocation……Page 168
Duties and responsibilities……Page 169
Harmonized standards……Page 170
University program in Biomedical/Clinical Engineering……Page 171
Further reading……Page 172
Brief history……Page 173
Conclusion……Page 175
Acknowledgments……Page 176
History of clinical engineering in Uganda……Page 178
Current status of medical equipment……Page 180
The future……Page 181
Section 3
Healthcare technology management……Page 182
28
Introduction to medical technology management practices……Page 183
The scope of technology to be managed……Page 184
Strategic planning process……Page 185
Technology audit……Page 186
Prerequisites for medical technology assessment……Page 187
Technology assessment program……Page 188
Technology assessment and clinical engineering……Page 190
Device evaluation……Page 191
Technical asset management……Page 192
Clinical engineering needs……Page 193
Further Information……Page 194
Global CE day……Page 195
Recommendation(s)……Page 196
Further reading……Page 197
Organizational strategic plan……Page 198
Technology surveillance and healthcare technology assessment……Page 199
Construction of healthcare strategic planning report……Page 201
References……Page 202
31
Technology evaluation/US and global perspectives……Page 203
Technology and alternatives……Page 204
Risks, hazards, and clinical efficacy……Page 205
Resources……Page 206
Conceptual needs analysis……Page 207
Incoming inspection……Page 208
Maintenance and service requirements……Page 209
Clinical evaluation……Page 210
Final evaluation and selection……Page 211
References……Page 212
Technology evaluation process……Page 213
Technical specifications and other requirements……Page 214
Subjective bias……Page 215
Request for quotation……Page 216
Standard template……Page 217
Response analysis……Page 218
Contract……Page 219
Conclusion……Page 220
Further reading……Page 221
Recommended data that should be included in inventory records (from WHO, 2011)……Page 222
The challenge of managing mobile equipment……Page 223
Further reading……Page 224
The CMMS core……Page 225
Work order subsystem……Page 226
Parts and service provider management……Page 227
Recalls and alerts……Page 228
Advanced reporting and dashboards……Page 229
Data accuracy and integrity……Page 230
Equipment planning……Page 231
Regulatory compliance……Page 232
Benchmarking and data sharing……Page 233
Implementation……Page 234
References……Page 235
Risk management……Page 236
Maintenance requirements……Page 237
Further reading……Page 238
Two service models……Page 239
OEM asset management/multivendor service programs……Page 240
Maintenance insurance……Page 241
Summary……Page 242
Further Information……Page 243
Introduction……Page 244
Key factors to assess……Page 245
Medical equipment replacement planning……Page 248
Prior work on equipment replacement planning……Page 249
Example equipment replacement report……Page 250
Summary……Page 251
References……Page 252
Why iHTP ( Peter, 2007)……Page 253
How is iHTP used ( WHO, n.d.)……Page 254
Software tool description ( WHO, n.d.)……Page 255
Reports—static →……Page 256
Case studies ( Judd, 2009)……Page 257
Mexico……Page 258
Further reading……Page 259
Background……Page 260
Glossary……Page 261
Innovation……Page 262
Access……Page 263
Health systems……Page 264
Safety and quality……Page 266
HTM……Page 267
e-Technology……Page 268
Web Links……Page 269
Cybersecurity background……Page 270
Medical device cyber risks……Page 271
Pertinent standards and regulations……Page 272
Addressing medical device cyber risks……Page 273
References……Page 274
Clinical engineer……Page 276
Group of indicators ( Nagel et al., 2009)……Page 277
Conclusions……Page 282
References……Page 284
Managing Medical Devices (UK Medicines and Healthcare Products Regulatory Agency, 2015)……Page 285
Guide des bonnes pratiques biomédicales en établissement de santé (Guide to Good Biomedical Practices in Health Facilities— ………Page 286
American National Standards Institute/Association for the Advancement of Medical Instrumentation (ANSI/AAMI) EQ56/2013, Rec ………Page 287
AAMI HTM Levels Guide (2016)……Page 288
Clinical Engineering Standards of Practice for Canada (CESOP), published by the Canadian Medical & Biological Engineering ………Page 289
