Medical Devices: FDA Should Enhance Its Oversight of Recalls PDF Download
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Author: Marcia Crosse
Publisher: DIANE Publishing
ISBN: 1437988067
Category : Medical
Languages : en
Pages : 57
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Book Description
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 FDA oversees implementation of the recall. FDA classifies recalls based on health risks of using the recalled device. 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 info. to aid its oversight; and (2) the extent to which the process ensures the effective implementation and termination of the highest-risk recalls. Charts and tables. A print on demand report.
Author: Marcia Crosse
Publisher: DIANE Publishing
ISBN: 1437988067
Category : Medical
Languages : en
Pages : 57
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Book Description
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 FDA oversees implementation of the recall. FDA classifies recalls based on health risks of using the recalled device. 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 info. to aid its oversight; and (2) the extent to which the process ensures the effective implementation and termination of the highest-risk recalls. Charts and tables. A print on demand report.
Author:
Publisher:
ISBN:
Category : Medical instruments and apparatus
Languages : en
Pages : 51
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Book Description
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. To aid its oversight of the medical device recall process, FDA should routinely assess information on device recalls, develop enhanced procedures and criteria for assessing the effectiveness of recalls, and document the agency's basis for terminating individual recalls. HHS agreed with GAO's recommendations.
Author: United States Government Accountability Office
Publisher: Createspace Independent Publishing Platform
ISBN: 9781983616839
Category :
Languages : en
Pages : 58
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Book Description
Medical Devices: FDA Should Enhance Its Oversight of Recalls
Author: United States. General Accounting Office
Publisher:
ISBN:
Category : Medical instruments and apparatus
Languages : en
Pages : 40
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Book Description
Author: U S Government Accountability Office (G
Publisher: BiblioGov
ISBN: 9781289073848
Category :
Languages : en
Pages : 40
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Book Description
The U.S. Government Accountability Office (GAO) is an independent agency that works for Congress. The GAO watches over Congress, and investigates how the federal government spends taxpayers dollars. The Comptroller General of the United States is the leader of the GAO, and is appointed to a 15-year term by the U.S. President. The GAO wants to support Congress, while at the same time doing right by the citizens of the United States. They audit, investigate, perform analyses, issue legal decisions and report anything that the government is doing. This is one of their reports.
Author: United States. General Accounting Office
Publisher:
ISBN:
Category : Medical instruments and apparatus
Languages : en
Pages : 33
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Book Description
Author: United States. General Accounting Office
Publisher:
ISBN:
Category : Medical instruments and apparatus
Languages : en
Pages : 48
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Book Description
Author: U S Government Accountability Office (G
Publisher: BiblioGov
ISBN: 9781289134747
Category :
Languages : en
Pages : 50
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Book Description
Pursuant to a congressional request, GAO provided information on 1,635 medical devices recalled between fiscal years 1983 and 1988. GAO found that: (1) the Food and Drug Administration (FDA) classified 1,026 of the recalled devices as medium-serious, 561 as least-serious, and 48 as most-serious in terms of potential adverse health consequences; (2) the annual number of recalls fluctuated, with annual totals not exceeding 200 prior to 1985, but consistently near or above 300 after 1985; (3) although recalled devices represented all 19 medical specialty categories, 80 percent of recalled devices fell into 8 categories, and the top 2 categories, cardiovascular and anesthesiology devices, accounted for 25 percent of recalls; (4) even recalls categorized as least-serious could pose serious health consequences; (5) recalled devices included such high-risk, life-supporting devices as replacement heart valves, such medium-risk devices as tanning booths, and such low-risk devices as dental irrigation syringes; (6) design and production problems accounted for almost 75 percent of recalls; (7) 74 percent of all most-serious recalls involved medium-risk devices; (8) only 22 percent of recalls had the required medical device reporting regulation report in their files; (9) about 5 percent of recalled products had received FDA premarketing approval; and (10) premarketing-approved devices were more likely to be classified under the most-serious classification than under the other two categories.
Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309162068
Category : Medical
Languages : en
Pages : 132
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Book Description
The Food and Drug Administration (FDA) is responsible for ensuring that medical devices are safe and effective before they go on the market. Section 510(k) of the Federal Food, Drug, and Cosmetic Act requires a manufacturer of medical devices to notify FDA of its intent to market a medical device at least 90 days in advance. That window of time allows FDA to evaluate whether the device is substantially equivalent to a product already legally on the market (called a predicate), in which case the device does not need to go through the premarket approval (PMA) process. As part of its assessment of the FDA's premarket clearance process for medical devices, the Institute of Medicine (IOM) held a workshop on July 28, 2010 to discuss how medical devices are monitored for safety after they are available to consumers. Its primary focus was on monitoring the safety of marketed medical devices, including FDA's postmarket surveillance activities, analysis of safety concerns that resulted in medical device recalls, and non-FDA sources of adverse-event information. Public Health Effectiveness of the FDA 501(K) Clearance Process summarizes the views of the workshop participants.
Author:
Publisher:
ISBN:
Category :
Languages : en
Pages : 66
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Book Description
This report contains our additional descriptive analyses and profiles of two types of medical device recalls, based on the data we collected for our August 1989 report entitled Medical Device Recalls: An Overview and Analysis 1983-88 (GAO/PEMD-89-15BR). In that report, we provided information on the overall numbers and selected characteristics of all recalls that were initiated during the 1983-88 study period. Appendix I of this report contains further background information and a description of our study's objectives, scope, and methodology. In appendices II and III, we have included the results of our further analyses of two types of recall: (1) those that involved medical devices approved for marketing by the Food and Drug Administration (FDA) through its premarket approval (PMA) process and recalled for some type of design problem (hereafter referred to as PMA-design recalls) and (2) those that FDA classified as the most serious according to health risk (class I). Our medical device recall profiles include product and manufacturer identification, the nature of the problem for which the device was recalled, the health consequences of the device problem, and a description of the recall. In our additional analyses and profile development, we found that there were 28 PMA-design and 48 classes I recalls. Six recalls fell into both groups, and taken together, the two categories accounted for 70, or 4 percent, of the universe of recalls (1,635) initiated during fiscal years 1983 through 1988. Although they are a relatively small proportion of the total, these two types of recall are probably among the most important from a public health perspective. (KT).
