Usability testing of medical devices

Usability Testing of Medical Devices

Volumn , Issue , 2010, Pages 1-354

  Wiklund, Michael E ^a   Kendler, Jonathan ^a   Yale, Allison S ^a  

^a NONE

Author keywords

[No Author keywords available]

Indexed keywords

HUMAN ENGINEERING; LAWS AND LEGISLATION; REVIEWS; TESTING;

DEVELOPMENT TEAMS; GOVERNMENT REGULATION; INDUSTRY STANDARDS; MEDICAL DEVICE MANUFACTURERS; MEDICAL DEVICES; TESTING PROCESS; USABILITY TESTING; USABILITY TESTS;

USABILITY ENGINEERING;

EID: 85055218825     PISSN: None     EISSN: None     Source Type: Book    
DOI: 10.1201/b10458     Document Type: Book

References (94)

1. U.S. Food and Drug Administration (FDA). 2009. Is the product a medical device? Retrieved from http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/ClassifyYourDevice/ucm051512.htm.
2. European Union. 1993. Council Directive 93/42/EEC of 14 June 1993 concerning medical devices. Article 1: Definitions, scope. Retrieved from http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:31993L0042:EN:HTML. Note: Only European Union legislation printed in the paper edition of the Official Journal of the European Union is deemed authentic.
3. U.S. Food and Drug Administration (FDA). 2009. General and special controls. Retrieved from http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/GeneralandSpecialControls/default.htm.
4. Kinnealey, E., Fishman, G., Sims, N., Cooper, J., and DeMonaco, H. 2003. Infusion pumps with “drug libraries” at the point of care-A solution for safer drug delivery. Retrieved from http://www.npsf.org/download/Kinnealey.pdf.
5. Design validation. Code of Federal Regulations, 21 CFR 820.30, Part 820, Subpart C, Subsection G. Retrieved from http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?FR=820.30.
6. Food and Drug Administration (FDA)/Center for Devices and Radiological Health (CDRH). 1996. Do it by design: An introduction to human factors in medical devices. Retrieved from http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationand Guidance/GuidanceDocuments/ucm095061.pdf.
7. Food and Drug Administration (FDA)/Center for Devices and Radiological Health (CDRH). 2000. Medical device use-safety: Incorporating human factors engineering into risk management. Retrieved from http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm094461.pdf.
8. U.S. Food and Drug Administration (FDA) Web site. 2009. About FDA-What we do. Retrieved from http://www.fda.gov/opacom/morechoices/mission.html
9. Medicines and Healthcare Products Regulatory Agency Web site. 2010. About us. Retrieved from http://www.mhra.gov.uk/Aboutus/index.htm.
10. Pharmaceuticals and Medical Devices Agency, Japan, Web site. 2009. Message from chief executive. Retrieved from http://www.pmda.go.jp/english/about/message.html.
11. Pharmaceuticals and Medical Devices Agency, Japan, Web site. 2010. Our Philosophy. Retrieved from http://www.pmda.go.jp/english/about/philosophy.html.
12. Federal Institute for Drugs and Medical Devices Web site. 2007. About us. Retrieved from http://www.BfArM.de/cln_030/nn_424928/EN/BfArM/bfarm-node-en.html_nnn=true.
13. Design validation. Code of Federal Regulations, 21 CFR 820.30, Part 820, Subpart C, Subsection G. Retrieved from http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?FR=820.30.
14. Food and Drug Administration (FDA). 2009. Human factors implications of the new GMP rule overall requirements of the new quality system regulation. Retrieved January 24, 2010, from http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/PostmarketRequirements/HumanFactors/ucm119215.htm.
15. Association for the Advancement of Medical Instrumentation (AAMI). 2001. ANSI/AAMI HE74: 2001 Human factors design process for medical devices. Arlington, VA:Association for the Advancement of Medical Instrumentation, page 2.
16. European Commission. 2009. Summary list of titles and references harmonised standards relating to in vitro diagnostic medical devices. Retrieved from http://ec.europa.eu/enterprise/policies/european-standards/documents/harmonised-standards-legislation/list-references/iv-diagnostic-medical-devices/.
17. Virzi, R. A. (1992). Refining the test phase of usability evaluation: How many subjects is enough? Human Factors 34: 457-468.
18. Dumas, J. S., and Redish, J. C. 1999. A practical guide to usability testing (rev. ed.). Portland, OR: Intellect.
19. Association for Advancement of Medical Instrumentation (AAMI). 2009. ANSI/AAMI HE75:2009: Human factors engineering-Design of medical devices. Arlington, VA:Association for Advancement of Medical Instrumentation, Annex A.
