Medical Devices

Home Use Devices Initiative

In 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 include:

1) Issuing “Guidance for Industry and Food and Drug Administration Staff: Design Considerations for Devices Intended for Home Use” to encourage manufacturers to take into consideration a range of factors when designing, testing, and labeling home use devices in order to optimize their safe use in the home and other non-clinical settings.

The FDA developed this guidance with input from manufacturers, the health care community and other stakeholders, most of which came from a May 4, 2010 public workshop and written comments received on the draft guidance. Included in the guidance 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 guidance is intended to improve the design and quality of home use devices to reduce errors that may occur during use. It provides recommendations that take into account the device user, the use environment, the device itself, and its labeling.

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 2013 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 continues 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. The FDA partnered with:

  • Kwikpoint, under a Cooperative Research and Development Agreement, to design visual communication aids for medical devices such as patient lifts and sharps (e.g., needles, syringes, lancets, and auto injectors). Like fire hazard or public restroom signs, these guides provide the user with information without language or literacy barriers.
  • The American Association for Homecare disclaimer icon to educate providers, manufacturers, and others involved in home health about medical device safety and the 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 Caregiver Action Network disclaimer icon to gain a more fully formed picture of the challenges faced by family caregivers in the home.

 

Page Last Updated: 08/04/2014
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