The new article describes in detail the aspects related to environmental considerations.
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 the design considerations for 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 to ensure compliance thereto. At the same time, provisions of the guidance are non-binding and are not intended to introduce new rules or impose new requirements. Moreover, 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 scope of the guidance covers, inter alia, the aspects related to the environment in which the device is intended to be used. In particular, the authority states that when designing a home-use device, [the manufacturer] should account for the range of environments in which it might be used and the applicable environmental conditions [outlined in the guidance]. Such an approach should be applied concerning any devices intended to be used outside of the clinical setting. The authority also mentions that the appropriate warnings should be duly included in the labeling. At the same time, the manufacturer should focus on mitigating the risks associated with the use of the device, even if such risks are addressed in the product’s labeling. The authority also expects the manufacturer applying for marketing approval to provide information about the measures taken in this respect. The FDA additionally emphasizes that only the relevant elements should be included in the submission.
First of all, the authority mentions that the design of a home-use device should be appropriate in terms of the locations where the device is intended to be used. In this respect, the manufacturer should take into consideration specific conditions associated with these environments to ensure the device operates safely and efficiently. For instance, it is important to consider the aspects related to the possibility to move the device within the premises it is used in. Apart from that, it is also important to take into account specific risks associated with the use environment, including the ones related to interferences the device could be subject to.
Another important aspect highlighted in the guidance is the risk of the device being affected by contaminants. This becomes especially important due to the non-sterile nature of the home use environment. The risks associated with various sources of contamination that are common in the home use environment should be assessed carefully by the manufacturer, and the appropriate measures should be taken to mitigate them. This includes, inter alia, mitigation of risks related to the potential impact of household chemicals.
The document also addresses specific aspects related to the environmental conditions and additional needs the device requires to operate properly, such as water supply, temperature, dampness and humidity, atmospheric pressure changes, and airflow. In this respect, the authority states that:
- Home-use devices should be designed for the anticipated temperature range in the intended use environment, especially those that are portable and might be exposed to fluctuations and extremes in temperature;
- Home-use devices should be designed for the variability in humidity levels that are expected to be present in the intended use environment;
- Home-use devices should be designed to operate properly within a range of atmospheric pressures such as lower pressures that occur in the mountains and during air travel;
- Home-use device design should ensure that airflow will be adequate for proper device operation.
Travel and International Use
Apart from the aforementioned aspects, the scope of the guidance also covers the matters related to the use of medical devices when traveling. This includes, inter alia, the matters related to the transportation conditions, as well as adaptability to the electrical supply in different countries and regions. In certain cases, the device should have additional elements ensuring its uninterrupted operations when the device is used abroad, e.g., electrical converters, adaptors, or battery back-up. The specific approach to be applied depends on the device itself, the way it should be used, and the electrical supply it requires. Furthermore, the authority states that the labeling of the device should include additional considerations regarding the potential malfunctions and the way they could be addressed.
The authority additionally emphasizes the importance of considering specific aspects related to body-worn medical devices concerning passing through security screening systems. In particular, the manufacturer shall assess the way such systems could potentially impact the operations of the device, and the risks associated thereto. The instructions for use should provide additional information to be considered by users of the device when traveling.
The scope of information to be communicated to the users includes, inter alia, the aspects related to the storage of the product, as well as the components and accessories thereto. The manufacturer should specify the particular storage conditions to be followed to ensure proper operations of the device safely and efficiently within the whole period of shelf life of the device.
In summary, the present FDA guidance describes in detail specific aspects to be considered by medical device manufacturers concerning the environment in which the device is intended to be used. As explained by the authority, home use devices could be used in an environment that differs substantially from the clinical setting, hence, the approach to be applied should be different as well to ensure that all the risks associated with the use environment are duly identified and mitigated to the acceptable level, while all the important use-related information is communicated to end-users.
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