The Food and Drug Administration and reprocessing of single-use medical devices: A revised policy and new questions

被引：8

作者：

Smith, JJ

Henderson, JA

Baim, DS

机构：

[1] Massachusetts Gen Hosp, Dept Radiol, Boston, MA 02114 USA

[2] Harvard Univ, Sch Med, Dept Radiol, Boston, MA 02115 USA

[3] Harvard Univ, Sch Med, Dept Med, Boston, MA 02115 USA

[4] Brigham & Womens Hosp, Dept Med, Boston, MA 02115 USA

[5] Ctr Integrat Med & Innovat Technol, Boston, MA USA

来源：

JOURNAL OF VASCULAR AND INTERVENTIONAL RADIOLOGY | 2002年 / 13卷 / 12期

关键词：

catheters and catheterization; medical devices;

D O I：

10.1016/S1051-0443(07)61962-9

中图分类号：

R8 [特种医学]; R445 [影像诊断学];

学科分类号：

1002 ; 100207 ; 1009 ;

摘要：

引用

页码：1179 / 1182

页数：4

共 50 条

[1] Federal regulation of single-use medical devices: A revised FDA policy
Smith, JJ
Agraz, JA
[J]. FOOD AND DRUG LAW JOURNAL, 2001, 56 (03) : 305 - 316
[2] Reprocessing of single-use devices
Schwetz, BA
[J]. JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION, 2001, 286 (13): : 1569 - 1569
[3] Going 90 in a 55 MPH speed zone: Reprocessing of used single-use medical devices and the Food and Drug Administration's non-enforcement of the Food, Drug, and Cosmetic Act
Karst, KR
[J]. FOOD AND DRUG LAW JOURNAL, 2001, 56 (01) : 57 - 76
[4] Regulatory and legal implications of reprocessing and reuse of single-use medical devices
Wang, EP
[J]. FOOD AND DRUG LAW JOURNAL, 2001, 56 (01) : 77 - 98
[5] Products liability implications of reprocessing and reuse of single-use medical devices
Hogan, JM
Colonna, TE
[J]. FOOD AND DRUG LAW JOURNAL, 1998, 53 (03): : 385 - 402
[6] Reprocessing and reuse of single-use medical devices in China: a pilot survey
Wang, Duojin
Wu, Jing
[J]. BMC PUBLIC HEALTH, 2019, 19 (1)
[7] Reprocessing and reuse of single-use medical devices in China: a pilot survey
Duojin Wang
Jing Wu
[J]. BMC Public Health, 19
[8] Reprocessing single-use devices: An orthopaedic perspective
Sikka, RS
Fischer, DA
Swiontkowski, MF
[J]. JOURNAL OF BONE AND JOINT SURGERY-AMERICAN VOLUME, 2005, 87A (02): : 450 - 457
[9] Reprocessing single-use devices: an international perspective
Collier, Roger
[J]. CANADIAN MEDICAL ASSOCIATION JOURNAL, 2011, 183 (11) : 1244 - 1244
[10] Health regulation on reuse and reprocessing of single-use medical devices: an international overview
Costa, Eliana Auxiliadora M.
[J]. VIGILANCIA SANITARIA EM DEBATE-SOCIEDADE CIENCIA & TECNOLOGIA, 2016, 4 (01): : 36 - 44

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