医療機器におけるユーザビリティとFDAガイダンス
Contents
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28. 6 1 10 1 10 2 F 72 ef SUE eee Y FDA as 3 unary ee Va NIHON KOHDEN FDA identify and Investigate Use related Hazards Analytical Processes Section 6 Formative Evaluations and Testing Section 7 Prioritize Critical Risks Associated with Use Related Hazards Develop and Implement Risk Risk Mitigation Mitigation and Control Strategies Section 8 ge Sassesstal implemontetion me igation trategie n xc of Mitigation Control Strategies ectio Risks Associated with Use related Hazards Acceptable Yes New Use related Hazards Introduced Human Factors Validation Testing Section 10 Yes IEC62366 Usabilit 12 A C Wa NIHON KOHDEN D 2 6 pied oe IEC
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31. ISO14971 3 HFE UES JT e vcs3xeS OOICFAIR CHS 6180 7 8 HF gt 10 b Ay d fud ala 43 Ast d dul Va NIHON KOHDEN 3 BZ lt gt identity and Investigate Use related Hazards Analytical Processes Section 6 Formative Evaluations and Testing Section 7 J Mond e da eder ennt iated HFE UE m Develop and Implement Risk Risk Mitigation Mitigation and Control Strategies Section 8 Verify Successful Implementation Verification of Mitigation Control Strategies Section 9 Yes M3 i
32. 38 p MN At als f POV ADP d ful Va NIHON KOHDEN 4 HFE UE gt 42 FDA Human Factors Implications of the New GMP Rule Overall Requirements of the New Quality System Hegulation Design Control Guidance for Medical Device Manufacturers Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices Guidance on Medical Device Patient Labeling and Guidance for Industry and FDA Staff Total Product Life Cycle Infusion Pump Premarket Notification 5 10 k Submissions 4 3 Table 1 National and intemational standards involving human factors and usability engineering AAMIUANSI HE75 2009 Human Factors Engineering Design Comprehensive reference that of Medical Devices include general principles usability E 2 testing design elements integrated solutions ga dk V J ISO TEC 62366 2007 Medical devices Application of HFE UE process applied to ali usability engineering to medical medical devices with emphasis o2 devices risk management ANSIAAMITSO Medical Devices Application of rizk 14971 2007 management to medical devices medical devices IEC 60601 1 8 2006 Medical electrical equipment Part 1 HFE UE proc
33. 1 5 A act 7 hM d fud ual f POX Ash t d ftu Va NIHON KOHDEN B gt IEC TR6236G 2 EC TR62366 Table zz Cumulative probability of detecting a USABILITY problem umber of Test Partici Number of Test Participants 1 75 2 025 65 0 50 0 75 0 88 0 97 096 0 99 1 00 100 100 1 00 1 00 100 100 100 PS 75 os4 098 100 100 1 00 1 00 1 00 1 00 1 00 100 1 00 1 00 1 00 _ 09 o9 os9 100 100 100 100 100 100 100 100 100 100 100 1 00 p Ay ita vla f 4 As 3 B Va NIHON KOHDEN xK NO a 4 A d fad ala f M
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35. Human Factors Validation Testing Section 10 b X d fud ala f POX Ash t d ful Va NIHON KOHDEN 4 HFE UE gt 4 1 21CFR 820 FDA FDA CDRH
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37. e sos 201 1 201 1 6 Applying Human Factors and What s New in Human Factors Pre Market Review March 2013 PDF 199KB Human Factors Engineering of Combination Products and the FDA July 2012 PDF 332KB FDA Perspectives on Human Factors in Device Development June 2012 PDF 954KB Human Factors Review Perspective for Premarket Submissions March 2012 PDF 180KB FDA Human Factors Draft Guidance Document Agency Expectations for Human Factors Data in Premarket Submissions March 2012 PDF 659KB The FDA Perspective on Human Factors in Medical Device Software Development February 2012 PDF 1MB American Medical Informatics Association AMIA Pre Symposium Washington DC FDA Initiatives on Human Factors and Usability for Medical Devices October 2011 PDF 368KB Regulatory Affairs Professional Society RAP S Annual Conference Indianapolis IN Human Factors Considerations for Combination Products October 2011 PDF 552KB Meet the Human Factors Pre market Review Team at FDA s Office of Device Evaluation 2011 HFES Annual Meeting September 2011 PDF 1 1MB Identifying Use Errors and Human Factors Approaches to Controlling Risks Public Workshop Quarantine Release Errors September 2011 PDF 538KB Identifying and Mitigating P
