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Responsible use of high-risk medical devices / Imgard Vinck / Brussels [Belgium] : KCE = Federaal Kenniscentrum voor de Gezondheidszorg = Centre Fédéral d'Expertise des Soins de Santé = Belgian Health Care Knowledge Centre (2018)
Responsible use of high-risk medical devices : the example of 3D printed medical devices [printed text] / Imgard Vinck , Author ; An Vijverman, Author ; Erik Vollebregt, Author ; Nils Broeckx, Author ; Karlien Wouters, Author ; Mariel Piët, Author ; Natalija Bacic, Author ; Joan Vlayen , Author ; Nancy Thiry, Author ; Mattias Neyt , Author . - Brussels [Belgium] : KCE = Federaal Kenniscentrum voor de Gezondheidszorg = Centre Fédéral d'Expertise des Soins de Santé = Belgian Health Care Knowledge Centre, 2018 . - 158 p. : ill., ; A4. - (KCE Reports. Health Technology Assessment (HTA); 297C) .
ISSN : D/2018/10.273/03 : € 0,00
Languages : English (eng)
Descriptors: Classification
W 82 Biomedical technology (General)
Indexation
2016-01 ; Device Approval ; Equipement and Supplies ; European Union ; Government Regulation ; Printing, Three-Dimensional ; R297Contents note: SCIENTIFIC REPORT 9 -- 1 BACKGROUND 9 -- 1.1 SCOPE AND RESEARCH QUESTIONS 11 -- 2 SOME TECHNICAL ASPECTS 12 -- 2.1 TECHNIQUES OF 3D PRINTING 12 -- 2.2 COMPONENT ELEMENTS 12 -- 2.3 PROCESS OF 3D PRINTING (MEDICAL) DEVICES 13 -- 3 SYSTEMATIC REVIEW OF THE MEDICAL LITERATURE 16 -- 3.1 RESEARCH QUESTION 16 -- 3.2 METHODOLOGY 16 -- 3.2.1 Literature search and study selection 16 -- 3.2.2 Quality appraisal and data extraction 17 -- 3.2.3 Statistical analysis 17 -- 3.2.4 GRADE 17 -- 3.3 RESULTS 18 -- 3.3.1 Overall yield of the search 18 -- 3.3.2 Custom-made implants 21 -- 3.3.3 Surgical guides 21 -- 3.3.4 Model for surgery planning 26 -- 3.3.5 Model for implant shaping 26 -- 4 SYSTEMATIC REVIEW OF THE ECONOMIC LITERATURE 27 -- 4.1 METHODS 27 -- 4.1.1 Inclusion and exclusion criteria 27 -- 4.1.2 Search strategy 27 -- 4.1.3 Selection procedure 28 -- 4.1.4 Data extraction 28 -- 4.2 OVERVIEW OF THE ECONOMIC LITERATURE 29 -- 4.2.1 Technical characteristics of the economic evaluations 29 -- 4.2.2 Medical and clinical characteristics of the economic evaluations 30 -- 4.2.3 Cost items 32 -- 4.2.4 Outcome measures 32 -- 4.2.5 Results of the economic evaluations 33 -- 4.3 DISCUSSION 36 -- 5 LEGAL PART 38 -- 5.1 RESEARCH QUESTIONS 38 -- 5.2 METHODOLOGY 39 -- 5.3 MAIN LEGAL TEXTS AND DEFINITIONS 40 -- 5.4 LEGAL QUALIFICATION (AND CLASSIFICATION) AND REQUIREMENTS FOR THE PLACING ON THE MARKET OF 3D PRINTING OF / 3D PRINTED MEDICAL DEVICES UNDER EU RULES 43 -- 5.4.1 Current regime: Medical Devices Directive & IVD Directive 45 -- 5.4.2 Future regime: Medical Devices Regulation & IVD Regulation 57 -- 5.5 LEGAL QUALIFICATION OF 3D PRINTING/3D PRINTED MEDICAL DEVICES IN BELGIUM 64 -- 5.5.1 Legal qualification 64 -- 5.5.2 Applicable requirements for the placing on the market 65 -- 5.5.3 Conclusion 68 -- 5.6 LIABILITY AND INSURANCE ISSUES ASSOCIATED WITH 3D PRINTED MEDICAL DEVICES 69 -- 5.6.1 Liability and insurance issues associated with 3D printed medical devices in the EU 70 -- 5.6.2 Liability and insurance issues