Medical devices in the home: An FDA challenge

http://www.ncbi.nlm.nih.gov/pubmed/22398505

Work. 2012 Jan 1;41(3):361-5.

Medical devices in the home: A unique challenge for the FDA.

Fu M, Weick-Brady M, Tanno E.

Source

Center for Devices and Radiological Health, Silver Spring, MD, USA.

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 carerecipients, depend on a properly functioning medical device for recovery. As efficient as this method may be, homehealthcare 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.

Methods: 

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

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. 

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.