Human factor studies form an integral part of any medical device or drug delivery system submissions to the Food and Drug Administration. The FDA requires that the companyfulfil the requirements for medical device safety.As such, pharmaceutical and medical device company executives should understand what human factor studies are, what regulations govern those human factor studies, what factors should be considered when designing the human factor studies, and how to performthose human factor studies.
”Human factor" is a term that isused to describe the application of human ability and limitations to the design and usability of a medical devices. It has to do with the device usability and how it affects the efficacy, efficiency, and the ease of learning to use the device, comfort and user’s satisfaction with the device features and functionality.
The Food and Drug Administration is concerned with human factors studies because human factors influence the safety and efficacy of the medical device. The Food and Drug Administration expects that the device manufacturer to conduct a comprehensive risk assessment of the medical device, identify and decrease the risks, and conduct human factor and design validation studies that are designed to decrease those risks. Medical device companies should then document these studies in the device design history file.
Human factor studies are governed by IEC 62366-1:2015 and21 Code of Federal Regulations Part 820.30. This federal regulation contains provisions for the design input, verification, and validation of a medical device. The design input refers to the needs of the patient as they relate to the safety and efficacy of the device.
By testing the design input, the investigatorcan ascertain whether the user can operate the medical device without injuring themselves or others and in a manner consistent with its intended use.
Using the human factor studies, the manufacturers should attempt to eliminate errors of use and failures of the device to the greatest extentpossible. Through verification and validation of the design, investigators determine whether they made the device correctly and whether the device suits the needs of the population for which it was made.
The international standards that provide guidance on human factor studies include AAMI/IEC 62366-1:2015 and IEC 60601-1-6 third edition. AAMI/IEC 62366-1:2015 provides a structured approach to conduct the human factor studies. Specific features include an overview of the design process for human factor studies, planning of human factor studies, and methods and techniques used for conducting the human factor studies. IEC 60601-1-6 third edition includes general provisions for the risk management process for medical electrical equipment and the usability engineering process.
When designing the human factor studies, device companies should consider the population for which the device is intended, the environment in which the device would be used, and possible interface issues. Device companies should determine whether the population using the device comprises professionals or non-professionals, what the user’s education levels are, what age the users are, what functional limitations they might have, and what mental and sensory conditions they might have.
The environment in which the device would be used should also be taken into consideration. Some possible device use environment includes: a hospital; transitional care center; home; a community setting such as a school, office, or park; and a mobile environment such as a car or ambulance.Interface issues that should be considered include the set-up, cleaning, maintenance, and disposal of the device; the interactive features of the device that should be considered include plugs, touchscreens, and knobs; and sensory components such as displays, alarms, and vibration.
Our FDA 510(k) Consultant at IngenesTMcan help you with Risk Management and HFE/UE validation studies. Our study groups included participants from both lay person and professional users.Our simulated use studies of the medical devices by lay person and professionals have assisted many of our clients in their 510(k) Submission to FDA for clearance.
Please contact us for further information about our Human Factor and Usability Engineering Studies Support services. We may be able to assist you to get your testing done at a significantly lower cost.
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