Technological development in the medical device industry has allowed for the growth of devices meant for use by the patient, caregiver, or qualified healthcare professional. With the growing aging population, there has been more of a move towards home healthcare, including the use of such medical devices as infusion pumps, ventilators, and wound care therapies. However, with this move to home healthcare, there comes a risk of improper usage of medical devices by the patient or caregiver due to lack of training. Improper use can result in detrimental effects to the health of the patient. For this reason, it is imperative that medical devices come with proper and well-written instruction manuals so that the patient or caregiver can effectively use their medical device.
The FDA has specific outlines on what instruction manuals should look like for medical devices. There are a variety of factors to consider in the instructions for use for medical devices including the purpose of the device, when it should and should not be used, how to maintain it or dispose of it, how to set up the device, and more. The FDA recommends that instructions for use for medical devices must be thorough but written in a language that is easy to understand for a layperson. Given that medical device usage may come with a lot of technical language it can be difficult to produce an instruction manual that is comprehensive but easy to follow. Technical writers are adept at taking in technical information and creating user guides that are simple enough for anyone to understand. This is of utmost importance when it comes to medical devices, especially when used by the patient outside of a hospital setting.
What Goes into a Medical Device Instruction Manual?
In order to produce a thorough instruction manual for medical devices meant for use by patients or caregivers, they should generally follow a format as suggested by the FDA. This format includes the following sections:
- Table of contents
- Glossary (to define medical terms)
- Purpose of the device
- Set up instructions
- Operating instructions
- Importance of the need to monitor the activity of the device
- Cleaning instructions
- Storage instructions
- Troubleshooting information
- User assistance information
These are only some of the sections that should be included in a medical device instruction manual. The user instructions for medical devices help assure that the user will be knowledgeable on how to effectively use their medical devices and be aware of any maintenance required for a device. To achieve readability of such lengthy instructions, the user guide must be written in language that is accessible to all. This means that medical language must be translated successfully while ensuring that no original intent of the use of the medical device is lost. Technical writers are experienced in the ability to take difficult language and convert it into content that is well understood by the layperson.
FDA Requirements for Medical Device Instructions For Use
Instruction manuals for medical devices must also follow regulations set forth by the FDA under such legislation as the Food, Drug, and Cosmetic Act. This piece of legislation requires that medical devices must have labeling that includes adequate instructions for use, operating and servicing instructions, and information necessary for the protection of the users. According to the FDA, misuse of a medical device is often tied back to inadequate directions for use as a result of manufacturers’ failure to fully address user needs. Compliance with the labeling requirements, which includes user instructions, is integral to getting a medical device to market. This also further ensures that the medical device will be effectively used by the patient or caregiver. To avoid issues with user guides for medical devices it is important for the manufacturer to consider who is using the device and how it is to be used. Additionally, the user instructions must be written with the reader in mind. The manufacturer that is familiar with technical language may not realize that this language is not suitable for the layperson. In this regard, technical writers come in handy as they understand how to craft guides that are user-friendly and can simplify medical terminology and language without losing any vital information.
Clear and thorough medical device instruction manuals are crucial to the proper usage and compliance with FDA regulations for medical device labeling. With the increasing development of medical devices meant for use at home, it is even more important for the user instructions to cater to the layperson. EDC’s technical writers are experienced in the production of successful user instructions that include accessible language, clear visuals, easy-to-follow steps, and enough information for the proper use of a product. With adequate instruction manuals, users will not have to rely so much on technical support and will help boost their confidence in the manufacturer of their medical device.
How EDC can help
Whether you need a team of consultants to produce a complete line of documentation or a single technical writer for a brief project, Essential Data’s Engagement Manager will lead the project from start to finish. At Essential Data Corporation, the quality of our work is guaranteed. Contact us today to get started. (800) 221-0093 or email@example.com
Written by Diana Guerra