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Human Factors Team's Move to ODE: Increased Emphasis on Use Error |
AAMI Human Factors Workshop Scheduled for Sept 30-Oct 2, 2009 |
In late 2007, the FDA Human Factors team was moved from the Office of Health and Industry Programs (OHIP) to the Office of Device Evaluation within the CDRH organization. This means increased emphasis and scrutiny on submissions for human factors evaluation, testing, and analysis. This has resulted in manufacturers receiving detailed questions on their 510K submissions related to testing of user interfaces and analysis and prioritizing of use error risk. Human Factors team members are participating on consults and reviews on a daily basis at ODE instead of an "advisory role" as they had at OHIP. |
The Association for the Advancement of Medical Instrumentation (AAMI) has announced intentions to hold a three day workshop on Human Factors related to medical device design. A survey that assesses industry needs is available on line. Human Centered Strategies will serve as lead for the development and planning of the workshop which will feature both lecture and practical exercise formats with an emphasis on planning human factors efforts that are responsive to the latest requirements by the FDA for ensuring safe and effective user-device interactions. Watch the AAMI website for coming announcements of sign up details! |
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Use Error Risk Management Requires Multi-Method Approach |
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Success in Usability Studies May Not Prove Evidence of Use Error Management to Reviewers |
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The FDA continues to stress the importance of employing human factors techniques in understanding and controlling use error risks in medical device design and development. According to FDA reviewers, webinars and educational programs over the past five years have increased the quantity and quality of submissions that address human factors appropriately. This is good news for all concerned since testing devices for safety in the hands of intended users improves overall device use safety. Usability engineering has found its place in many companies as traditional market discriminators such as speed, size, weight, and sophistication have become "commodity items." User friendly products have begun to create more market share, especially as medical devices increasingly become a part of the home health care environment. The FDA is seeing more human factors and usability study work than ever before, but caution should be exercised to ensure that usability testing is focused on assessment of the risk and management of use errors. As indicated in recent FDA submissions, manufacturers are too often submitting "usability studies" which are measuring usability in terms of subjective preference which has little validity with respect to safety. In addition, measuring "success rates" on given tasks can be problematic for the FDA . For instance, a 95% reported success rate is highly encouraging and indicative of good user interface design practices, but a 5% failure rate could be significant and dangerous if a device were to be cleared for general use. In essence, FDA reviewers are most interested in a focus on error rates, what they represent for actual device use, and how they have been addressed. |
With respect to developing a complete use error profile of a device, formative usability studies, where users are observed interacting with various design versions of the device, can be powerful tools. These studies should not be used in isolation since much useful information on error can generally be found through heuristic reviews with experts in human-machine interaction, discussions with expert users, trainers, and field engineers, along with researching MDRs and MAUDE datebase reports. FDA reviewers look for evidence of a comprehensive approach to anticipating and controlling use errors that may lead to patient or user harm. That includes a proportional mitigation effort based on severity of risk. This means applying the science of risk management and human factors engineering -- estimating severity of an error from a clinical view, looking at the frequency of probable occurrence, and prioritizing focus based on these assessments. Thus, the approach is often multi-method and multi-disciplinary -- a combination of observational techniques (like usability studies) and analytic processes including expert opinion and field reporting. Usability testing methods are critical to the overall control of use error risk including the cost and implications of user dissatisfaction and adverse events. The key for manufacturers is applying the appropriate types of usability studies and and risk assessment and management methods. (For more information from the FDA perspective, see a recent article published in MDDI concerning usability studies and use error risk management. Or, call us today at 719-598-3196 to discuss this topic and find out how Human Centered Strategies can help!) |
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