Safety Procedures and Instructions for Remote Afterloader Units, Teletherapy Units and Gamma Stereotactic Radiosurgery Units

Section 335 Section 335.8040  Safety Procedures and Instructions for Remote Afterloader Units, Teletherapy Units and Gamma Stereotactic Radiosurgery Units a)         A licensee using sealed sources in remote afterloader units, teletherapy units or gamma stereotactic radiosurgery units for therapeutic medical uses shall: 1)         Secure the unit, the console, the console keys and the treatment room when not in use or unattended, if applicable; 2)         Permit only individuals approved by the authorized user, Radiation Safety Officer or authorized medical physicist to be present in the treatment room during treatment or emergencies with the sources; 3)         Prevent dual operation of more than one radiation producing device in a treatment room, if applicable; and 4)         Develop, implement and maintain written procedures for responding to an abnormal situation when the operator is unable to place the sources in the shielded position, or remove the patient or human research subject from the radiation field with controls from outside the treatment room.  These procedures shall include: A)        Instructions for responding to equipment failures and the names of the individuals responsible for implementing corrective actions; B)        The process for restricting access to and posting of the treatment area to minimize the risk of inadvertent exposure; and C)        The names and telephone numbers of the authorized users, the authorized medical physicist and the Radiation Safety Officer to be contacted if the unit or console operates abnormally. b)         A copy of the procedures required by subsection (a)(4) and the manufacturer's instruction manual shall be physically located at the unit console. c)         A licensee shall post instructions at the unit console to inform the operator of: 1)         The procedures located there as required by subsection (b); and 2)         The names and telephone numbers of the authorized users, the authorized medical physicist and the Radiation Safety Officer to be contacted if the unit or console operates abnormally. d)         Operational and Safety Training 1)         Prior to the first use for patient treatment of a new unit or an existing unit with a manufacturer upgrade that affects the operation and safety of the unit, the licensee shall ensure that vendor operational and safety training is provided to all individuals who will operate the unit.  The vendor operational and safety training must be provided by the device manufacturer or by an individual certified by the device manufacturer to provide the operational and safety training. 2)         Initially and at least annually, the licensee shall provide operational and safety instructions to all individuals who operate the unit at the facility, as appropriate to the individual's assigned duties, in: A)        The procedures identified in subsection (a)(4); and B)        The operating procedures for the unit. e)         A licensee shall ensure that operators, authorized medical physicists and authorized users participate in drills of the emergency procedures, initially and at least annually. f)         A licensee shall retain a record of the instruction required by subsection (d). The record shall be retained for five years and include a list of the topics covered, the date of the instruction, the names of the attendees and the names of the individuals who provided instruction. g)         A licensee shall retain a copy of the procedures required by subsections (a)(4) and (d)(2)(B) until the licensee no longer possesses the remote afterloader, teletherapy unit or gamma stereotactic radiosurgery unit. h)         A licensee shall maintain a copy of the record documenting results of the drills of emergency procedures required by subsection (e) for five years.