ML20211K377
| ML20211K377 | |
| Person / Time | |
|---|---|
| Site: | 07001402 |
| Issue date: | 07/13/1983 |
| From: | NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| To: | ABINGTON MEMORIAL HOSP., ABINGTON, PA |
| Shared Package | |
| ML20211K358 | List: |
| References | |
| NUDOCS 8606270387 | |
| Download: ML20211K377 (3) | |
Text
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UNITED STATES NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C.
20555 4
LICENSE:
SNM-1412 ABINGTON MEMORIAL HOSPITAL EXPIRATION DATE:
09/30/83 1200 YORK ROAD PROGRAM CODE:
22160 ABINGTON PENNSYLVANIA 19001 NOTICE DATE:
07/13/83
SUBJECT:
NOTICE OF EXPIRATION 1
THIS LETTER IS TO REMIND YOU THAT YOUR HRC LICENSE (AS IDENTIFIED ABOVE)
AUTHORIZING USE OF PLUTONIUM-238 NUCLEAR-POWERED PACEMAKERS WILL EXPIRE SOON (FOR SPECIFIC DATE. SEE ABOVE).
WE WANT TO CALL YOUR ATTENTION TO SOME SPECIAL CONDITIONS ON YOUR LICENSE AND EXPLAIN HOW THESE CON-DITIONS AFFECT YOUR DECISION WHETHER TO RENEW THE LICENSE.
IN THE UNITED STATES, ANYONE WHO POSSESSES AND USES PLUTONIUM MUST BE COVERED BY A LICENSE (10 CFR 10.3).
PATIENTS IN WHOM YOU HAVE IMPLANTED PLUTONIUM PACEMAKERS ARE COVERED BY THE HOSPITAL"S LICENSE; SEE CONDITION
- 11. OF YOUR LICENSE.
IN CONDITIONS 15. AND 16. OF YOUR LICENSE YOU ARE COMMITTED TO FOLLOWING ALL PATIENTS WITH IMPLANTED PLUTONIUM PACEMAKERS FOR THE LIFE OF THE PATIENT OR UNTIL THE PACEMAKER IS REMOVED AND RETURNED TO THE MANUFACTURER FOR PROPER DISPOSAL.
FOLLOW-UP PROCEDURES MUST BE IN ACCORDANCE WITH THE PROTOCOL ESTABLISHED BY THE MANUFACTURER AND APPROVED BY NRC.
I.
TERMINATION A.
YOU CAN REQUEST TERMINATION OF YOUR LICENSE IF:
- YOU DO NOT WANT TO IMPLANT PLUTONIUM PACEMAKERS IN THE FUTURE ANQ
- YOU HAVE NEVER RECEIVED ANY PLUTONIUM PACEMAKERS QR
- All PLUTONIUM PACEMAKERS THAT WERE RECEIVED WERE RETURNED TO THE MANUFACTURER BEFORE IMPLANT IN A PATIENT AND/OR
- All PLUTONIUM PACEMAKERS IMPLANTED IN PATIENTS HAVE BEEN RECOVERED AND RETURNED TO THE MANUFACTURER.
B.
TO REQUEST TERMINATION OF YOUR LICENSE, PLEASE SEND US A SHORT LETTER, SIGNED BY THE HOSPITAL ADMINISTRATOR.
YOUR LETTER SHOULD BE RECEIVED BY HRC BEFORE YOUR LICENSE EXPIRES.
YOUR LETTER SHOULD SPECIFY YOUR LICENSE NUMBER AND SHOULD CLEARLY EXPLAIN THE CIRCUMSTANCES AT YOUR HOSPITAL THAT MAKE TERMI-NATION APPROPRIATE.
8606070387 860508 REG 1 LIC70 SNM-1412 PDR
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LICENSE NO:
SNM-1412 C.
PLEASE REQUEST TERMINATION OF YOUR LICENSE RATHER THAN SIMPLY ALLOWING Tile LICENSE TO EXPIRE.
NRC EXPENDS A SIGNIFICANT AMOUNT OF EFFORT IN DETERMINING Tile STATUS OF MATERIALS AUTil0RIZED BY EXPIRED LICENSES, THEIR DISPOSITION, ETC. AND IN MAKING APPROPRIATE CHANGES Ill OUR RECORDS; WE WOULD APPRECIATE YOUR HELP IN THIS MATTER.
II.
RENEWAL A.
RENEWAL OF YOUR LICENSE IS APPROPRIATE IF:
- YOU NEED TO CONTINUE Ti1E FOLLOW-UP PROCEDURES FOR PATIENTS W ITil IMPLANTED PLUTONIUM PACEMAKERS AND/OR
AWAITING SHIPPING INSTRUCTIONS AND MATERIALS FROM M AtlU F AC TU R E R ) AND/OR
- YOU WAl1T TO MAltlTAIN Tile OPTION OF IMPLAtlTING PLUTONIUM PACEMAKERS.
