Guidance on Medical Device Patient Labeling:- Appendix F

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

What is pretesting?
Pretesting of medical device patient labeling is the systematic and formal gathering of target audience reactions to medical device patient labeling’s content and format, before the medical device patient labeling is issued in final form. It is typically one of the evaluations conducted in the early stages of message development. Pretesting may assist you in:
  • determining which of a number of labeling presentations is most effective for the intended audience and in identifying strengths and weaknesses in the presentation,
  • identifying sensitive and controversial elements,
  • revising and improving materials before distribution to users, and
  • identifying the best method to distribute the labeling to the target audience.
What methods of pretesting the medical device patient labeling should be used?
Pretesting methods include methods such as individual in-depth interviews, focus group interviews, self-administered questionnaires, usability testing, and readability testing (See Appendix A Readability).
Pretesting can check the potential users’ comprehension of the medical device patient labeling and their ability to follow instructions in the medical device patient labeling in order to operate the device. User-oriented testing helps to find places where the patient labeling may be inaccurate, incomprehensible, or poorly organized.
Individual in-depth interviews:
A potential user provides ideas and impressions of possible ways that the medical device patient labeling could be most effectively written.
Focus group interviews:
A small group of potential users, usually 8 to 10 people, discusses their perceptions, opinions, beliefs, and attitudes (POBAs) toward the medical device patient labeling. The discussion is guided by a skilled moderator.
Self-administered questionnaires:
Potential users are asked to review the medical device patient labeling, complete the written questions in the questionnaire about the medical device patient labeling, and return it within a specified time.
Usability testing:
The concept of usability refers to the extent to which people who use a product can use it quickly and easily to accomplish specific tasks. The usability of a product is composed of the combined usability of the product’s sub-components, which can include hardware, software, menus, icons, messages, labels, manuals, reference materials, and software-based help. Consideration of the usability of a device may focus on all or some of these sub-components. For medical devices, patient labeling is often an important sub-component of usability considerations.
Usability testing is a technique designed to determine how usable a product is. This technique involves systematic observation of actual users trying out a product (or sub-component) and the collection of information from the users about aspects of the product that are easy and those that are difficult for them. Performing usability testing on medical device patient labeling materials involves the use of the device and its labeling materials by a group of intended users of the device. Data are then collected on how well the labeling materials support the users, how effectively they are able to use the device, how many and what kind of errors they make, and any difficulties they encounter.
From the perspective of medical device patient labeling reviews, it is desirable for you to demonstrate that labeling materials can be used safely and effectively through the application of usability testing. If usability test results are submitted, they can be used to assist the process of reviewing patient labeling. To the extent that safety concerns are adequately reflected in the test, these results can be considered an indication of the adequacy of the medical device patient labeling.

 Checklist Summary:

Use this checklist to make sure that you have considered all the recommendations in this guidance.
The medical device patient labeling contains the following content:
___ Table of Contents
___ Glossary

Descriptive Information:

___ Purpose of the device (indications for use)
___ Description of the device
___ When the device should not be used (contraindications)
___ Risks and benefits
___ Expectations of the device and the procedure associated with the device
___ Importance of the need to adhere to a care regimen

Operating Information:

___ Setup instructions
___ Checkout procedures
___ Operating instructions
___ Importance of the need to monitor the activity of the device
___ Cleaning instructions
___ Description of maintenance and who should do it
___ Storage instructions
___ Expected failure time and mode and its effect on the patient
___ Instructions on how to safely dispose of the device
___ Instructions on accessories
___ Instructions on related, additional devices

Troubleshooting Information:

___ Troubleshooting

Additional Information:

___ Clinical studies
___ Disease and self-care information
___ Adverse events
___ Warranty
___ Travel or international use
___ Index
___ Date of Printing
___ User Assistance Information
The medical device patient labeling adheres to the guidance recommended for:
___ Readability
___ Writing for increased comprehension
___ Appearance of text
___ Appearance of graphics
___ Warnings and precautions
___ Pretesting

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