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U.S. Department of Health and Human Services

Medical Devices

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Make Sure the Medical Device You Choose Is Designed for You

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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