Manual of Management of Maintenance of Biomedical Equipment for Human Use—Republic of Colombia (2016)……Page 290
References……Page 291
Definition of the term “medical device”—Global harmonization task force (GHTF)a……Page 293
Safety issues……Page 294
Reuse of SUDs—Identified problems……Page 295
Further reading……Page 296
Results……Page 297
ACCE International Committee……Page 298
Case study 1: Lima, Peru 2012 ( Clark et al., 2012)……Page 300
ACEW outcomes……Page 301
Case study 3: Brazil: “Floripa” ACEW 2013 ( Wang et al., 2013)……Page 302
References……Page 303
References……Page 305
Quality management systems……Page 306
Quality and CE-IT……Page 308
Various CE-IT references……Page 311
Staffing levels……Page 313
Education and skills……Page 319
Retention……Page 320
Management……Page 321
Productivity……Page 322
References……Page 323
The evolution of management theory……Page 324
West meets east……Page 325
The creative process……Page 326
Communication skills……Page 327
The written word……Page 328
Mentoring……Page 329
Motivation……Page 330
Performance review criteria……Page 331
Stress management……Page 332
Interviewing……Page 333
Employment laws and regulations……Page 334
Communication skills……Page 335
Employment laws and regulations……Page 336
Introduction……Page 337
Many uses of this simple but comprehensive framework for medical device management……Page 338
Updating the 2004 edition of this Handbook (Chapter 31) “good management practice for medical equipment”……Page 340
Recommendations……Page 341
References……Page 343
Section 5
Safety……Page 345
Background……Page 346
Group 2: (mainly clinical engineers and technologists)……Page 347
Group 4: (mainly patient safety and technology assessment expertise)……Page 348
Conclusions……Page 349
References……Page 350
51
Risk management……Page 351
Healthcare risk management program structure……Page 352
Governmental and professional organizations’ contributions to the importance of healthcare clinical engineering risk manage ………Page 353
Contract review……Page 355
Data collection, analysis, and reporting for management of risk……Page 356
Documentation……Page 357
Federal statutory risk management requirements……Page 358
Healthcare organization accreditation and certification as a clinical engineering risk management technique……Page 359
The CE and clinical staff……Page 361
The CE and senior management……Page 362
Resources……Page 363
Further reading……Page 364
The safety officer……Page 365
The performance improvement cycle……Page 366
Life safety management……Page 367
Further reading……Page 368
Introduction……Page 369
Three essential steps to ensure patient safety……Page 370
Recommendations……Page 371
References……Page 372
Syringe use, disposal, and safety……Page 373
Ultimate safe and appropriate disposal of sharps waste……Page 374
Application of life cycle management……Page 375
Appendix. Comparison of methods for the disposal of sharps waste……Page 376
Further reading……Page 377
Electromagnetic radiation……Page 378
Footprinting……Page 379
Fingerprinting……Page 380
Prevention……Page 381
An unusual source……Page 382
Interference not caused by EMI……Page 383
Programs and procedures……Page 384
Summary……Page 387
Further reading……Page 388
56
The great 1970s debate on electrical safety—In retrospect……Page 389
References……Page 392
Section 6
Professionalism, education, and ethics……Page 393
Sociological definition……Page 394
Elements of the professionalization process……Page 395
Code of ethics……Page 396
Relationship of a profession to an employer……Page 397
The role of professional societies in the professionalization process……Page 398
References……Page 399
Membership……Page 400
Leadership……Page 401
ACCE symposium series……Page 402
Clinical engineering hall of fame……Page 403
ACCE healthcare technology foundation……Page 404
References……Page 405
Rationale for certification……Page 406
Process……Page 407
Further reading……Page 408
Clinical Engineering Internship Sponsor Hospitals (1999–2019)……Page 409
UCONN clinical engineering graduate education……Page 410
Academic course work……Page 411
Hospital-based internships……Page 412
Examples of the types of work expected of the interns during the 2-year internship……Page 413
