Medical devices in the home: a unique challenge for the FDA

Work. 2012;41(3):361-5. doi: 10.3233/WOR-2012-1305.


Objective: With the rising numbers of elderly populations and those with chronic diseases, the Home Healthcare field has inevitable expanded within the United States. Patients, more specifically home-bound patients, are becoming increasingly dependent on medical technology to help sustain and improve their quality if life. Often times, home care patients, or care recipients, depend on a properly functioning medical device for recovery. As efficient as this method may be, home healthcare also comes along with many challenges involving use and management of medical devices. Difficulties regarding device function, use, the environment, and human factors can all serve as factors to jeopardize patient safety. FDA recognizes that devices need to be safe and capable of meeting needs in an uncontrolled home environment.

Participants: Major stakeholders such as manufacturers, distributors, human factor specialists, professional health organizations, healthcare professionals, patient/caregivers, and other government agencies.

Result: FDA would assure that manufacturers are designing and testing devices for the home, that proper training and education to use the device are available and completed, and the public knows how to report problems with their devices.

Methods: FDA launched the Medical Device Home Use Initiative in April 2010 which proposed different methods that can support safety and safe use of medical devices in the home environment.

Conclusion: FDA faces many challenges in assuring safe usage of medical devices in the home. FDA hopes that stakeholders can also become actively involved in working with us to address a total life cycle approach on device safety.

MeSH terms

  • Commerce
  • Documentation
  • Equipment Safety / standards*
  • Home Care Services*
  • Homebound Persons*
  • Humans
  • Product Surveillance, Postmarketing / standards
  • United States
  • United States Food and Drug Administration*