ML19224A405
| ML19224A405 | |
| Person / Time | |
|---|---|
| Issue date: | 01/12/1979 |
| From: | NRC OFFICE OF INSPECTION & ENFORCEMENT (IE) |
| To: | |
| References | |
| IEC-79-1, NUDOCS 7901160383 | |
| Download: ML19224A405 (5) | |
Text
.
!iUCLEAR RE5bi.hTORY CCf"1ISSION OFFICE OF INSPECTION AMD EliFORCE'!E!!T tlASHINGT0!!, D.C.
E05E5 January 12, 1979 IE Circular !;o. 79-01 ACNI!ilSTRATION OF U!: AUTHORIZED BYFRODUCT MATERIAL TO HU!WIS Description of Circunstances:
Recently the U. S. Nuclear Regulatory Comissicn (!;RC) hcs investigated two incidents in which reagent grade compounds containing byproduct raterial were administered as intravenous radicpharmaceuticals to humans.
These compounds had neither been tenufactured for use as radiopharra-ceuticals nor undergene testing for human use.
In theee incidents the byproduct caterials were in chanical foms other that the for s used in diagnostic studies and should not have.been shipped by the supcifer.
In one case Selenien-75 labeled selenious acid was shipped instead of Selenium-75 labeled selencrethionine.
In the other case Ytterbium-169 labeled chloride was shipped instaad of Ytterbium-169 labeled diethylere:riatinepentaacetic acid (LTPA).
The hospitals '.thich received these riaterials should not have accepted then since they were not authorized to nossess them by thcir ':RC license.
In additien, the hospital parscnnel preparing the patient doses shculd not have prepared these caterials for administration to a patient since the labels, leaflets, and brochure's fr. each case identified the radioisctece and chemical fem and included a warning inat the radioactive rcterial was not for use in humans or clinical diagnosis.
?!otice to !!edical Licensees:
'*edical licensees should have' procedures to be folicwed by persens preparing radiophamaceutic.als. for administratica to humans.
The procedures should include the _folicwing steps:
a.
confir ation that the compound is a radicpharraceutical intandad for human use, b.
verification that the type, chemical form and quantity of byproduct naterial is he correct one for the particular patient and the medical procedure being us.ed, and
~
c.
verification that the radiophamaceutical was nanufactured and distributed under a license issued by,the t;RC or and Agrecrent State.
l 2,.. c *
...s.-
8
- NRC FCUt !!1 (9 'o n NROf 3243
- s. s.
o = < =' "
- e'
- 5 3 * * ' e ti ' a r e - e
+
IE Circular."o.
79- 01 January 12,1979 These confir-ations and verifications can be accceplished by reviewing the labels, leaflets, and brochures enclosed in the package.
tedical licensees shculd instruct and require personnel to folicw these precedures in preparing and a&inistering radiopharmaceuticals to patients.
The contents of this Circular should be brought to the attention of all personnel who prepare and administer licensed radiophar-.aceuticals to hucan patients.
No writtc.n response % this Circular is required.
If you recuire additiona'. info m:icn recarding this subject, please contact the Director of'the appreoriate "RC Ecgional Office.
e 0 " ': 8 **
5
- "E
..,n--oo~,--
NRC 70013 3 ( 9-76 ) 'iRC4 ^2 40 t v: s.2avr== m =r...=n=a one.cr.is?e-.:
421 002
I. Circular No. 79-01 January 12, 1979 LISTING OF IE CIRCULARS ISSUED I!! 1973 Circular Subject Date Issued To tio.
cf Issue 78-01 Less of Hell Logging 4/5/73 All Holders of Scurce Hell Logging Scurce Licenses 78-02 Proper Lubricating Oil 4/20/78 All Holders of for Terry Turbines Recctor CLs or cps 78-03 Packaging Greater Than 5/12/78 Fil Holders of Type A Oucntities of Reactor Ols, cps, Low Specific Activity Fuel Cycle, Padioactive aterial Priority I Material for Transport and'U2ste Disposal Licenses 78-C4 Installation Error That 5/15/78 All Folders of Could Prevent Closing of Reactor CLs or Fire Doors cps 70-05 Inadvertant Safety Infection 5/23/78 All Fcidars of During Ccoldown Reactor CLs or cps 75-05 Potential Ccamen flode 5/23/73 All Eciders of Flecding of ECCS Equipment
.9eacter CLs cr Recms at EUR Facilities cps 73-07 Damaged Cceponents of a 5/31/73 All Helders cf Bergen-?atersen Series Reactor CLs or 25003 Hydraulic Test cps Stand 7C-03 Envircr.nental Qualification 5/31/73 All Molders of of Safety Related Equipment 2eactor CLs or at nuclear Power F_lants cps 73-09 Arcing of General Electric 6/5/78 All Holders of Ccrpany Sfae 2 Centacters cps Enclorure Pege 1 cf 3 l
S y e ev a n t >
_. - -. - -. - ~. - -
.. ~
3 aft >
M C TG724 !!3 (2 5) N3Cf C:40 C v a s. s o v t = ~ ~ t ~ r * * "'m 2 o ' c '8 'e eam
LE.CirculaF.':c. 79-01 January 12, 1979 LISTING OF IE CIRCUL'.:',5 ISSUE 3 Iti 1973 Circular Subject Date of Issued to No.
