Safe and Effective Instructions for Use
The intent of most device instructions is to provide necessary and useful information in a form that can be easily read and understood. Medical device instructions are intended to provide adequate directions for use such that the device can be used safely and effectively. The responsibility for assessment of whether device instructions are adequate is shared among device manufacturers, hospital educators and end users.
All medical devices used in hospitals come with a user instruction manual, commonly called Instructions for Use (IFU) or Directions for Use. Typically an IFU includes basic operational “how to” information as well as pages of warnings, cautions, and other general or device-specific information beyond simply how to operate the device. Operational trouble shooting, contingency instructions and maintenance information may also be included.
Why is medical device patient labeling important?
Medical device patient labeling is essential to assure safe and effective use of many, but not all, devices. It informs patients or their lay caregivers about proper use, risks, and benefits of the device in language they can understand.
Medical device patient labeling assists patients or their lay caregivers in understanding the device; its operation, care, and maintenance; the way it interacts with the body to accomplish its purpose; its place and purpose in the patient care regimen; and any safety or disposal issues.
Patient labeling is important for all devices operated by lay users. Adequate directions for operating the devices are needed to make devices safe and effective. For example, as more patients use complex medical devices at home, medical device patient labeling becomes necessary to better communicate to the lay person how to operate the device.
Guidance on Medical Device Patient Labeling; Final Guidance for Industry and FDA Reviewers http://www.fda.gov/cdrh/ohip/guidance/1128.pdf
If you are a manufacturer, please contact me to discuss whether you can benefit from my services. I have over 20 years’ experience in the development of service manuals for medical equipment and write procedures for the testing and maintenance of manufacturers’ medical devices and systems. Manuals I create include information on precautions under which the device can be safely used, including maintenance and service schedules.
Terence Pyle
Technical Writer and Editor
