ML100750655
| ML100750655 | |
| Person / Time | |
|---|---|
| Issue date: | 03/12/2010 |
| From: | Bhachu U S, Jankovich J J NRC/FSME/DMSSA/LISD/LB |
| To: | MDS Nordion |
| Kime T | |
| References | |
| 10-13 | |
| Download: ML100750655 (16) | |
Text
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE
No.: NR-0220-D-849-S DATE: March 12, 2010 PAGE 1 OF 9 (Supercedes NR-0220-D-113-S)
DEVICE TYPE:
Glass Microsphere MODEL: TheraSphere
MANUFACTURER/DISTRIBUTOR: MDS Nordion, A Division of MDS (Canada) Inc.
(Formerly Atomic Energy of Canada, Ltd.)
447 March Road
Ottawa, Ontario
Canada K2K 1X8
ISOTOPE: MAXIMUM ACTIVITY:
Yttrium-90 20 GBq (540 mCi)
LEAK TEST FREQUENCY: None
PRINCIPAL USE: (AF) Other Medical Uses
CUSTOM SOURCE:
YES x NO
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE
No.: NR-0220-D-849-S DATE: March 12, 2010 PAGE 2 OF 9 (Supercedes NR-0220-D-113-S)
DEVICE TYPE:
Glass Microsphere DESCRIPTION:
TheraSphere is a therapeutic device consisting of insoluble glass
microspheres in which the radionuclide yttrium-90 (Y-90) is an
integral constituent. TheraSphere is used to treat liver tumors
via a catheter inserted in the hepatic artery. The size of
microspheres causes them to be embolized in the tumor vasculature
and hence, retained within the tumor. The microspheres are not
biodegradable and, once they have entered the tumor, do not
redistribute to other organs of the body. An Administration Set (supplied with the TheraSphere device) and Administration
Accessory Kit (supplied to new user sites) facilitate the
transfer of the radioactive microspheres from their container
into the tumor.
Yttrium-90 is an integral component of the glass matrix in the
microspheres. The beta particle emitted by the yttrium-90 during
radioactive decay has an average tissue penetration of 2.5 mm
(0.1 inch) and a maximum tissue penetration of approximately 8 mm
(0.3 inch). Therefore, this device delivers highly localized
radiation doses to tumors, while minimizing the damage to
surrounding healthy liver tissue. Yttrium-90, a pure beta
emitter, decays to stable zirconium-90 with a physical half life
of 64.2 hours2.314815e-5 days <br />5.555556e-4 hours <br />3.306878e-6 weeks <br />7.61e-7 months <br /> (2.68 days).
The microspheres have a mean diameter of 25 m ( 10 m), with less than 5% below 15 m and less than 10% above 35 m. Each milligram contains between 22,000 and 73,000 microspheres. Each
product vial can contain between 22 and 216 mg of spheres, depending on the radioactivity content.
The TheraSphere dose is supplied in 0.05 mL of sterile water
suspension contained in a 0.3-mL vee-bottom vial which is secured
within a 12 mm clear lucite vial shield (Attachment 1).
TheraSphere is available in various dose sizes up to a maximum of
20 GBq (540 mCi). A pre-assembled single use Administration Set
is provided with each dose.
The Administration Set is a single use delivery system designed
to deliver the microspheres to the disease site and to minimize
radiation exposure to administering personnel.
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE
No.: NR-0220-D-849-S DATE: March 12, 2010 PAGE 3 OF 9 (Supercedes NR-0220-D-113-S)
DEVICE TYPE:
Glass Microsphere DESCRIPTION (cont
=d):
The pre-assembled Administration Set has inlet and outlet
needles, a needle guide set and inlet and outlet lines that
facilitate infusion of the microspheres from the dose vial.
shows the positioning needle guide and priming
needle guide. The manufacturer specified that only 20 Ga needles
with long, tapered bevels should be used. The manufacturer also
specified that an inflation syringe, capable of delivering a
liquid volume of 20 cc with a minium pressure of 10 psig, should
be used with the Administration Set. Throughout the
administration procedure, the TheraSphere dose vial remains
sealed within the clear acrylic vial shield in which it was
supplied. A removable plug at the top of the vial shield
provides access to the septum of the dose vial. The needle guide
set permits proper placement of the inlet and outlet needles
during TheraSphere priming and administration steps.
The product is shipped with a package insert detailing the
directions for administration. The Administration Set and dose
vial are stored at room temperature until use. The TheraSphere
dose and Administration Set are shipped in a F400/F390 Type A
package (Attachment 3).
