Home Use Device
Home Healthcare Medical Device
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 healthcare-related 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.
What is a Home Use Device?
A home use medical device is a medical device intended for users in any environment outside of a professional healthcare facility. This includes devices intended for use in both professional healthcare facilities and homes.
- A user is a patient (care recipient), caregiver, or family member that directly uses the device or provides assistance in using the device.
- A qualified healthcare professional is a licensed or non-licensed healthcare professional with proficient skill and experience with the use of the device so that they can aid or train care recipients and caregivers to use and maintain the device.
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:
- 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 and/or your local authority
- Report these events to your supplier.
- FDA will take action when needed to protect the public's health.
For more information about Home Use Device, visit FDA