ML20217H661
| ML20217H661 | |
| Person / Time | |
|---|---|
| Issue date: | 03/20/1998 |
| From: | Steven Baggett, John Lubinski NRC |
| To: | |
| Shared Package | |
| ML20217H641 | List: |
| References | |
| SSD, NUDOCS 9804060023 | |
| Download: ML20217H661 (9) | |
Text
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-REGISTRY!OF RADIOACTIVE SEALED SOURCES AND UEVICES-SAFETY EVALUATION OF DEVICE NO.: NR-440-D-806-S DATE:
MAR 2 01998; PAGE 1 OF'7' DEVICE TYPE:
. Technetium-99m. Pertechnetate Generator MODEL:
Ultra-Technekow~Models 006 through 012 DISTRIBUTOR / MANUFACTURER:
Mallinckrodt Medical, Inc.
2703 Wagner Place Maryland Height, MO 63043
. SEAT.pn SOURCE MODEL DESIGNATION:
Not Applicable i
ISOTOPE:
MAXIMUM ACTIVITY:
I
. Molybdenum-99 1350 mci (50 GBq)*
I l'
- See Description Section l
T.RAK TEST FREOUENCY:
Not Required I
' PRINCIPAL USE:
(V) General Medical Use 1
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. ~.
~ CUSTOM DEVICE:
YES X
NO p! '
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! REGISTRY OF RADIOACTIVE. SEALED SOURCES'AND DEVICES.
SAFETY EVALUATION OF-' DEVICE NO.: NR-440-D-806-S DATE:
MAR 2 01998 PAGE 2 OF 7 g
DEVICE' TYPE Te$hnetium-99m' Pertechnetate Generator DESCRIPTION:
The generator consists basically of the eluant reservoir, the
- lead shielded glass column containing the molybdenum-99 adsorbed
- on alumina, and necessary connections.
The outer shell is made of blue plastic, approximately 14" (36 cm) wide.
The eluant, 17.6 oz (500 ml) of sterile, pyrogen-free 0.9% sodium chloride solution, is contained in a 19.4 oz (550 ml) glass bottle sealed with a rubber septum and aluminum crimp.
The bottle is vented to the atmosphere via an air vent with a bacteriological filter.
The molybdenum-99 is adsorbed on alumina inside a column approximately 3" (7.6 cm) long and la (2.54 cm) in diameter.
The connections consist of hypodermic needles and tubes, needle hubs, latex and plastic connections, and silicone rubber tubing.
These basic components are fitted into a molded plastic housing.
Leur-Lock needles and sterile evacuated collecting vials are also contained in the plastic housing.
Collection vial sizes available on request are 0.18, 0.35, 0.71, and 1.06 oz (5, 10, 20, and 30 ml).
The manufacturer's package insert contains instructions for elution and radioassay.
Radioactive caution vial labels and radioassay pressure-sensitive shield labels are enclosed.
Since no preliminary preparation is required, initial elution procedures are the same as subsequent ones.
Elution is achieved by attaching a sterile needle to the plunger assembly and
. lowering the locking the plunger so that the needle pierces the shielded' evacuated collection vial.
The saline then automatically flows from the reservoir into the upper end of the
~
glassicolumn containing the Tc-99m, through the column, out the F
bottom end of the column,.and into the collection vial.
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REGISTRY OF-RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE g
PAGE 3 OF 7 NO.: NR-440-D-806-S DATE:
NMR 2 0 %G8 DEVICE TYPE:
Technetium-99m Pertechnetate Generator DESCRIPTION (Cont'd):
When shipped and between elutions, the plunger is kept in a raised position.
In this position, a spring pinches off the tubing which leads to the air vent and to the bottom end of the column.
The manufacturer makes available a Model No. 775 assay kit, MOLYTECH Calibration unit, suitable for radiometric assay for Mo-99 using a 1/8" (0.32 cm) lead assay cup.
The instructions sent with the Model No. 775 assay kit state that the AEC and Agreement States require that the molybdenum contamination should not exceed one microcurie of molybdenum-99 per millicurie of technetium-99m, and that the total administrated dose of technetium-99m should contain no more than 5 microcuries (0.185 MBq) of molybdenum-99.
