ML20235G898
| ML20235G898 | |
| Person / Time | |
|---|---|
| Site: | 07001500 |
| Issue date: | 03/11/1987 |
| From: | Johansen J NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION I) |
| To: | |
| Shared Package | |
| ML20235G901 | List: |
| References | |
| NUDOCS 8707140422 | |
| Download: ML20235G898 (3) | |
Text
{{#Wiki_filter:; j - I 3 U PAGE OF l l w' am m ' df.~u.S. NUCLEAR REGULATORY COMMISSION PAGES
'. MATERIALS LICENSE Amendment No. 09 i Pursuant to the Atomic Energy Act of 1954, as amended, the Energy Reorganization Act of 1974 (Public Law 93-438), and Ti;le 10, j f Code of Federal Regulations, Chapter I, Parts 30,31,32,33,34,35,40 and 70, and in reliance on statements and representations l g heretofore made by the licensee, a license is hereby issued authorizing the licensee to receive, acquire, possess, and transfer byproduct, i
( source, and special nuclear material designated below; to use such material for the purpose (s) and at the place (s) designated below;to l 4 deliver or transfer such material to persons authorized to receive it in accordance with the regulations of the applicable Part(s). This l' license shall be deemed to contain the conditions specified in Section 183 of the Atomic Energy Act of 1954, as amended, and is i g subject to all applicable rules, regulations and orders of the Nuclear Regulatory Commission now or hereafter in effect and to any ! gl conditions specified below. gg , m !
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Licensee In accordance with letter dated i 3-{anuarg7,1987, i I' Washington Hospital Center "" 5' " l SNM-1446 is amended in R ATTN: Executive Vice President its entirety to read as follows: i d W j 2. 110 Irving Street, N.W. Washington, D.C. 20010
- 4. ' Expiration 'date Janua ry 31, 1989 l
g l N 5. Docket or I i 4 Reference No. 070-01500 !
'lj 6. Byproduct, source, and/or 7. Chemical and/or physical 8. Maximum amount that licensee l' special nuclear material form may possess at any one time l f; , under this license i f A. Plutonium (Principal A. Sealed sources A. 10.75 grams (43 individuals, q Radionuclides Pu-238) sources not to exceed 6 250 milligrams each) l, % B. Plutonium (Principal. B. Sealed sources B. 2.,475 grams (11 individual ! % RadionuclidePu-238) sources not to exceed l 225 milligrams each) l flC.
g Plutonium (Principal C. Sealed sources C. 5.0 grams (4 individual i ( Radionuclides Pu-238) sources not to exceed 4250 milligrams each) l !-
,jD. Plutonium (Principal D. Scaled sources D. 5.25 grams (21 individual ;
a Radionuclides Pu-238) sources not to exceed ; ,, 9 , 250 milligrams each) i h l g 9. Authorized use j
' ' l 6 . . ;
R A. As a component of Coratomic Nodel C-100 or C-101 nuclear-powered cardiac pacemakers j N and pacemakers with Serial Numbers 1150, 1151, 1154, 1156 and 1157 for clinical 8 evaluation in accordance with the " Human Clinical Protocol for the Coratomic C-101 8 Radioisotope Powered Cardiac Pacer, " dated November 1, 1975. This license l authorizes possession of these pacemakers for purposes of explantation, recovery i and disposal but not for reimplantation. ! 6 B. Implantation in humans as a component of Cordis Nuclear Omni-Stanicor Model 184A 1 R nuclear-powered cardiac pacemakers for clinical evaluation in accordance with f I " Master Protocol for Clinical Evaluttion of the Programmable Cordis Nuclear M Omni-Stanicor Pacemaker," dated October 30, 1974. p l C. As a component of Caratomic Model C-101P riuclear-powered pacemakers to be used in q i accordance with Investigational Device Exemption (IDE) G 810104/A2 (and an) !p* W subsequent amendments) as approved by the Food and Drug Administration. This l. W license authorizes possession of these pacemakers for purposes of explantation, H recovery and disposal but not for reimplantation. ,' D. Implantation in humans as a component of Coratomic Model C-101P nuclear-powered ll g pacemakers in accordance with " Human Implantation Protocol for the Coratomic C-101P gI Radioisotope Powered Cardiac Pacemaker," dated March 2, 1983. != 8707140422 870311 )\ ' fl " REG 1 LIC70 5NM-14A6 ppp ggggg,,,,,,gg7,;,,,,,,,g,g,,,,m3lllc -
y[ amenerv---------------- U.S. N aesmmmemunununennemusewezMLM AR REGULATORY COMMISSION Form 374 A 2 b PAGE OF PAGEL E , . License nurnW MATERIALS LICENSE - Docket or Reference number SUPPLEMENTARY SHEET Amendment No. 09 CONDITIONS
- 10. Licensed material shall be used only at Washington Hospital Center, 110 Irving Street, N.W., Washington, D.C.
