Wis. Admin. Code Department of Health Services DHS 157.66 - Sealed sources for diagnosis

(1) USE OF SEALED SOURCES FOR DIAGNOSIS.

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

1. The sealed sources are approved in the sealed source and device registry for diagnostic medicine.

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.

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

1. Both the sealed sources and medical devices are approved in the sealed source and device registry for diagnostic medical uses.

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.

(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.

(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:

(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.

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.

(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:

1. Radiation physics and instrumentation.

2. Radiation protection.

3. Mathematics pertaining to the use and measurement of radioactivity.

4. Radiation biology.

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

Notes

Wis. Admin. Code Department of Health Services DHS 157.66

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. Amended by, CR 22-015: r. and recr. (1), am. (2) (intro.) cr. (2) (c) Register June 2023 No. 810, eff. 7/1/2023