This statement is not included in the instructions sent with each generator.
A dilution method for Tc-99m assay using a Co-57 source is presented in the package insert.
The suggested administered dose ranges for 154 lb (70 kg) patients which appear in the package insert for Tc-99m pertechnetate are:
Procedure Dose Range brain imaging 10-20 mci (370-74 0 MBq) thyroid gland imaging 1-10 mci (37-370 MBq) salivary gland imaging 1-5 mci (37-185 MBq) placenta localization 1-3 mci (37-111 MBq) blood pool imaging 10-20 mci (370-740 MBq)
'Predosing with potassium Perchlorate for brain, blood pool, and placenta studies is recommended.
No imaging instrumentation limitations are specified.
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE PAGE 4 OF 1 NO.: NR-440-D-806-S DATE:
MAR 2 01998 DEVICE TYPE:
Technetium-99m Pertechnetate Generator DESCRIPTION (Cont'd):
Generators will be manufactured on Saturday, and calibrated for the following Friday.
A decay time of at least 15 half-lives in a storage area is the recommended disposal method.
Contents of generators:
Model No.
MOLYBDENUM-99 ACTIVITY (Calibration date)
(Four days before) 006 50 mci (1.85 GBq) 135 mci (5.0 GBq) 007 100 mci (3.7 GBq) 270 mci (10 GBq) 008 200 mci (7.4 GBq) 540 mci (20 GBq) 009 300 mci (11.1 GBq) 810 mci (30 GBq) 010 400 mci (15 GBq) 1080 mci (40 GBq) 011 500 mci (18.5 GBq) 1350 mci (50 GBq) 012 150 mci (5.6 GBq) 400 mci (15 GBq)
EXTERNAL RADIATION LEVELS:
The lead shield surrounding the glass generator column is approximately 1-1/2" (3. 81 cm) thick for all Mallinckrodt models.
An optional auxiliary shield (Catalog No. 020) designed to provide a minimum of 3/4" (19.05 mm) additional lead for the front and sides is available.
The center section of the three-piece shield is moved to allow access for elution.
The 011, nominal 500 mci (18.5 GBq) model, is fitted with a 1/4" (6.35 mm) supplemental hemi-sleeve lead shield in the housing to reduce exposure rates on the right side.
REGISTRY.OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE NO.: NR-440-D-806-S DATE:
NMR 2 01998 PAGE 5 OF 7 DEVICE TYPEt Technetium-99m Pertechnetate Generator EXTERNAL RADIATION LEVELS (Cont'd)-
The manufacturer submitted personnel exposure estimates for the.
elution of the units based'on time and survey instrument readings at the housing.
Attendance time assumed was 45 seconds per elution.
Assay and handling of eluates were not included.
The-use cycle was Monday through Sunday with the Friday calibration date within this. cycle.
The 1/4" (6.35 mm) lead Mallinckrodt
" Sight Glass" Elution Shield was used.
The quarterly estimates for the use of a 50 mci (1.85 GBq) model each week were 1 mrem to whole body and.3 mrem to hands.
The quarterly estimates for the 500 mci (18.5 GBq) model were 10 mrem to whole body and 32 mrem to hands.
LIMITATIONS AND/OR OTHER CONSIDERATIONS OF USE:
The devices may be used by persons specifically licensed by the NRC or an Agreement State.
Handling, storage, use, transfer and disposal are to be determined by the licensing authority.
Leak test for this device is not required.
I This registration sheet and the information contained within the references shall not be changed without the written
. consent of the NRC.
G-b
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r REGISTRY OFTRADIOACTIVE SEALED SOURCES AND DEVICES
' SAFETY EVALUATION OF DEVICE
.PAGE 6 OF 7 NO.: NR-440-D-806-S DATE:
gg' 2 01998 DEVICE' TYPE:
Technetium-99m~ Pertechnetate Ge'nerator-SAFETY ANALYSIS
SUMMARY
The Model 006 through 012 devices are not current products manufactured by Mallinckrodt_ Medical Inc.
Although there may be
' physical pieces of these generators in the field, there is no radioactivity left in the. columns.
The half life of Mo-99 is 2.75 days,' and the half life of Tc-99m is 6.02 hours2.314815e-5 days <br />5.555556e-4 hours <br />3.306878e-6 weeks <br />7.61e-7 months <br />.
