ML19296A280
| ML19296A280 | |
| Person / Time | |
|---|---|
| Issue date: | 01/12/1979 |
| From: | Seyfrit K NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION IV) |
| To: | AIR FORCE SCHOOL OF AEROSPACE MEDICINE, BROOKS AFB |
| References | |
| NUDOCS 7903060098 | |
| Download: ML19296A280 (1) | |
Text
_
8ps %g'#c Of.lT L O S T AT rS e
fJUCLE Alt HCGlJL A TOR / COWIT.3 ION O \\*
/^
liCGION IV h *}pr 011 IlYAf; PLAZA DalVE, SUITE 1000 S
gg Rfp
- p, pj A R ufiG TON, T E X A'. 76011
,g' v -s g-January 12, 1979 License !!os.
42-05834-01 42-05834-02 Department of the Air Force USAF School of Aerospace Medicine Brooks AFB, Texas Gentlemen:
The enclosed IE Circular 79-01, is forwarded to you for infornation.
If there are any questions related to your understanding of the suggested actions, please contact i.his office.
Sincerely, f
(V. Seyfr
.;f Karl Director
Enclosures:
1.
IE Circular !!o. 79-01 2.
List of IE Circulars Issued in 1978 3
D wD b
u Ax g
UNITED STATES g
fiUCLEAR REGULATORY C0!@11SSION OFFICE OF INSPECTION AND ErlFORCEMENT WASHINGTON, D.C.
20555 IE Circular No. 79-01 January 12, 1979 Page 1 of 2 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 selenic d acid was shipped instead of Selenium-75 labeled selenomethionine.
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 authrized 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 the 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, "Dd88 7901160 383