The hospitals who participate in the internship program as of 2019……Page 414
Graduate student internship interview process……Page 415
University of Toronto (Canada) clinical engineering graduate education……Page 416
Further reading……Page 417
The bachelor’s degree and graduate study options……Page 418
Not all accreditations are the same……Page 419
Internships are the trial run of a HTM student……Page 420
An advisory committee……Page 421
State schools are not well funded……Page 423
New students and risk vs reward……Page 424
Future trends……Page 425
Methods of distance education……Page 426
Healthcare technology distance learning……Page 427
Student evaluation and grading……Page 428
Summary……Page 430
References……Page 431
When to conduct in-service training……Page 432
How to train……Page 434
Lecture improvement……Page 435
References……Page 436
AAMI affiliation……Page 437
Structure……Page 438
Meetings……Page 439
Membership……Page 440
Ongoing education……Page 441
References……Page 442
References……Page 443
Epidemiology……Page 444
Medical device sales……Page 445
Attitudes……Page 446
Device-patient……Page 447
Example: Treating patients with diabetes……Page 448
Insulin injections……Page 449
References……Page 450
Further reading……Page 451
Introduction……Page 452
Humanitarian use devices (humanitarian device exemptions)……Page 453
Improving ergonomics……Page 454
Product improvements……Page 455
Equipment selection and evaluations……Page 456
Clinical trials……Page 457
Monitoring for conformance to design……Page 458
Minimizing use errors through ergonomics in device design……Page 459
Acknowledgment……Page 460
Further reading……Page 461
From inventor to innovator……Page 462
The life cycle of a product……Page 463
Technology assessment……Page 464
Forms of exploitation……Page 465
Further reading……Page 466
Complexities of hospital purchase of medical equipment……Page 467
Identifying equipment needs……Page 468
Detailed comparative evaluation criteria……Page 469
Ease of use and other human factors issues……Page 470
Testing for compliance with evaluation criteria……Page 471
Summary……Page 472
Further reading……Page 473
Introduction: Prosthetic lower limb history and structure……Page 474
K-levels systems to define a choice of prosthetics components and efficiency of feet……Page 476
Designing prosthetic foot to reduce the gap with sound limb and to allow the accessibility to high technology……Page 477
Sessions and time-space parameters……Page 478
Kinematic parameters of BK amputee……Page 479
Case study: Walking foot……Page 480
Further reading……Page 484
The kick-off phase……Page 485
Clinical experience review……Page 486
References……Page 487
Idea……Page 489
Prototype development……Page 490
Conclusion……Page 491
Section 8
Medical devices: Utilization and service……Page 492
Circle system……Page 493
Drawover anesthesia……Page 494
EMO……Page 495
Self-inflating bag/bellows……Page 496
Characteristics of important anesthetic agents……Page 497
Further reading……Page 498
73
Cardiovascular techniques and technology……Page 499
Clinical indications……Page 501
Further reading……Page 505
74
Inspection of medical devices……Page 506
Blood pressure monitors inspection……Page 507
EEG inspection……Page 508
Respirators and anesthesia machines inspection……Page 509
Inspection of dialysis machines……Page 510
Pediatric and neonate incubator inspection……Page 511
Further reading……Page 512
75
Hospital beds……Page 513
Intensive Care Unit beds……Page 514
National and international governing standards……Page 515
Further reading……Page 517
Lines……Page 518
Urinary catheter……Page 519
Storage areas/service areas……Page 520
Brain death……Page 521
Measurement of outcome……Page 522
Further reading……Page 523
Sources……Page 524
Theory of X-ray attenuation……Page 525
Fluoroscopy……Page 526
MRI……Page 527
Further reading……Page 528
78
Pediatric and neonate incubators……Page 529
Preventive maintenance qualitative tests……Page 531
Preventive maintenance……Page 533
Further reading……Page 534
Major inspection and routine tests……Page 535
System level……Page 536
The policy for dealing with hard failures—Component level……Page 537
Further reading……Page 540
Section 9
