Creating Instructions for Medical Device Users

The Approach

User noncompliance with procedures for cleaning contact lenses was determined to be a major contributing cause of eye health problems. Noncompliance was traced in part to inadequate manufacturer lens care instructions.

The FDA contracted with PSE to evaluate manufacturers' lens care instruction booklets and to develop an improved booklet based on human factors principles of document design and user training.

Task analysis identified deficiencies in manufacturers' lens care booklets. Observations of lens cleaning by experienced and inexperienced lens wearers revealed specific problem behaviors that could be related to booklet deficiencies.

The Solution

We developed a model lens care booklet that incorporated human factors document design principles.

The booklet included rationales and warnings with the lens cleaning procedures. In addition, it included a quick reference card for use by experienced lens wearers who have already learned lens cleaning basics. This card emphasized those aspects of lens care that were most problematic for experienced contact lens wearers.

Benefits

The model booklet promoted improved compliance with lens care procedures compared to the manufacturers' booklets. Performance and motivational deficiencies noted for the manufacturers' booklets were eliminated by the model booklet.

PSE also developed document design principles applicable to many types of medical devices besides contact lenses. These principles address the format and content aspects of documentation. Format includes language and readability; information organization; legibility; highlighting; graphics and illustrations; and physical features. Content includes background information; personal information; procedural instructions; warnings and precautions; and rationales for performing particular actions.