Sealed Source and Device Registry: Supplement for 10 CFR Part 35 Uses

Among other changes in 10 CFR Part 35, the revised regulations (effective October 24, 2002) in 10 CFR 35.400(a), 35.500, and 35.600(a) require NRC licensees to use only sources and devices "as approved in the Sealed Source and Device Registry " (SSDR). To ensure compliance with these requirements, NRC medical use license applicants, licensees, and license reviewers should check the Sealed Source and Device Registry to determine whether a source or device has a sealed source or device (SSD) certificate in the SSDR. The certificate should be reviewed to identify the authorized medical use(s) authorized (i.e., 35.400 - manual brachytherapy; 35.500 - diagnosis; 35.600 - photon emitting remote afterloader unit, teletherapy unit, or gamma stereotactic radiosurgery unit; or 35.1000 - other uses). If the source or device does not have a SSD certificate or the medical use is not specifically included in the certificate, then NRC medical use license applicants, licensees, and license reviewers should review the following sections of this supplement to determine whether the medical use is consistent with a use listed below.

Sources and Devices without SSD Certificates

1. After October 24, 2002, a Type A medical use licensee of broad scope can continue to use sources and devices that do not have SSD certificates if the sources and devices were made by the licensee for medical use under the conditions of the license.

2. Strontium-90 (Sr-90) medical eye applicators that were manufactured and distributed before 1963 can continue to be used for treatment of superficial eye conditions.

Sources and Devices with SSD Certificates

Medical use sources and devices with SSD certificates that do not contain the category of medical use specified 10 CFR Part 35, Sections 35.400, 35.500, and 35.600 can be used "as approved in the Sealed Source and Device Registry" provided that they are identified in the following medical use categories¹:

I. 35.400, Manual Brachytherapy

A. Sources and Devices Authorized for Medical Use prior to October 24, 2002

1. Sources registered for medical use may be used for the following manual brachytherapy uses which were authorized in 10 CFR Part 35 prior to October 24, 2002:

1. cesium-137 as a sealed source in needles and applicator cells for topical, interstitial, and intracavitary treatment of cancer

2. cobalt-60 as a sealed source in needles and applicator cells for topical, interstitial, and intracavitary treatment of cancer

3. gold-198 as a sealed source in seeds for interstitial treatment of cancer

4. iridium-192 as seeds encased in nylon ribbon for interstitial treatment of cancer

5. strontium-90 as a sealed source in an applicator for treatment of superficial eye conditions

6. iodine-125 as a sealed source in seeds for interstitial and topical treatment of cancer

7. palladium-103 as a sealed source in seeds for interstitial and topical treatment of cancer

2. Sealed sources and devices that have certificates in the SSDR which were authorized on a medical use license prior to October 24, 2002 for brachytherapy uses in 35.400, provided the sources and devices can be used in accordance with all the requirements for manual brachytherapy identified in 10 CFR Part 35 after October 24, 2002. (Note: this does not include high dose rate remote afterloaders or gamma stereotactic radiosurgery devices which are now addressed in 10 CFR 35.600. See Section III below.)

3. Sources and Devices with SSD Certificates Added after October 24, 2002

[Under development]

II. 35.500, Use of sealed sources for diagnosis

1. Sources and Devices Authorized for Medical Use prior to October 24, 2002

1. Sealed sources registered for medical use may be used for the following diagnostic uses that were authorized in 10 CFR Part 35 prior to October 24, 2002:

1. iodine-125, americium-241, or gadolinium-153 as a sealed source in a device for bone mineral analysis

2. iodine-125 as a sealed source in a portable imaging device

2. Sealed sources or devices that have certificates in the SSDR which were authorized on a medical use license for diagnostic use prior to October 24, 2002, provided they can be used in accordance with all the requirements for sealed sources for diagnosis after October 24, 2002.²

2. Sources and Devices with SSD Certificates Added after October 24, 2002

[Under development]

III. 35.600, Use of sealed sources in a remote afterloader unit, teletherapy, or gamma stereotactic radiosurgery unit

1. Sources and Devices Authorized for Medical Use prior to October 24, 2002

1. teletherapy units for medical use that contain a sealed source of cobalt-60 or cesium-137

2. photon emitting remote afterloaded sources and devices that were authorized prior to October 24, 2002, by specific line items on the medical use license for topical, interstitial, intraluminal and intracavitary uses

3. photon emitting gamma stereotactic radiosurgery units that were authorized prior to October 24, 2002, by a specific line item on the medical use license

2. Sources and Devices with SSD Certificates after October 24, 2002

[Under development]

IV. 35.1000, Other medical uses

1. Microsphere Brachytherapy Sources and Devices

1. TheraSphere yttrium-90 microspheres

2. SIRSphere yttrium-90 microspheres

2. Liquid Brachytherapy Sources and Devices

1. I-125 GliaSite liquid brachytherapy source and radiation therapy system
   (manufactured and distributed by Cytyc Surgical Products)

3. Intravascular Brachytherapy Sources and Devices

1. Cordis Checkmate™ system (no longer manufactured or distributed)

2. Novoste Beta-Cath™ systems (manufactured and distributed by BEST Vascular)

3. Guidant Galileo system (no longer manufactured or distributed)

4. Permanent implant low dose-rate remote afterloader

1. Nucletron seedSelectron system

2. Nucletron FIRST (Fully Integrated Real-Time Seed Treatment) system

5. Iodine-125 and Palladium-103 Low Dose Rate Brachytherapy Seeds Used for Localization of Non-Palpable Lesions

6. Leksell Gamma Knife® Perfexion™

Uncategorized

For other uses of registered medical sources and devices, licensees should contact the NRC staff or Agreement State licensing staff for a determination on whether the use is approved in the SSDR and whether a license amendment and/or certificate amendment is required prior to use.

¹ The intent is to (1) permit the continued medical use of sources and devices that were authorized for medical use prior to October 24, 2002, and (2) add those sources and devices that are added to the SSDR after October 24, 2002, but do not specifically list a medical use identified in 10 CFR Part 35.

² If a licensee intends to use a source or device that was listed for this use on a license, then the licensee should contact NRC Headquarters so the source or device can be listed in this supplement to the SSDR.