Affiliations: Center for Devices and Radiological Health, Silver Spring, MD, USA
Note: [] Address for correspondence: Mary Weick-Brady, MSN, RN, FDA,
Center for Devices and Radiological Health, 10903 New Hampshire Avenue, Silver
Spring, MD 20993, USA. Tel.: +1 301 796 6089; Fax: +1 301 847 8125; E-mail: [email protected]
Abstract: 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.
Keywords: Caregiver, care recipient, manufacturer, human factors, policy
