ML19261A997
| ML19261A997 | |
| Person / Time | |
|---|---|
| Issue date: | 01/12/1979 |
| From: | James O'Reilly NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION II) |
| To: | MEDICAL COLLEGE OF HAMPTON ROADS, NORFOLK, VA (FORMER |
| References | |
| NUDOCS 7902090176 | |
| Download: ML19261A997 (1) | |
Text
g, NUCLEAR REGULATORY COMMISSION REGloN il g
3 g
E 101 M ARIETTA STREET, N.W.
,8, ATLANTA, GEORGIA 30303 JAN 121979 EASTERN v ! R G I t. I A MEDICAL C AUTHORIT 855 aEST Braw 8LET0" AVENUE NORF(!LK vA 23510 Gentlemen:
The enclosed IE Circular 79-01, is forwarded to you for information.
If there are any questions related to your understanding of the cuggested actions, please contact this office, LO $;
my gmes P. O'Reilly Di ector C
Enclosures:
1.
IE Circular No. 79-01 2.
List of IE Circulars Issued in 1978 7902090179
t UNITED STATES NUCLEAR REGUIMORY COMISSIQi OFFICE T INSPIL7IOJ RO DJDRCDeir k'ASHDolui, D.C.
20555 January 12, 1979 IE Circular No. 79-01 ACEINISTRATIQi OF UNAUDDRIZID BYPRODUC'T MATERIAL 'IO IDrANS Description of Circunstances:
Recently the U. S. Nuclear Regulatory Ccmnission (NRC) has investigated two incidents in which reagent grade ecstpounds containing byproduct material were adnunistered as intravenous radicpharmaceuticals to humans.
These ccupounds 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 that the forms used in diagnostic studies and should not have been shipped by the supplier.
In cne case Seleniun-75 labeled selenious acid wzs shipped instead of Selenlun-75 labeled selencinethionine. In the other case Ytterbiun-169 labeled chloride was shipped instead of Ytterbiun-169 labeled diethylenetrianunepentaacetic acid (DTPA).
'Ihe hospitals which received these materials should not have accepted thcnn since they were not authorized to possess thern by their NRC license.
In additicn, the hospital personnel preparing the patient doses should not have prepared these materials for adnunistration to a patient since the labels, leaflets, and brochures in each case identified the radioisotcpe and chemical form and included a warning that the radioactive material was not for use in hurans or clinical diagnosis.
Noticx! to Medical Licensees:
Medical licensees should have procedures to be follo d by persons preparing radiophanraceuticals for adnunistration to hurans. The
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procedures should incitrie the following steps:
a.
ccnfinnation that the cxmpound is a radicpharmaceutical intended for hunan use, DUPLICATE DOCUMENT Entire document previously entered 1 of 2 into system under:
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