R Please use this checklist to use

and maintain your medical device

safely and effectively in your home.

As a homecare medical device

user, you should know how

your device works.

* Read your patient education

information.

* Ask your doctor or supplier questions

about your device and take notes.

* Ask what you need to operate your

device.

- Do you need electricity, running

water, telephone, or computer

connections to operate your device?

* Check to see that your home is suited

for your device.

- Do the stairs, doorways, bathrooms,

house wiring, present any problems?

* Keep Instructions for Use close to

your device. 

* Pay attention to alarms and error

messages.

- Be familiar with what the alarms

and error messages mean.

* Follow Instructions as given.

* Call supplier for help if you don't

understand how your device works.

* Report to your doctor or device

supplier any new problems you have

with the device.

Take care of your device

and operate it according

to the manufacturer's

directions.

* Read your instructions for taking care

of your device and follow them for:

- cleaning

- replacing batteries, filters

- protecting your device (e.g. keep

food and drinks away from your

device).

* Can you safely take your device from

home to school, work, church, and

vacation spots? 

- Check ahead to see if these other

places are suited for your device.

* Dispose of your medical device according

to the manufacturer’s instructions. 

Always have a back-up plan

and supplies.

* Make sure you know what to do if

your device fails.

* Have emergency phone numbers for

suppliers, homecare agency, doctor,

and manufacturer. 

- Be sure that you have the after-hour

phone numbers.

* If appropriate, keep extra batteries for

your device.

- Know how to replace them.

Educate your family and

caregivers about your

devices.

* Include them in hospital planning

meetings or any device demonstrations.

* Ask them to do a hands-on demonstration

to show they can effectively use the device.

Keep children and pets

away from your medical

device.

* Don't let children play with dials,

settings, on/off switches, tubings,

machine vents, or electrical cords.

* Don't allow pets to chew or play

with electrical cords.

* Check with your supplier to see if you

can turn off your device when not using it.

Contact your doctor and

home healthcare team

often to review your health

condition.

* Check to see if there are new conditions

that may change the way you or your

caregiver use the device. 

- Are there changes in vision,

hearing, ability to move? 

- Have you had an illness, new

medicines, loss of feeling?
Report any serious

injuries, deaths, or

close calls.

* Report these events to FDA at

1-800-332-1088.

* Report these events to your supplier.

* FDA will take action when needed to

protect the public's health.

Endorsing Organizations 

American Association for Home Care:

http://www.aahomecare.org

National Association for Home Care:

http://www.nahc.org

National Patient Safety Foundation:

http://www.npsf.org

Resource Organization:

National Family Caregivers Association:

http://www.nfcacares.org

A medical device is any product or

equipment used to diagnose a disease or

other conditions, to cure, to treat or to

prevent disease. The Food and Drug

Administration’s Center for Devices and

Radiological Health regulates medical

devices to provide reasonable assurance

of their safety and effectiveness. 

A home healthcare medical device is

any product or equipment used in the

home environment by persons who are

ill or have disabilities. These persons,

or their providers of care, may need

education, training, or other healthcarerelated services to use and maintain

their devices safely and effectively in

their homes or in other places such as

work, school, and church. Examples

of some home healthcare devices are

ventilators and nebulizers (to help

breathing); wheelchairs; infusion

pumps; blood glucose meters, apnea

monitors, and other home monitoring

devices.

For additional government sources and

information visit:

CDRH Home Healthcare Committee

http://www.fda.gov/cdrh/cdrhhhc/

August 2003

U.S. Department of Health and Human Services

Food and Drug Administration

Center for Devices and Radiological Health

Home Healthcare

Medical Devices:

A Checklist

The contents of this brochure is not copyrighted and may

be republished or reprinted without permission from the

Food and Drug Administration (FDA). Credit to FDA as

the source is appreciated.