The TheraSphere Administration Set is to be used with the
Administration Accessory Kit. The Accessory Kit constitutes the
equipment which provides the layout for the Administration Set.
The Accessory Kit facilitates the infusion process and provides
the medical team with beta radiation shielding. The Accessory
Kit is an assembly of re-usable components which include the
support stand, two Model RAD-60R radiation dosimeters, the
shielding acrylic box, and handling tools. Attachment 4 shows
the Accessory Kit with the Administration Set and an inflation
syringe installed. Attachment 4 lists the inflation syringe, all
components in the Administration Set, and all components in the
Accessory Kit, providing for each component its name, location, supplier/vendor, and working life.
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE
No.: NR-0220-D-849-S DATE: March 12, 2010 PAGE 4 OF 9 (Supercedes NR-0220-D-113-S)
DEVICE TYPE:
Glass Microsphere DESCRIPTION (cont
=d):
Before administering the first procedure with the TheraSphere
device, all institutions must undergo the TheraSphere training
program as provided by the manufacturer or equivalent. All
clinical and technical support staff, such as radiation safety
personnel, physicians, medical physicists, technicians and
nurses, are required to demonstrate proficiency both in academic
knowledge and clinical skills in their respective areas regarding
the clinical use of the system. The training program addresses
such topics as the indication for use, description of available
doses, device description, patient preparation, dose calculation, radiation monitoring, and administration. The radiation safety
aspects of the training program include licensing, radiation
safety overview, expected dose rates, and detection of
microspheres.
The shelf life of the Administration Set is three years. The
shelf life of the needle guides is six months after
sterilization.
DIAGRAMS:
See Attachments 1 - 4.
LABELING:
Because of their small size, individual microspheres cannot be
labeled, therefore, each shipping container is labeled.
The lead-pot/Lucite-shield container is labeled with a 2x3 inch
(51x76 mm) label which indicates the date of assay, activity
level (in GBq), amount of microspheres (in mg), specific activity (in GBq/mg), and displays a yellow/black radiation symbol with the words A Caution Radioactive.
@ The label designates the content as A TheraSphere Yttrium-90 Microsphere Injection.
@ On the labels the designation A Lot@ and A Lot Number
@ are used to identify the individual TheraSphere doses and administration sets
similarly to the use of serial numbers.
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE
No.: NR-0220-D-849-S DATE: March 12, 2010 PAGE 5 OF 9 (Supercedes NR-0220-D-113-S)
DEVICE TYPE:
Glass Microsphere CONDITIONS OF NORMAL USE:
The TheraSphere is designed for use in hospital or clinical
environments for the treatment of cancerous tumors. The
TheraSphere should be used only by physicians who are qualified
by specific training in the safe use and handling of
brachytheraphy radionuclide sources. Adequate shielding and
precautions for handling radioactive material must be maintained.
The TheraSphere dose vial is supplied with a clear acrylic vial
shield to limit production of bremsstrahlung and radiation
exposure to personnel. Because of the dose rate at the vial
shield surface, the manufacturer requires caution including the
use of tongs and a lead shielded container when possible. The
vial should always be stored in a shielded location away from
personnel.
PROTOTYPE TESTING:
Prototype testing of individual microspheres has not been
performed by MDS Nordion, due to the limitations of their
microscopic size. Traditional physical/mechanical prototype
tests cannot be performed on a microsphere. The manufacturer
provided test data on lots of bulk microspheres regarding
chemical durability and stability.
The manufacturer subjected the F400/F390 type A transport
container to a series of tests which included a water spray test, a 9 m (354 in.) drop test and two sequential penetration tests.
The container maintained its integrity in the tests. The F390
lead pot and the TheraSphere acrylic shield were drop-tested from
1 m (39.4 in.) in various configurations onto a concrete floor
and demonstrated that the containment could withstand normal
handling accidents which might occur in a hospital environment.
