Home Use Devices
- What is a Home Use Device?
- Why is FDA's Center for Devices and Radiological Health (CDRH) interested?
- What can CDRH do?
- What information does this website provide?
- Links to Informational Videos
- Case Study of the Month
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.
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.
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
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.
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 Studies for July 2014
Infant with Implant
An infant was born with a meningocele at the base of her scalp. When the infant was three weeks old, a neurosurgical team repaired the site; at 8 weeks old, her parents brought her back for an additional surgical procedure. Another lump had grown and she showed signs of delayed cognitive development. During the surgical procedure, a valve and catheter were implanted into her head. The infant’s mother stated that after the implant was installed, the infant’s head would occasionally drop to her chest. Seven months after the surgery, the infant was taken to the emergency room because she was wheezing. She was treated at the hospital and sent home. Two days later, she was found dead by the caretaker who stated she walked away for a few minutes and came back to find the infant unresponsive. The results of the primary autopsy showed severe structural defect in the infant’s cerebellum. The doctor did not think the implant was attributed to the infant’s death. However, she planned to get it tested to see if it was still functional.
Skin Injury Associated with Cold Therapy Device
An individual received a prescription for a cold therapy device following a surgical procedure that occurred earlier this year. During the continuous use of the device, the individual developed a skin injury despite following the guideline on the device. This injury required additional surgical procedures. Unfortunately, the individual will remain permanently disabled.
Recalls & Alerts
Office of Communication and Education
Center for Devices and Radiological Health
Food and Drug Administration
10903 New Hampshire Avenue
WO66-4621Silver Spring, MD 20993