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and other stakeholders, most of which came from a May 4, 2010 public workshop and written comments received on the draft guidance.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 preliminary labeling repository pilot in 2011, which provided manufacturers of devices labeled for home use with the opportunity to voluntarily and electronically submit their labeling to the FDA through the FDA Gateway using an existing system for drug labeling. 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.
Building upon what FDA learned during the preliminary labeling repository pilot, from the public meeting and through other formative research, CDRH announced the availability of an Electronic Submission for Home Use Device Labeling Pilot Program on April 17, 2015.During this pilot, participants were asked to navigate through the Registration and Listing electronic submissions system and practice submitting labels and package inserts to the database. The pilot ended in December 2015 and provided industry and CDRH staff the opportunity to evaluate the submissions process and system, and usability of the database. The pilot confirmed that it is possible to use the FDA’s existing Registration and Listing system to receive electronic labeling information. Next steps would include making the submitted labeling accessible to the public through an FDA-managed or partner Internet website. On October 14, 2016, the FDA issued a proposed rule for manufacturers that label Class II and Class III devices for home use to submit device labeling information electronically to the FDA so that patients and health care providers can access this information online. Comments on the proposed rule may be submitted to the public docket beginning October 17, 2016. Go to regulations.gov, then copy and paste docket number FDA-2016-N-2491 in the search field. The comment period will be open for 90 days following its October 17, 2016 publication (until January 17, 2017). After the comment period closes, the FDA will review all comments prior to issuing the final rule.
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 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 to gain a more fully formed picture of the challenges faced by family caregivers in the home.
- Design Considerations for Devices Intended for Home Use - Guidance for Industry and Food and Drug Administration Staff (PDF - 523KB)
- Consumer Update: Always Tired? You May Have Sleep Apnea
- Continuous Positive Airway Pressure (CPAP) Tips from FDA
- Patient Lifts
- Home Use Devices
- Medical Device Home Use Initiative - White Paper (PDF - 56KB)
- 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)
- Device Labeling Study: Practitioner Perspectives on Utility, Format and Content of an Abbreviated Version of Labeling: Final Report Summary