Medical Devices: FDA Should Enhance Its Oversight of Recalls

United States. Government Accountability Office.

United States. Government Accountability Office.

关键词: Government accountability -- United States.;    justice and law enforcement;    health care;    medical devices;    letter report;   

RP-ID  :  GAO-11-468
RP-ID  :  319583

美国|英语

来源: UNT Digital Library

【 摘 要 】

A letter report issued by the Government Accountability Office with an abstract that begins "Recalls are an important tool to mitigate serious health consequences associated with defective or unsafe medical devices. Typically, a recall is voluntarily initiated by the firm that manufactured the device. The Food and Drug Administration (FDA), an agency within the Department of Health and Human Services (HHS), oversees implementation of the recall. FDA classifies recalls based on health risks of using the recalled device--class I recalls present the highest risk (including death), followed by class II and class III. FDA also determines whether a firm has effectively implemented a recall, and when a recall can be terminated. This report identifies (1) the numbers and characteristics of medical device recalls and FDA's use of this information to aid its oversight, and (2) the extent to which the process ensures the effective implementation and termination of the highest-risk recalls. GAO interviewed FDA officials and examined information on medical device recalls initiated and reported from 2005 through 2009, and reviewed FDA's documentation for a sample of 53 (40 percent) of class I recalls initiated during this period."