Essentials of usability engineering in point-of-care devices

IEEE EMBS Special Topic Conference on Point-of-Care (POC) Healthcare Technologies: Synergy Towards Better Global Healthcare, PHT 2013

Volumn , Issue , 2013, Pages 184-187

  Bartoo, Grace ^a   Bogucki, Terese ^a  

^a Decus Biomedical LLC   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

BEHAVIORAL SCIENCE; HEALTHCARE TECHNOLOGY; INCIDENT REPORTS; INTERNATIONAL REGULATORY BODIES; KEY ELEMENTS; MEDICAL DEVICES; POINT OF CARE; SIMULATED ENVIRONMENT; STRUCTURED APPROACH; US FOOD AND DRUG ADMINISTRATION; USABILITY ENGINEERING PROCESS; USE ERRORS; VALIDATION STUDY;

BIOMEDICAL EQUIPMENT; DEVELOPING COUNTRIES; ERRORS; HEALTH CARE; TECHNOLOGY;

USABILITY ENGINEERING;

EID: 84874573846     PISSN: None     EISSN: None     Source Type: Conference Proceeding    
DOI: 10.1109/PHT.2013.6461315     Document Type: Conference Paper

References (8)

1. Kohn LT, Corrigan JM, Donaldson MS. Institute of Medicine (U.S.) Committee on Quality of Health Care in America. To Err Is Human: Building a Safer Health System. Washington, DC: National Academy Pr; 2000.
2. Medical devices - Application of usability engineering to medical devices. ISO/IEC standard 62366, 2007
3. Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability, IEC standard, 60601-1-6, 2010
4. Human factors engineering - Design of medical devices, ANSI/AAMI standard, HE75, 2009
5. FDA document UCM259760 Human Factors Usability to Optimize Medical Device Designhttp://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/ GuidanceDocuments/ucm259748.htm, [accessed 14 September 2012]
6. FDA Human factors website - http://www.fda.gov/MedicalDevices/ DeviceRegulationandGuidance/HumanFactors/default.htm [accessed 15 September 2012]
7. FDA Medical Device Databases - http://www.fda.gov/MedicalDevices/ DeviceRegulationandGuidance/Databases/default.htm [accessed 15 September 2012]
8. Faulkner, L. Beyond the five-user assumption: Benefits of increased sample sizes in usability testing. Behavior Research Methods, Instruments, and Computers, 35 (3), 379-383, 2003. (Pubitemid 37545007)