ML19269B856
| ML19269B856 | |
| Person / Time | |
|---|---|
| Issue date: | 01/12/1979 |
| From: | James O'Reilly NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION II) |
| To: | VIRGINIA COMMONWEALTH UNIV., RICHMOND, VA |
| References | |
| NUDOCS 7901170288 | |
| Download: ML19269B856 (1) | |
Text
98 #foug UNITED STATES
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NUCLEAR REGULATORY COMMISSION
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o RE GION il 101 MARIETT A STREET, N.W.
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ATLANTA. GEORGI A 30303
- '4' JAN 121979 VIRGINIA C. ()" u rit.
- E A L T H U'.I/EW3ITY CHAIRMAN, I SOTOPE CD'eI T T EE 1200 EAST PuoAD STREET HICHMOND VA 23219 Gentlemen:
The enclosed IE Circular 79-01, is forvarded to you for information.
If there are any questions related to your understanding of the suggested actions, please contact this office, n
n L( C es P. O'Reilly Di ector r
Enclosures:
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IE Circular No. 79-01 2.
List of IE Circulars Issued in 1978
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NUCLEAb b Lb b I3 f COMMISSION OFFICE OF INSPECTION AND ENFORCEMEhT WASHINGTON, D.C.
20555 January 12, 1979 IE Circular No. 79-01 ADMINISTRATION OF UNAUTHORIZED BYPRODUCT MATERIAL TO HUMANS Description of Circumstances:
Recently the U. S. Nuclear Regulatory Commission (NRC) has investigated two incidents in which reagent grade compounds containing byproduct material were administered as intravenous radiopharmaceuticals to humans.
These compounds had neither been manufactured for use as radiopharma-ceuticals nor undergone testing for human use.
In these incidents the byproduct materials were in chemical forms other than the forms used in diagnostic studies and should not have been shipped by the supplier.
In one case Selenium-75 labeled selenious acid was shipped instead of Selenium-75 labeled selenamethinnine.
In the other case Ytterbium-169 labeled chloride was shipped instead of Ytterbium-169 labeled diethylenetriaminepentaacetic acid (DTPA).
The hospitals which received these materials should not have accepted them since they were not authorized to possess them by their NRC license.
In addition, the hospital personnel preparing the patient doses should not have prepared these materials for administration to a patient since tne labels, leaflets, and brochures in each case identified the radioisotope and chemical form and included a warning that the radioactive material was not for use in humans or clinical diagnosis.
Notice to Medical Licensees:
Medical licensees should have procedures to be followed by persons preparing radiopharmaceuticals for administration to humans. The procedures should include the following steps:
a.
confirmation that the compound is a radiopharmaceutical intended for human use, I of 2
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IE Circular No. 79-01 b verification that the type, chernical form and quantity of byproduct material is the correct one for the particular patient and the medical procedure being used, and c.
verification that the radiopharmaceutical was manufactured and distributed under a license issued by the NRC or and Agreement State.
These confirmations and verifications can be accomplished by reviewing the labels, leaflets, and brochures enclosed in the package.
Medical licensees should instruct and require personnel to follow these procedures in preparing and administering radiopharmaceuticals to patients.
The contents of this Circular should be brought to the attention of all personnel who prepare and administer licensed radiopharmaceuticals to human patients.
No written response to this Circular is required.
If you require additional information regarding this subject, please contact the Director of the appropriate NRC Regional Of fice.
IE Circular No. 79-01 January 12, 1979 LISTING OF IE CIRCULARS ISSUED IN 1978 Circular Subject Date Issued To No.
of Issue 78-01 Loss of Well Logging h/5/78 All Holders of Source Well Logging Source Licenses 78-02 Proper Lubricating 011 h/20/78 All Holders of for Terry Turbines Reactor OLs or cps 78-03 Packaging Greater Than 5/12/78 All Holders of Type A Quantities of Reactor OLs, cps, Low Speeffic Activity Fuel Cycle, Rsdioactive Material Priority I Material for Transport and Waste Disposal Licenses 78-OL Installation Error That 5/15/78 All Holders of Ceuld Prevent Closing of Reactor OLs or Fire Doors cps 78-05 Inadvertent safety Injection 5/23/78 All Holders of During Cooldovn Reacter OLs or cps 78-06 Potential Co=:en Mode 5/23/78 All Folders of Flooding of ECCS Equip =ent Reactor OLs or hoo=s at BWR Facilities cps 78-07 Damaged Co=ponents of a 5/11/78 All Holders of Bergen-Paterson Series Reactor OLs or 25000 Hydraulic Test cps St and 78-08 Environ = ental Qualification 5/31/78 All Holders of of Safety Related Equipment Reacter OLs er at Nuclear Power Plants cps 78-09 Arcing of General Electrie 6/5/78 All Holders of Company Size 2 Contactors cps Enclosure Page 1 of 3
IE Circular No. 79-01 January 12, 1979 LISTING OF IE CIRCULARS ISSUED IN 1978 Circular Subject Date of Issued to No.
Issue 78-10 Control of Sealed 6/14/78 All Medical Sources Used in Licensees in Radiation Therapy Categories G and C1 78-11 Recirculation M-G 6/15/78 All Holders of Set Overspeed Stops BWR OLs or cps 78-12 HPCI Turbine Control 6/30/78 All Holders of Valve Lift Rod Bending HWR OLs or cps for plants with HPCI Terry Turbine 78-13 Inoperability of Multiple 7/10/78 All Holders of Service Water Pumps Reactor OLs and cps except for plants located in: AL, AK, CA, FL, CA, LA, MS, SC 78-14 HPCI Turbine Reversing 7/12/78 All Holders of BWR Chamber Hold Down Bolting OLs or cps for plants with a HPCI Terry Turbine excepting Duane Arnold and Monticello 78-15 Checkvalves Fail to 7/20/78 All Holders of Close In Vertical Reactor OLs or cps Position 78-16 Limitorque Valve 7/26/78 All Holders of Actuators Reactor OLs or cps Inad qqnte Guard Training /
10/13/78 All Holders of 78-17 i
Qu' 'Micetion and Falsified and applicants itai.ing Records for Reactor OLs.
Enclosure Page 2 of 3
IE Circular No. 79-01 January 12, 1979 LISTING OF IE CIRCULARS ISSUED IN 1978 Circular Subject Date Issued To No.
of Issue 78-18 UL Fire Test 11/6/78 All Holders of Reactor OLs or cps 78-19 Manual override (Bypass) of 12/29/78 All Holders of Safety Actuation Signals Reactor cps