ML100750655
| ML100750655 | |
| Person / Time | |
|---|---|
| Issue date: | 03/12/2010 |
| From: | Bhachu U, Jankovich 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 Fm (" 10 Fm), with less than 5% below 15 Fm and less than 10% above 35 Fm. 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 ACaution Radioactive.@ The label designates the content as ATheraSphere Yttrium-90 Microsphere Injection.@ On the labels the designation ALot@ and ALot 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 Blue Stopcock Red Stopcock Pot at Dose Vial Start and After 25-30 mR/hr 1-2 mR/hr 1-2 mR/hr Priming*
During Infusion 25 mR/hr 30-50 mR/hr** 30-50 mR/hr**
reducing to >2000 R/hr 0 mR/hr End of 0-1 mR/hr 1-4 mR/hr** 1-4 mR/hr**
Successful 5-20 R/hr Infusion
- 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)
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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)
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Parts List Comp. Comp. Name Location Supplier Working Life No. or Vendor 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 Accessory for Physician Single Use Syringe Administration Set or MDSN 6 Inlet Line Administration Set MDSN Single Use 7 Inlet Needle Administration Set MDSN Single Use with Check Valve 8 TheraSphere7 Dose Vial MDSN Single Use Dose Vial 9 Lead Pot (Dose Dose Vial Packaging MDSN Single Use Vial) 10 Acrylic Vial Dose Vial Packaging MDSN Single Use Shield 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 Empty Vial 15 Administration Set MDSN Single Use Lead Pot (Empty 16 Accessory Kit MDSN Permanent Vial)
Priming Needle 17 Administration Set MDSN Single Use Guide 18 Needle Guide Administration Set MDSN Single Use 19 Dosimeter RAD- Accessory Kit MDSN Permanent 60R (RADOS 1)
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)
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Parts List (Cont=d)
Comp. Comp. Name Location Supplier Working Life No. or Vendor 20 Acrylic Accessory Kit MDSN Permanent Enclosure Cover 21 Dosimeter RAD- Accessory Kit MDSN Permanent 60R (RADOS 2) 22 Stopcock Holder Accessory Kit MDSN Permanent (Outlet Line) 23 Support Arm Accessory Kit MDSN Permanent 24 Stand Accessory Kit MDSN Permanent 25 Acrylic Accessory Kit MDSN Permanent Enclosure Bottom 26 Stopcock Accessory Kit MDSN Permanent Extension Handle 27 Tweezers Accessory Kit MDSN Permanent 28 Stopcock Holder Accessory Kit MDSN Permanent (Inlet Line) 29 Clevis Pin Accessory Kit MDSN Permanent 30 Syringe Holder Accessory Kit MDSN Permanent 31 Hook for Fluid Accessory Kit MDSN Permanent Source