associated with 3D printed medical devices in Belgium 75 -- 5.6.3 Conclusion 85 -- 5.7 DATA PROTECTION ISSUES ASSOCIATED WITH 3D PRINTED MEDICAL DEVICES 86 -- 5.7.1 EU 86 -- 5.7.2 Belgium 95 -- 5.7.3 Conclusion 98 -- 5.8 PATIENTS’ RIGHTS ISSUES ASSOCIATED WITH 3D PRINTED MEDICAL DEVICES 98 -- 5.8.1 EU 99 -- 5.8.2 Belgium 101 -- 5.8.3 Conclusion 103 -- 5.9 TRACEABILITY ISSUES ASSOCIATED WITH 3D PRINTED MEDICAL DEVICES 104 -- 5.9.1 EU 104 -- 5.9.2 Belgium 107 -- 5.9.3 Conclusion 111 -- 5.10 REIMBURSEMENT ISSUES ASSOCIATED WITH 3D PRINTED MEDICAL DEVICES 112 -- 5.10.1 EU 112 -- 5.10.2 Belgium 113 -- 5.10.3 Conclusion 136 -- 5.11 INTELLECTUAL PROPERTY RIGHTS ISSUES ASSOCIATED WITH 3D PRINTED MEDICAL DEVICES 139 -- 5.11.1 EU 142 -- 5.11.2 Belgium 153 -- 5.11.3 Conclusion 154 -- REFERENCES 156 Link for e-copy: http://doi.org/10.57598/R297C Format of e-copy: PDF (2,24 Mb) Record link: https://kce.docressources.info/index.php?lvl=notice_display&id=4348 Responsible use of high-risk medical devices / Joan Vlayen / Brussels [Belgium] : KCE = Federaal Kenniscentrum voor de Gezondheidszorg = Centre Fédéral d'Expertise des Soins de Santé = Belgian Health Care Knowledge Centre (2018)
Responsible use of high-risk medical devices : the example of 3D printed medical devices – Appendix 1 [printed text] / Joan Vlayen , Author . - Brussels [Belgium] : KCE = Federaal Kenniscentrum voor de Gezondheidszorg = Centre Fédéral d'Expertise des Soins de Santé = Belgian Health Care Knowledge Centre, 2018 . - 38 p. : ill., ; A4. - (KCE Reports. Health Technology Assessment (HTA); 297S1) .
ISSN : D/2018/10.273/04 : € 0,00
Languages : English (eng)
Descriptors: Classification
W 82 Biomedical technology (General)
Indexation
2016-01 ; Device Approval ; Equipement and Supplies ; European Union ; Government Regulation ; Printing, Three-Dimensional ; R297Contents note: 1. SEARCH STRATEGIES MEDICAL LITERATURE 3 2. SELECTION RESULTS 6 -- 3. QUALITY APPRAISAL 9 -- 3.1. QUALITY APPRAISAL TOOLS 9 -- 3.1.1. Systematic reviews 9 -- 3.1.2. Primary studies for therapeutic interventions 10 -- 3.2. QUALITY APPRAISAL RESULTS 12 -- 4. EVIDENCE TABLES 14 -- 4.1. SYSTEMATIC REVIEWS 14 -- 4.2. RCTS 25 -- 5. SEARCH ORIGINALLY FOCUSED ON CUSTOM IMPLANTS 31 -- 5.1. SEARCH STRATEGIES 31 -- 5.2. SELECTION RESULTS 33 -- 5.3. RESULTS 33 -- 5.3.1. Overall yield of the search 33 -- 5.3.2. Evidence by anatomic location 33 Link for e-copy: http://doi.org/10.57598/R297S1 Format of e-copy: PDF (607 KB) Record link: https://kce.docressources.info/index.php?lvl=notice_display&id=4351 Responsible use of high-risk medical devices / Nancy Thiry / Brussels [Belgium] : KCE = Federaal Kenniscentrum voor de Gezondheidszorg = Centre Fédéral d'Expertise des Soins de Santé = Belgian Health Care Knowledge Centre (2018)
Responsible use of high-risk medical devices : the example of 3D printing – Appendix 2 [printed text] / Nancy Thiry, Author ; Mattias Neyt , Author . - Brussels [Belgium] : KCE = Federaal Kenniscentrum voor de Gezondheidszorg = Centre Fédéral d'Expertise des Soins de Santé = Belgian Health Care Knowledge Centre, 2018 . - 6 p. : ill., ; A4. - (KCE Reports. Health Technology Assessment (HTA); 297S2) .