20. Food and Drug Administration (FDA)/Center for Devices and Radiological Health (CDRH). 2000. Medical device use-safety: Incorporating human factors engineering into risk management. Retrieved from http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm094461.pdf.
21. U.S. Food and Drug Administration (FDA). Medical Device Reporting (MDR) database. http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMDR/Search.cfm.
22. International Organization for Standardization (ISO). 2007. ISO14971:2007-Medical devices-Application of risk management to medical devices. Geneva, Switzerland:International Organization for Standardization, Table D.4.
23. Quality Associates International. Severity, Occurrence, and Detection Criteria for Design FMEA. Retrieved from http://www.fmeainfocentre.com/guides/DesignPktNewRating.
24. International Organization for Standardization (ISO). 2007. ISO 14971: Medical devices-Application of risk management to medical devices. Geneva, Switzerland:International Organization for Standardization.
25. American Law Institute. 1965. Restatement (second) of torts. Section 402A, Comment k. Philadelphia, PA: ALI Publishers.
26. Association for Advancement of Medical Instrumentation (AAMI). 2001. ANSI/AAMI HE74:2001: Human factors design process for medical devices. Arlington, VA:Association for Advancement of Medical Instrumentation, p. 27.
27. Association for Advancement of Medical Instrumentation (AAMI). 2009. ANSI/AAMI HE75:2009: Human factors engineering-Design of medical devices. Arlington, VA:Association for Advancement of Medical Instrumentation, Annex A.
28. Association for Advancement of Medical Instrumentation (AAMI). 2009. ANSI/AAMI HE75:2009: Human factors engineering-Design of medical devices. Arlington, VA:Association for Advancement of Medical Instrumentation, Annex A.
29. Association for Advancement of Medical Instrumentation (AAMI). 2009. ANSI/AAMI HE75:2009: Human factors engineering-Design of medical devices. Arlington, VA:Association for Advancement of Medical Instrumentation, Annex A.
30. Association for the Advancement of Medical Instrumentation (AAMI). 2001. ANSI/AAMI HE74:2001 Human factors design process for medical devices. Arlington, VA:Association for the Advancement of Medical Instrumentation.
31. International Electrotechnical Commission (IEC). 2007. IEC 63266:2007, Medical devices-Application of usability engineering to medical devices. Geneva, Switzerland:International Electrotechnical Commission.
32. National Information Center on Health Services, Research and Health Care Technology (NICHSR), National Library of Medicine. 2008. HTA 101: Glossary-Benchmarking. Retrieved from http://www.nlm.nih.gov/nichsr/hta101/ta101014.html
33. International Electrotechnical Commission (IEC). 2007. IEC 63266:2007, Medical devices-Application of usability engineering to medical devices. Geneva, Switzerland:International Electrotechnical Commission, AnnexG.
34. U.S. Food and Drug Administration (FDA) Web site. About FDA-What we do. Retrieved from http://www.fda.gov/opacom/morechoices/mission.html
35. Medicines and Healthcare Products Regulatory Agency Web site. About us. Retrieved from http://www.mhra.gov.uk/Aboutus/index.htm.
36. Pharmaceuticals and Medical Devices Agency, Japan, Web site. Message from chief executive. Retrieved from http://www.pmda.go.jp/english/about/message.html.
37. Pharmaceuticals and Medical Devices Agency, Japan, Web site. Our Philosophy. Retrieved from http://www.pmda.go.jp/english/about/philosophy.html.
38. Federal Institute for Drugs and Medical Devices Web site. About us. Retrieved from http:// www.BfArM.de/cln_030/nn_424928/EN/BfArM/bfarm-node-en.html__nnn=true.
39. For a list of directives pertinent to medical device approval, see http://ec.europa.eu/enterprise/policies/european-standards/documents/harmonised-standards-legislation/list-references/medical-devices/index_en.htm
40. For a list of notified bodies specializing in assessments of medical device development processes, see http://ec.europa.eu/enterprise/newapproach/nando/index.cfm? fuseaction=directive.notifiedbody&dir_id=13&type_dir=NO%20CPD&pro_id= 99999&prc_id=99999&ann_id=99999&prc_anx=99999
41. U.S. Department of Health and Human Services, National Institutes of Health, Office of Extramural Research. 2010. Glossary and acronym list. Retrieved from http://grants. nih.gov/grants/glossary.htm.
42. General requirements for informed consent. Code of Federal Regulations, Title 45, Pt. 46.116 (2009 ed.)
43. IRB membership. Code of Federal Regulations, Title 21, Pt. 56.107(a) (2009 ed.).
