Information Notice 2007-10, Yttritium-90 Theraspheres and Sirspheres Impurities

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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

.

ML063470020

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

Enforcement Discretion When

(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.