Issue 78-10 Control of. Sealed '
6/14/78 All l'edical Scarces L' sed in Licensees in Radiation Therapy.
Categories G and G1 7S-11 Recirculation M-G 6/15/70 All Holders of
' Set Oversceed Stops E!!R CLs cr cps 72-12 MPCI Turbine Control C/30/7S All Holders of Valve lift Rod Sending MR Ots or CFs for plants with HPCI Terry Turbine 75-13 Inoperability of Multiple 7/10/73 All ~ Holders of Servic: k'ater Pu. ps Reactor GLs and cps except for plants located in: AL, AK, CA, FL, GA, lA,**S, SC 73-14 HPCI Turbine Eeversing 7/12/78 All Holdars of E"rl?,
Chamber Hold Dcwn Solting CLs or cps for plants with a HPCI Terry Turbine encaptinc Cuane Arncid and Ponticello 70-15 Checkvalves Fail to 7/23/70 All Holders of Cicsc In Vertical Peactor OLs cr C?s Position
[
73-16 Li..itcrque Valve 7/2G/70 All Holde.s of Actuators reactor CLs er cps 73-17 Inadequate Guard Trai:ing/
10/13/73 All Holders of Qualification and, Falsified and asplicants Training Records for Reactor CLs.
70-13 UL Fire Test 11/6/78 All Holders of Peactor CLs or cps inclosure Page 2 cf 3 orrecs e e v = = a ne s p-O AIE *
- - ~. ~
NRC :C?Ji 313 i? 6) 'iR CN 0 ? 40
- 1' s. s. c. o v s = = = : = t ** = rr=a c e r.c ri +,7e - e a e.e aa 421 004
IE CiFiull? "c M-M.
January 12, 1979 LISTING CF Is CI?.CL'LC.S ISCUE0 IN 1973 i
Circular Subject D:te of Issued to l
No.
Issue 73-10 Control of. Sealed '
6/14/73 All t'edical Scurces L' sed in Licensees in Radiation Therapy.
Catecories G and G1 78-11 Recirculation M-G ~
C/16/7C-All Holders of Set Overspeed Stops El:R CLs or CFs 73-12 ElPCI Turbine Control C/30/7S All Holders of Valve lift Rod 5ending BWR Ols or CFs for plants with HFCI Terry Turbine 75-13 Incperability of Multiple 7/10/73 Ali liciders of Service L'ater Fu. ps Reactor CLs and C?s e.xcept for plants Iccated in: AL, AK, CA, FL, GA, LA, "S,
SC 73-14 HPCI Turbine Reversing 7/12/73 All Holdars of EW?,
Chamber Pold Derm Solting CLs or C?s for p12nts with a HPCI Terry Turbine er.ceptinC Cur.e Arncid and Fonticello 70-15 Chackvalves Fail to 7/23/70 All Holders of Cicsc In 'inrtical, Peactor CLs cr C?s Fosition 70-16 Linitcrcue Valve 7/2G/70 All Holders of Actuators Eenctor CLs cr cps 73-17 Inadecuate Guard Training /
10/13/78 All Folders of Qualificatien and Falsified and applicants Training P.ecords for F.eacter Cis.
70-13 UL Fire Test 11/5/78 All Holders of
- ecctor CLs or CRs Enclosure Page 2 cf 3 c, : o-
{
=.., _
i _____
w c 3c w m r. u - w r u.o
. u... m,---,,- ~ c, *
...-.....m 421 005
IE Circular t o. 79-01 January 12, 1979 l
i LISTIi;G OF IE CIRCULARS ISSUED I!! 197S i
i Circular Subject Date Issued To I
f!o.
cf Issue 73-19 Manual Override (2ypass) of 12/29/73 All Holders of Safety Actuation Signals Peactor cps i
04'th S.RC OU{3 ' 9 ' 's ) N3 OI 3240 J,3 v g e oe me t su ' *
- i m ei se G C F W ' C E, f874= ele 424 421 r06}}