Guidance on Medical Device Patient Labeling:- Appendix B

Posted on February 21, 2012. Filed under: Uncategorized |

Writing for increased comprehension:
The following principles foster the readable writing of medical device patient labeling. We encourage you to follow these principles in order to write for increased comprehension.
General principles:
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. Well-organized material provides occasional repetition and thoughtful summary.
Repeat the most important points to increase patient recall and comprehension.
Emphasize and summarize main points.
Use headings and summaries to aid organization and provide message repetition.
Organize medical device patient labeling to meet varied skill and knowledge needs.
  • One approach is to provide one well-segmented, highlighted document with a table of contents and the most-desired, basic information up front. Put additional information in appendices to the primary document, or make it available on demand.
  • Another approach is to distribute a quick reference card of important reminder information for the experienced user, in addition to the full patient labeling. Also, the experienced user can benefit from an intermediate form (a mini manual) with an expansion of the important information in the quick reference card, especially key use information, in addition to the full patient labeling.
Locating information in lengthy and/or, complex medical device patient labeling:
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.
Include chapter names and numbers, if chapters are used.
Principles for clear, concise writing:
Eliminate unnecessary words:
  • Avoid “aware of the fact that.”
Poor: Be aware of the fact that dampness may affect the device and cause rust.
Better: Dampness may affect the device and cause rust.
  • Avoid the unnecessary use of make, made, and making.
Poor: Make an attempt to clean your braces twice a day.
Better: Clean your braces twice a day.
  • Substitute a single word for a phrase.
Poor: It may take a good deal of practice to operate the device.
Better: It may take much practice to operate the device.
  • Use clear and simple phrases whenever possible.
Poor: Endeavor to ascertain the hospital closest to your home.
Better: Try to find the hospital closest to your home.
  • Avoid overuse of “it is.”
Poor: It is possible that you may need to use more cleaner.
Better: You may need to use more cleaner.
  • Reduce long, complicated phrases.
Poor: You are not able to use another manufacturer’s cable.
Better: You cannot use another manufacturer’s cable.
  • Simplify prepositional phrases.
Poor: Store the device in a dry area at all times.
Better: Always store the device in a dry area.
Technical vocabulary:
  • Define technical words or use them in context to help increase comprehension. Use lay language first with the technical word in parentheses. In addition to parentheses, use italics or other highlighting techniques to give the reader a signal for the technical vocabulary.
Poor: 65 mm is the tolerance level.
Better: Do not set this gauge above 65 mm (tolerance level).
  • Define terms the first time they occur in the text. Keep the definitions simple and concise. If you need to define many words on one page, define them in a set off section of the page on which the words first appear. For example, use a sidebar.
  • Provide examples to explain technical words.
  • Provide a glossary of technical words. If a glossary is used, it should be placed after the table of contents to alert readers that it is there to help them. Whether or not a glossary is used, definitions should appear in the text.
Word choice:
  • Personalize the material by using the second person “you” instead of the third person “he,” “she,” or “they.” Using “you” focuses the information directly to the patient, which makes it more important and personal.
Poor: The user should not operate this device near water.
Better: You should not operate this device near water.
  • Use terms consistently throughout the text. Use the same term to identify the device and its parts throughout the medical device patient labeling. Avoid synonyms or alternate phrases.

If you start with “dial,” do not call it a “knob” later.

