SCOPUS 정보 검색 플랫폼

Journal of Oncology Practice

Volumn 8, Issue 1, 2012, Pages 53-56

US Food and Drug Administration regulation of medical devices and radiation oncology: Can reform improve safety?

(3) Hattangadi, Jona A a,b,c O'Reilly, James T a,b,c Recht, Abram a,b,c

a HARVARD RADIATION ONCOLOGY PROGRAM (United States)

b HARVARD MEDICAL SCHOOL (United States)

c UNIVERSITY OF CINCINNATI (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ADVERSE OUTCOME; ARTICLE; CANCER PATIENT; CANCER RADIOTHERAPY; CLINICAL EFFECTIVENESS; DATA BASE; DEVICE APPROVAL; DEVICE SAFETY; FOOD AND DRUG ADMINISTRATION; HUMAN; LEGAL ASPECT; MEDICAL DEVICE; ONCOLOGY; RADIATION INJURY;

EID: 84863085272 PISSN: 15547477 EISSN: 1935469X Source Type: Journal
DOI: 10.1200/JOP.2011.000290 Document Type: Article

Times cited : (5)

References (28)

1
- 79951709133
- Radiation offers new Cures, and ways to do harm
- January 23
- Bogdanich W: Radiation offers new Cures, and ways to do harm. New York Times, January 23, 2010:A1
- (2010) New York Times
- Bogdanich, W.¹

2
- 78650866306
- As technology surges, radiation safeguards lag
- January 27
- Bogdanich W: As technology surges, radiation safeguards lag. New York Times, January 27, 2010:A1
- (2010) New York Times
- Bogdanich, W.¹

3
- 79951709133
- Radiation bills raise question of supervision
- February 26
- Bogdanich W, Ruiz R: Radiation bills raise question of supervision. New York Times, February 26, 2010:A1
- (2010) New York Times
- Bogdanich, W.¹ Ruiz, R.²

4
- 84863089001
- At hearing on radiation, calls for better oversight
- February 27
- Bogdanich W: At hearing on radiation, calls for better oversight. New York Times, February 27, 2010:A12
- (2010) New York Times
- Bogdanich, W.¹

5
- 84863104250
- 21 U.S.C. § 360c et seq
- 21 U.S.C. § 360c et seq

6
- 84863107471
- 21 C.F.R. § 860.3
- 21 C.F.R. § 860.3

7
- 84863104255
- US Food and Drug Administration: Overview of medical device regulation: General and special controls. http://www.fda.gov/MedicalDevices/ DeviceRegulationandGuidance/Overview/GeneralandSpecialControls/default.htm
- Overview of Medical Device Regulation: General and Special Controls

8
- 84863107474
- 21 C.F.R. § 807.81-807.97
- 21 C.F.R. § 807.81-807.97

9
- 84863093393
- 21 C.F.R. § 26.31-26.50
- 21 C.F.R. § 26.31-26.50

10
- 84863103381
- Third-party review of devices come under scrutiny at the FDA
- March 15
- Mundy A, Favole J: Third-party review of devices come under scrutiny at the FDA. Wall Street Journal, March 15, 2010:A5
- (2010) Wall Street Journal
- Mundy, A.¹ Favole, J.²

11
- 84863104248
- US Food and Drug Administration: FDA determines knee device should not have been cleared for marketing. http://www.fda.gov/NewsEvents/Newsroom/ PressAnnouncements/ucm229384.htm
- FDA Determines Knee Device Should Not Have Been Cleared for Marketing

12
- 84863107476
- 21 C.F.R. § 807.81
- 21 C.F.R. § 807.81

13
- 84863093388
- US Food and Drug Administration database of 510(k) and recalls. http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm
- US Food and Drug Administration Database of 510(k) and Recalls

14
- 77955016199
- Left to their own devices: Breakdowns in United States medical device premarket review
- Hines JZ, Lurie P, Yu E, et al: Left to their own devices: Breakdowns in United States medical device premarket review. PLoS Med 7:e1000280, 2010
- (2010) PLoS Med , vol.7
- Hines, J.Z.¹ Lurie, P.² Yu, E.³

15
- 84863104249
- US Food and Drug Administration: Review of the Regen Menaflex: Departures from processes, procedures, and practices leave the basis for a review decision in question. http://www.fda.gov/downloads/NewsEvents/PublicHealthFocus/ UCM183642.pdf
- Review of the Regen Menaflex: Departures from Processes, Procedures, and Practices Leave the Basis for A Review Decision in Question

