The new article describes in detail the approach to be applied to design considerations for home use 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 to be used in a home environment. 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. In particular, the guidance highlights the most important aspects resulting from the specific nature of home use devices, the intended use environment, and potential users. The scope of the guidance also covers the aspects related to the design considerations for home-use products.
It is important to mention that provisions of the guidance are non-binding, and should not be construed as introducing new rules or imposing new obligations. Furthermore, the authority explicitly states that an alternative approach could be applied, provided such an approach is in line with the existing legislation and has been agreed with the authority in advance.
The authority acknowledges the important role the software plays nowadays in the healthcare sphere – various software products are widely used to operate medical devices and ensure their safety and effectiveness. As further explained by the FDA, the key points here are performance, error detection, control, and recovery. According to the guidance, when developing a home use device, [the manufacturer] should broaden existing concept development and preliminary testing processes to account for the needs of home users and requirements for straightforward device operation, obvious interface layouts, and appropriate alarm methods. The authority also mentions that special attention should be paid to software updates to ensure they will not adversely impact the safety and performance of the device operated by the software. In all cases, the approach applied should be based on the lowest risk to a person using the device, and the least burden for the manufacturer.
The document also provides references to the applicable standards and FDA guidance documents to be taken into consideration in the context of software used in medical devices. The said documents include, inter alia, the following ones:
- IEC 62304 First edition 2006-05, Medical device software – Software life cycle processes and the identical standard ANSI/AAMI/IEC 62304:2006;
- FDA guidance on General Principles of Software Validation;
- FDA guidance on the Content of Premarket Submissions for Software Contained in Medical Devices.
As explained by the authority, lock-out mechanisms are the ones used to control access to certain functions of a medical device. For instance, they can prevent a patient from changing the settings of the device. At the same time, in the case of home use devices, these mechanisms are not the main ones ensuring the safety and proper performance of the device – the authority states that the medical device manufacturer should check out other solutions first. Nevertheless, should a lock-out mechanism be the only solution for mitigating certain risks, it should be used.
As with any other medical device, home use products require certain maintenance to be performed regularly to ensure their continued safety and effectiveness when used for the intended purpose. At the same time, due to the specific nature of home use, medical device manufacturers are encouraged to limit the maintenance required to the lowest extent possible. All the procedures required should be described clearly and understandably, and the respective information should be duly communicated to potential users. The maintenance procedures themselves should be easy enough to perform so that lay persons having no proper qualification or training be able to complete them properly.
Under the general rule, home use devices should be designed in a way ensuring they will not require calibration during normal use. However, in case calibration is still necessary due to the nature of the device in question and the way it operates, the appropriate procedure should be minimal and easy for a potential user to perform. The device requiring calibration should be provided with detailed enough instructions describing the calibration process clearly and understandably. The authority also mentions that the measures related to calibration also include an indication on the device that states that it is calibrated, when it was last calibrated, and when the next calibration is needed. Should the effectiveness of the device depend significantly on proper calibration with the calibrators needed, traceability should be ensured accordingly. In case the device requires a calibration procedure to be performed by a professional, the appropriate statement should be included in the product’s documentation as well. In this respect, the manufacturer may refer to the applicable FDA-recognized voluntary consensus standards the device is subject.
Should the device be designed in a way ensuring its portability for frequent change of use locations, the manufacturer should pay additional attention to the potential impact of external factors the device may face during normal use. According to the guidance, devices should have a minimal number of parts that could be detached or fall off and present an inhalation, swallowing, or tripping hazard. The document also provides references to the applicable voluntary standard related to medical electrical equipment which outlines the requirements in the sphere of mechanical strength the medical devices should meet depending on the way they are expected to be used and the portability required. Under the general rule, the mechanical strength should be enough to ensure the device withstands the impact of factors that are common to the intended use environment, which is outside the clinical setting.
In summary, the present FDA guidance outlines the main design considerations for home use medical devices reflecting the specific nature of the intended use environment. The document describes the approach to be followed by medical device manufacturers to ensure their home use products would fit the intended purpose, and would not expose users or patients to additional risks.
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