U.S. flag An official website of the United States government
  1. Home
  2. Medical Devices
  3. Device Advice: Comprehensive Regulatory Assistance
  4. Human Factors and Medical Devices
  5. Make Sure the Medical Device You Choose Is Designed for You
  1. Human Factors and Medical Devices

Make Sure the Medical Device You Choose Is Designed for You

PDF Printer Version

Information drawn from:
Medical Device Use-Safety: Incorporating Human Factors Engineering into Risk Management

This checklist is designed for health care professionals and patients to use when choosing a medical device that is best for the patient. It is intended to be modified by health professionals to focus on particular devices for certain target populations (e.g., arthritics, diabetics, heart patients).

  1. Do you have limitations that can affect your use of the device?
___Could your health (stress, tired, medication effects, disease) affect the way you use the device?
___Do you have the physical size and strength (hand strength, lifting ability, and endurance) to use the device?
___Will you be able to see the display, hear the alarm, and feel the controls (knobs, buttons, switches, and keypads)?
___Do you have the coordination (manual dexterity, balance) to adjust the controls?
___Will you be able to understand and use the device?
___Do you need to remember complex instructions to use the device?
  1. Is the device right for the environment where you plan to use it?
___Does the device have safety features to prevent it from harming your children or pets, and to prevent them from harming the device?
___Will you be able to hear the device’s alarm in a noisy environment?
___Will the light levels (low or bright) in your environment affect your ability to use the device?
___Are you using other devices at the same time?
___Will sources of electromagnetic interference (e.g., Ham radio, AM FM TV broadcast antenna, electrical machinery, hand-held transmitters) affect the device?
___What things about your home will affect your use of the device (e.g., high heat and humidity, very dry air in the winter, too few electrical outlets, narrow doorways, wood stove heating)?
___What happens if you put the device in an inappropriate environment?
  1. Are there device characteristics that can affect its use?
___Is the device simple to set up, operate, clean, maintain, and dispose of; and what happens if you don’t do these things properly?
___What replacement parts or batteries are required, how frequently are they needed, how expensive are they, and are there special instructions for safely disposing of the device or its parts?
___What reading or training is required of you?
___Are there things about this device that are different from other similar devices you have operated?

Version 1.0
20 September 00

Back to Top