Information Notice 2007-10, Yttritium-90 Theraspheres and Sirspheres Impurities
| ML063470020 | |
| Person / Time | |
|---|---|
| Issue date: | 03/02/2007 |
| From: | Schlueter J NRC/FSME |
| To: | |
| References | |
| IN-06-010 | |
| Download: ML063470020 (7) | |
March 15, 2007 UNITED STATES
NUCLEAR REGULATORY COMMISSION
OFFICE OF FEDERAL AND STATE MATERIALS
AND ENVIRONMENTAL MANAGEMENT PROGRAMS
WASHINGTON, D.C. 20555-0001 NRC INFORMATION NOTICE 2007-10: YTTRIUM-90 THERASPHERES AND
SIRSPHERES IMPURITIES
ADDRESSEES
All U.S. Nuclear Regulatory Commission (NRC) Medical Licensees and NRC Master Materials
Licensees. All Agreement State Radiation Control Program Directors and State Liaison
Officers.
PURPOSE
The NRC is issuing this Information Notice (IN) to alert addressees to the presence of
radioactive contaminants in two variations of commercially available Yttrium-90 (Y-90) labeled
microspheres, SIRSpheres and TheraSpheres, manufactured by Sirtex Medical, Inc. and
MDS Nordion, respectively and the possible problems with their disposal in accordance with
10 CFR 35.92. Recipients should review the information, contained in this IN, for applicability to
their facilities, and consider actions, as appropriate. However, recommendations contained in
this IN are not new NRC requirements; therefore, no specific action nor written response is
required.
NRC is providing this IN to the Agreement States for their information, and for distribution to
their medical use licensees, as appropriate.
BACKGROUND
TheraSpheres and SIRSpheres are therapeutic devices that deliver radiation directly to
tumors in the liver, using glass or resin microspheres. Y-90 is either integrated into the glass
matrix or attached to the resin beads with diameters from 15 to 35 microns (µ). Millions of
these microspheres are injected into the hepatic artery, the liver's main blood vessel, in a
manner that preferentially traps them in the capillary bed feeding the tumor, and not the larger
blood vessels feeding healthy tissues. The SIRSpheres and TheraSpheres are designed to
deliver radiation directly to tumors, while sparing healthy tissues.
DESCRIPTION OF CIRCUMSTANCES
On March 20, 2006, the staff at the Vanderbilt University, Department of Radiology and
Radiological Science, informed NRCs Operation Center of its discovery of the presence
of radioactive contaminants in SIRSpheres and TheraSpheres. As a follow-up, on March 21,
2006, Vanderbilt University staff, in a letter to the Radiological Devices Branch of the U.S. Food
and Drug Administration (FDA), explained that they detected contaminants in the samples by
using a high-purity germanium detector.
The Y-90 SIRSpheres sample contained detectable amounts of Yttrium-88 (Y-88), with a half- life of 106.6 days and the TheraSpheres sample had measurable amounts of the following
radionuclides: Y-88; Europium-154 (half-life 8.8 years); Europium-152 (half-life 13.6 years);
Cobalt-57 (half-life 270.9 days); and Cobalt-60 (half-life 5.27 years). It is important to note that
only one sample from each device was analyzed. Further characterization of radioactive levels
in more samples may yield more accurate results.
DISCUSSION
The main reason the Vanderbilt University, Department of Radiology and Radiological Science
reported this issue, to both NRC and FDA, was because the samples of TheraSpheres, held
for decay-in-storage, appeared to be radioactive for much longer than would have been
expected, because of the presence of Y-88 and other contaminants.
The staff at the Vanderbilt University, Department of Radiology and Radiological Science
performed a preliminary evaluation of the radiation dose that might be delivered to the liver of
an adult, assuming 100 percent of the activity of the microspheres containing contaminants was
distributed uniformly in the liver and was removed only by physical decay. Based on this
evaluation, the dose to the liver from the contaminants did not exceed the medical event limit, i.e., the dose delivered did not differ from the prescribed dose by 20 percent or more, and did
not differ from the prescribed dose by more than 0.5 Sv (50 rem) to an organ. However, licensees should be concerned with disposal of microspheres. Depending on the contaminants, licensees may need to: (1) hold the remaining microspheres longer in decay-in-storage, in
accordance with 10 FR 35.92; (2) return the microspheres to the manufacturer; or (3) transfer
to an authorized recipient according to 10 CFR 20.2006.