44. Department of Health and Human Services, National Institutes of Health, Office for Protection from Research Risks. 1998. Protection of human subjects: Categories of research that may be reviewed by the Institutional Review Board (IRB) through an expedited review. Federal Register Vol. 63, No. 216. Retrieved from http://www.hhs.gov/ohrp/humansubjects/guidance/expedited98.htm
45. Virzi, R. A. 1992. Refining the test phase of usability evaluation: How many subjects is enough? Human Factors 34(4): 457-471.
46. Association for Advancement of Medical Instrumentation (AAMI). 2009. ANSI/AAMI HE75:2009: Human factors engineering-Design of medical devices. Arlington, VA:Association for Advancement of Medical Instrumentation, Annex A.
47. Brault, M. W. 2008. Americans with disabilities: 2005 (P70-117). U.S. Census Bureau. Retrieved from http://www.census.gov/prod/2008pubs/p70-117.pdf.
48. United Nations (UN). 2006. Some facts about persons with disabilities. Prepared for the Convention on the Rights of Persons with Disabilities. Retrieved from http://www.un.org/disabilities/convention/facts.shtml.
49. American Optometric Association. Low vision. Retrieved from http://www.aoa.org/lowvision. xml.
50. PayScale. 2010. Hourly Rate Snapshot for Registered Nurse (RN) Job. Retrieved from http://www.payscale.com/research/US/Job=Registered_Nurse_(RN)/Hourly_Rate
51. http://www.hhs.gov/ocr/privacy/hipaa/understanding/index.html for an explanation of HIPAA regulations.
52. Cellular-news. 2009. Countries that ban cell phones while driving. Retrieved from http://www.cellular-news.com/car_bans/.
53. Airdisaster.com Accident database. Retrieved from http://www.airdisaster.com/cgi-bin/view_details.cgi?date=12291972®=N310EA&airline=Eastern+Air+Lines.
54. Medical Education Technologies Incorporated. 2010. About METI: Company info. Retrieved from http://www.meti.com/about_main.htm.
55. Medical Education Technologies Incorporated. 2010. METIman. Retrieved from http:// www.meti.com/products_ps_metiman.htm.
56. Association of Standardized Patient Educators (ASPE) Home Page. 2009. http://www.aspeducators.org/.
57. Wallace, P. 1997. Following the threads of an innovation: The history of standardized patients in medical education. Caduceus 13(2): 5-28.
58. Leonard A. Lewis, Bernard P. Nussbaum, and Harry R. Leeds. 1986. U.S. Patent 4596528. Simulated skin and method. Retrieved from http://www.freepatentsonline. com/4596528.html.
59. Community Emergency Response Team (CERT) Los Angeles. 2007. Moulage information-Moulage recipes. Retrieved from http://www.cert-la.com/education/moulagerecipes. pdf.
60. Loughborough Enterprise Club. 2006. World’s first osteoarthritis simulation suit developed by Loughborough ergonomists. Innovation Express. Retrieved from http://www.loughboroughenterpriseclub.co.uk/downloads/IXNov06.pdf.
61. Birthways Childbirth Resource Center Incorporated. About the Belly. Retrieved from http://www.empathybelly.org/the_belly.html.
62. Cambridge Research System. Variantor glasses. Retrieved from http://www.crsltd.com/catalog/variantor/index.html.
63. KbPort. Kb Port simulation environments. Retrieved from http://www.kbport.com/products.php.
64. American Diabetes Association. Diabetes basics-Common terms. Retrieved from http://www.diabetes.org/diabetesdictionary.jsp.
65. U.S. National Library of Medicine. 2002. Hippocratic Oath. Trans. M. North. Retrieved from http://www.nlm.nih.gov/hmd/greek/greek_oath.html.
66. Kuniavsky, M. 2003. Observing the user experience: A practitioner’s guide to user research. Boston: Morgan Kaufman.
67. International Electrotechnical Commission (IEC). 2006. IEC 60601-1-8:2006, Medical electrical equipment-Part 1-8: General requirements for basic safety and essential performance-Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems. Geneva, Switzerland: International Electrotechnical Commission.
68. Backinger, C.L., Kingsley, P.A. 1993. Write it Right: Recommendations for Developing User Instructions for Medical Devices Used in Home Health Care. U.S. Department of Health and Human Services, Public Health Service, Food and Drug Administration, Center for Devices and Radiological Health. Retrieved from http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM070771.pdf
69. U.S. Food and Drug Administration (FDA). Medical device quality systems manual. Retrieved from http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/PostmarketRequirements/QualitySystemsRegulations/MedicalDeviceQualitySystems Manual/default.htm
70. National Electrical Manufacturers Association (NEMA). 2007. ANSI Z535.3: 2007, American National Standard criteria for safety symbols. Rosslyn, VA: National Electrical Manufacturers Association.
