Medical Devices
Home Use Devices Initiative
FDA has launched the Medical Device Home Use Initiative to improve the safe use of medical devices in the home. Through this initiative, FDA will take proactive steps to assure the safety, quality, and usability of devices labeled for home use, as well as to provide more information for home care recipients and caregivers to support their safe use, such as:
1) Developing a guidance document recommending actions that manufacturers should take to receive FDA approval or clearance of devices intended to be used in the home.
FDA’s future guidance document will be developed with input from manufacturers, the healthcare community, and other stakeholders. FDA intends to hold a public workshop on May 24, 2010, to discuss steps manufacturers can take to design and test devices for use in the home, and to develop user-friendly instructions for home care recipients and caregivers.
2) Developing a home use device labeling repository for medical devices that have been approved or cleared for home use.
FDA is announcing a pilot program through which manufacturers of devices labeled for home use may voluntarily submit their labeling electronically to FDA for the Agency to post in a central location online. The pilot program will begin mid-summer, 2010 and will last for approximately 10 months. FDA will work with manufacturers who are interested in participating.
Additional information about the pilot program is available in a 60-day notice published in the Federal Register.
3) Increasing public awareness
FDA will strengthen collaborations with other federal agencies, as well as with external organizations to provide home care recipients, caregivers, and healthcare practitioners with information about potential safety concerns surrounding medical device use in the home. The FDA is currently partnering with the following groups:
- The Centers for Disease Control and Prevention (CDC) to incorporate medical device training into the CDC's Healthy Homes training curriculum for community health workers.
- The American Association for Homecare to educate providers, manufacturers, and others involved in home health about medical device safety and FDA's role with respect to home use devices.
- The Community Health Accreditation Program, the Joint Commission, and the Accreditation Commission for Health Care, Inc. (ACHC) to strengthen home health agency accreditation criteria that relate to Medical device safe use practices.
- The Coalition of Enteral Nutrition Manufacturers, the Coalition of Respiratory Care Manufacturers and the Coalition of Wound Care Manufacturers to identify, strategize and take action on regulatory and legislative issues impacting home care.
For additional information about the Medical Device Home Use Initiative, visit these resources:
