The evolution of usability guidelines and standards for medical devices highlights an increasing recognition of the crucial role human factors play in device safety. The International Organization for Standardization (ISO) began formally addressing usability in the early 2000s. The development of ISO 13485 (Quality Management Systems for Medical Devices) underscored the importance of incorporating user-centered design into quality management processes.

The publication of IEC 62366 in 2007 marked another significant milestone in usability engineering. This standard outlines the process for manufacturers to analyze, define, develop, and evaluate the usability of medical devices. It establishes detailed requirements for usability engineering to ensure that medical devices are designed to minimize use errors and enhance overall safety. It emphasizes the necessity of usability testing throughout the product development lifecycle to identify and mitigate potential use-related risks.

In 2016, the FDA issued a guideline on Applying Human Factors and Usability Engineering to Medical Devices, emphasizing the importance of usability in medical devices. The FDA’s guidance highlights the necessity for manufacturers to conduct comprehensive usability testing and demonstrate that devices are designed to minimize the potential for use-related errors. While there are many similarities between EU and US requirements, key differences exist.

For instance, the FDA stresses that testing should involve representative groups of users likely to operate the device in each of its intended contexts. The guidance also recommends that the number of participants shall be sufficient to identify usability issues effectively, suggesting a minimum of 15 participants. In contrast, the EU’s requirements, particularly those outlined in the ISO 62366 standard, do not specify a minimum number of participants but emphasize involving representative users throughout the usability testing process. Both regions recognize the necessity of evaluating devices in real-world scenarios, but the FDA provides a more defined framework on participant characteristics and study design.

Additionally, while the FDA emphasizes the importance of human factors and usability testing as part of the device approval process, the ISO 62366 standard, which is closely aligned with EU regulations, mandates a systematic approach to usability engineering throughout the product lifecycle. This approach includes assessing the device’s usability and integrating user feedback into design revisions to enhance safety and performance as part of post-market requirements.

The IEC 60601 series of standards, which focus on the safety and effectiveness of medical electrical equipment, have also incorporated usability considerations in later revisions. These standards now require manufacturers to assess usability as part of the risk management process (including identification of use related hazards), recognizing that use errors can result in significant risks.

The focus on usability engineering is well-justified. A 2018 study by Johns Hopkins estimates that over 250,000 deaths occur annually in the U.S. due to medical errors, many of which are related to human factors. While Europe may not have a unified study directly comparable to those in the U.S., several studies and reports highlight similar challenges across the European healthcare systems, thereby underscoring the importance of Usability Engineering.