Aircraft Pilot Type Ratings and Medical Device Usability Engineering

To operate an aircraft as a pilot, in addition to obtaining a basic Commercial Pilot License (CPL) or Airline Transport Pilot License (ATPL), an additional aircraft-specific qualification called a “Type Rating” is required for the specific aircraft to be operated. This system is internationally standardized based on the International Civil Aviation Organization (ICAO) Annex 1 “Personnel Licensing,” and civil aviation authorities in each country implement regulations in accordance with this standard. Type ratings have been established as a fundamental requirement to ensure the safe operation of aircraft.

According to ICAO regulations, type ratings shall be established for aircraft that require a minimum crew of at least two pilots, or when considered necessary by the licensing authority. In the United States, the Federal Aviation Administration (FAA) regulates this under 14 CFR Part 61, while in Europe, the European Union Aviation Safety Agency (EASA) has established uniform standards based on Part-FCL (Flight Crew Licensing) regulations. Obtaining a type rating requires completion of aircraft-specific flight training, written examinations, and successful completion of a skill test for the relevant aircraft type.

Modern aircraft are highly complex systems. For example, while both the Boeing 787 and Airbus A350 are state-of-the-art wide-body passenger aircraft, they differ significantly in many aspects: the layout of instruments in the flight deck, characteristics of the control systems (Boeing’s column-type control yoke versus Airbus’s sidestick), design philosophy of automation systems (Flight Management System operation logic), and emergency response procedures. Therefore, pilots are required to complete specialized training programs for each aircraft type and pass rigorous examinations. Training programs include type-specific theoretical education, flight simulator training, and actual aircraft training.

It is noteworthy that even when pilots hold type ratings for multiple aircraft types, they typically operate only one type in actual operational environments. This is a measure to prevent confusion in operational procedures between different aircraft types (Negative Transfer) and to maximize safety. Each airline conducts regular recurrent training and proficiency checks for pilots to ensure the maintenance of piloting skills and aircraft type knowledge.

Similarities with Medical Device Usability Engineering

Similar principles are applied in medical device usability engineering. Medical device operators need to fully understand and become proficient in device-specific operating methods, safety features, alarm systems, and emergency response procedures. For example, even though ventilators from different manufacturers may have the same basic functions, their operating interfaces, alarm systems, ventilation mode settings, and emergency response procedures can differ significantly. Such differences can increase the risk of use errors when healthcare professionals alternately use equipment from multiple manufacturers, particularly under stress or in emergency situations.

IEC 62366-1:2015+AMD1:2020 (Application of usability engineering to medical devices) specifies a process for analyzing, specifying, developing, and evaluating the usability of medical devices as it relates to safety. This standard is closely integrated with ISO 14971:2019 (Application of risk management to medical devices) and requires manufacturers to assess and mitigate risks associated with correct use and use errors during normal use.

The 2020 amendment (Amendment 1) explicitly positioned “training” as a third priority control measure, in addition to inherently safe design, protective measures, and information for safety, in the hierarchy of risk control measures. This emphasizes that training is not merely a supplementary measure but an important element of risk reduction. Manufacturers are required to identify device-specific operational risks and develop user training programs to minimize them. Healthcare institutions are also expected to establish systematic training systems that consider the characteristics of each device.

Similar to aircraft, the issue of “cross-training (confusion of operations between different models)” exists with medical devices. Differences in operating methods between different models can become more pronounced problems under stress or emergency situations. IEC 62366-1 requires systematic evaluation of such risks through analysis of use environments, user groups, and tasks. Factors contributing to use errors include physical mismatch (formerly called action errors), cognitive errors (lack of understanding of instructions, memory lapses), and difficulty interpreting visual information.

From a patient safety perspective, it is important for healthcare professionals to limit the equipment they handle and maintain deep understanding and proficiency with that equipment. This is based on the same principle as the type rating system for pilots in aviation. Furthermore, ISO 14971:2019 emphasizes the importance of post-production activities, requiring manufacturers to actively collect feedback from actual use settings and reflect it in their risk management processes.

Systematic Approach to Usability Evaluation

IEC 62366-1 specifies a two-stage evaluation approach consisting of formative evaluation and summative evaluation. Formative evaluation is conducted iteratively during the design and development phase with the purpose of identifying and resolving usability issues early. Summative evaluation is usability validation conducted in the final stage of development, requiring demonstration that representative users can safely perform critical tasks in representative use environments.

The 2020 amendment added new requirements for summative evaluation, including explicitly stating how participants in the evaluation are representative of the intended user profiles and describing how the test environment and conditions of use are adequately representative of the intended use environment. These additions further strengthen the validity and reliability of evaluations.

Building a Continuous Safety Culture

Thus, the aircraft pilot type rating system and medical device usability engineering form the foundation of safety culture in their respective fields. Both emphasize systematic training and continuous skill maintenance for the operation of highly specialized equipment, thereby ensuring user safety.

To respond to the increasing sophistication and complexity of equipment accompanying technological advancement, continuous updating and improvement of education and training systems are required. This is a characteristic universally observed in professional fields that prioritize safety. Additionally, in both fields, the quality and effectiveness of training programs are continuously evaluated through regular audits and standardization inspections by regulatory authorities.

By applying the principles of the type rating system established in the aviation field to the operation of medical devices, it becomes possible to build a more effective safety management system. Specifically, it is important to establish a cycle that includes systematic initial training at the time of medical device implementation, regular skill maintenance training, user skill evaluation, and continuous post-market feedback collection and improvement. This approach is fully consistent with the requirements of IEC 62366-1 and ISO 14971:2019 and contributes to the improvement of patient safety.