The new article describes the measures to be applied to eliminate or reduce use-related hazards and also provides a brief overview of human factors validation testing and key points associated thereto.
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The Food and Drug Administration (FDA or the Agency), the US regulating authority in the spare of medical devices and other healthcare products, has published a guidance document dedicated to the application of human factors and usability engineering to medical devices. The document provides additional clarifications regarding the way the provision of applicable legislation should be interpreted, as well as recommendations to be taken into consideration by medical device manufacturers intended to market their products in the US. Due to the legal nature of the document, provisions thereof are non-binding, nor should be construed as ones introducing new rules or requirements. Moreover, the Agency explicitly states that an alternative approach could be applied, provided such an approach is in line with the existing regulatory framework and has been agreed with the authority in advance.
The scope of the guidance covers the matters related to the assessment and evaluation of human factors describing how the way the device is used by the customer impacts the overall safety and effectiveness of the product. The document also highlights the aspects to be considered by medical device manufacturers when analyzing information about the use of the products to develop and implement efficient measures reducing use errors arising from the design of the device itself and also from the issues associated with user interface design.
Elimination or Reduction of Use-Related Hazards
As it is stated by the FDA, medical device manufacturers should take all the steps necessary to identify use-related hazards in the course of preliminary analyses and evaluation. The matters related to different types of preliminary analyses and specific aspects associated thereto are described in detail in previous articles. Once the issues have been identified, the manufacturer should develop and implement the measures to eliminate the hazards to the minimum extent possible, and also reduce the likelihood of them giving rise to incidents and adverse events, and causing harm to patients. The authority explicitly states that such measures should be taken before the device in question will be subject to human factors validation testing.
To achieve the purpose described hereinabove, the appropriate risk management strategies should be applied. In certain cases, multiple strategies should be applied simultaneously for the desired result to be achieved. The document provides risk management options as described in the applicable standard ANSI/AAMI/ISO 14971. The options include, inter alia, the following ones:
- Inherent safety by design (for instance, the manufacturer may use a specific type of connectors that makes it impossible to connect the components that are not compatible with the device, or remove the operation that results in use errors, or improve the way the important use-related information is provided in labels);
- Protective measures in the medical device itself or the manufacturing process (for instance, the manufacturer may introduce physical safety guards or introduce similar safety mechanisms to the software operating the device, add notifications informing the user about conditions that should be in place before using the device, incorporate special alerts notifying users about hazardous conditions, or employ the technologies requiring less maintenance);
- Information for safety (for instance, the manufacturer may supply its products accompanied with written information outlining the use-related hazards associated with the device, or provide additional training for potential users).
According to the guidance, the most efficient way to reduce the risks associated with the use-related errors is to identify the issues contributing to such risks and then develop and implement the appropriate changes to the device itself or its user interface. However, should it appear that the changes needed are not technically feasible, an alternative solution could be to implement additional protective measures intended to reduce the risks associated with the issues identified. The appropriate information should be reflected in the labeling of the device to make sure all important safety-related warnings are duly communicated to users. At the same time, the authority mentions that such an approach has its weak points as well – the labeling is not all the time available for users, and the actual fulfillment of new recommendations depends on the training and skills of a particular device user. Nevertheless, the said approach should be applied to at least reduce the risks associated with use-related errors and mitigate hazards associated thereto.
The authority also mentions that irrespective of the particular approach the medical device manufacturer will apply, the actual effectiveness of the measures taken should be subject to validation through respective testing.
Human Factors Validation Testing: Key Points
According to the guidance, human factors validation testing is conducted to demonstrate that the device can be used by the intended users without serious use errors or problems, for the intended uses, and under the expected use conditions. The authority additionally emphasizes the importance of ensuring that the scope of such testing covers all the important aspects and is efficient enough to identify use errors resulting from issues associated with the user interface design.
As explained by the FDA, the human factors validation testing should be based on the following:
- The test participants represent the intended (actual) users of the device;
- All critical tasks are performed during the test;
- The device user interface represents the final design;
- The test conditions are sufficiently realistic to represent actual conditions of use.
As further explained by the Agency, the testing to be conducted should be rigorous enough to identify the use-related errors even if such errors were not spotted by the user himself/herself. For the device to meet the acceptance criteria, the human factors validation testing should demonstrate that there are no issues that could potentially result in or contribute to adverse events or incidents.
In summary, the present FDA guidance describes the approach to be applied by medical device manufacturers when taking measures to mitigate the risks associated with use-related factors. The document also outlines the key points related to the human factors validation testing, its purposes, and specifics.
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