16
- 36148998363
- The Impact of Advanced Technologies on Treatment Deviations in Radiation Treatment Delivery
- DOI 10.1016/j.ijrobp.2007.08.017, PII S0360301607039028
- Marks LB, Light KL, Hubbs JL, et al: The impact of advanced technologies on treatment deviations in radiation treatment delivery. Int J Radiat Oncol Biol Phys 69:1579-1586, 2007 (Pubitemid 350116431)
- (2007) International Journal of Radiation Oncology Biology Physics , vol.69 , Issue.5 , pp. 1579-1586
- Marks, L.B.¹ Light, K.L.² Hubbs, J.L.³ Georgas, D.L.⁴ Jones, E.L.⁵ Wright, M.C.⁶ Willett, C.G.⁷ Yin, F.F.⁸

17
- 77953962317
- Trend analysis of radiation therapy incidents over seven years
- Bissonnette JP, Medlam G: Trend analysis of radiation therapy incidents over seven years. Radiother Oncol 96:139-144, 2010
- (2010) Radiother Oncol , vol.96 , pp. 139-144
- Bissonnette, J.P.¹ Medlam, G.²

18
- 16344387976
- Error in the delivery of radiation therapy: Results of a quality assurance review
- DOI 10.1016/j.ijrobp.2004.10.017
- Huang G, Medlam G, Lee J, et al: Error in the delivery of radiation therapy: Results of a quality assurance review. Int J Radiat Oncol Biol Phys 61:1590-1595, 2005 (Pubitemid 40470445)
- (2005) International Journal of Radiation Oncology Biology Physics , vol.61 , Issue.5 , pp. 1590-1595
- Huang, G.¹ Medlam, G.² Lee, J.³ Billingsley, S.⁴ Bissonnette, J.-P.⁵ Ringash, J.⁶ Kane, G.⁷ Hodgson, D.C.⁸

19
- 0037402939
- Facilitation of radiotherapeutic error by computerized record and verify systems
- DOI 10.1016/S0360-3016(02)04418-8
- Patton GA, Gaffney DK, Moeller JH: Facilitation of radiotherapeutic error by computerized record and verify systems. Int J Radiat Oncol Biol Phys 56:50-57, 2003 (Pubitemid 36403676)
- (2003) International Journal of Radiation Oncology Biology Physics , vol.56 , Issue.1 , pp. 50-57
- Patton, G.A.¹ Gaffney, D.K.² Moeller, J.H.³

20
- 84863104253
- US Food and Drug Administration: Class II recall: C-Series Clinac, Trilogy, and Novalis TX. http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/ cfRES/res.cfm?id=86503
- Class II Recall: C-Series Clinac, Trilogy, and Novalis TX

21
- 79959562402
- A pintpoint beam strays invisibly, harming instead of healing
- December 29
- Bogdanich W, Rebelo K: A pintpoint beam strays invisibly, harming instead of healing. New York Times, December 29, 2010:A1
- (2010) New York Times
- Bogdanich, W.¹ Rebelo, K.²

22
- 84863107472
- US Food and Drug Administration: Medical device safety: How to report a problem. http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm
- Medical Device Safety: How to Report A Problem

23
- 0006759303
- US Food and Drug Administration: MedWatch: The FDA safety information and adverse event reporting program. http://www.fda.gov/Safety/MedWatch/default.htm
- MedWatch: The FDA Safety Information and Adverse Event Reporting Program

24
- 77950496547
- 552 U.S. 312
- Riegel v. Medtronic, 552 U.S. 312 (2008)
- (2008) Riegel V. Medtronic

25
- 75849161739
- 129 S. Ct. 1187
- Wyeth v. Levine, 129 S. Ct. 1187 (2009)
- (2009) Wyeth V. Levine

26
- 79952637061
- US Food and Drug Administration: CDRH plan of action for 510(k) and science. http://www.fda.gov/downloads/AboutFDA/CentersOffices/CDRH/CDRHReports/ UCM239450.pdf
- CDRH Plan of Action for 510(k) and Science

27
- 80051834248
- Institute of Medicine
- Institute of Medicine: Medical Devices and the Public's Health: The FDA 510(k) Clearance Process at 35 Years. http://www.nap.edu/catalog.php?record-id= 13150
- Medical Devices and the Public's Health: The FDA 510(k) Clearance Process at 35 Years

28
- 84863104256
- American Society for Radiation Oncology: ASTRO committed to patient safety, eliminating medical errors. http://www.astro.org/PressRoom/News Releases/2010NewsReleases/documents/FinalNYTResponse.pdf
- ASTRO Committed to Patient Safety, Eliminating Medical Errors

* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.