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U.S. Department of Health and Human Services

Medical Devices

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Home Use Devices Initiative

In April 2010, the FDA launched the Medical Device Home Use Initiative to support the safe use of medical devices in the home. Through FDA’s efforts, additional information and resources for manufacturers, health care professionals, home care recipients, consumers, and caregivers have been and continue to be developed to encourage the safe use of medical devices in the home. The major efforts in which the FDA has taken a lead role are listed below:

1) Issued a draft guidance document for manufacturers recommending actions they should take to receive FDA approval or clearance of devices intended to be used in the home.

The FDA developed this draft guidance with input from manufacturers, the health care community and other stakeholders, some of which came from a May 4, 2010 public workshop. Included are steps that manufacturers can take to design and test devices for use in the home, and to develop user-friendly instructions (labeling) for home care recipients, consumers, and caregivers. The draft guidance is intended to improve the design and quality of home use devices to eliminate or reduce errors that occur during use. It provides recommendations that take into account the device user, the use environment, the device itself, and its labeling. The FDA is interested in your comments and suggestions on the draft guidance—you can find more information in the Federal Register notice announcing its availability.

2) Developing a labeling repository for medical devices that have been approved or cleared for home use.

Home care recipients, consumers and caregivers need immediate and easy access to information on medical devices used in the home. Health care professionals also need ready access to labeling that may not always accompany a medical device. To help facilitate that access, the FDA initiated a labeling repository pilot, which provided manufacturers of devices labeled for home use with the opportunity to voluntarily and electronically submit their labeling to the FDA. We then worked with those manufacturers that participated to identify the best approach to foster the development of a labeling repository.

CDRH held a public meeting in April 2011 to discuss any comments or questions the public had about making medical device labeling available online, as well as soliciting input on what information medical device users want and need in labeling, and how they would prefer to access it. CDRH surveyed caregivers and health care professionals in separate research studies to understand how they use and access medical device labeling. Results of these surveys are currently being analyzed and will help to inform next steps.

The FDA will continue to work with interested stakeholders to explore the feasibility of making labeling available on the Internet.

3) Increasing public awareness

There are many unique challenges that must be considered when medical devices are used outside the clinical setting. The FDA will continue its collaborations to provide home care recipients, consumers, caregivers, and health care professionals with information about these and other potential safety concerns surrounding medical devices used in the home and other non-clinical settings. Recently, the FDA has partnered with:

  • The American Association for Homecare disclaimer icon to educate providers, manufacturers, and others involved in home health about medical device safety and FDA's role with respect to home use devices.
  • Device manufacturers to take initial steps to make the labeling for home use devices available to the public on the Internet. The FDA and device manufacturers conducted a pilot program to address public Internet access to product labels. Currently we are evaluating the results from the pilot program. These results will inform any future plans to make labeling available on the Internet.
  • The National Family Caregivers Association disclaimer icon to gain a more fully formed picture of the challenges faced by family caregivers in the home.
  • Kwikpoint, under a Cooperative Research and Development Agreement (CRADA), to enable the company and the FDA to work collaboratively to design visual communication aids for various medical devices such as patient lifts and sharps (e.g., needles, syringes, lancets, and auto injectors).