The article highlights specific aspects related to medical device patient labeling as described in the appendixes to the respective guidance document. In particular, the article explains the way the manufacturers may improve the readability of medical device patient labeling and information contained therein.
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 use-related information directly to patients. 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. Moreover, the authority explicitly states that an alternative approach could be applied, provided such an approach is in line with existing legislation and has been agreed with the authority in advance.
The document contains appendixes providing additional information regarding certain specific aspects related to the medical device patient labeling and the requirements it should meet to ensure the patients are duly informed about all the important matters that could affect the use of the device for its intended purpose.
The guidance describes, inter alia, the concept of readability, which stands for the ease of understating or comprehension achieved by the style of writing. As explained by the FDA, a person reading the text should be able to read it and understand its meaning. The document further provides additional recommendations to be taken into consideration by medical device manufacturers to improve the readability of medical device patient labeling.
- The manufacturer should pay attention to the wordings used making sure they will be understandable for the intended users based on their expected level of education and literacy. When assessing the labeling, the manufacturer should involve people from the same group for the results of such testing to be representative.
- Apart from this, the manufacturer shall take additional steps to make the medical device patient labeling more understandable. Such steps include, inter alia, the following ones:
- Define complex medical terminology and jargon when it first appears in the text;
- Carefully organize medical device patient labeling from a user’s perspective (organized in the way the user will use the information); repeat important points and summarize important information, to increase the reader’s recall and reading comprehension; the reader will remember the messages when key points are reinforced;
- Organize sections with headings and questions.
- The authority additionally emphasizes that when developing a medical device patient labeling, the manufacturer should use the wordings and formulations understandable at the eight-grade level at maximum, since this is the average reading level among adults. Should the complexity be higher, the text should be amended to meet the said level. At the same time, the authority states that any formulas used to assess the readability of the text cannot predict precisely the way the text will be interpreted by users, hence, it is important to conduct tests with the potential users involved. According to the guidance, this is the only way to assess the actual readability of the text. However, qualitative factors could still be used when initially developing the medical device patient labeling and deciding on the way the information should be presented to ensure the potential users will be able to read and understand it perfectly, even though this method is not fully accurate. So, the best solution is to pretest the medical device patient labeling with the target audience to see if they comprehend it.
The document further describes the approach to be applied to increase comprehension of medical device patient labeling. In particular, the guidance outlines the key principles to be followed by medical device manufacturers to help potential users in understanding the meaning of the text correctly. According to the guidance, the general principles are the following:
- Write with a specific type of person in mind;
- Stress the «need to know» information;
- Use concrete examples to clarify abstract ideas;
- Consider who will be using the device (are they elderly, disabled, or children, would their vision or hearing likely be impaired);
- Consider where the devices will likely be used;
- Group (chunk) similar information together;
- Use well-mapped carefully organized writing;
- Repeat the most important points to increase patient recall and comprehension;
- Emphasize and summarize main points;
- Use headings and summaries to aid the organization and provide message repetition.
The authority also describes the approaches to be applied when organizing and structuring the information medical device patient labeling contains. For instance, the focus should be made on the most important information, while additional details that are not critical for ensuring the safety of use could be included in appendices or even provided to the user upon request. Alternatively, the manufacturer may provide a quick reference card to assist users in navigating the information provided.
The document pays special attention to the factors related to navigation and locating information in case medical device patient labeling is complex or lengthy enough to make it difficult to find the information needed. In such a case, the manufacturer should:
- Include a summary page with critical information;
- Include a table of contents;
- Include an index;
- Include page numbers to make it easier to locate information; and
- include chapter names and numbers, if chapters are used.
In summary, the present FDA guidance highlights the key points to be considered concerning the readability of medical device patient labeling. The document provides specific recommendations to be followed by medical device manufacturers to ensure the information is provided in a way ensuring the potential users will be able to read it and understand it correctly, as this is vitally important from the safety and performance standpoints.
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