Management of digital healthcare, information systems, and health informatics innovations……Page 542
Why HIT needs CE?……Page 545
Global health, EHRs, and standards……Page 546
Government regulations over providers……Page 548
Transition to MIPS, accountable care organization, and bundled payments……Page 550
Problems with interoperability……Page 551
Evolving technologies in health care……Page 553
Healthcare security challenges……Page 554
Discussion……Page 555
References……Page 556
Further reading……Page 557
Medical device interoperability……Page 558
Interface standards……Page 559
IHE PCD DEC……Page 560
Middleware……Page 561
Security of network-connected medical devices……Page 562
References……Page 564
The telemedicine evolution……Page 565
Same challenges: New solution……Page 566
The telemedicine system……Page 567
The telemedicine practice……Page 568
The telecommunications component……Page 569
References……Page 570
History and background……Page 571
Current state……Page 572
Natural language processing (NLP)……Page 573
Healthcare AI……Page 574
NLP and medical technology……Page 575
Why CDSS is useful……Page 576
CDSS regulations……Page 577
Intersection of AI and big data……Page 578
Challenges of data acquisition……Page 579
Potential benefits/challenges of AI……Page 580
Potential benefits/challenges for consumers/patients……Page 581
References……Page 582
Scope……Page 584
References……Page 585
Logging requirements……Page 586
ITI domain profiles……Page 587
ITI ATNA ITI-20 record audit event……Page 589
ITI CT TS actor interface variables……Page 590
ITI PIX Query Manager actor……Page 591
ITI XDS Consumer actor testing preconditions……Page 592
PCD domain profiles……Page 593
PCD ACM AC actor……Page 594
PCD ACM AM actor……Page 595
PCD ACM AM actor testing preconditions……Page 596
PCD ACM AR actor……Page 597
PCD ACM PCD-04 example—Alarm, physiologic, start phase, physiological monitor, metric, SPO2, low……Page 598
PCD ACM PCD-04 example—Alarm, technical, start phase, infusion pump, and occlusion……Page 599
PCD ACM PCD-04 example—Advisory, start phase, workflow system, and undocumented timeout……Page 600
PCD ACM PCD-06 example—Submit request, paired MCR……Page 601
PCD ACM PCD-07 example—Message queued……Page 602
PCD ACM PCD-07 example—Message read……Page 603
PCD DEC DOC actor interface variables……Page 604
PCD DEC DOR actor interface variables……Page 605
PCD DEC PCD-01 communicate PCD data (sent by DEC DOR)……Page 606
PCD DEC PCD-01 example—Episodic observation Łreport, physiological monitor……Page 607
PCD IDCO Consumer actor interface variables……Page 608
PCD IDCO Reporter actor testing preconditions……Page 609
PCD DEC PCD-09 example—Observation report……Page 610
PCD IPEC DOR……Page 611
PCD IPEC PCD-10 communicate infusion event data (sent by IPEC DOR)……Page 612
PCD IPEC PCD-10 example—Delivery start event……Page 613
PCD PIV IOC actor……Page 614
PCD PIV IOP actor interface variables……Page 615
PCD PIV PCD-03 communicate infusion order (sent by PIV IOP)……Page 616
PCD PIV PCD-03 example—Infusion programming Łrequest……Page 618
PCD POI DOR actor……Page 619
PCD POI DOR actor testing preconditions……Page 620
PCD POI PCD-01 Communicate PCD Data (sent by POI DOR)……Page 621
PCD RDQ PCD-12 data query acknowledgment (sent by RDQ RDR)……Page 622
HL7 v2.x MLLP……Page 624
Acknowledgments……Page 625
What is “Devices on FHIR (DoF)®”?……Page 626
How does FHIR® work?……Page 627
Devices on FHIR……Page 628
FHIR is NOT solely for devices, nor does it replace IHE profiles or ISO/IEEE 11073-x standards……Page 629
Additional references and text……Page 630
The essentials of enterprise image management……Page 631
Digital imaging and communication in medicine and health level 7……Page 632
Integrating the healthcare enterprise……Page 633
Enterprise imaging network infrastructure……Page 634
Enterprise imaging functional network topology……Page 635
Healthcare cybersecurity in network infrastructure……Page 636
Enterprise image and data archives……Page 637
Archiving costs……Page 638
VNA and enterprise viewers……Page 639
Cloud-based storage and distribution solutions……Page 640
The reading room in radiology……Page 641
Clinical workflow for other users of medical images……Page 642
Dermatology……Page 643
Pathology……Page 644
