Medical devices, the FDA, and the home healthcare clinician.

Abstract

This article introduces the U.S. Food and Drug Administration's (FDA's) MedWatch adverse event reporting program that consumers and healthcare professionals can use to voluntarily report potential problems associated with medical devices. It discusses devices commonly used in the home and other "nonclinical" environments and suggests what clinicians can do when encountering device problems or issues. With the increasing use of medical devices in the home and other nonclinical environments, it is becoming more important for users and caregivers to participate in voluntary reporting to help the FDA best address medical device problems that may be unique to these environments.