EXTERNAL RADIATION LEVELS:
The manufacturer reported the following external radiation levels
for a device containing an activity of 19.1 GBq (515 mCi) are as
follows:
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE
No.: NR-0220-D-849-S DATE: March 12, 2010 PAGE 6 OF 9 (Supercedes NR-0220-D-113-S)
DEVICE TYPE:
Glass Microsphere EXTERNAL RADIATION LEVELS (cont
=d):
Distance from Measured radiation levels
source Lucite Vial Lucite Vial in F390 Lead Pot (cm) (inch) (mrem/hr) (mSv/hr) (mrem/hr) (mSv/hr) 0 0 810 8.1 85 0.85 5 230 2.3 33 0.33 30 20 0.2 2.7 0.027
100 2.2 0.022 0.6 0.006
The level of ambient radiation in the vicinity of the
Administration Accessory kit is a function of the activity being
administered. The manufacturer reported that for a delivered
dose of 10 GBq (270 mCi) the radiation fields are typically as
listed below:
Location
Time 1" Behind Lead Pot at Dose Vial Blue Stopcock Red Stopcock
Start and After Priming* 25-30 mR/hr 1-2 mR/hr 1-2 mR/hr
During Infusion 25 mR/hr reducing to
0 mR/hr 30-50 mR/hr**
>2000 R/hr 30-50 mR/hr**
End of Successful
Infusion 0-1 mR/hr 1-4 mR/hr**
5-20 R/hr 1-4 mR/hr**
- Effective priming with only minor introduction of spheres above the dose vial.
- Bremsstrahlung
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE
No.: NR-0220-D-849-S DATE: March 12, 2010 PAGE 7 OF 9 (Supercedes NR-0220-D-113-S)
DEVICE TYPE:
Glass Microsphere QUALITY ASSURANCE AND CONTROL:
MDS Nordion employs a quality assurance and quality control
program to insure that each component is manufactured to the
specifications furnished to the NRC. The quality assurance
program has been assessed and registered as meeting the
requirements of ISO 9001. The quality assurance program has been
deemed acceptable for licensing purposes by NRC. A copy of the
program is on file with NRC.
MDS Nordion provided quality assurance specifications which are
maintained for the glass frit and the microspheres made from the
acceptable frit. The specifications address physical and
chemical attributes, purity requirements, inspection
requirements, handling and storage instructions.
LIMITATIONS AND/OR OTHER CONSIDERATIONS OF USE:
$ The Model TheraSphere device shall be manufactured and distributed according to the requirements of Section 32.74, 10 CFR Part 32 and distributed only to persons specifically
licensed by the NRC or an Agreement State.
$ This registration sheet and the information contained within the references shall not be changed without the written
consent of the NRC.
$ Handling, storage, use, transfer, and disposal: To be determined by the licensing authority. The devices shall be handled only in accordance with the manufacturer
=s instructions and with appropriate equipment (e.g., due to
the activity level, forceps are recommended).
$ REVIEWER NOTE: Please ensure the safety procedures outlined in 10 CFR Part 35 are adhered to, especially as they pertain
to the handling of the devices.
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE
No.: NR-0220-D-849-S DATE: March 12, 2010 PAGE 8 OF 9 (Supercedes NR-0220-D-113-S)
DEVICE TYPE:
Glass Microsphere LIMITATIONS AND/OR OTHER CONSIDERATIONS OF USE (cont
=d): $ REVIEWER NOTE: The clinical staff who administers the TheraSpheres must complete a training program that is
specific to the TheraSphere administration procedure, as
described above.
$ REVIEWER NOTE: Previous experience in delivering the microspheres from the clear acrylic vial resulted in
development of the Administration Accessory Kit and needle
guide set, as well as introduction of an inflation syringe, capable of delivering a liquid volume of 20 cc with a
minimum pressure of 10 psig and 20 gauge needles with long
tapered bevels. These components are needed to enhance
delivery of the TheraSpheres and prevent misadministration.
$ REVIEWER NOTE: The TheraSpheres disposal should be handled in accordance with Information Notice 2007-10, "Yttrium 90
TheraSpheres and Sirspheres Impurities."
SAFETY ANALYSIS
SUMMARY
Based on our review of the information and test data cited below
and the past history of similar designs, we continue to conclude
that the MDS Nordion, Model TheraSphere devices are acceptable
for licensing purposes.
Furthermore, we continue to conclude that these devices would be
expected to maintain their integrity for normal and accidental
conditions of use which might occur during the uses specified in
this registration sheet.
REFERENCES
The following supporting documents for the MDS Nordion, Model
TheraSphere Yttrium-90 glass microsphere device are hereby
incorporated by reference and are made a part of this registry
document.
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE
No.: NR-0220-D-849-S DATE: March 12, 2010 PAGE 9 OF 9 (Supercedes NR-0220-D-113-S)
DEVICE TYPE:
Glass Microsphere REFERENCES (cont
=d): $ MDS Nordion application, dated July 2, 1999, with enclosures thereto. $ MDS Nordion letters dated August 13, 1999, December 17, 1999, January 19, 2000, and February 2, 2000, with
enclosures thereto.
$ MDS Nordion
=s letters dated September 6, 2001, March 1, 2002, March 21, 2002, and telefax dated January 9, 2002, with enclosures thereto.