  • Put adjectives and adverbs close to the words they modify.
Poor: Use the wire that is covered with green plastic.
Better: Use the green wire.
  • Avoid adverbs that are difficult to define or interpret.
Poor: Respond quickly.
Better: Respond within one minute.
  • Use active rather than passive verbs.
Poor: The dial should be turned clockwise.
Better: Turn the dial clockwise.
  • Use action verbs, not nouns created from verbs.
Poor: Avoidance of cellular phones is necessary when operating the device.
Better: Avoid cellular phones when operating the device.
  • Use specific terms. Vague terms may be misinterpreted.
Poor: Device operates poorly in a cool room.
Better: Device will not operate below 60 degrees F.
  • Avoid abbreviations or acronyms. If abbreviations or acronyms are necessary, define them the first time. Use them consistently.
Abbreviation: oxygen instead of O2
Acronym: home medical equipment
instead of HME
  • The burden for short-term memory is greater for longer sentences. Use as few words as possible to present an idea or describe an action.
Poor: Find the opaque plastic container that has a blue line on the upper half of it and fill it with any type of water until you reach the blue line.
Better: Fill the plastic container to the blue line with tap water.
  • Use no more than one clause in a sentence.
Poor: Check the power cord and do not use it if you find cuts or frays or it is loosely connected to the device.
  1. Look at the power cord for cuts or frays. If it is cut or frayed, do not use the device.
  2. Tug lightly on the power cord. If it slips out of the device, do not use the device.
  3. Call 1-800-xxx-xxxx if you need help.
  • Place phrases that describe or explain at the end of the sentence. Phrases at the beginning or in the middle of a sentence may be confusing.
Poor: Before using this device, you should read the instruction manual.
Better: Read the instruction manual before using this device.
  • Write the way you talk. Avoid formal language.
Poor: Insert the blue cable into the blue socket on the anterior section of the machine to form a completed circuit of the electrical system.
Better: Plug the blue cord into the blue hole on the front of the machine.
  • Express ideas of similar content in similar form.
Poor: Twist the large dial clockwise until it stops. Turning the small dial, move it 3 notches counterclockwise.
  1. Turn the large dial marked X clockwise until it stops.
  2. Turn the small dial marked Y counterclockwise 3 notches from the “Off” position.


  • Users should be able to read instructions aloud. Do not use parentheses for information that should be read. Parentheses cause the reader to hesitate, making it hard to read. Use parentheses only for extra information such as technical terms.
  • Don’t promote the product in the medical device patient labeling. Ads or promotions in the text will interfere with the patient’s ability to follow instructions.
  • Use bullets, lists, or more than one sentence instead of a long sentence that requires a lot of punctuation.
  • Begin paragraphs with a simple topic sentence that states the main idea.
  • Paragraphs should be cohesive about a single thought.
  • Focus on what the target audience should do as well as know. (For example, “If mercury leaks, call the local authorities for help with the mercury spill. Mercury is toxic.”)
  • Use questions throughout the text as headings and summary points to encourage active learning.
Writing procedures:
  • Write procedures in short, identifiable steps. Put the steps in the order they should be performed.
  • Before each set of steps, tell the reader how many steps are in the procedure. This helps the reader avoid missing steps.
  • Number each step in Arabic numbers such as 1, 2, 3. Do not use Roman numerals such as I, II, III; letters such as A, B, C; or words such as one, two, three. People most readily identify Arabic numbers with steps in a sequence.
  • Limit each step to no more than three logically connected actions. If actions are not related, put them in separate steps.
    Make the instructions for each action clear and definite to prevent misunderstandings. This approach is especially critical for steps that require more than one action.
Poor: Turn the machine on.
Better: To turn the machine on:
  1. Plug the power cord into an AC outlet.
  2. Face the front of the machine. Find the black power switch on the right side.
  3. Turn the power switch to the “ON” position.
  • Tell the user what to expect from an action.
Poor: Flip the switch to the “ON” position.
Better: Face the front of the machine. Flip the black switch on the left side, marked “ON/OFF,” to the “ON” position. The green light will go on.
  • Discuss common errors at the point in the procedures where they are likely to occur. Provide information to prevent and correct use errors.
  • Each step should be contained on one page. If the entire step will not fit on a single page, break the step into smaller substeps, each fitting on a page or less. Put more than one step on a page only if each step and accompanying graphics are complete on that page.
  • Avoid referring the user to another place in the manual for other information (cross referencing). It is confusing to the reader and interrupts the flow of the procedures. If cross referencing is absolutely necessary, make sure the reader knows when to return to the original place.
Poor: If the alarm sounds, go back to the beginning of chapter X.
Better: If the alarm sounds:
  1. Turn to page X.
  2. Repeat steps 1 and 2 on page X.
  3. Return to step 1 on page Y.

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