The new article addresses the aspects related to labeling 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 for home use. The document provides additional clarifications regarding the applicable regulatory requirements, as well as recommendations to be considered by medical device manufacturers and other parties involved. In particular, the document highlights the key considerations based on the specific nature of home-use products and the risks associated thereto.
According to the guidance, the approach to be applied for medical devices intended for home use should be slightly different from the one which applies to general ones due to the following:
- Home-use devices are intended to be used outside clinical settings, hence, could be subject to the impact caused by numerous external factors, which are less predictable than the ones which are common for healthcare facilities;
- The expected users of home-use products are laypersons without special qualifications or knowledge, even though in certain cases they can undergo additional training, their use of the devices could be different due to their lack of experience and knowledge.
The abovementioned factors should be taken into consideration by medical device manufacturers at all stages of the design and development process. Moreover, it is also important to ensure that all the information necessary to ensure the use of the device safely and efficiently is duly communicated to its intended users. For this purpose, the authority provides detailed recommendations regarding the way such information should be communicated to ensure its proper interpretation.
Labeling: Key Points
According to the guidance, the requirements the labeling for home-use devices should meet are set forth by regulations 21 CFR Part 801 and 809.10. Under the general rule, the instructions for use (IFU) for the user should be simple, concise, and easily understood; instructions written for the users should be written in a narrative format, and pictures may be helpful to explain instructional steps; although instructions, labeling, and training can influence users to use devices safely and effectively, use of such material assumes that the user will remember or refer back to the information. At the same time, the authority additionally emphasizes that merely providing clear instructions would not be sufficient – the device itself should be initially designed in a way ensuring it will be used safely and efficiently (this includes, inter alia, special measures and controls to be introduced on the design and development stage). However, the labeling for home-use devices should contain safety warnings and precautions to be considered when using the device for its intended purpose. The content of such communications should address the issues that cannot be mitigated in full. The authority also mentions that the same terminology should be used throughout the whole documentation related to the device to ensure its proper interpretation by potential users and avoid confusion. As it is stated in the guidance, labeling on devices should be simple, visible, clear, and readily understood by the user; it should also be able to withstand defacement or wear. The authority also encourages medical device manufacturers to consider situations when the initial labeling has been removed (separated) from the device – in such a case, it should be an alternative solution for obtaining information the labeling contains – for instance, downloading it from the Internet or requesting from a third party, or requesting the assistance with the use of the device.
Apart from the said regulations, the authority also refers to the following documents:
- Labeling of Home-Use In Vitro Testing Products: Approved Guideline, Clinical and Laboratory Standards Institute, GP-14 (June 1996);
- FDA’s guidance on Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment (December 11, 2014);
- FDA’s Guidance on Medical Device Patient Labeling (April 19, 2001);
- FDA’s guidance Investigational Device Exemptions (IDE) for Devices Indicated for Nocturnal Home Hemodialysis (April 15, 2008);
- Clause 5 of ISO 15197:2003, In vitro diagnostic test systems – Requirements for blood-glucose monitoring system for self-testing in managing diabetes mellitus.
Handling the Device in an Emergency
The scope of the guidance also covers certain specific aspects to be addressed in documentation accompanying home-use medical devices. This includes, inter alia, the details about the way the device should be handled in case of an emergency. In this respect, FDA recommends that manufacturers of life-supporting and life-sustaining care devices for the home have plans for providing emergency service and suppliers during natural disasters and public health emergencies. The manufacturers may also refer to the guidance Home Use Devices: How to Prepare for and Handle Power Outages for Medical Devices that Require Electricity, which provides additional recommendations and outlines the scope of information to be communicated to potential users for the latter to be able to act accordingly. In particular, users should be recommended to keep all the information regarding the device in one place. Furthermore, the patients using vitally important medical devices are encouraged to contact their local electricity authorities and inform them about their special needs. The aforementioned document also describes the way users may identify potential damage caused to the device and determine whether the device could be safely used in the future.
Another important aspect addressed in the guidance is related to the maintenance of the device in terms of hygienic requirements. According to the document, since home users do not have easy access to the cleaning, disinfecting, and sterilization supplies that are readily available in professional health care facilities; ideally, home use devices should be designed to be clean, disinfected, or sterilized with readily available suppliers and use simple techniques. In this respect, the authority also refers to the guidance on reprocessing medical devices in health care settings.
In summary, the present FDA guidance addresses the main points related to the labeling for home-use medical devices. The document outlines the scope of information to be communicated to potential users to ensure the device will be used safely and efficiently.
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