38. F DA A 33 I 7 Va NIHON KOHDEN 12 gt HFE UE ma Sri 7 b X d fud ala f POD sit d ft MESA HH UF gt PMA HFE UE ce Va NIHON KOHDEN Table A 1 AN t Intended device users uses use environments and training Intended user population s and critical differences in capabilities between multiple user populations Intended uses and operational contexts of use Use environments and key considerations Tra
39. Draft 500 Terminology Ron Kaye Human Factors Pre market Review Team Leader FDA CDRH ODE HFPMET International Symposium on Human Factors and Ergonomics in Health Care Advancing the Cause March 13 Tow xK XN din eai f POR ADP d Ki Va NIHON KOHDEN FDA x vs X d fud uix f POR Adi d i Va NIHON KOHDEN 1 2 HA 3 4 HFE UE Formative Evaluaion Design Verificaion Testing 1O Human Factors Validation Testing ONOI HFE UVUERSS B mc w ta A MN dE fud ual f POX AD d ful Wa NIHON KOHDEN 1 2 3 4 5 6 exe ASIE G T 10 B
40. USE RELATED FAILURE HAZARDS HAZARDS ke d ful ala t Med dere dd 3 Va NIHON KOHDEN gt SRI 1 HFE UE
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43. E48 1993 2004 2005 Guidance for the Content of Premarket Submissions for Software Contained in Medical Device IEC 60601 1 6 Ed 1 2004 2006 IEC 60601 1 6 Ed 2 2006 2007 IEC 62366 Ed 1 2007 2009 t ANSI AAMI HE75 2009 2010 IEC 60601 1 6 Ed 3 201O 201 1 Applying Human Factors and usability Engineering to Optimize Medical Device Design 2013 2014 IEC 62366 Ed 1 Am1 2014 2015 IEC 62366 1 Ed 1 IEC 60601 1 6 Ed 3 Am1 2013 IEC 62366 2 Ed 1 b dd mab ft ROX dere j HE IZROOZI EX T ec Za NIHON KOHDEN 8O 9O 2000 2010 2014 FDA HFE22F ANSI AAMI AAMI ANSI AAMI ANSI AAMI ANSI AAMI HE 1988 HE48 1993 HE74 2001 HE75 2009 EC6O6O1 1 EC6O6O1 1 Ed 3 2005 Ed 3 Am1 2012 IEC IEC60601 1 6 IEC60601 1 6 pi IEC 60601 1 6 IEC 60601 1 6 Usability Ed 1 2004 Ed 2 2006 E 15 EG os IEC 62366 IEC 62366 Ed 1 2007 Am1 2014 Legacy devices Usability IEC 62366 4 201X IEC TR62366 2 201X JETA ME 2001 2002 2005 Va NIHON K
44. Guidance Document Agency Information and Resources involves reviewing new device submissions promoting effective and focused Expectations for Human human factors evaluation and good design practices for medical devices Factors Data in Premarket Submissions March 2012 PDF 659KB Contact Us The premarket team works with scientific reviewers across the Office to evaluate use related risk analyses and human factors usability information and validation study data submitted as part of various types of premarket submissions e The FDA Perspective on Human premarket notification 510 k submissions premarket approval PMA Factors in Medical Device applications Investigational Device Exemption IDE applications and Pre IDE Software Development submissions The team provides recommendations on human factors February 2012 PDF 1MB components of manufacturers design validation documents as required by the FDA s Quality System Regulation The team also collaborates with colleagues in other FDA Centers by providing human factors recommendations such as for combination products i e autoinjectors pen injectors inhalation products pre filled syringes etc in their pre approval review processes In addition the team Contact FDA Develops and provides content for FDA Guidance documents to help manufacturers understand and apply human factors engineering HFPMET fda hhs gov Conducts outreach to industry and academia throug
