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Medical Devices in the Home: 

Design Considerations and

Guidance for Industry

September, 2014

Mary Weick- Brady, MSN,RN

Senior Policy Advisor

Office of the Center Director

Center for Devices and Radiological Health

U.S. Food and Drug Administration
Why Focus on the Home?

• Faster discharges 

from clinical facilities 

• Elderly population 

• Chronic diseases 
What is considered “Home”?

Any environment 

other than a 

professional 

healthcare facility or 

clinical laboratory 

where a device may 

be used
Home Use Devices Are:

• Disposables & Accessories

– Oxygen therapy related devices

– Needles, syringes, IV catheters, tubing, foley catheters, gloves

• Implantables

– Defibrillators, 

– Hip/knee implants 

• Computerized Medical Systems 

– Infusion pumps

– Dialysis

• Reagents

– Fecal occult blood tests

– Lyme Disease tests

• Durable Medical Equipment

- Wheelchairs

- Patient Lifts
Home Use Medical Device 

Initiative 2010

1. Establish guidelines for 

manufacturers of home use devices; 

2. Develop a home use device labeling 

repository; 

3. Partner with home health accrediting 

bodies to support safe use; 

4. Enhance postmarket oversight; and 

5. Increase public awareness and 

education
Three Main Considerations

Environmental 

User Design
A. Environmental Considerations

• Location

– Urban/suburban/rural

– School/office/retail environments

– Electromagnetic interference (EMI)

– Crowded environment

– Movement from room to room

– Wireless signal

• Contaminants

– Non-sterile environment

– Vermin, pets, tobacco, smoke, household chemicals

• Water Supply

– Type of water: ex. well water vs. distilled water
Environmental Considerations 

(cont.) 

• Temperature

– Fluctuations and extremes in temperature

• Dampness and humidity

– Static

– Mold 

• Airflow

• Atmospheric pressure changes

– Low pressures on mountains/air travel

• *removed ‘childproofing’ and ‘tampering’ from final 

guidance
Environmental Considerations 

(cont.)

• Travel and International Use

– Electrical supply/voltage rates

– Electrical converters

– Back up batteries

– Passing through security – pat down, backscatter x-ray

• Fluid Exposure

– Fluid spills

– Submersion

• Storage
B. User Considerations

Physical: size, mobility, 

coordination, flexibility, 

strength, stamina, dexterity

Sensory/Perceptual:

vision/hearing abilities, tactile 

sensitivities, ambient light 

conditions, alarm visibility

Cognitive: literacy level, 

cognitive impairment 

Emotional:anxiety, fear

*inappropriate use replaces childproof and tampering
C. Design Considerations

• Lock-out Mechanisms

• Maintenance

• Calibration

– No calibration/minimal calibration

– Step-by-step instructions

• Mechanical Strength

– Portability

– Withstand transport conditions
Design Considerations (cont.) 

Electrical Issues

• Supply Mains

– Interruption of power 

supply/supply mains

– Voltage limitations

• Internal electrical 

power source

– Typical operation time

– Recharging

– Replacing

• Permanently installed 

devices

– Protective grounding

• Outlets and 

Adapters

– Surge protection

• Power outages

– Back-up power

– Emergency contact 

information

• Battery life
Design Considerations (cont.)

• Electromagnetic Compatibility (EMC)

– EMC testing

• Wireless Technology

– Radio frequency (RF) wireless technology

• Alarm Systems

– Noise inside/outside the home

– Hearing impairments 

– Visual, auditory, tactile alarm signals
D. Human Factors

• Human factors validation study

• User training and certification

• Outline responsibilities of care partner, 

caregiver, and care recipient 

• Recertification/retraining 
E. Labeling

• Handling the device in an emergency

– Natural disasters

– Power outages

• Disposal 

– Regular versus biological waste

– Sharps disposal

• Hygienic maintenance

– Cleaning, disinfecting, sterilizing
Post Market Considerations

• Customer service

– Technical assistance phone numbers, 

website, email address

• Medical Device Reporting

– MedWatch

• * removed: Selling/Purchasing used prescription devices
Home Use Devices Should Be:

• Useful

• Usable

• Iterative

• Intentional

• Intuitive

• Integratable

• Informative

• Addressing the risks unique to the home
SAFE AND RELIABLE DEVICES LEAD 

TO LIVING WELL
Resources

www.fda.gov/homeusedevices

FAQs

Guidance

Resources

Educational materials
Thank you for participating

Please send your questions to:

DICE@fda.hhs.gov

For more information on the regulation of 

medical devices, visit CDRH Learn and 

Device Advice in the Medical Device section 

of FDA.gov