Human Factors Engineering for Medical Devices
ANNOUNCEMENT:
Wiklund Research & Design is now part of the UL family. Click here to read the press release. Find out more about how Wiklund Research and Design helps clients develop safe, usable and satisfying products at www.wiklundrd.com
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The safety of medical devices extends beyond electrical safety so that the people who are using and applying the medical device must be able to do so safely and effectively. There are several terms commonly used to describe the science behind incorporating effective and safe use into a device's design, including "usability," "human factors engineering (HFE)" and "ergonomics."
HFE has been added to regulatory requirements to reduce medical device use error, create more operator friendly and intuitive devices and reduce the training costs for both manufacturers and end-users.
Why do I need Human Factors Engineering - Regulatory requirements
Demonstrating safe use through Human Factors Engineering is one of the key components required by the major regulatory agencies. Requirements for HFE are included in IEC 60601:2005 3rd edition and IEC 60601-1-6. The 3rd edition requires compliance with the collateral standards to achieve compliance with the main standard.
UL Services
UL provides full life-cycle human factors engineering services to meet regulatory, standards certifications and marketing requirements which allows manufacturers to use an independent third party to assess their products, design processes, and improve their in- house knowledge
- Program Development: Creating and refining human factors engineering programs that will satisfy global HFE requirements
- User Research: Observations, user interviews and benchmark usability tests
- Analysis: Function, task, and use-related risk analysis
- User Interface Design Support: Assessment of software and hardware user interfaces, as well as accompanying documents (e.g., user manuals, quick reference guides)
- Evaluation: Critiques of evolving design solutions and both formative and summative, usability testing, etc.
- Training: Technical talks and workshops
Advantages of using UL
- Comprehensive services through one provider - UL offers full-service testing, certification and regulatory services, eliminating the need to manage multiple vendors.
- Integrated assessments - You can receive an integrated assessment to ISO 62366 and IEC 60601:2005, the standards recognized by most global regulatory agencies.
- Global locations, local expertise - You have access to experts in your time zone and language who understand the markets that you are selling to. In addition to gaining compliance you will gain insight on how to increase the marketability of your product.
Standards for Human Factors Engineering
- ANSI/AAMI HE 75:2009, Human factors engineering - design of medical devices. Provides detailed guidance on how to perform specific human factors analyses and provides a wealth of design principles
- ISO/IEC 60601-1-6, General requirements for basic safety and essential performance - Collateral standard: Usability
- ISO/IEC 62366:2007, Medical devices - application of usability engineering to medical devices.
Additional Resources
Link to Wiklund R&D, specializing in Human Factors Engineering for the medical industry, acquired by UL in November 2012.
Training courses
Articles
- "Achieving Success at User Face Validation" MD&DI (2012)
- "Improving Patient Safety: Checking Errors Off the List" MD&DI (2011)
- "Animated Videos Guide User Interactions with Complex Medical Devices" MD&DI (2008)
- "Designing Usable Medical Devices for People with Diabetes" MD&DI (2008)
- "The Art of Screen Design: Part 1" MD&DI (2007)
- "The Art of Screen Design: Part 2" MD&DI (2007)
Contact UL at Medical.Inquiry@UL.com for more information.