CONTACT
S
This IN requires no specific action nor written response. If you have any questions about the
information in this notice, please contact the technical contact below.
/RA/
Janet R. Schlueter, Director
Division of Materials Safety
and State Agreements
Office of Federal and State Materials
and Environmental Management Programs
Technical Contact:
Mohammad S. Saba, FSME
Phone: 301-415-7608 E-mail: mss@nrc.gov
Enclosure: List of Recently Issued NMSS/FSME
Generic Communications The Y-90 SIRSpheres sample contained detectable amounts of Yttrium-88 (Y-88), with a half-life of 106.6 days and the TheraSpheres sample had measurable amounts of the following radionuclides: Y-88;
Europium-154 (half-life 8.8 years); Europium-152 (half-life 13.6 years); Cobalt-57 (half-life 270.9 days);
and Cobalt-60 (half-life 5.27 years). It is important to note that only one sample from each device was
analyzed. Further characterization of radioactive levels in more samples may yield more accurate results.
DISCUSSION
The main reason the Vanderbilt University, Department of Radiology and Radiological Science reported
this issue, to both NRC and FDA, was because the samples of TheraSpheres, held for decay-in-storage, appeared to be radioactive for much longer than would have been expected, because of the presence of
Y-88 and other contaminants.
The staff at the Vanderbilt University, Department of Radiology and Radiological Science performed a
preliminary evaluation of the radiation dose that might be delivered to the liver of an adult, assuming 100
percent of the activity of the microspheres containing contaminants was distributed uniformly in the liver
and was removed only by physical decay. Based on this evaluation, the dose to the liver from the
contaminants did not exceed the medical event limit, i.e., the dose delivered did not differ from the
prescribed dose by 20 percent or more, and did not differ from the prescribed dose by more than 0.5 Sv
(50 rem) to an organ. However, licensees should be concerned with disposal of microspheres.
Depending on the contaminants, licensees may need to: (1) hold the remaining microspheres longer in
decay-in-storage, in accordance with 10 FR 35.92; (2) return the microspheres to the manufacturer; or (3)
transfer to an authorized recipient according to 10 CFR 20.2006.
CONTACT
S
This IN requires no specific action nor written response. If you have any questions about the information in
this notice, please contact the technical contact below.
Janet R. Schlueter, Director
Division of Materials Safety
and State Agreements
Office of Federal and State Materials
and Environmental Management Programs
Technical Contact:
Mohammad S. Saba, FSME
Phone: 301-415-7608 E-mail: mss@nrc.gov
Enclosure: List of Recently Issued NMSS/FSME Generic Communications
.
OFFICE MSEAB TechEd MSEAB MSEAB MSEAB MSSA
NAME MSaba EKraus CFlannery SWastler MOrendi JSchlueter
DATE 12/20/06 01/22/07 01/18/07 01/30/07 02/06/07 03/2/07 OFFICIAL RECORD COPY Recently Issued FSME/NMSS Generic Communications
Date GC No. Subject
Addressees
12/13/06 RIS-06-27 Availability of NRC 313A Series of All NRC medical-use licensees, Forms and Guidance for their commercial nuclear pharmacies, and
Completion U.S. Nuclear Regulatory Commission
(NRC) Master Materials Licensees. All
Agreement State Radiation Control
Program Directors and State Liaison
Officers.
12/7/06 RIS-06-26 TRAINING AND EXPERIENCE All NRC medical licensees and Radiation
AND GRANDFATHER Control Program Directors.
PROVISIONS FOR AUTHORIZED
MEDICAL PHYSICISTS UNDER
10 CFR PART 35
12/7/06 RIS-06-25 Requirements For The Distribution All U.S. Nuclear Regulatory Commission
And Possession Of Tritium Exit (NRC) licensees distributing tritium exit
Signs And The Requirements In 10 signs and those possessing a tritium exit
CFR 31.5 AND 32.51a sign under a general license.
11/15/06 RIS-06-22 Lessons Learned From Recent 10 All Title 10 Code of Federal Regulations
CFR PART 72 Dry Cask Storage (10 CFR) Part 72 specific licensees and
Campaign certificate holders and holders of
operating licenses for nuclear power
reactors (including those who have
permanently ceased operations and have
certified that fuel has been permanently
removed from the reactor vessel) that are
not 10 CFR Part 72 specific licensees.