$ MDS Nordion
=s facsimile dated April 15, 2002, with enclosure thereto. $ MDS Nordion
=s letters dated September 15, 2004 and December 17, 2004, with enclosures thereto.
$ MDS Nordion letter dated, July 13, 2009, with enclosures thereto.
ISSUING AGENCY
- U.S. Nuclear Regulatory Commission
Date: March 12, 2010 Reviewer:
/RA/ John J. Jankovich
Date: March 12, 2010 Concurrence:
/RA/
Ujagar S. Bhachu
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE No.: NR-0220-D-849-S DATE: March 12, 2010 ATTACHMENT 1 (Supercedes NR-0220-D-113-S)
TheraSphere Container for Microsphere Vials
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE No.: NR-0220-D-849-S DATE: March 12, 2010 ATTACHMENT 2 (Supercedes NR-0220-D-113-S)
Positioning Needle and Priming Needle Guide (For Explanation of the Parts Numbers, See the Parts List in
)
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE No.: NR-0220-D-849-S DATE: March 12, 2010 ATTACHMENT 3 (Supercedes NR-0220-D-113-S)
Item No. Description 1 F390 Lead Pot Body 2 Shield Base (Cast Acrylic) 3 Dose Vial 3ml
4 Septum 5 Aluminum Crimp Cap 6 Shield Cap (Cast Acrylic) 7 Shield Plug (Cast Acrylic) 8 F390 Lead Pot Cap 9 Tamper Evidence Seal 10 3M Fibre Filament Tape
TheraSphere Transportation Package Schematic
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE No.: NR-0220-D-849-S DATE: March 12, 2010 ATTACHMENT 4 (Supercedes NR-0220-D-113-S)
(Page 1/3)
Administration Accessory Kit (Shown Assembled in the Administration Set)
(For Explanation of Parts Numbers, See Parts List in the
Following Pages)
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE No.: NR-0220-D-849-S DATE: March 12, 2010 ATTACHMENT 4 (Supercedes NR-0220-D-113-S)
(Page 2/3) Parts List Comp. No. Comp. Name Location Supplier or Vendor Working Life
1 Fluid Source Supplied by hospital Physician N/A 2 Piercing Pin Administration Set MDSN Single Use
3 Fluid Line Administration Set MDSN Single Use
4 Red Stopcock Administration Set MDSN Single Use
5 Inflation Syringe Accessory for Administration Set Physician or MDSN Single Use
6 Inlet Line Administration Set MDSN Single Use
7 Inlet Needle with Check Valve Administration Set MDSN Single Use
8 TheraSphere 7 Dose Vial Dose Vial MDSN Single Use
9 Lead Pot (Dose Vial) Dose Vial Packaging MDSN Single Use
10 Acrylic Vial Shield Dose Vial Packaging MDSN Single Use
11 Outlet Needle Administration Set MDSN Single Use
12 Outlet Line Administration Set MDSN Single Use
13 Blue Stopcock Administration Set MDSN Single Use
14 Vent Line Administration Set MDSN Single Use
15 Empty Vial Administration Set MDSN Single Use
16 Lead Pot (Empty Vial) Accessory Kit MDSN Permanent
17 Priming Needle Guide Administration Set MDSN Single Use 18 Needle Guide Administration Set MDSN Single Use 19 Dosimeter RAD-60R (RADOS 1) Accessory Kit MDSN Permanent REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE No.: NR-0220-D-849-S DATE: March 12, 2010 ATTACHMENT 4 (Supercedes NR-0220-D-113-S)
(Page 3/3) Parts List (Cont
=d) Comp. No. Comp. Name Location Supplier or Vendor Working Life
20 Acrylic Enclosure Cover Accessory Kit MDSN Permanent
21 Dosimeter RAD-60R (RADOS 2)
Accessory Kit MDSN Permanent
22 Stopcock Holder (Outlet Line)
Accessory Kit MDSN Permanent
23 Support Arm Accessory Kit MDSN Permanent
24 Stand Accessory Kit MDSN Permanent
25 Acrylic Enclosure Bottom Accessory Kit MDSN Permanent
26 Stopcock Extension Handle Accessory Kit MDSN Permanent
27 Tweezers Accessory Kit MDSN Permanent
28 Stopcock Holder (Inlet Line)
Accessory Kit MDSN Permanent
29 Clevis Pin Accessory Kit MDSN Permanent
30 Syringe Holder Accessory Kit MDSN Permanent
31 Hook for Fluid Source Accessory Kit MDSN Permanent