Extracting radiomics……Page 646
QIBA and QIN……Page 647
The medical imaging cockpit of the future……Page 648
Types of medical imaging and their information yields……Page 649
Virtual reality……Page 650
Augmented reality……Page 651
Further reading……Page 652
Foundational principles and concepts……Page 653
The rapidly evolving complex 21st-century clinical system……Page 654
Management approaches for 21st-century complex clinical systems……Page 656
References……Page 657
Further reading……Page 658
A brief History of relevant ICT and mHealth innovations……Page 659
Procedures……Page 660
Summary……Page 661
Reference……Page 662
Devices……Page 663
Academia……Page 664
Recommendations……Page 665
Patient and population health outcomes……Page 666
References……Page 667
Section 10
Engineering the clinical environment……Page 669
Further reading……Page 670
Domestic water……Page 671
Fire basics……Page 672
Barriers……Page 673
Fire safety……Page 674
Supply and exhaust airflow and pressure……Page 676
Humidification……Page 677
HVAC in resource-scarce settings……Page 679
Resources……Page 680
Normal electrical power……Page 681
Isolated power systems……Page 682
Resources……Page 683
My suction doesn’t work … do something!”……Page 684
Master alarms……Page 685
Certified systems……Page 686
Resources……Page 687
Joint Commission standards……Page 688
References……Page 689
Resources……Page 690
Radiation safety program philosophy……Page 691
Control of radioactive materials……Page 692
The radiation safety office……Page 693
Other……Page 694
Further reading……Page 695
Introduction……Page 696
Steam sterilization (autoclaving)……Page 697
Low-temperature steam and formaldehyde……Page 698
Necessary equipment……Page 699
Anesthesia equipment……Page 700
Healthcare waste and its management……Page 701
Safe disposal in hospital premises……Page 702
Insect control……Page 703
Appendix: Infection Prevention and Control (IPC) glossary……Page 704
Healthcare waste……Page 706
Further reading……Page 707
Planning……Page 708
Water treatment and conditioning……Page 709
End users……Page 710
Acknowledgment……Page 711
Water and hemodialysis……Page 712
98
Disaster planning and emergency preparedness……Page 713
National Fire Protection Association (NFPA)……Page 714
Department of Health and Human Services (DHHS)……Page 715
Medical devices……Page 716
Natural disasters-earthquakes, tornadoes, hurricanes, typhoons……Page 717
Biological and chemical contamination of equipment……Page 718
Recovery……Page 719
Other……Page 720
Requirements for providing good healthcare……Page 721
Constraints relevant to healthcare engineering……Page 722
Constraints in information……Page 723
Constraints in logistics……Page 724
References……Page 725
Section 11
Medical device standards, regulations, and the law……Page 726
Need for standards……Page 728
Standardization bodies……Page 729
ISO standards are developed through a multi-stakeholder process……Page 730
Identification of standards……Page 731
Standards used in the manufacturing process of medical devices……Page 732
Standards and technical regulations……Page 733
Further reading……Page 734
History of medical devices regulation in the United States……Page 735
Third-party review……Page 736
Risk management……Page 737
International medical device regulators forum……Page 738
References……Page 739
Joint Commission on Accreditation of Healthcare Organizations……Page 741
Occupational Safety and Health Administration……Page 742
References……Page 743
Introduction……Page 744
Resource requirements……Page 745
Management system requirements……Page 746
Conclusion……Page 747
References……Page 748
Origin of EQ56—Recommended practice for a medical equipment management program……Page 749
Specific requirements of ANSI/AAMI EQ56:2013……Page 750
Specific contents of ANSI/AAMI EQ89:2015……Page 753
References……Page 754
Introduction……Page 755
Transducers and devices……Page 756
Measurement systems/quality control materials……Page 760
Standards……Page 763
References……Page 764
Further reading……Page 765
Introduction……Page 766
European Union medical device regulations, directives, and conformity assessment……Page 767
Harmonized standards and common specifications……Page 770
European medical devices vigilance and metrology system……Page 771
