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Medical Devices
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Other Resources
- FDA Information
- Other Government Reports about Patient Safety and Human Factors
- Human Factors Training
- Special Population Considerations
- Human Factors and Medical Device Sources
FDA Information
FDA investigates and develops information for the public on safe use of medical devices. Some reports of our findings and recommendations can be found by clicking on the links below:
You can check these FDA sources for information about devices that you use now or are considering for your facility:
- CDRH Public Health Notifications
- CDRH Medical Device Recalls List
- CDER: Medication Errors
- Medical Device Safety (Alerts/Recalls, Patient Safety News)
Other Government Reports about Patient Safety and Human Factors
- Preventing Medication Errors, Institute of Medicine report, 2006)
- Making Health Care Safer: A Critical Analysis of Patient Safety Practices Agency for Research Healthcare Research and Quality (AHRQ) report, 2001
Human Factors Training
- FAA’s Human Factors Awareness Web Course (Human Factors Model is overview of discipline, Usability module discusses usability testing, Visual Display, Non-Visual Displays, Controls, Cognition modules discuss human factors considerations for each design area)
Special Population Considerations
- FDA’s Pediatric Medical Devices (note that the guidance has special labeling requires for these devices)
- Section 508 of the US Rehabilitation Act
- DisabilityInfo.gov
- Assistive Technology section of Standards.gov
- ABLEDATA, National Institute on Disability and Rehabilitation Research (NIDRR) information/resources on accessing and maintaining accessibility
- Guidelines: Making Health Settings & Information Accessible, The Center for Disease Control’s (CDC)
- Center for Universal Design, North Carolina State University
- Trace Center, University of Wisconsin website on Designing a More Usable World; contains many links on additional resources, including guidelines based on disability type (e.g., Blindness) and extensive reference listings
- National Public Website on Assistive Technology
Human Factors and Medical Device Sources
- Association for the Advancement of Medical Instrumentation (AAMI)
- Human Factors and Ergonomic Society (HFES)
- Human Factors Professional Interest section, Industrial Design Society of America
- Medical DeviceLink (the monthly magazine often has human factors articles)
- Usability Net
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