Human Factors Collection
This NEW collection is your single source for standards and guidance on applying human factors to medical devices.
Searchable and easy to use, this CD includes more than 30 documents including AAMI/American National Standards, FDA Guidance, and articles from industry experts. Contents of CD is listed below.
Order Information:
- Order Code: HFCOL-CD
- List Price: $390
- Member Price: $195
- Buy now online!
Human Factors Standards
- ANSI/AAMI HE75:2009 Human factors engineering - Design of medical devices
- ANSI/AAMI/IEC 62366:2007 Medical devices - Application of usability engineering to medical devices
- AAMI TIR49:2013 Design of training and instructional materials for medical devices used in non-clinical environments
FDA Guidance including:
- Draft Guidance for Industry and Food and Drug Administration Staff: Applying Human Factors and Usability Engineering to Optimize Medical Device Design (DRAFT GUIDANCE)
- Guidance for Industry and FDA Staff: Total Product Life Cycle: Infusion Pump - Premarket Notification [510(k)] Submissions (DRAFT GUIDANCE)
- Human Factors Implications of the New GMP Rule Overall Requirements of the New Quality System Regulation
- Medical Device Use-Safety: Incorporating Human Factors Engineering into Risk Management
- Human factors/usability for infusion pumps: Additional test data requested in new draft guidance
- FDA Human Factors of Medical Devices: Ensuring a safe, user friendly device-user interface
- Human Factors Points to Consider for IDE Devices
Articles from industry experts including:
- Human Factors is No Picnic
- Quality, Safety of Home Healthcare and Role of Human Factors Addressed in New Report
- Biomeds Speak Out on Common Design Flaws
- HE75 Standard Tapped as Vital New Practical Resource
- A Roundtable Discussion… Increased Focus on Human Factors Drives Device Safety Improvements
- Top 10 Ways to Easily Identify Human Factors Engineering Hazards
- Using Human-Centered Systems Engineering to Reduce Nurse Stakeholder Dissonance
- Human Factors Recommendations and Testing Considerations for FDA Premarket Medical Device Submissions
- Conducting Effective Summative Usability Tests of Medical Devices
- Choosing Safer Medical Technologies: How Human Factors Methods Can Help in the Procurement Process
- Using Data to Improve Smart Intravenous Infusion Pumps
- Do Smart Pumps Actually Reduce Medication Errors?
- Remote Patient Monitoring: A Human Factors Assessment
- Human Factors Initiatives Aim to Make Tubing Misconnections Old News
- Don’t Forget the Maintainer
- The Complexities of the Human-Medical Device Interface
- First, Do No Harm: Making Infusion Pumps Safer
- A Guide to Navigating the Expanded Human Factors Standard
- Using Human Factors Engineering Principles to Strengthen Technology Management
- Improving Equipment Purchasing Decisions Through Human Factors Engineering
- Human Factors Considerations Relevant to CPOE Implementations (Journal of Healthcare Information Management)
- Misidentification of alphanumeric symbols in both handwritten and computer-generated information (Institute for Safe Medication Practices)