What Is HFE and Usability?
There are numerous terms normally utilized to explain the phenomenon behind incorporating effective and hazard-free implementation into a device’s design, together with “usability,” “human factors engineering (HFE)” and “ergonomics.” HFE has been incorporated to regulatory requirements to reduce medical device implementation error, produce more operator friendly and intuitive devices and reduce the training costs for both producers and end-customers.
From New Latest MDR 2017/745:
“Devices shall achieve the performance intended by their manufacturer and shall be designed and manufactured in such a way that, during normal conditions of use, they are suitable for their intended purpose. They shall be safe and effective and shall not compromise the clinical condition or the safety of patients, or the safety and health of users or, where applicable, other persons, provided that any risks which may be associated with their use constitute acceptable risks when weighed against the benefits to the patient and are compatible with a high level of protection of health and safety, taking into account the generally acknowledged state of the art”.
IEC 62366 is the reference standard for medical device usability subject and identifies a process for a producing company to assess, explain, develop, and validate the usability of a medical device as it concerns to safety:
Component 1 has been upgraded to incorporate current concepts of usability engineering, while also streamlining the process.
Component 2 provides more detailed descriptions of usability engineering methods that can be applied normally to medical devices.