ISSN : D/2018/10.273/05 : € 0,00
Languages : English (eng)
Descriptors: Classification
W 82 Biomedical technology (General)
Indexation
2016-01 ; Device Approval ; Equipement and Supplies ; European Union ; Government Regulation ; Printing, Three-Dimensional ; R297Contents note: 1 Search strategies 2 -- 2 Selestion procedure 5 Link for e-copy: http://doi.org/10.57598/R297S2 Format of e-copy: PDF (357 KB) Record link: https://kce.docressources.info/index.php?lvl=notice_display&id=4352 Responsible use of high-risk medical devices / Natalija Bacic / Brussels [Belgium] : KCE = Federaal Kenniscentrum voor de Gezondheidszorg = Centre Fédéral d'Expertise des Soins de Santé = Belgian Health Care Knowledge Centre (2018)
Responsible use of high-risk medical devices : the example of 3D printing of medical devices – Appendix 3 [printed text] / Natalija Bacic, Author ; Alex Denoon, Author ; Julian Hitchcock, Author ; Laure Le Calvé, Author ; Erik Vollebregt, Author . - Brussels [Belgium] : KCE = Federaal Kenniscentrum voor de Gezondheidszorg = Centre Fédéral d'Expertise des Soins de Santé = Belgian Health Care Knowledge Centre, 2018 . - 75 p. : ill., ; A4. - (KCE Reports. Health Technology Assessment (HTA); 297S3) .
ISSN : D/2018/10.273/06 : € 0,00
Languages : English (eng)
Descriptors: Classification
W 82 Biomedical technology (General)
Indexation
2016-01 ; Device Approval ; Equipement and Supplies ; European Union ; Government Regulation ; Printing, Three-Dimensional ; R297Contents note: APPENDIX 2 REPORT 1 -- TABLE OF CONTENTS 1 -- LIST OF TABLES 4 -- 1. LEGAL QUALIFICATION OF 3D PRINTING/3D PRINTED MEDICAL DEVICES UNDER VARIOUS NATIONAL REGIMES 5 -- 1.1. UNITED KINGDOM 5 -- 1.1.1. Legal qualification 5 -- 1.1.2. Applicable requirements for the placing on the market 5 -- 1.2. FRANCE 6 -- 1.2.1. Legal qualification 6 -- 1.2.2. Applicable requirements for the placing on the market 13 -- 1.3. THE NETHERLANDS 14 -- 1.3.1. Legal qualification 14 -- 1.3.2. Applicable requirements for the placing on the market 14 -- 1.4. USA 15 -- 1.4.1. Legal qualification 15 -- 1.4.2. Applicable requirements for the placing on the market 19 -- 1.4.3. Quality system requirements 20 -- 2. LIABILITY AND INSURANCE ISSUES ASSOCIATED WITH 3D PRINTED MEDICAL DEVICES UNDER VARIOUS NATIONAL REGIMES 24 -- 2.1. UNITED KINGDOM 24 -- 2.1.1. Liability 24 -- 2.1.2. Insurance 25 -- 2.2. FRANCE 25 -- 2.2.1. Liability for defective product 26 -- 2.2.2. Specific fault-based liability for healthcare actors (Article L. 1142-1 of PHC) 29 -- 2.2.3. General fault-based liability (Articles 1240 et seq. of CC) 29 -- 2.2.4. Insurance (Articles L. 1142-2, L. 