09/22/06 RIS-06-14 Enforcement Discretion for Facility All fuel cycle licensees regulated under
Changes Under 10 CFR Title 10 of the Code of Federal
70.72(c)(2) Regulations (10 CFR) Part 70, Subpart H.
09/14/06 RIS-06-20 All community water systems (CWSs), in
Guidance for Receiving
U.S. Nuclear Regulatory Commission
(NRC) non-Agreement States, that during
Concentrating Uranium at
the treatment of drinking water, may
Community Water Systems
accumulate and concentrate naturally- occurring uranium in media, effluents, and other residuals, above 0.05 percent
by weight.
09/14/06 RIS-06-19 Availability of Guidance on All NRC medical licensees.
Radioactive Seed Localization
08/31/06 RIS-06-18 Requesting Exemption from the All NRC medical licensees.
Public Dose Limits for Certain
Caregivers of Hospital Patients Date GC No. Subject
Addressees
08/15/06 RIS-06-16 Transfer of the Management All NRC materials licensees.
Oversight Of Certain NRC Region I
Licensees in Mississippi
To the NRC Region IV Office
07/20/06 RIS-06-11 Requesting Quality Assurance All 10 CFR Part 71 quality assurance
Program Approval Renewals program and certificate holders.
Online by Electronic Information
Exchange
04/23/06 RIS-06-10 Use of Concentration Control for All licensees authorized to possess a
Criticality Safety critical mass of special nuclear material.
01/26/06 RIS-02-15, NRC Approval of Commercial Data All authorized recipients and holders of
Rev. 1 Encryption Products For the sensitive unclassified safeguards
Electronic Transmission Of information (SGI).
Safeguards Information
01/24/06 RIS-06-01 Expiration Date for NRC-Approved The U.S. Nuclear Regulatory Commission
Spent Fuel Transportation Routes (NRC) licensees who transport, or deliver
to a carrier for transport, irradiated
reactor fuel (spent nuclear fuel (SNF)).
01/13/06 RIS-05-27, NRC Timeliness Goals, All 10 CFR Parts 71 and 72 licensees
Rev. 1 Prioritization of Incoming License and certificate holders.
Applications and Voluntary
Submittal of Schedule for Future
Actions for NRC Review
11/14/06 IN-06-25 Lessons Learned From NRC All power reactors, category I fuel cycle
Inspection Of Control And facilities, independent spent fuel storage
Accounting Of Special Nuclear installations, conversion facility, and
Material At Commercial Nuclear gaseous diffusion plants. Note that the
Power Reactors information notice contains physical
security information and is, therefore, being withheld from public disclosure in
accordance with 10 CFR 2.390
11/7/06 IN-06-23 Events Involving Potential All power reactors, category I fuel cycle
Tampering Or Malfeasance By facilities, independent spent fuel storage
Persons Granted Unescorted installations, conversion facility, and
Access gaseous diffusion plants. Note that the
information notice contains physical
security information and is, therefore, being withheld from public disclosure in
accordance with 10 CFR 2.390 Date GC No. Subject
Addressees
07/10/06 IN-06-13 Ground-Water Contamination All holders of operating licenses for
Due to Undetected Leakage of nuclear power and research and test
Radioactive Water reactors including those who have
permanently ceased operations and
have certified that fuel has been
permanently removed from the
reactor and those authorized by Title
10 of the Code of Federal Regulations
(10 CFR) Part 72 licenses to store
spent fuel in water-filled structures.
07/06/06 IN-06-12 Exercising Due Diligence When All materials licensees.
Transferring Radioactive
Materials
06/12/06 IN-06-11 Applicability of Patient Intervention All medical licensees.
in Determining Medical Events for
Gamma Stereotactic Radiosurgery
and Other Therapy Procedures
03/31/06 IN-06-07 Inappropriate Use of a Single- All licensees authorized to possess a
parameter Limit as a Nuclear critical mass of special nuclear material.
Criticality Safety Limit
03/21/06 IN-02-23, Unauthorized Administration of All medical licensees.
Supl. 1 Byproduct Material for Medical Use
01/19/06 IN-06-02 Use of Galvanized Supports and All holders of operating licenses for
Cable Trays with Meggitt Si 2400 nuclear reactors except those who have
Stainless- Steel-jacketed Electrical permanently ceased operations and have
Cables certified that fuel has been permanently
removed from the reactor vessel; and fuel
cycle licensees and certificate holders.
Note: NRC generic communications may be found on the NRC public website at http://www.nrc.gov, under
Electronic Reading Room/Document Collections.