The Resource Medical Device Recalls: Examination of Selected Cases

Medical Device Recalls: Examination of Selected Cases

Label
Medical Device Recalls: Examination of Selected Cases
Title
Medical Device Recalls: Examination of Selected Cases
Contributor
Subject
Language
eng
Summary
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)
Cataloging source
DTICE
Index
no index present
Literary form
non fiction
http://library.link/vocab/relatedWorkOrContributorName
GENERAL ACCOUNTING OFFICE WASHINGTON DC PROGRAM EVALUATION AND METHODOLOGY DIV
http://library.link/vocab/subjectName
  • Market research
  • Defects(materials)
  • Medical equipment
  • Economics and cost analysis
  • Medical facilities, equipment and supplies
  • Health
  • Medicine
  • Consumer problems
  • Profiles
  • Marketing
  • Public health
  • Public safety
  • Risk
  • Drugs
Target audience
adult
Label
Medical Device Recalls: Examination of Selected Cases
Instantiates
Publication
Carrier category
online resource
Carrier category code
  • cr
Carrier MARC source
rdacarrier
Content category
text
Content type code
  • txt
Content type MARC source
rdacontent
Dimensions
23 x 29 cm
Extent
66 pages
Form of item
online
Governing access note
APPROVED FOR PUBLIC RELEASE
Media category
computer
Media MARC source
rdamedia
Media type code
  • c
Note
Hein Online
System control number
  • (OCoLC)227752088
  • (OCoLC)ocn227752088
Label
Medical Device Recalls: Examination of Selected Cases
Publication
Carrier category
online resource
Carrier category code
  • cr
Carrier MARC source
rdacarrier
Content category
text
Content type code
  • txt
Content type MARC source
rdacontent
Dimensions
23 x 29 cm
Extent
66 pages
Form of item
online
Governing access note
APPROVED FOR PUBLIC RELEASE
Media category
computer
Media MARC source
rdamedia
Media type code
  • c
Note
Hein Online
System control number
  • (OCoLC)227752088
  • (OCoLC)ocn227752088

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