The new article describes specific aspects related to human factors to be considered when assessing the safety and effectiveness of medical devices.
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The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published a guidance document describing the way human factors and usability engineering should be applied concerning medical devices. The document is intended to provide additional clarifications regarding the applicable regulatory framework, as well as recommendations to be considered by the medical device manufacturers and other parties involved to ensure compliance thereto. However, FDA guidance documents are non-binding, so an alternative approach could be applied, provided such an approach complies with the respective regulatory requirements and has been agreed with the authority in advance.
Actual Use Testing
The authority acknowledges that sometimes it is impossible to assess the safety and performance of a medical device in a simulated use environment due to the nature of the device and its specific features, so the results of such testing would not be accurate or reliable enough. In such cases, testing should be performed in the actual use environment. According to the guidance, human factor testing performed under actual use conditions should be preceded by appropriate simulated-use testing to ensure that the device is sufficiently well designed to be safe in actual use (to the degree that simulated-use testing can provide such assurance). As further explained by the FDA, an Investigational Device Exemption (IDE) could be required to proceed with the commencement of a study that provides the involvement of human participants. The authority additionally emphasizes that study participants should represent the target group based on the claims and statements made by the product’s manufacturer to ensure the reliability of the results.
The guidance also describes the difference between the actual-use testing and clinical study (even though the first one could be a part of the latter). According to the guidance, clinical study participants are closely supervised, while for actual-use testing this could impact the accuracy of study results. The authority also mentions that usually, a clinical study provides the use of a significant number of medical devices to ensure statistically significant results, while actual-use testing could be conducted using fewer products.
It is also stated that the sources of data related to actual-use testing should include both observations and self-reports to ensure that all the important aspects are covered and duly reflected in the results. However, the use of observation data could be limited in case the device in question is intended to be used by customers in a home environment without supervision.
The FDA also mentions that the study sponsor should consult with the respective internal institutional review board for the protection of human subjects (IRB) concerning additional measures to be implemented to ensure the safety of patients and protect the privacy of their data.
Documentation
The guidance also describes the approach to be applied by study sponsors when documenting the study and the most important aspects associated thereto. According to the guidance, documenting risk management, HFE/UE testing, and design optimization processes (e.g., in [the] design history file as part of design controls) provides evidence that [the sponsor] considered the needs of the intended users in the design of [the] new device and determined that the device is safe and effective for the intended users, uses and use environments.
As further explained by the authority, the parties responsible for medical devices should provide such information to the authority for review when applying for marketing authorization for the product. In such a way, they can address some important aspects related to the device in question, which will eliminate the need for additional requests and streamline the review process in general. The guidance also contains a brief description of the information to be included in such a report to assist medical device manufacturers in ensuring that the information submitted is complete and comprehensive. According to the guidance, an interested party should submit a report containing a summary of all the testing performed, while the level of detail should allow the authority to clearly understand the particular methods used, as well as the results achieved. At the same time, there is no need to include raw test data in the submission dossier. However, all the documentation related to the evaluation of human factors and the use of the device should be duly kept by the manufacturer to be provided to the authority upon request.
In summary, the authority states that the rigorous evaluation of human factors and use-related aspects is vitally important for ensuring the safety and correct operations of medical devices. Moreover, the appropriate methods allow to reduce significantly the costs and efforts associated with the identification and elimination of use-related errors since all necessary changes could be implemented at early development stages. Consequently, this also allows for reducing the timeline for placing new products on the market, as well as the regulatory burden associated thereto. In certain cases, the assessment of human factors and use-related errors is the only way to identify potential issues arising when the device is used for its intended purpose, and to prevent adverse events and incidents since a lot of use-related factors cannot be assessed properly in any other way.
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