45. OD did d ful Va NIHON KOHDEN Usability gt Patient Safety FDA gt lt gt IEC62366 1 IEC62366 2 FDA ANSI AAMI END A a
46. OHDEN 3 FDA x e Xv d fd wala f POR ADP d Ki Va NIHON KOHDEN Medical Device Guidance Documents 2000 7 Medical Device Use Safety Incorporating Human Factors Engineering into Risk Management FDA Web Guidance for Industry and FDA Premarket and Design Control Reviewers Medical Device Use Safety Incorporating Human Factors Engineering into Risk Management Document issued on July 18 2000 is document replaces the draft guidance document of August 3 1999 entitled Device Use Safety Incorporating Human Factors in Risk Management U S Department of Health and Human Services Food and Drug Administration Center for Devices and Radiological Health Division of Device User Programs and Systems Analysis Office of Health and Industry Programs amp X Ai wath f PO Ay dt d Ki Va NIHON KOHDEN Medical Device Drat Guidance Documents 201 1 6 Applying Human Factors and Usability Engineering to Optimize Medical Device Design FDA Web ontains Nonbmding Recommendations Du Not for Dupiementation Draft Guidance for Industry and Food and Drug Administration Staff Applying Human Factors and Usability Engineering to Optimize Medical Device Design DRAFT GUIDANCE This guidance d
47. V A De d fl 1 iae 1 Za NIHON KOHDEN gt AREA SN s sb FAIS COPS TA SODA aN C CHEER HFE UE A 4 b Ay ity waia f MOV di d fl 5D felis Fa NIHON KOHDEN gt e Cs d COREL LU
48. Wa NIHON KOHDEN Usability FDA 2014 3 7 2 IEC C62 FS B gt Hw A d fud alb f POD O78 d dul b Za NIHON KOHDEN EX 1 2 Usability 3 FDA Human Factors Usability 4 FDA 5 2 Ah 2 P 3 4 i i amp 14 hs A Se MS wa f b RHO YR My 1 4 Tul Va NIHON KOHDEN A vs A Av itd ala f 4 3 dT d ful N I Va NIHON KOHDEN Human Factor Usability FDA Human Factor FDA Human Factor amp S88SxICFHUYC IEC Usability IEC Usability FDA Human Factor Usability Human Factor Usability
49. ance OCER Guidance ODE Guidance 2010 2014 ODE Guidance 1998 2009 ODE Guidance 1976 1997 OIR Guidance OSB Guidance OSEL Guidance Radiation Emitting Products Guidance U S Food and Drug Administration Protecting and Promoting Your Health Radiation Emitting Products Va NIHON KOHDEN FDA Web AtoZ Index Fol T log SEARCH Vaccines Blood amp Biologics Animal amp Veterinary Cosmetics Tobacco Products Home Medical Devices Device Advice Comprehensive Regulatory Assistance Guidance Documents Medical Devices and Radiation Emitting Products Recent Medical Device Guidance Documents CDRH Industry Get e mail updates Recent Guidance Documents Title Organization Reporting of Computational ODE OSEL Modeling Studies in Medical Device Submissions Draft Guidance for Industry and Food and Drug Administration Staff 01 17 14 Custom Device Exemption Draft Guidance for Industry and Food and Drug Administration Staff PDF 248KB CDRH ODE CDRH OC 01H44 Blood Glucose Monitoring Test Systems for Prescription Point of Care Use Draft Guidance for Industry and Food and Drug Administration Staff PDF 261KB 01 07 14 Self Monitoring Blood Glucose Test Systems for Over the nunte e Dra i OIR DCTD 01 0744 T lia PAD d fal ual f POR Ash t d ful Human Factors and MEDICAL Devices f Health amp Huma A to Z Index n FDA V
50. echanics Imaging amp Applied Mathematics Electrical amp Software Engineering more International Programs International Medical Device Regulators Forum Medical Device Single Audit Program Pilot xK Home Food Drugs Medical Devices Radiation Emitting Products Vaccines Blood amp Biologics Animal amp Veterinary Cosmetics Tobacco Products Spotlight Blood Glucose Monitoring Test Systems for Prescription Point of Care Use Draft Guidance PDF 261KB Self Monitoring Blood Glucose Test Systems for Over the Counter Use Draft Guidance PDF 263KB eCopy Program for Medical Device Submissions Considering Women s Needs in Developing Medical Devices Here s HoW Recent IDE Tracking Improvements Recalls amp Alerts Safety Communication Nipple Aspirate Test ls Not An Alternative To Mammography Safety communication HeartStart automated external Va NIHON KOHDEN all 1 b Ae di ual f MOV AD d ful Medical Device Guidance Documents FDA Medical Devices Medical Devices Web Device Advice Comprehensive Regulatory Assistance Guidance Documents Medical Devices and Radiation Emitting Products Human Factors Usability Cross Center Guidance Documents OC Guidance OCD Guid