Since 1979 when the last generators were produced, enough half lives would
- have elapsed to effectively eliminate any radioactivity originally present in the generator.
REFERENCES:
The following supporting documents for the Models 006 through 012 generators are hereby incorporated by reference and are made a part of this registry document.
- Mallinckrodt letter of September 24, 1992, requesting that this registry be made inactive.
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REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE NO.: NR-440-D-806-S DATE:
NMR 2 01998 PAGE 7 OF 7 i
DEVICE TYPE:
Technetium-99m Pertechnetate Generator REFERENCES (Cont'd)*
NRC Registry NR-440-D-103-U dated' March 22, 1974, describing these devices.
ISSUING AGENCYr U.S. Nuclear Regulatory Commission IS90 Reviewer:
Date:
John W Lubinski D
NZR 2 01998 Concurrence:
Date:
SEeven L.
Baggett "Mf]
PAGE1 NRC FORM 567 U. S. NUCLEAR REGULATORY COMMISSION REQUEST FOR A SEALED SOURCE OR DEVICE EVALUATION INSTRUCTIONS: Send tNs request AND a copy of all related istters/apphcations and drowings to: The Sealed Source Safety Section, ATTN: Ctwof, OWFN Ma# Stop 6 H3. Change the Ucense Tracidng System milestone to 19 and assign to rev6 ewer code I-5.
NOTE: Retain a copy of this request with the applicatbn and background flies.
REouEsTER REGION / LOCATION:
M A//f/)(,[ N d [
]I R ll R lli IV CV HQ R LFDCB TELEPHONE NUMeER DME TYPE OF ACTION REQUESTED (Check as,
- y. ' ^
APPUCANTS NAME SOURCE REVIEW AMENDMENT OF REGISTRATION SHEET g,
gh. 4 uAt courROL NUh4 ER@
DEVICE REVIEW LETTERIAPPUCADON DAM UCENSE NUMBER 05)
CUSTOM REVIEW S - / C' P 3 q yt _ -
~*'
) QO j jAja} & A f/A&.
A/IA '/Ud fY JAN /MO d30 V3 f
i FOR SSSS USE ONLY REVIEWER MODEL NUMeERS NUMeER AssGNED I/kdl0uU N~O DArE REcEwD cATE ASSONED DATE TO FEES
/ '
TYPE OF ACTION (Indcate the number of each type) l COMMERCIAL DISTRIBUTION (FORMAL) l USE BY A SINGLE APPUCANT (CUSTOM)
SOURCE (9C)
DEVICE (9A)
SOURCE (90)
DEVICE (98)
NEW NEW NEW NEW
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AMENDMENT
-TMENDMENT
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AMENDMENT AMENDMENT JO SAFETY EVALUATION REQUIRED j UCENSING ACTION REQUIRED IF KNOWN NO NO FEES REQUIRED j OTHER (Speedy)
TOTAL NUMBER OF NOTES REVIEW HOURS g ggg 7fdA d.b C NUMBER OF DEFICIENCY LETTERS NUMBER OF DEFICIENCY CALLS FOR BILUNG PURPOSES ONLY j NEW REGISTRATION -
_j PRODUCTINACTIVE-NAME CHANGE ADDRESS CHANGE ADD TO BILUNG REMOVE FROM BILLING FOR FEE USE 00LY TYPE OF FEE FEE CATEGORY
~
9C 90 l9A 9B AMOUNT RECEMD CHEM NUMeER nMTANN UPDATED AS REQUIRED j MATSYS UPDATED
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DAM & cHEG LOG AS REQUIRED APMiovsD eY DATE RETURN DATE b
COMMENTS NRC PORM 987 (H5)
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SY3//7 NOTE T0: Files NR-0440-D-101-U, NR-0440-0-103-0, NR-0440-D-104-U j
i Hallinckrodt Registries NR-0440-D-101-U, NR-0440-0-103-0, and NR-0440-D-104-U j
were removed from the registry system. These registration certificates are
{
for products that are not considered to be sources or devices. The certificates were originally AEC catalogue sheets that were inadvertently turned into registration certificates.
The information in these files is for information purposes only.
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