DHS 157.66 DHS 157.66 Sealed sources for diagnosis.

DHS 157.66(1) (1) Use of sealed sources for diagnosis.

DHS 157.66(1)(a) (a) A licensee may use sealed sources that are not in medical devices for diagnostic medical uses if all of the following are met:

DHS 157.66(1)(a)1. 1. The sealed sources are approved in the sealed source and device registry for diagnostic medicine.

DHS 157.66(1)(a)2. 2. If the diagnostic medical uses are not explicitly listed in the sealed source and device registry, the sealed sources are used in accordance with the radiation safety conditions and limitations described in the sealed source and device registry.

DHS 157.66(1)(b) (b) A licensee may use medical devices containing sealed sources for diagnostic medical uses if all the following are met:

DHS 157.66(1)(b)1. 1. Both the sealed sources and medical devices are approved in the sealed source and device registry for diagnostic medical uses.

DHS 157.66(1)(b)2. 2. If the diagnostic medical uses are not explicitly listed in the sealed source and device registry, the diagnostic medical devices are used in accordance with the radiation safety conditions and limitations described in the sealed source and device registry.

DHS 157.66(1)(c) (c) Sealed sources and devices for diagnostic medical uses may be used for research in accordance with an active investigational device exemption application accepted by the U.S. Food and Drug Administration, and provided the requirements of s. DHS 157.61 (6) are met.

DHS 157.66(2) (2) Training for use of sealed sources for diagnosis. Except as provided in s. DHS 157.61 (10), a licensee shall require the authorized user of a diagnostic sealed source for use in a device authorized under sub. (1) to have received training in the use of the device for the uses requested. The licensee shall also require the authorized user to be a physician, dentist or podiatrist who meets any of the following requirements:

DHS 157.66(2)(a) (a) Is certified by a specialty board whose certification process includes all of the requirements in par. (b) and whose certification is recognized by the department, the NRC or an agreement state.

DHS 157.66 Note Note: Specialty boards whose certification processes have been recognized by the department, the NRC or an agreement state will be posted on the NRC’s web site at www.nrc.gov.

DHS 157.66(2)(b) (b) Has completed 8 hours of classroom and laboratory training in basic radionuclide handling techniques specifically applicable to the use of the device that includes all of the following:

DHS 157.66(2)(b)1. 1. Radiation physics and instrumentation.

DHS 157.66(2)(b)2. 2. Radiation protection.

DHS 157.66(2)(b)3. 3. Mathematics pertaining to the use and measurement of radioactivity.

DHS 157.66(2)(b)4. 4. Radiation biology.

DHS 157.66(2)(c) (c) Is an authorized user under s. DHS 157.63 (2), or equivalent NRC or agreement state requirements.

DHS 157.66 History History: CR 01-108: cr. Register July 2002 No. 559, eff. — see Note at the start of the chapter; CR 06-021: r. and recr. (2) Register October 2006 No. 610, eff. 11-1-06; CR 22-015: r. and recr. (1), am. (2) (intro.) cr. (2) (c) Register June 2023 No. 810, eff. 7-1-23.

DHS 157.67 DHS 157.67 Photon emitting remote afterloader, teletherapy and gamma stereotactic radiosurgery units.

DHS 157.67(1) (1) Use of a sealed source in a remote afterloader, teletherapy or gamma stereotactic radiosurgery unit.

DHS 157.67(1)(a) (a) A licensee shall use sealed sources in photon emitting remote afterloader units, teletherapy units or gamma stereotactic units for therapeutic medical uses that meet any of the following criteria:

DHS 157.67(1)(a)1. 1. Is approved in the sealed source and device registry.

DHS 157.67 Note Note: The sealed source and device registrations may be obtained from the manufacturer or by writing the department at: Department of Health Services, Radiation Protection Section, P.O. Box 2659, Madison WI 53701-2659.

DHS 157.67(1)(a)2. 2. In research involving photon-emitting remote afterloader units, teletherapy units, or gamma stereotactic radiosurgery units in accordance with an active effective investigational device exemption application accepted by the FDA provided the requirements of s. DHS 157.61 (6) (a) are met.

DHS 157.67 Note Note: The FDA requirements for investigational devices may be found at: http://www.fda.gov/radiation-emittingproducts/default.htm.

DHS 157.67(1)(b) (b) A licensee shall use photon-emitting remote afterloader units, teletherapy units, or gammastereotactic radiosurgery units that meet any of the following criteria:

DHS 157.67(1)(b)1. 1. Is approved in the sealed source and device registry to deliver a therapeutic dose for medical use. These devices may be used for therapeutic medical treatments that are not explicitly provided for in the sealed source and device registry, but must be used in accordance with radiation safety conditions and limitations described in the sealed source and device registry.

DHS 157.67(1)(b)2. 2. In research in accordance with an active investigational device exemption application accepted by the FDA and provided the requirements of s. DHS 157.61 (6) are met.