51. eded and is outweighed by the benefits that may be derived from the device 5 use xK i AX d fal wata f POV di t d ful Va NIHON KOHDEN UE gt 1 gt 2 3 E 4 rjr NN 5 up Kd 6 JJ T uavit poets T m ac uuu B A X itn ala f POV Ash d dul Va NIHON KOHDEN B Jj A gt Table B 1 Percentage of Total a eon Found in 100 Analysts Samples No wsers e S 5 Faulkner 2003 l 5 QO 97 15 SSO
52. ess applied to alarm 8 General requirements for basic systems for medical electrical safety and essential performance equipment and systems Collateral Standard General requirements tests and guidance for alarm systems in medical electrical equipment and medical electrical 39 systems b ful Va NIHON KOHDEN gt controls van HADINUYIBSEN IYI YINI package insert n 5S9 4 x i vj bh A du waia f 4 3 MM t d ftu N KOHDEN DDS gt
53. h presentations at CDRH Human Factors Team conferences and public meetings 4 Provides training and guidance for other FDA personnel about human factors Office of Device Evaluation use safety and design of medical devices Center for Devices and Radiological Participates with National and International Standards committees in the Health development of Human Factors related Standards Food and Drug Administration Encourages users and manufacturers to report serious adverse incidents 10903 New Hampshire Avenue involving medical devices through the FDA s Medical Device Reporting MDR WO66 Room 2531 system Silver Spring MD 20993 Contributes to the analysis involving post market reports and recalls of medical device in which use error is involved Page Last Updated 06 04 2013 Note If you need help accessing information in different file formats see Instructions for Downloading Viewers and Players EDA Accessibility ContactFDA Careers FDA Basics FOIA NoFearAct SiteMap Transparency Website Policies FDA Web pA d fd ab ft POX dere Ht NIHON KQHDEN General Human Factors Informatior h Hesources FDA Web ent of Health amp Human Services U S Food and Drug Administration DN Protecting and Promoting Your Health Home Food Drugs Medical Devices Medical Devices Home Medical Devices Device Advice Compret Device Advice Compreh Regulatory A
54. he machine human device user interface The user interface includes all components with which users interact while preparing the device for use e 9 unpacking set up calibration using the device or performing maintenance e g cleaning replacing a battery making repairs Why is HFE important to medical devices For medical devices the most important goal of the human factors usability engineering process is to minimize use related hazards and risks and then confirm that these efforts were successful and users can use the device safely and effectively Specific beneficial outcomes of applying human factors usability engineering to medical devices include Easier to use devices Safer connections between device components and accessories e g power cords leads tubing cartridges Easier to read controls and displays Better user understanding of the device s status and operation Better user understanding of a patient s current medical condition More effective alarm signals Easier device maintenance and repair Reduced user reliance on user manuals Reduced need for user training and retraining Reduced risk of use error Reduced risk of adverse events and Reduced risk of product recalls M gt m p Ay ita vla f dA 725022 Va NIHON KOHDEN FDA Web CDRH Human Factors Presentations Most Recent 20135