B.
TO REQUEST RENEWAL OF YOUR LICENSE, PLEASE SEND US A LETTER, SIGNED BY THE HOSPITAL ADMINISTRATOR.
YOUR LETTER SHOULD BE RECEIVED BY NRC AT LEAST 30 DAYS BEFORE YOUR LICENSE EXPIRES AND SHOULD CONTAIN THE FOLLOWING INFORMATION IN SUPPORT OF YOUR RENEWAL REQUEST:
1.
NUMBER OF YOUR LICENSE TilAT IS TO BE RENEWED.
2.
YOUR IllSTITUTION"S NAME At1D MAILING ADDRESS AS THEY SHOULD APPEAR IN ITEMS 1 AND 2 0F YOUR RENEWED LICENSE.
3.
Tile NUMBER OF PLUTONIUM PACEMAKERS TO BE AUTil0RIZED.
IF YOU ARE AUTl10RIZED FOR MORE TilAN ONE MANUFACTURER"S UNIT, SPECIFY THE tlUMBER OF EACil MANUFACTURER"S PACEMAKERS WE SHOULD AUTHORIZE.
BE SURE Til AT THE NUMBERS YOU SPECIFY ARE SUFFICIENT TO COVER ALL PATIENTS WITil IMPLANTED PLUTONIUM PACEMAKERS AND ANY EXTRA YOU MAY WANT FOR FUTURE IMPLANTS.
4.
ACTIVITIES TO BE CONDUCTED UtIDER YOUR LICENSE.
Tile PRINCIPAL REASONS FOR RENEWING A PLUTONIUM PACEMAKER LICENSE ARE:
(1) TO C0tlTINUE Tile AUTl10RIZED ACTIVITIES (I.E.,
RECEIVE AND IMPLANT PACEMAKERS, FOLLOW PATIENTS WI Til IMPLANTED DEVICES, RETURN EXPLANTED PACENAKERS TO MANUFACTURER FOR PROPER DISPOSAL) AND (2) TO FOLLOW PATIENTS WITil IMPLANTED PACEt1AKERS AtlD TO RETURt1 EXPLANTED PACEMAKERS TO Tile MANUFACTURER FOR PROPER DISPOSAL (BUT NOT TO IMPLANT PACEMAKERS IN Tile FUTURE).
PLEASE EXPLAIN EXACTLY WHAT YOU WISil TO DO WITH PLUTONIUM PACEMAKERS.
e-9 o
i LICENSE NO:
SNM-1412 3-5.
UPDATE OF THE !.ISTING OF PHYSICIANS WHO ARE INVOLVED IN YOUR PLUTONIUM PACEMAKER PROGRAM.
-THE NAMES OF THE PHYSICIANS ARE FOUND IN CORRESPONDENCE LISTED IN CONDITION
- 16. OF YOUR LICENSE.
FOR EACH HEW PHYSICIAN TO BE ADDED TO YOUR LICENSE, SPECIFY THE PHYSICIAN"S NAME, OFFICE ADDRESS AND TELEPHONE NUMBER, STATE.IN WHICH LICENSED TO PRACTICE MEDICINE, SPECIALTY BOARD CERTIFICATION, POSITION WITH YOUR INSTITUTION, AND DESCRIBE THE PHYSICIAN"S PREVIOUS EXPERIENCE WITH PACEMAKERS (NOT NECESSARILY PLUTONIUM PACEMAKERS).
YOU SHOULD ALSO SUBMIT A STATE-MENT SIGNED BY EACH NEW PHYSICIAN CERTIFYING THAT THE PHYSICIAN IS FAMILIAR WITH THE MANUFACTURER"S NRC-APPROVED PROTOCOL AND AGREES TO FOLLOW THAT PROTOCOL.
6.
DESCRIPTION OF ANY CHANGES IN THE COMMITMENTS CONTAINED IN THE CORRESPONDENCE LISTED IN CONDITION 16. OF YOUR 4
LICENSE.
III.
FEES A.
NO FEE IS REQUIRED FOR TEMINATIONS.
I B.
NO FEE IS REQUIRED FOR RENEWAL OF A PLUTONIUM PACEMAKER LICENSE IF YOUR HOSPITAL HOLDS ANOTHER NRC LICENSE.
C.
A RENEWAL FEE IS REQUIRED BY 10 CFR 170.31 IF YOUR HOSPITAL DOES NOT HOLD ANOTHER NRC LICENSE.
(RENEWAL FEE SHOULD ACCOMPANY REHEWAL REQUEST.)
i ENCLOSURES:
MATERIAL LICENSING' BRANCH 10 CFR PARTS 70 AND 170 DIVISION OF FUEL CYCLE AND MATERIAL SAFETY 4
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