1142-25 et seq. of PHC and L. 426-1 of the French Insurance Code) 29 -- 2.3. THE NETHERLANDS 30 -- 2.3.1. Product 31 -- 2.3.2. Producers 32 -- 2.4. USA 34 -- 3. DATA PROTECTION ASSOCIATED WITH 3D PRINTED MEDICAL DEVICES UNDER VARIOUS NATIONAL REGIMES 37 -- 3.1. UNITED KINGDOM 37 -- 3.2. FRANCE 37 -- 3.2.1. Personal data protection 37 -- 3.2.2. The hosting of personal health data 38 -- 3.3. THE NETHERLANDS 41 -- 3.4. USA 41 -- 4. PATIENTS’ RIGHTS ISSUES RELATED TO 3D PRINTING IN VARIOUS NATIONAL REGIMES 45 -- 4.1. UNITED KINGDOM 45 -- 4.2. FRANCE 46 -- 4.2.1. Medical secrecy 46 -- 4.2.2. The patient's right to information 47 -- 4.3. THE NETHERLANDS 48 -- 4.4. USA 49 -- 5. TRACEABILITY ISSUES ASSOCIATED WITH 3D PRINTED MEDICAL DEVICES IN VARIOUS NATIONAL REGIMES 52 -- 5.1. UNITED KINGDOM 52 -- 5.2. FRANCE 53 -- 5.3. THE NETHERLANDS 56 -- 5.4. USA 56 -- 5.4.1. Traceability of the medical (implantable) device 57 -- 5.4.2. Labelling 57 -- 6. REIMBURSEMENT ISSUES UNDER VARIOUS NATIONAL REGIMES 59 -- 6.1. UNITED KINGDOM 59 -- 6.2. FRANCE 60 -- 6.2.1. Reimbursement of medical devices listed on the LPPR (Articles L. 165-1 and R. 165-1 et seq. of SSC) 60 -- 6.2.2. Reimbursement of innovative medical devices and services (Articles L. 165-1-1 and R. 165-63 and seq. of SSC) 63 -- 6.3. THE NETHERLANDS 64 -- 6.4. USA 66 -- 7. INTELLECTUAL PROPERTY ISSUES UNDER VARIOUS NATIONAL REGIMES 68 -- 7.1. UNITED KINGDOM 68 -- 7.2. FRANCE 70 -- 7.3. THE NETHERLANDS 71 -- 7.4. USA 72 Link for e-copy: http://doi.org/10.57598/R297S3 Format of e-copy: PDF (722 KB) Record link: https://kce.docressources.info/index.php?lvl=notice_display&id=4353 Les ressources humaines du système de santé en Belgique / Bui Dang Ha Doan / Paris [France] : Centre de Sociologie et de Démographie Médicales (2007)
Les ressources humaines du système de santé en Belgique = The joint Operation : The single wealth is man ; L'Opération Conjointe : Il n'est de richesse que d'homme [printed text] / Bui Dang Ha Doan, Publishing director . - Paris [France] : Centre de Sociologie et de Démographie Médicales, 2007 . - 226 p. : ill. ; 22 cm. - (Cahiers de sociologie et de démographie médicales, ISSN 0007-9995; 47(2)) .
ISSN : 0007-9995-47-02 : € 30,00
Languages : English (eng) French (fre)
Descriptors: Classification
W 76 Health manpower and services, distribution and characteristics
Indexation
Belgium ; Health Manpower ; Periodicals ; Physicians ; Public Health ; Social sciences ; statistics and numerical data [Subheading]Record link: https://kce.docressources.info/index.php?lvl=notice_display&id=2074 ContentHold
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