The new article provides an overview of the human factors considerations related to home use of medical devices.
The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published a guidance document dedicated to medical devices intended for home use. The document is intended to provide additional clarifications regarding the applicable regulatory requirements, as well as recommendations to be considered by medical device manufacturers and other parties involved to ensure compliance thereto. At the same time, provisions of the guidance are non-binding in their legal nature and are not intended to introduce new rules or impose new requirements the parties involved should follow. Moreover, the authority explicitly states that an alternative approach could be applied, provided such an approach is in line with the respective legislation and has been agreed with the authority in advance.
The authority acknowledges the specific nature of medical devices intended for home use, as well as specific risks associated thereto (mostly resulting from the use in the home environment by lay persons having no special knowledge and experience), and provides recommendations to be taken into consideration to address properly the above risks. The scope of the guidance covers, inter alia, the aspects related to the environmental, user, and design considerations, including the potential impact of such factors as water supply, storage conditions, physical conditions of persons using the device, necessary maintenance, and calibration, etc. This particular article describes in detail the approach to be applied concerning human factors. It is important to mention that the general matters related to human factors and their evaluation are also addressed in a separate guidance document issued by the FDA.
Human Factors: Key Points
First of all, the authority states that to understand the hazards associated with the use of a medical device in the home, it is necessary to have an accurate and complete understanding of how a device will be used; understating and optimize how people use and interact with technology is the subject of human factors engineering, which is based on the use of well-established methods used to identify potential issues that could impact adversely the safety and performance of a medical device in question. This includes, inter alia, usability testing as one of the main methods to be applied. As further explained by the FDA, usability testing stands for the simulated use of a medical device in an environment that is realistic enough to ensure the accuracy and reliability of the results achieved. The idea of such testing is to identify potential issues that could have a place when the device is used for its intended purpose and in the intended use environment (for home use devices – home or any location outside healthcare facilities / clinical setting). Depending on the intended use environment, the simulated use environment should be sophisticated enough to simulate the impact of the main factors the device would be subject to during real use. The authority encourages performing such testing from the very early stages of the design process since at this stage it would be easier (and more cost-efficient) to address the issues identified. According to the guidance, testing early in the design process and then several more times as the design evolves is an effective way to prevent user interaction problems from persisting into the later stages of the design process, at which point effective solutions to problems may be more limited and more expensive to implement. It is also important to mention that the authority also encourages medical device manufacturers to conduct human factors validation studies.
Concerning the general matters related to human factors, the authority refers to the guidance document “Applying Human Factors and Usability Engineering to Medical Devices”, as well as to the applicable standards, namely:
- ANSI/AAMI HE 75:2009, Human factors engineering – Design of medical devices; and
- ANSI/AAMI/IEC 62366:2007/(R) 2013, Medical devices – Application of usability engineering to medical devices.
User Training and Certification
The document also describes in detail the aspects related to user training and certification. In particular, the authority mentions that medical device manufacturers should always take into account the expected knowledge and abilities of potential users of the device. For instance, it could be difficult for users to understand multiple steps, or operate the device without additional training. Users could also fail to understand numerous warnings and precautions to be considered when using the device for its intended purpose. Apart from this, users may not realize the importance of proper maintenance, cleaning, and calibration of the device for ensuring its safety and effectiveness. In some cases, proper training is vitally important for ensuring safety during the use of the device. Thus, the need for training potential users should undergo should be determined based on the complexity of the device and the way it should be used, and other device-specific factors. The authority also encourages medical device manufacturers to validate the actual effectiveness of the training program developed.
Sometimes a care partner is needed to operate a medical device or to monitor the patient when the device is used. In such cases, the manufacturer should indicate the responsibilities of the care partner/caregiver, and the recipient/patient in the course of training, and also provide detailed enough instructions regarding the actions to be taken to prevent or overcome incidents of adverse events. The information regarding regular retraining/recertification required to ensure continuous safety should be also duly communicated to the potential users. In this respect, the authority refers to the recommendations provided in the standard AAMI TIR49:2013, Design of training and instructional material for medical devices used in non-clinical environments.
In summary, the present FDA guidance highlights the key points related to the human factors to be considered concerning medical devices intended for home use. The authority outlines the matters that require special attention due to the risks arising when medical devices are used by non-professionals outside clinical settings.
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