Medical Devices
Home Use 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.
Why is FDA's Center for Devices and Radiological Health (CDRH) interested?
Changes in health care have moved care from the hospital environment to the home environment. In fact, according to results of the 2000 National Home and Hospice Care Survey “approximately 1,355,300 patients were receiving home health care services from 7,200 agencies.” In 2004, the National Association for Home Care & Hospice reported that more than 7 million people in the United States receive home health care annually.
As patients move to the use of home health care services for recuperation or long-term care, the medical devices necessary for their care have followed them. As a result, complex medical devices are used more frequently in the home, many times under unsuitable conditions. This in turn has implications for the safe and effective operation of these devices, especially those with sophisticated requirements for proper operation or maintenance.
CDRH regulates medical devices; however, the regulatory authority alone is not enough to ensure that devices are safe and effective when used in the home. CDRH has been receiving an increasing number of adverse event reports about medical devices that are used in the home.
What can CDRH do?
CDRH wants to decrease the number of problems that occur in the home environment; but the issues are complex. To be successful, the government agencies involved in home care need to collaborate with relevant stakeholders:
- Manufacturers and Distributors
- Health care professionals
- Health care organizations
- Accrediting bodies (Private or governmental bodies that grant recognition that an institution has met certain standards or requirements)
- Human factors experts
What information does this website provide?
This website will provide safety information and resources about medical products used in the home environment geared for a variety of audiences – consumers, patients, healthcare providers and manufacturers.
Case Study of the Month
The FDA encourages consumers and health care professionals to report problems they have with their devices while they are using them. This could be anything from an injury or death to a malfunction or near miss with a device while it is being used. Users should report these problems to the FDA so that we can accumulate information on products in our national database and take any action if needed. The reporting number you should use is 1-800-FDA-1088.
Case Study for April 2012: Fire in the bed
An elderly patient was bedridden to a remote control hospital-type bed. Due to electrical wiring complications, a fire was ignited when the patient was stuck in the bed. The man suffered from severe burns and died as a result of the fire.Case Study for May 2012: Tragedy with Oxygen Therapy
A patient who uses oxygen therapy at home was cooking in the kitchen cooking with the therapy equipment on. Through a series of unexpected events, an explosion erupted in the kitchen and fire spread throughout the house. The patient killed in the explosion.
Spotlight
- Medical Device Home Use Initiative - White Paper (PDF - 56KB)
- Class 1 Recall: Smiths Medical Bivona Neonatal, Pediatric and Flextend Tracheostomy Tubes
- Safety Communication: Negative Pressure Wound Therapy System Complications (Update)
- Information on Artificial Pancreas Systems
Needles and Other Sharps (Safe Disposal Outside of Health Care Settings)
Contact FDA
Office of Communication, Education and Radiation Programs
Center for Devices and Radiological Health
Food and Drug Administration
10903 New Hampshire Avenue
WO66-4621
Silver Spring, MD 20993