55. ming intended for users and provided to test participants Device user interface Graphical depiction drawing or photograph of device user interface Verbal description of device user interface Summary of known use problems Known problems with previous models cx cw problem with similar devices User b secti characterization and peace Risk analysis methods Use related hazardous situation and risk summary Crtcal tasks identified and included in HFE UE validation tests Summary of formative evaluations Evaluation methods Key results and design modification implemented Key findings that mformed the HFE UE validation testing protocol Validation testing Rationale for test type selected 1 e simulated use or clinical evaluation Number and type of test participants and rationale for how they represent the mtended user populations Test goals critical tasks and use scenarios studied Technique for unanncipated use errors Test results eaa of device uses success and failure occurrences oe assessment hed test participants of any cntical task failures and difficultes The lt Name Model gt has been found to be reasonably safe and effective for the intended users The methods and results described in the preceding sections support this conclusion Any residual risk that remains after the validation testing would not be further reduced by modifications of design of the user interface including any accessones and the IFU is not ne
56. ocument i being distributed for comment purpose only Document issued on June 22 2011 You should subest comments i L Idennfy mamber listed in the notice ef availabilay that publishes in the Federal For questions regarding this document contact Ron Kaye at ron kayedifda hhs gov or 301 796 6289 or Molly Story at molly storviui ia hhs gov or 310 796 1456 When final this document will supersede Medical Device Use Safety Incorporating Human Factors Engineering into Risk Management Issued July 18 2000 i re and Drug Administration anim Center Sor Devices and Radiological Health Cp Office of Device Evaluation Ry oe A A itn ala f MO dd Kf Va NIHON KOHDEN Q Draft Guidance for Industry and Food and Drug Administration Staff Q Draft Guidance This guidance document is being distributed for comment purpose only Document issued on June 22 201 1 Q Ron Kaye Molly Story X NNNM v bh A d fu ual f POX Ash t d ful _ x Va NIHON KOHDEN FDA Web FDA Ponit senes AEN 2013 3 FDA What s New in Human Factors Pre Market Review
57. oice Blog ED U S Food and Drug Administration VAN Protecting and Promoting Your Health Home Medical Devices Device Advice Comprehensive Regulatory Assistance Human Factors Medical Devices H Uu man Facto rs Device Advice Comprehensive ee Devices Spotlight Regulatory Assistance le UY CO z Human Factors Program at FDA EPE is C x Pom paea FDA works with manufacturers to help ensure the application of human factors Say ea Review March RES engineering to the design of new products as well as to postmarket surveillance of 2013 PDF 199KB AN V Premarket Information Device currently marketed products O Design and Documentation Human Factors Engineering of Processes Human Factors at Center for Devices and Radiological Health Combination Products and the m CDRH FDA July 2012 PDF 332KB ostmarket Information Device Surveillance and Reporting FDA Perspectives on Human Processes Office of Device Evaluation ODE Factors in Device Development iconos der Cou Nur The Human Factors Premarket Evaluation Team is located in the Office of Device June 2012 PDF 954KB Patients and Caregivers s Evaluation ODE The purpose of the FDA s Human Factors Pre Market Evaluation 9 Team is to ensure that new medical devices have been designed to be reasonably FDA Human Factors Draft General Human Factors safe and effective when used by the intended user populations The effort primarily
