The present article provides additional information regarding the details to be reflected in medical device patient labeling for operations of the product.
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 device patient labeling – a specific type of labeling intended to communicate important safety- and performance-related information to patients and laypersons using the device. The document provides additional clarifications regarding the existing regulatory requirements, as well as recommendations to be considered 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 obligations. Moreover, the authority explicitly states that an alternative approach could be applied, provided such an approach is in line with existing regulatory requirements and has been agreed with the authority in advance.
Operating Information: Key Points
According to the guidance, it is vitally important to provide medical device users with the details about the actions to be performed, the exact way they should be performed, and the appropriate timing. Hence, the operating information to be provided by the manufacturer via the medical device patient labeling should address, inter alia, the following aspects:
- The exact way the device should be operated (at the same time, the said information should be provided in a way that will not result in an information overload – the manufacturer shall consider that the device will be used by laypersons having no special knowledge or qualification).
- A detailed step-by-step description of all the steps to be performed to ensure the device will operate properly when used for its intended purpose.
- The purpose and the expected outcome of each task.
As further explained by the FDA, it is important to explain which steps are mandatory, and which are optional. All the information should be provided clearly and understandably to make sure the potential users will understand it after reading it for the first time.
According to the guidance, medical device patient information shall provide clear setup instructions. The authority also mentions that in case the setup should not be performed by a user, it should be clearly stated in the instructions as well. The setup instructions should include, inter alia, the following elements:
- A part list, if appropriate;
- List of materials and tools needed for setup;
- Unpacking instructions, if appropriate;
- Instructions on proper disposal of packing materials or how to return packaging to [the manufacturer] for reuse;
- Direction for whether the device should be placed, such as on a table or floor;
- Any warnings or safety instructions specifically related to setup placed right before the corresponding task or instruction;
- Results of incorrect setup;
- Numbered setup instruction steps in logical order;
- Any special preparation required before the first use of the device, such as cleaning or disinfecting;
- Space to write in user-specific instructions;
- Who to call if there is a problem?
Apart from the setup instructions, the medical device patient labeling should include a detailed checkout procedure to be completed before using the device for its intended purpose to make sure it is ready and could be used safely and efficiently. The said procedure depends on the medical device and its complexity – for some medical devices a simple visual inspection will be sufficient, while for others additional calibration or quality control checks will be required. According to the guidance, a checkout procedure should provide such details as:
- The indication of a frequency of checkouts (for instance, users may need to perform them each time before using the device);
- The exact procedure to be performed (as a step-by-step process description);
- The actions to be taken in case the checkout shows that the device does not operate as intended;
- The indication of the way users may get external assistance.
The next block of information, the operating instructions, describes in detail the exact actions to be completed by users when using the device for its intended purpose. Operating instructions include not only the use process itself but all the actions to be taken straight before or after the use (e.g., pre-use warming up). In this section, the manufacturer should also describe the actions to be taken in case of any issues users may face.
The authority additionally emphasizes the importance of the need to monitor the activity of the device. The appropriate statement should be included in medical device patient labeling, together with the details regarding the way users may ensure the device operates properly or identify various issues associated thereto. For instance, the manufacturer can outline the key points to be checked when the device is in use.
The information to be communicated to users should also include detailed enough cleaning instructions describing the way the device should be cleaned after each use. The said instructions should:
- List the supplies needed;
- Give step-by-step procedures;
- State how often to clean the device;
- Tell the user what cleaning accomplishes;
- Tell the use what results of failure to clean will be;
- Include appropriate warnings and precautions for cleaning agents;
- Describe the results of using improper cleaning solutions or methods;
- Include suggestions for the proper disposal of the suggested cleaning agents, if appropriate.
According to the document, medical device patient labeling should also address the aspects related to the proper maintenance of the device and indication of the ones responsible for this (i.e., whether the maintenance should be performed by the user himself/herself, or external assistance will be required). In this case, some of the procedures should be performed by a user, while some of them – be by a qualified specialist, this section could be split into two parts to ensure clarity.
In summary, the present guidance describes in detail the operational aspects to be addressed in the medical device patient labeling. The document highlights the key points to be covered and also explains the proper way the information is to be provided to ensure it will be understandable for users.
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