Regulatory Guidelines and Standards

There are a number of regulatory guidelines and standards that should be followed when developing healthcare products. These aim to ensure that medical devices are designed to reduce use errors to ensure safety to users and recipients of medical devices. There are three standards to assist in ascertaining the usability of a product: ANSI HE75 (Human Factors Engineering – Design of Medical Devices), IEC 60601-1-6(General requirements for basic safety and essential performance), and IEC 62366 (Application of usability engineering to medical devices).

These standards detail the human factors methods used to help identify use errors and high-risk scenarios so that the design of the system can either remove or mitigate these risks. To achieve this, they recommend using the methods provided in this document to identify, describe, and categorise use errors and hazard-related use scenarios. Using these same methods, they advocate conducting formative evaluation alongside the design development and ending in conducting a summative usability evaluation.

In Annex D of IEC 62366-2:2016, it specifies that not all reports are required in order to comply with the standards, but rather recommended to promote good usability engineering practice without becoming a paperwork generation exercise. However, there are a number of reports that are required, including: use specification, user interface characteristics related to safety and potential use errors, known of foreseeable hazards or hazardous situations, hazard related use scenarios, user interface specifications, user interface evaluation plan, formative evaluation usability test reports (if conducted), and the summative usability evaluation test protocol with accompanying test report. Using the methods outlined on this website, these reports can be generated to ensure the standards requirements are met.

For more information on understanding how to apply human factors to the development of healthcare products, please visit the UK government’s medical devices regulation and safety website. Other regulatory authorities have published local guidance that can complement this – for example, guidance from the US FDA.