Conclusions……Page 773
Further reading……Page 775
Food, Drug, and Cosmetic Act……Page 777
Medical Device User Fee Amendments (MDUFA 2007, 2012, and 2017)……Page 778
General controls……Page 779
The regulations process, advisory panels, and the Federal Register……Page 780
Premarket notification (510(k))……Page 781
Premarket approval……Page 782
GMPs, inspections, and audits……Page 783
Tracking……Page 784
Guidance……Page 785
Further reading……Page 786
Medical devices……Page 787
Metrology……Page 788
Standards……Page 789
Legal Metrology Framework for Medical Devices……Page 790
Conclusion……Page 791
References……Page 792
The introduction of medical devices into the legal metrology system of Bosnia and Herzegovina……Page 793
Dynamic descriptive indicators……Page 794
Inferential statistical analysis……Page 797
Regression and correlation analysis……Page 798
References……Page 799
Section 12
Health technology assessment……Page 800
Health technology assessment……Page 802
Economic evaluation……Page 803
HTA process……Page 805
References……Page 806
Product life cycle……Page 808
Issues in use……Page 810
References……Page 811
Healthcare technology and health technology assessment……Page 812
Early stage HTA (eHTA)……Page 813
Cost-effectiveness analysis: Markov models……Page 814
Headroom analysis……Page 816
Stakeholder preference elicitation and multicriteria decision analysis……Page 817
References……Page 818
Multicriteria decision analysis in early health technology assessment……Page 820
User experience……Page 821
Questionnaires on user experience and clinical pathway mapping……Page 822
References……Page 823
Further reading……Page 824
Hospital-based HTA (HB HTA): What is it about?……Page 825
Why should decision-makers adopt HB HTA?……Page 826
How to manage/implement an HTA unit within a hospital……Page 827
The evaluation process……Page 828
References……Page 829
Further reading……Page 830
Case series……Page 831
Cohort studies……Page 832
Experimental studies. Randomized controlled trials (RCTs)……Page 833
Methodology for conducting a systematic review and meta-analysis……Page 834
Searching for studies……Page 835
Selecting studies and extracting the data……Page 836
Presenting results……Page 837
Continuous outcomes……Page 838
Assessing between-study heterogeneity……Page 839
References……Page 840
Further reading……Page 841
What are human factors and ergonomics?……Page 842
The role of HFE in value engineering……Page 843
References……Page 844
Introduction……Page 845
The IFMBE HTA eLearning platform and contents……Page 846
Results and platform utilization……Page 847
Further reading……Page 848
Section 13
Introduction to human factors……Page 849
References……Page 850
Background……Page 851
Workflow……Page 852
Shift work……Page 853
Working with EHR……Page 854
Recommendations……Page 855
References……Page 856
Further reading……Page 858
120
Cognitive ergonomics……Page 859
Working memory……Page 860
Learning……Page 861
Judgment and decision-making……Page 862
Further reading……Page 863
History and evolution……Page 864
Supportive healing environment……Page 865
Patient and staff safety……Page 866
References……Page 867
Further reading……Page 868
Background……Page 870
Assessment……Page 873
Recommendation(s)……Page 874
References……Page 875
Background……Page 877
Recommendations……Page 879
References……Page 881
Usability and the regulatory landscape……Page 883
Heuristic evaluation……Page 884
User testing……Page 885
Implementation of usability methods……Page 886
References……Page 887
HIT safety taxonomies……Page 888
Retrospective analysis……Page 889
Usability testing……Page 890
References……Page 891
Patient engagement for patient-centered care……Page 893
Health equity and addressing social determinants of health……Page 894
Human factors solutions to differences in health literacy……Page 895
Limited English proficiency……Page 896
References……Page 897
Assessment……Page 899
References……Page 901
A……Page 903
B……Page 904
C……Page 905
D……Page 907
E……Page 908
F……Page 909
H……Page 910
I……Page 912
L……Page 913
M……Page 914
N……Page 916
P……Page 917
R……Page 919
S……Page 920
T……Page 921
W……Page 922
X……Page 923
Back Cover……Page 924

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