Nuclear Regulatory Commission regulatory status of approved intravascular brachytherapy systems

Cardiovascular Radiation Medicine

Volumn 3, Issue 1, 2002, Pages 60-66

  Glasgow, Glenn P ^a  

^a LOYOLA UNIVERSITY CHICAGO   (United States)

Author keywords

Intravascular brachytherapy; Regulations

Indexed keywords

IRIDIUM 192; PHOSPHORUS 32; STRONTIUM 90; YTTRIUM 90;

ARTICLE; BRACHYTHERAPY; CLINICAL ARTICLE; CONTROLLED STUDY; ELECTRON THERAPY; GAMMA RADIATION; HUMAN; MEDICAL EDUCATION; PRACTICE GUIDELINE; PRIORITY JOURNAL; RADIATION DOSE; RADIATION HAZARD; RESTENOSIS;

BRACHYTHERAPY; CORONARY RESTENOSIS; HUMANS; QUALITY OF HEALTH CARE; RADIOISOTOPES; RADIOTHERAPY DOSAGE; UNITED STATES;

EID: 0036451779     PISSN: 15221865     EISSN: None     Source Type: Journal    
DOI: 10.1016/S1522-1865(02)00151-8     Document Type: Article

References (13)

1. Federal Food, Drug, and Cosmetic Act as Amended by the Food and Drug Administration Act of 1997, Chapter IX, Miscellaneous. Sec. 906, Practice of Medicine. Food and Drug Administration, Revised Nov. 17, 1998.
2. Cool DA. Draft Guidance to NRC Regions for Licensing Cordis and Novoste Intravascular Brachytherapy Systems. Division of Industrial and Medical Nuclear Safety, US Nuclear Regulatory Commission, February 2, 2001.
3. Cool DA. Revised guidance for licensing intravascular brachytherapy procedures. Division of Industrial and Medical Nuclear Safety, US Nuclear Regulatory Commission, June 12, 2001.
4. Hickey JW. Guidance to NRC regions for licensing Cordis, Novoste, and Guidant intravascular brachytherapy systems. Division of Industrial and Medical Nuclear Safety, US Nuclear Regulatory Commission, December 12, 2001.
5. Information required for licensing remote afterloading devices. Policy and Guidance Directive FC 86-4, Revision 1. Division of Industrial and Medical Nuclear Safety, US Nuclear Regulatory Commission, September 28, 1993.
6. Medical Use of Byproduct Material. 10 CFR Part 35. Codified and Reissued. US Nuclear Regulatory Commission, September 1995.
7. Glasgow G.P. Potential regulatory consequences of the U.S. Nuclear Regulatory Commission designation of food and drug administration approved intravascular brachytherapy systems as high dose rate remote afterloading devices. Med Phys. 28:2001;1237-1238.
8. Medical use of byproduct material: proposed revisions. 10 CFR Parts 20, 32, and 35; medical use of byproduct material; draft policy statement; proposed rules. 10 CFR Chapter 1, Federal Register 1998; Vol. 63, No. 156 (August 13): 43516-43586.
9. Medical use of byproduct material: final rule. 10 CFR Parts 20, 32, and 35. Federal Register 2002; Vol. 67, No. 79 (April 24): 20250-20397.
10. Standards for protection against radiation; final rule. 10 CFR Part 20, Federal Register 1991; Vol. 56, No. 98 (May 21): 23360-23474.
11. Glasgow G.P. Radiation control, personnel training, and emergency procedures for remote afterloading units. Endocuriether/Hyperthermia Oncol. 12:1996;67-79.
12. Kubo H.D., Glasgow G.P., Pethel T.D., Thomadsen B.R., Williamson J.F. High dose-rate brachytherapy treatment delivery: report of the AAPM Radiation Therapy Committee Task Group No. 59. Med Phys. 25:1998;375-403.
13. Glasgow G.P., Dogan N., Mick F. Quality assurance autoradiographs of Ir-192 and Sr-90 intravascular brachytherapy systems. Med Phys. 29:2002;1225.