- 11. The specified possession limit includes all licensed material possessed by the !
licensee under this license whether in storage, implanted in patients, or ! otherwise in use. l
; 12. The licensee shall report to the U.S. Nuclear Regulatory Commission, Region I, ATTN: Chief, Nuclear Materials Safety and Safeguards Branch, 631 Park Avenue, King of Prussia, Pennsylvania 19406, within 24 hours of occurrence, the death of any nuclear pacemaker patient, and any adverse reaction and/or malfunction involving a pacemaker system, including the leads. A written report giving details of the adverse '
reaction and/or malfunction shall bb submitted within 30 days.
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- 13. The licensee shall' report to the U.S. Nuclear Regulatory Commission, Region I, ATTN: Chief, Nuclear Materials Safety and Safeguards Branch, 631 Park Avenue, .
King of Prussia,' Pennsylvania 19406, within 10 days ~of loss o contact with a nuclear pacemaker p tient.
- 14. The licensee shall continue patient follow up'an'd' replacement procedures for the nuclear pacemaker during the life.of the patient.J Procedures for recovery and authorized disposal-of the nuclear pacemaker by return to the manufacturer shall be followed upon the death of the patient. '
- 15. Sealed sources or detector cells containing licensed material'shall not be opened or sources removed from source holders or detector cells by the licensee.
- 16. The licensee may transport licensed matlerial in accordan$e' with the provisions of 10 CFR Part 71, " Packaging and Transportation.of Radioactive Material".
- 17. Notwithstandingotherprovisionsorrequiremdnts'ofIDEG810104/A2andany subsequent amendments as approved by the Food and Drug Administration, the licensee shall comply with all conditions of this license and with the following requirements as they pertain to the licensee's use of the Coratomic Model C-101P pacemaker as authorized in Subitems 6.C. , 7.C. , 8.C. , and 9.C. of this license.
A. Before implanting a Model C-101P pacemaker, the licensee shall obtain a legally binding document, signed by the patient (or by a person authorized to consent for the patient), stating that the patient agrees to abide by the requirements outlined below, regardless of the patient's status with respect to participation in the above-referenced IDE.
- 1. Upon the patient's death or earlier if the Model C-101P pacemaker is removed for any reason, the Model C-101P pacemaker shall be returned to I
the licensee for return to the manufacturer for proper disposal.
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* ;. Form 374A U.S. ,N AR REGULATc RY COMMISSION 3 og 3 ,,ces PAGE i
ll . . Licei.se number
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MATERIALS LICENSE SNM-1446 SUPPLEMENTARY SHEET 070-01500 4 Amendment No. 09 (17. continued) CONDITIONS
- 2. The patient shall carry an identification card that: identifies the carrier as a patient with an implanted radionuclides-powered cardiac F pacemaker, specifies the manufacturer's name and model number,of the i implanted pacemaker, specifies the radionuclides contained in the pacer, f and presents explicit instructions for notification of responsible parties in the event of accident or difficulty. f)
- 3. The patient shall carry a uniform anatomical Gift Act Card authorizing removal of the Model C-101P pacemaker. , If the patient has not attainr.1 majority age, the, agreement card shall be, executed by the patient where possible and by his or her legal guardian. J 4
'4. The patient shall wear. an identification bracelet or other jewelry of the medical-alert type that carries the patient's name and a statement that the proper emergency telephone ar.d physician-should be called in an ;
emergency. - - i
- 5. ThepatientshallcontactthelicenseeatregularinAervalsnottoexceed six (6) months and shall notify the licensee within 30 days of a change of address. .
I r .
- 6. The patient shall notify the licensee, in advance, of the patient's intention to travel to foreign countries f - ,
B. The licensee shall: , ', t
- 1. Promptly return explanted Model 'C-101P pacemakers' to the manufacturer in l accordance with instructions (supplied by the manufacturer. l 1
- 2. Promptly notify the manufacturer of a patient's intention to travel to j foreign countries.
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. 18. Except as specifically provided otherwise in'this license, the licensee shall F, conduct its program in accordance with the statements, representations, and E procedures contained in the documents including any enclosures, listed below.
The Nuclear Regulatory Comission's regulations shall govern unless the state- , ments, representations and procedures in the licensee's application and corre-spondence are more restrictive than the regulations. j A. Letter dated December 1, 1983 B. Letter dated January 27, 1987 1 1 1 l For the U.S. Nuclear Regulatory Commission Original Signed Byf MAR 11 1987 Jenny M. Johansen 3 l' Date By h,l Nuclear Materials Safety and pj l Safeguards Branch, Region I l King of prussia, Pennsylvania 19406 F) b
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