58. otential Use Errors June 2011 PDF 215KB Human Factors Usability for Medical Devices An Historical Perspective June 2011 PDF 62KB Usability Engineering to Optimize 7 Medical Device Design Presentation Enhancing the Quality of Device Labeling Molly Follette Story PhD PDF 249KB Presentation Ron Kaye MA Human Factors Usability for Infusion Pumps Additional Test Data Requested In New Draft Guidance PDF 527KB AAMI sponsored training Linking Human Factors with FDA s Quality System Regulation A Critical Component to the Design and Manufacturing Process April 25 2006 amp AAMUFDA Conference Human Factors in Medical Devices Design Regulation and Patient Safety A AY EG mabe t Med bait 1 HE Va NIHON KOHDEN FDA x e A A d fai walan f MOR di d ful Fi DA JJ L c y Wa NIHON KOHDEN ANSI AAMI 1997 Write it Right 1988 Human Factors Points to Consider for IDE Devices H FDA AAMI HE 1988 1993 1996 Do it by Design 1997 Design Control Guidance for Medical Device Manufacturers 2OQOQO ncorporating Human Factors Engineering into Risk Management 2001 Patient Labeling Final Guidance for Industry and FDA Reviewers ANSI AAMI HE74 2001 SE d a nue md enis quin tie rimi d i dd Qui E i icm Ql tu i emi d end nd em RR ues Mer c eed a i dA ANSI AAMI H
59. ssistance Human Factors Medical Devices Premarket Information Device Design and Documentation Processes Postmarket Information Device Surveillance and Reporting Processes Information for Consumers Patients and Caregivers b General Human Factors Information and Resources Contact Us AtoZ index Follow FDA FDA Voice Blog Radiation Emitting Products Vaccines Blood amp Biologics Animal amp Veterinary Cosmetics Tobacco Products B gx tance Human Factors Medical Devices ive Regulatory Ass General Human Factors Information and Resources What is Human Factors Usability Engineering Human factors usability engineering focuses on the interactions between people and devices The critical elementin these interactions is the device user interface depicted as the green zone in the figure below i ation Control Perception Actions Processing Reaction Flow chart adapted from Redmill and Rajan 1997 To understand the human machine system it s important to understand the ways that people Perceive information from the device Interpret the information and make decisions about what to do and Manipulate the device its components and or its controls It s also important to understand the ways that devices Reactto input from the user and then Provide feedback to the user about the effects of their actions Human factors usability engineering is used to design t
60. tic of the user interface that establishes effectiveness efficiency ease of user learning and user satisfaction ISO IEC 62366 2007 Definition 3 17 Va NIHON KOHDEN FDA Web ET Human Factors Engineering of Combination Products and the FDA Molly Follette Story PhD FDA CDRH ODE Drug Product for Biological Medicines Systems Challenging Formulations and Combination Products CaSSS CMC Strategy Forum July 17 2012 m SIMA TOY FORJM x d 77 o7 Mio A A du ual f MOV Ash t d fl Va NIHON KOHDEN 3 FDAcHuman Factors Usability gt e A A d fai ala f 4 3 Ash t d ful F DA f Health and Human U S Food and Drug FDA Web U S Food and Drug Administration Administration Medical Devices Home Medical Devices ald Medical Device Mobile Medical Applications Navigate the Medical Devices Section Products and Medical Procedures Approvals amp Clearances Home Use Surgical Implants amp Prosthetics In Vitro Diagnostics more Medical Device Safety Alerts amp Notices Recalls Report a Problem MedSun Emergency Situations Device Advice Comprehensive Regulatory Assistance Protecting and Promoting Your Health Science and Research Medical Devices Chemistry amp Materials Science Solid amp Fluid M
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