医疗设备、美国食品药品监督管理局与家庭医疗保健临床医生

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

作者信息

Simone Lisa K, Brumbaugh JoAnn, Ricketts Catherine

机构信息

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.

出版信息

Home Healthc Nurse. 2014 Jul-Aug;32(7):402-8. doi: 10.1097/NHH.0000000000000107.

DOI:10.1097/NHH.0000000000000107

PMID:24978574

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.

摘要

本文介绍了美国食品药品监督管理局（FDA）的MedWatch不良事件报告计划，消费者和医疗保健专业人员可利用该计划自愿报告与医疗器械相关的潜在问题。文中讨论了家庭及其他“非临床”环境中常用的器械，并就临床医生在遇到器械问题时可采取的措施提出了建议。随着医疗器械在家庭及其他非临床环境中的使用日益增加，用户和护理人员参与自愿报告变得愈发重要，这有助于FDA更好地应对这些环境中可能特有的医疗器械问题。