71. Association for Advancement of Medical Instrumentation (AAMI). 2010. ANSI/AAMI HE75:2009: Human factors engineering-Design of medical devices. Arlington, VA:Association for Advancement of Medical Instrumentation, Section 6.2.2.5 visual angle.
72. Federal Food, Drug, and Cosmetic (FD&C) Act, Chapter II (Definitions), Section 201(k). 2009. Retrieved from http://www.fda.gov/RegulatoryInformation/Legislation/Federa lFoodDrugandCosmeticActFDCAct/FDCActChaptersIandIIShortTitleandDefinition s/default.htm.
73. Retrieved from http://www.fda.gov/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct/FDCActChaptersIandIIShort TitleandDefinitions/default.htm.
74. Norman, D.A. 2004. Emotional design: Why we love (or hate) everyday things. New York: Basic Books.
75. iPhone Sales Chart. Retrieved from http://en.wikipedia.org/wiki/File:IPhone_sales_ per_quarter.svg. Apple reports third quarter results
76. Retrieved from http://www.apple. com/pr/library/2010/07/20results.html.
77. Collaborative Institutional Training Initiative (CITI). 2008. Basic Institutional Review Board (IRB) regulations and review process. Page 7. Retrieved from https://www.citiprogram. org/
78. U.S. Food and Drug Administration (FDA). 2010. Presentation by Ron Kaye: Human factors/usability for infusion pumps: Additional test data requested in new draft guidance. FDA Workshop on Infusion Pumps, slide 21. Retrieved from http://www.fda.gov/downloads/MedicalDevices/NewsEvents/WorkshopsConferences/UCM219683.pdf
79. Medlock, M. C., Wixon, D., Terrano, M., Romero, R., and Fulton, B. 2002. Using the RITE method to improve products: A definition and a case study. Usability Professionals Association, Orlando, FL, July.
80. Dumas, J. S., and Loring, B. A. 2008. Moderating usability tests: Principles and practices for interacting. Burlington, VT: Morgan Kaufmann.
81. Dumas, J. S., and Loring, B. A. 2008. Moderating usability tests: Principles and practices for interacting. Burlington, VT: Morgan Kaufmann.
82. Wojcieszak, D., Saxton, J. W., and Finkelstein, M. M. 2007. Sorry works! Disclosure, apology, and relationships prevent medical malpractice claims. Bloomington, IN:AuthorHouse.
83. Virzi, R. A. (1992). Refining the test phase of usability evaluation: How many subjects is enough? Human Factors 34: 457-468.
84. Kirk, R. E. 1999. Statistics: An introduction. New York: Harcourt Brace College.
85. International Organization for Standardization (ISO). 2006. ISO/IEC25062: Software engineering-Software product Quality Requirements and Evaluation (SQuaRE)-Common Industry Format (CIF) for usability test reports. Geneva, Switzerland:International Organization for Standardization.
86. http://zing.ncsl.nist.gov/iusr/formative/IUSR_Formative/index.html for a more examples of various formative usability test report elements.
87. Information about Morae 3.0 is available from http://www.techsmith.com/morae/record. asp
88. http://download.techsmith.com/morae/docs/datasheet/moraefeatures3.pdf
89. Design verification and Design validation. Code of Federal Regulations, Title 21, Part 820.30(f-g), 2009 ed.
90. We adapted this expression from “What’s past is prologue,” a line from Shakespeare’s play The Tempest. The original expression suggests that the past has a strong shaping effect on the future.
91. Critical incidents are events that stand out from others in terms of the positive or negative effect on things like user perception of a medical device and clinical outcome. Researchers can identify critical incidents by asking medical device users to tell stories about particularly positive and negative interactions with the given device.
92. Fanconi syndrome is a renal (i.e., kidney) disorder that can be inherited or acquired. Fanconi syndrome can cause renal failure or various metabolic abnormalities that lead to additional problems such as impaired growth, bone damage, and muscle weakness.
93. The FDA meeting on May 25-26, 2010 was announced in the Federal Register, Docket No. FDA-2010-N-0204, available at http://edocket.access.gpo.gov/2010/2010-9208. htm. The announcement stated, “The purpose of the meeting is to inform the public about current problems associated with external infusion pump use, to help the agency identify quality assurance strategies to mitigate these problems, and to solicit comments and input regarding how to bring more effective external infusion pumps to market.”
94. U.S. Food and Drug Administration (FDA). 2009. 510(k) clearances. Retrieved from http://www.fda.gov/medicaldevices/productsandmedicalprocedures/deviceapprovalsan dclearances/510kclearances/default.htm