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ROI CalculatorHuman Factors Engineering (HFE) is the application of knowledge regarding human actions, skills, shortcomings, and other features of users in the context of medical devices, including user interfaces driven by mechanics and software, systems, operations, user manuals, and user training to improve the safety and effectiveness medical devices.
The history of HFE dates back from the Second World War when people realized that it was not realistic to train each military person. The results of that work were published and were used for standardizing ergonomics and bringing uniformity to medical devices. As more sophisticated military equipment emerged, HFE started evolving. The form of the instruments developed took precedence over the fact that personnel could be trained to use them.
Despite the fact that human being is only one piece of the chain of failures, they are not always the most responsible. For instance, in aviation, the ratio of mistakes to accidents is 600:1, while in each of the cases, the error can lead to a catastrophe.
When we talk about incorporating Human Factors in the process, risks are used to define mistakes as well as the chances of human errors occurring. It is important to take person’s influence into account when using these methods, such as FMEA and Fault Tree Analysis (FTA). Human Factors Engineering influences our daily lives in all aspects.
When we speak about Human Factors, the question of good design arises. This means an understanding of the audience which will be explained as:
The knowledge possessed by the user
The environment in which the device will be used by the person
The user’s profile (if a person is a patient or a health-care specialist assisting the patient)
The demographic of the user
FDA offers help on human factors and suggests the need for its use in 21 CFR 820:30. Human factors must be a primary consideration of your design controls, such as:
Defining all end users of the device.
Identifying the environment in which the device will be used.
Identifying user interfaces and critical tasks.
Identifying any known issues, perhaps with similar devices.
Conducting usability testing and from those results, making an effort to reduce hazards with usability.
Conducting validation testing with human factors protocol.
The human factors protocol is necessary for your validation test. The FDA encourages you to send them the draft of your validation protocol so that you can get their feedback before you start conducting tests. It is much better to have a validation test evaluated early and know how you include human factors in your project rather than be forced to change your device at a later stage.
Adding Human Factors to your quality management system is a wise investment. It minimizes the risk associated with the product, and training costs are lower. Implementation and integration of Human Factors plays an important role from the perspective of patient safety.
