Clinical Engineering Handbook (Biomedical Engineering)

Clinical Engineering Handbook, Second Edition, covers modern clinical engineering topics, giving experienced professionals the necessary skills and knowledge for this fast-evolving field. Featuring insights from leading international experts, this book presents traditional practices, such as healthcare technology management, medical device service, and technology application. In addition, readers will find valuable information on the newest research and groundbreaking developments in clinical engineering, such as health technology assessment, disaster preparedness, decision support systems, mobile medicine, and prospects and guidelines on the future of clinical engineering.As the biomedical engineering field expands throughout the world, clinical engineers play an increasingly important role as translators between the medical, engineering and business professions. In addition, they influence procedures and policies at research facilities, universities, and in private and government agencies. This book explores their current and continuing reach and its importance. Presents a definitive, comprehensive, and up-to-date resource on clinical engineering Written by worldwide experts with ties to IFMBE, IUPESM, Global CE Advisory Board, IEEE, ACCE, and more Includes coverage of new topics, such as Health Technology Assessment (HTA), Decision Support Systems (DSS), Mobile Apps, Success Stories in Clinical Engineering, and Human Factors Engineering 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 a