ML20245F029
| ML20245F029 | |
| Person / Time | |
|---|---|
| Issue date: | 06/06/1989 |
| From: | Novak T NRC OFFICE FOR ANALYSIS & EVALUATION OF OPERATIONAL DATA (AEOD) |
| To: | Cunningham R NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| Shared Package | |
| ML20245F032 | List: |
| References | |
| AEOD-N901, NUDOCS 8906280022 | |
| Download: ML20245F029 (2) | |
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.'l' June 6, 1989 MEMORANDUM FORi Richard E. Cunningham, Director Division of Industrial and Medical Nuclear Safety, NMSS FROM:
Thomas M. Novak, Director Division'of Safety Programs, AE00
SUBJECT:
ENGINEERING EVALUATION: USE OF RADI0 ACTIVE IODINE FOR INFREQUENT MEDICAL STUDIES AND THOSE PERFORMED UNDER AN FDA INVESTIGATIONAL EXEMPTION FOR A NEW DRUG (IND)
AE0D/N901 We have reviewed several cases in which radioactive iodine was misused for diagnostic and therapeutic purposes and patients received an organ dose of several hundred rad.
Although the number of these reported cases and the amount of misused radio-active iodine are small, they affect the health and safety of the patients.
l It is our understanding that, in the future, medical institutions may be widely using much larger amounts of radioactive iodine for monoclonal antibody IND studies. As a result, the impact of any misadministration on '.? health and safety of the patients and the licensee employees could be much greater.
On the basis of our review, we believe that there may be a generic problem associated with the use of radioactive iodine for infrequent medical studies and those performed under an IND. Also, from our evaluation, we have concluded that management oversight of these studies is inadequate and that personnel performing them lack adequate training and experience with the appropriate quality assurance procedures. Our specific findings and conclusions are given in the enclosed report.
We will be glad to answer any questions that you may have regarding this matter.
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Thomas M. Novak, D r
j PNV Division of Safety Programs, AE0D
Enclosure:
As stated l
cc:
R. Bernero, NMSS E. Jordan, AE0D
Contact:
H. Karagiannis X24258 1
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MEMORANDUM FOR:
Richard E. Cunningham, Director Division of Industrial and Medical Nuclear Safety, NMSS FROM:
Thomas M. Novak, Director Division of Safety Programs, AE0D
SUBJECT:
ENGINEERING EVALUATION: USE OF RADI0 ACTIVE I0 DINE FOR INFREQUENT MEDICAL STUDIES AND THOSE PERFORMED UNDER AN FDA INVESTIGATIONAL EXEMPTION FOR A NEW D UG (IND)
AEOD/N901 We have reviewed several cases in which radioactive iodine w s misused for diagnostic and therapeutic purposes and patients received pn organ dose of several hundred rad.
Although the number of these reported cases and the amo nt of misused radio-active iodine are small, they affect the health and s (ety of the patients.
It is our understanding that, in the future, medica / institutions may be widely using much larger amounts of radioactive iodine fo monorlonal antibody IND studies. As a result, the impact of any misadmin trations on the health and safety of the patients and the licensee employees)could be much greater.
Onthebasisofourreview,webelievethatthe/re may be a generic problem associatedwiththeuseofradioactiveiodine/forinfrequentmedicalstudies and those performed under an IND. Also, froni our evaluation, we have concluded that management oversight of these studies /(s inadequate and that personnel performing them lack adequate training and experience with the appropriate quality assurance procedures. Our specif c findings and conclusions are given in the enclosed report.
We will be glad to answer any questic s that you may have regarding this matter.
l Thomas M. Novak, Director Division of Safety Programs, AEOD
Enclosure:
As stated
Contact:
H. Karagiannis X24258 Distribution DCS/PDR DSP R/F HKaragiannis KBlack l
VBenaroya NASllL_
NAS \\
DSP DSP HKaragiannis KBlack VBenaroya TNovak 3
6/n/89sr 6/{/89 6/ /89 6/ /89 l
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