Human Factors and Device Safety

Assistive technology (AT) devices put certain demands on the user that must be considered for patient safety. Often AT devices are not thought of as medical devices due misleading marketing or companies not knowing the differences or the similarities between them. If a patient has a medical condition a medical device would be the proper choice over a non-medical device (aka AT device) for patient safety and risk management.

Human factors in product design play an important role in patient safety. Often the devices medical and especially non-medical do not meet the needs of older consumers or people with disabilities due to poor design.

Below will give you an idea of how products place demands on the user and influence safety.

DEMANDS ON USER	CONSIDERATIONS
PHYSICAL - differences        Activity level, trunk/arm strength, ROM, Chest depth	Does the product accommodate variable user capabilities.
PHYSICAL - capacity        Isometric-Concentric strength, ROM	Does the product accommodate changing (dynamic) user needs.
MOVEMENT                                Speed, Control, Coordination	Is the product designed to accommodate these variables or changing user needs.
BALANCE:                                  Static, Dynamic, Gait, Postural	Does the product increase function in key areas as the users needs change.
ATTENTION                        Selective, Dividing, Switching	Attention the user needs to use a product safely. Do use limitations or instability require too much "attention" to be safe.

 

 

Do you know what the leading causes of fall deaths are?

Take a Fall Prevention Quiz and find out.

 

Fall Prevention Quiz (NSC.org link)

 

Below will give you an idea of how use limitations and instability create safety issues such as fall hazards.

 

Devices should increase function and should accommodate changing user needs.

 

Entrapment hazard from  a rolling off the bed.	Increased pressure points from metal supports under back/hips.	Tip over hazard
Bed fall hazard from product use limitation.	Entrapment hazard from a "bed fall".	Increased pressure points from wood platform.

Learn more about FDA bed safety guidelines and avoid bed safety risks:

• Clinical Guidance For the Assessment & Implementation of Bed Rails

• Hospital Bed System Dimensional & Assessment Guidance to Reduce Entrapment  

• Bed Rail Usage

• Bed Rail Dangers (link)

• What is a Medical Device

Updated May 18, 2008

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