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DEVICE USER INSTRUCTION MANUALS FOR HOME MEDICAL EQUIPMENT

This article was originally published in The Gray Sheet

Executive Summary

DEVICE USER INSTRUCTION MANUALS FOR HOME MEDICAL EQUIPMENT should be tested on potential users before being finalized, FDA suggests in a document on the preparation of instructions for lay users. "It is essential that you test what you have written to make sure that any user can safely and effectively operate your device following your instructions," FDA says, adding that the manual should be tested "mainly" on potential users, but that "health care professionals and home medical equipment suppliers can be valuable sources of information in this process." By gathering "user reactions to the information in your manual before it is produced in final form you can measure the user's acceptance and comprehension of such things as effectiveness of warnings and cautions, length of material, impact of the cover, clarity of the information, difficulty in reading, and order of activities," the document points out. Revision of the user instructions may then be made 11 while changes are still possible and affordable." FDA recommends that testing be done both during the planning of the manual and after it has been written. Among the potential methods of testing suggested by the agency are gathering together a It small group of potential users, usually six to eight people," to discuss "the best way to present your instructions." The group, which is "guided by a skilled moderator," could "develop various formats for drafting the instructions, or work toward a final form from a draft that you have created." Another possible format is asking potential users to operate the device according to the directions provided in the manual. In this scenario, "observers, as well as the users, look for problems with the instructions and differences between the instructions and operation of the device." Entitled "Write it Right: Recommendations for Developing User Instruction Manuals for Medical Devices Used in Home Health Care," FDA's document carries no regulatory weight and is intended only to assist manufacturers in preparing better user instructions. Copies of the recommendations, which may be obtained from the device center's division of small manufacturers assistance, have been mailed out to approximately 13,000 manufacturers. The agency notes in its cover letter to manufacturers that the "goal in providing this document is to help assure that all users of medical devices used in home health care have readable and understandable instructions in order to operate these devices safely and effectively." Current instruction manuals, FDA says, It may be inadequate for the average home user, exacerbating the problem of device user error." Many home use devices, according to FDAers, do not come with separate instructions that are intended for the lay user. While the agency is not asking manufacturers to revise their current instruction manuals, the expectation is that as manufacturers update their manuals they will incorporate instructions for lay users (or revise existing lay user instructions) based on the recommendations contained in FDA's publication. The document contains advice on all aspects of manual preparation, including: appropriate content, how to write instructions, warnings and cautions, design elements such as paper type and graphics, and testing and distributing the final manual. The publication has been under development at FDA for approximately three years and has involved consultations with the Health Industry Manufacturers Association and other interested parties. The agency began the effort after the American Association for Respiratory Care suggested that FDA do something to improve user instructions for respiratory products. Improved user instructions have also been urged for infusion pumps as the result of an investigation begun in 1989 by six state contractors ("The Gray Sheet" June 14, p. 14). FDA sought input from manufacturers, educators and others before preparing a first draft of the document. An independent contractor was then hired to circulate the draft among manufacturers for feedback. After revising the document based on comments, another contractor developed a home infusion pump user manual based on the recommendations in the report. That manual was then tested with lay users against a manufacturer-prepared manual for the same device. "The users overwhelmingly preferred the revised manual over the current manual," FDA notes in a Sept. 29 release on the new FDA publication.
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