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.
Links to Informational Videos
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 February 2013: Tragedy with a Tampon
A teenaged female was with her boyfriend when she felt dizzy and could not feel her legs anymore. Her boyfriend called the hospital and she was admitted into the ICU. She had used her tampon for 20 hours. The doctors concluded that she had an abscess on her heart and had developed kidney failure. The family had been notified that she had developed toxic shock syndrome. She passed away due to a brain hemorrhage.Case Study for March 2013: CPAP on Fire
An individual was using his CPAP at night when the individual saw flames emitting from the CPAP. Thankfully, the individual was not injured.Case Study for April 2013: Electrical Burn
An individual was using a neuromuscular electrical stimulation device for pain at home. During the third use, the individual felt like her skin was burning. When the individual took off the electrodes, the individual had burns on her skin where the electrodes had been placed.Case Study for May 2013: Humidifier Fire
An individual was using a humidifier in their room when it suddenly started emitting flames. The bottom of the humidifier burned the carpet and dresser. Luckily, the individual was not injured.Case Study for June 2013: Compress Explosion
An individual bought a new hot or cold compress. The individual had a pimple behind his ear drum and the individual’s doctor had recommended applying heat to the ear. When the individual picked up the compress to put it in the sleeve, it exploded and caused the hot gel to burn his neck, chest and arms.
Spotlight
Public Workshop - Accessible Medical Device Labeling in a Standard Content and Format, April 29-30, 2013 Medical Device Labeling for Health Care Practitioners Focus Group Study: Final Report (PDF - 359KB)National Family Caregivers Association (NFCA) Consumer Survey: Feedback on Medical Equipment labeling/instruction information (PDF - 44KB)Draft Guidance for Industry and FDA Staff - Design Considerations for Devices Intended for Home Use - Medical Device Home Use Initiative - White Paper (PDF - 56KB)
