The new article describes in detail the approach to be applied concerning certain specific aspects related to home use devices including, inter alia, the ones related to electrical issues, such as power outages or alarm systems.
- 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 design considerations for devices intended for home use. The document is intended to provide 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, nor are intended to introduce new rules or impose new obligations. 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 present article describes in detail the aspects related to electrical issues associated with home use devices that use electricity in the course of their operations. First of all, the authority mentions that manufacturers should take into consideration the differences existing between the clinical settings and the home use environment – the latter could have unreliable sources of electricity and poor electrical grounding. In this respect, it is important to follow provisions of the applicable standard, which is ANSI/AAMI ES60601-1:2012 Medical electrical equipment – Part I: General requirements for basic safety and essential performance. The said standard outlines the main issues related to the electrical supply and describes the way they could be addressed.
In case the device is intended to operate from the supply main, the appropriate specifications set forth by the applicable standards should be followed. The standards specify the voltage range for both life-supporting devices and the ones that are not life-supporting. According to the guidance, the standard to be followed is ANSI/AAMI/IEC 60601-1-2 Fourth edition 2014-02, Medical electrical equipment, Part 1-2: General requirements for basic safety and essential performance – Collateral standard: Electromagnetic disturbances – Requirements and tests.
Internal Electrical Power Source
The scope of the guidance also covers the aspects related to the internal power sources the device may use. In such a case, the instructions for use should clearly outline the expected operation time of the device when it is used on the internal power source, as well as the expected service life of the latter. The information communicated to the potential users should also contain indications of whether the device could be used while it is charging, and in the case of replaceable energy sources, the information should also contain details regarding the steps to be taken and safety measures related to such a replacement. Thus, in case the device can be operated using the energy deriving from a built-in battery, the manufacturer should indicate the expected time the device will be operating (which could be also expressed as the number of operations the device is expected to be able to perform within one charging period). Furthermore, the manufacturers are encouraged to add functionality allowing the device to notify the user about the low battery level and the need for recharging/replacement. When designing the device, the manufacturer should ensure the device does not require to be recharged too often or can operate safely and efficiently if inexpensive batteries are used.
Permanently Installed Devices
The guidance also mentions that specific requirements apply to medical devices that are to be permanently installed. In particular, the labeling and documentation accompanying such devices should provide the details regarding their proper installation including, inter alia, the aspects related to protective grounding. In certain cases, it should be recommended to engage a qualified professional to install the device.
Outlets and Adapters
According to the guidance, the medical device manufacturer should inform the user if the device should not share an outlet with another electrical device or be connected to an outlet controlled by a wall switch. The manufacturer should provide the details regarding the electric accessories the device could be used with, and also on the compatibility with outlets and adapters needed (if any) to ensure proper operations of the device.
In case the product requires AC power when used for its internal purpose, the manufacturer shall consider alternative energy sources to be used to ensure uninterrupted operations of the device in case the main source of energy is unavailable. These options may include additional batteries or a generator. The instructions for use should describe in detail the actions to be taken in case of a power outage. If the device cannot be used without a backup supply, it should be communicated by the manufacturer. Additionally, the manufacturer may provide recommendations regarding alternative treatment solutions to be used in case the device is unavailable due to the power outage. If the device contains batteries as an alternative source of energy, the general rule applies – the manufacturer should indicate the expected time the device will continue operating or the number of procedures the device will be able to perform after the main source of energy becomes unavailable. Hence, potential users should be duly informed regarding the expected performance of the device when the backup energy source is in use.
As in the case of medical devices intended to be used in healthcare facilities, the manufacturers of home use devices should consider the intended use environment and electromagnetic disturbances that may potentially be present there. Under the general rule, the device should be designed in a way ensuring it can withstand the impact of electromagnetic disturbances it could be subject to. It is also important to mention that the FDA has issued a separate guidance document dedicated to electromagnetic compatibility for medical devices.
In summary, the present FDA guidance highlights the key points associated with the sources of energy for the devices intended for home use. The document also provides recommendations to be followed by medical device manufacturers concerning the information about energy-related aspects to be duly communicated to potential users.
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