X-ray machines are widely used throughout the United States for a variety of purposes. These machines are common in medical and dental facilities to diagnose and treat medical conditions. X-ray machines also are used in airports and industrial facilities to scan materials and equipment to search for contaminants, contraband, or to help ensure products are manufactured properly. In addition, they are used for research and development to determine the properties of materials.
Companies that wish to purchase and install X-ray machines must comply with state regulations governing their registration, installation, and safe use. These regulations exist to help ensure the safety of workers, the public, and, in the case of medical applications, the patient. Requirements vary on a state-by-state basis. It is the responsibility of the owner/operator of each X-ray machine to verify that individual state requirements are met, notify the state regulatory agency of the schedule for the installation and use of an X-ray machine, and obtain the appropriate inspections.
The following is a brief overview of typical state regulatory requirements for open beam X-ray machines.
Radiation Shielding Plan and State Notification
Obtain a shielding calculation from a qualified physicist. The physicist should complete the appropriate paperwork for the state agency as advance notification of facility installation. This submittal also should include a floorplan with the orientation of the X-ray tube shown on the drawing. The state may also require a letter in advance of the shielding plan to include anticipated start date, location of facility, and number and type of X-ray machine(s).
Radiation Machine Registration Form
Complete and submit a Radiation Machine Registration Form for the facility.
Machine Registration Payment
Complete a payment transmittal form and include a check for the registration fee (if any) made out to the appropriate state agency. Fee payment is based on the type of machine being installed. To determine fees (if any), use the payment schedule posted by the state agency.
Notice of Installation
The company installing the X-ray equipment should complete and submit FDA Form 2579 and the in-state required notice of installation.
Radiation Survey
A facility representative (usually a physicist) shall conduct an area survey, complete the associated paperwork, and submit these to the state agency.
Inspection
A licensed state inspector or qualified medical physicist shall complete a full inspection and submit the appropriate forms to the state agency. In many cases, a re-inspection also will be required on an annual basis (for medical machines) with registration renewal.
Radiation Safety Program
Develop a program to use the X-ray machine safely, which includes:
- Assigning a person responsible for radiation safety,
- Training users, and
- Maintaining records.
Radiation Badges
Radiation dosimeters (badges) must be provided for appropriate staff to track occupational radiation doses.
Questions?
If you have questions about this information or need assistance for your company, facility, or project, please feel free to contact us.