title: 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.
authors: Lisa K. Simone, PhD, MS-MOT, is a Biomedical Engineer, Division of Electrical and Software Engineering, Office of Science and Engineering Laboratories, Center for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, Maryland. JoAnn Brumbaugh, BSN, RN, LNC, is a Nurse Consultant, Division of Postmarket Surveillance, Office of Surveillance and Biometrics, Center for Devices and Radiological Health, U.S Food and Drug Administration, Silver Spring, Maryland. Catherine Ricketts, BSN, RN, is a Nurse Consultant, Division of Postmarket Surveillance, Office of Surveillance and Biometrics, Center for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, Maryland.
authors: Lisa K
authors: LK
authors: Simone
authors: JoAnn
authors: J
authors: Brumbaugh
authors: Catherine
authors: C
authors: Ricketts
mesh_terms: D004869:Equipment Safety / Q000379:methods / Q000592:standards*; D006282:Health Personnel; D006699:Home Care Services; D006801:Humans; D014481:United States; D014486:United States Food and Drug Administration