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4.1 All machines which generate ionizing
radiation are subject to regulation by the Radiation Safety Committee.
This includes all clinical or research x-ray machines (radiographic,
fluoroscopic, bone densitometers, etc.), analytical x-ray machines,
electron microscopes and particle accelerators. Note: Any high voltage
vacuum device may be capable of producing x-rays. If there are any
questions regarding the capability of a device to produce ionizing
radiation, contact the Radiation Safety Office.
4.2 All machines producing ionizing radiation (radiographic, fluoroscopic, cabinet x-ray machines, particle accelerators, electron microscopes, analytical x ray units, etc.) must be registered with the Commonwealth of Pennsylvania. The Radiation Safety Office has the responsibility to maintain and modify these registrations. There are fees associated with these registrations. For particle accelerators, the Radiation Safety Office must notify the Commonwealth within 30 days after the initial order is placed and a license must be obtained prior to the first use. Effective February 1, 2003, all medical accelerators must be licensed by the Commonwealth of Pennsylvania, Department of Environmental Protection. The Radiation Safety Office has the responsibility to maintain and submit these licenses to the Commonwealth. Licensing fees will be managed by the Radiation Safety Office. 4.3 FACILITY DESIGN AND PREPARATIONDevices which produce significant external radiation fields may require that specialized shielding be installed. All shielding designs must be approved by the Radiation Safety Office prior to the start of construction. 4.4 PROCUREMENT AND INSTALLATION OF RADIATION PRODUCING MACHINESWhenever radiation producing machines are purchased, transferred, or disposed-of, the Radiation Safety Office shall be notified in writing by the responsible individual prior to installation or disposal of the equipment. Each newly purchased machine and the facility in which it is installed shall be surveyed by the Radiation Safety Office for compliance with applicable Commonwealth and Federal regulations. 4.5 AUTHORIZATION TO USE RADIATION PRODUCING MACHINES
The faculty member who is responsible for the overall supervision of the operation of any radiation producing machine must submit an application for such use. The application "Application to Possess and Use Radiation Generating Devices" (Form RSO XR314) should be completed with sufficient detail for the Radiation Safety Committee to determine that the applicant’s radiation protection program, equipment and facilities are adequate to minimize radiation exposures to workers and the environs. The application should be completed and sent to: Radiation Safety Office, G-7 Parran Hall, GSPH. Upon approval, a copy of the original application with all attachments will be returned to the applicant. Approval requires, as a condition, that the user follow all statements and representations set forth in the application and any supplements to it. 4.5.1.1 PERIOD OF AUTHORIZATION Applications must be reviewed and updated on a periodic basis. Authorization will be granted for intervals not to exceed 4 years. At the time of expiration a renewal will be required. The Radiation Safety Office will initiate the renewal process. 4.5.1.2 MODIFICATIONS TO FACILITIES, EQUIPMENT OR PROGRAM Modifications to facilities, equipment or the safety program requires prior approval of the Radiation Safety Officer and may require amendment to the Authorization and prior approval by the Radiation Safety Committee. 4.5.1.3 EXEMPTIONS Electron Microscopes and Cabinet X-Ray machines are exempted from the application process; however they must still be registered with the Radiation Safety Office, they are subject to annual audits and operators must receive training. The Radiation Safety Office must be notified if repairs or modifications are made which might result in increased radiation exposures in the machine environment. 4.5.2 AUTHORIZATIONS WITHIN CLINICAL FACILITIES Authorization (privileges) to use x-ray machines for clinical purposes
is the responsibility of the facility’s respective Medical Staff
Credentialing Program.
4.6 Assembly, modifications or repairs of equipment must be performed in accordance with Title 21 Code of Federal Regulations Parts 1000 and 1020 or other regulations as applicable, and are the responsibility of the User, or if appropriate, the manufacturer, service technician, etc. It is the User’s responsibility to keep the Radiation Safety Office apprised of any modifications to the machine, changes of personnel or any changes in the machine or facility which may impact safe use. The latter must be approved by the Radiation Safety Officer before the changes can be implemented. The User shall assure that all items of noncompliance noted as a result of audits performed by Radiation Safety Office staff will be corrected within a reasonable period of time following notification. In emergencies, or in situations of continued operation of radiation producing machines which fail to meet applicable regulations regarding their safe use, the Radiation Safety Officer is authorized to require immediate cessation of use of the machine and to take any other actions necessary to ensure safe conditions. 4.7 HUMAN USE FOR RESEARCH PURPOSES Research conducted within the jurisdiction of the University or associated UPMC facilities must be adequately justified through written petition to the Human Use Subcommittee. This requirement does not exempt the petitioner from any requirements for applicable approvals by other committees constituted to review research with human subjects. Amendment of the application is necessary if conditions of the use change. 4.8 OTHER X RAY MACHINE USES
Although the prime responsibility of the Radiation Safety Committee
lies in the areas of facility design, machine safety, and exposure
limitation, the need for x-ray machines in University locations outside of
a recognized clinical area will be reviewed; e.g., at athletic facilities.
If the Committee determines that there exists insufficient justification
for use or placement in a peripheral location, the matter will be
presented to the appropriate responsible authorities for resolution. |
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Radiation Safety Office Webmaster Revised February 9, 2001 |
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