Radiation producing devices are regulated by Federal and State agencies. The Food and Drug Administration (FDA) regulates manufacturers of electronic systems capable of producing X-rays. The state of Wisconsin Department of Health Services regulates and licenses radiation producing devices within the state. Wisconsin Administrative Code, Radiation Protection Chapter 157 describes regulations for radiation producing devices. Radiation Safety is the official liaison on behalf of the University of Wisconsin–Milwaukee for all matters involving applications, approvals, registrations, and operation of radiation producing devices on campus.
Note: Radiation producing devices that are used for healing arts (human-use) outside of standard of care (i.e., research purposes) must be reviewed and approved by one of UWM’s Institutional Review Boards and the Wisconsin Department of Health Services/X-ray Program Manager.
The Radiation Producing Device Manual describes the responsibilities and safe work practices for all individuals involved with the use of X-ray producing devices. At UW-Milwaukee, radiation producing devices are used for teaching and research purposes. Specific responsibilities for the equipment owner, user, and maintenance personnel are described throughout the manual.
This manual is not intended to be a fully comprehensive reference. Further advice concerning hazards associated with specific radiation producing devices and/or the development of new and unfamiliar procedures should be obtained through consultation with Radiation Safety.
New Device Process and Registry Information
Notify Radiation Safety
If you plan to purchase or have recently received a new radiation producing device, please contact Radiation Safety. Radiation Safety is required to inventory all radiation producing devices at UWM.
Register with the Wisconsin Department of Health Services (DHS)
All radiation producing devices must also be registered with the Wisconsin Department of Health Services within 30 days of installation. Radiation Safety will assist with registering all devices used at the UWM. When purchasing, replacing or repairing a radiation producing device, notify Radiation Safety so the necessary changes in registration can be accomplished. Here is a link to the State’s Registration Application.
Post Installation Inspection and Survey
Radiation Safety is required to inspect the radiation producing device setup, in addition to the manufacturer’s installation records, before operation begins to assure radiation safety prior to using the device. A post installation survey must also be conducted following relocation, device modification, and other changes made to the device.
All necessary signage and regulatory postings can be supplied by Radiation Safety during or after the post installation survey. All safety devices must be installed and verified to be operational.
It is the responsibility of the X-ray user to promptly notify Radiation Safety of any changes that warrant an inspection such as repairs or modification to a device.
For registration purposes, covered device categories include but are not limited to:
- Cabinet and Analytical X-ray Devices
- CT and Micro CT scanners
- Dental devices
- Dual-Energy X-ray (DEXA) Scanners
- Electron Microscopes
- Fluorescence Spectrometers (XRF)
- Fluoroscopy Devices (C-arm & mini C-arm)
- Linear Accelerator (Linac)
- TomoTherapy® Devices
- X-ray Diffraction Devices or X-Ray Crystallography
- X-ray Irradiators
Modification, Alterations, Repairs
In most instances, routine repairs by a qualified factory or vendor service representative does not require Radiation Safety approval, however, you must obtain approval from Radiation Safety prior to modifying or altering radiation-generating devices in any manner that can affect:
- Inherent shielding
- Interlock operation
- Warning lights
- Any factor that may implicate safety of:
- Research subjects
In some instances, such changes may require a re-survey of the radiation-generating device or new shielding plan approvals.
Removal (Disposal) Information
Disposal of radiation producing devices needs to be completed through Radiation Safety. Devices must be permanently disabled (e.g., typically sever the power cord) and any X-ray tubes with toxic beryllium windows or lead components removed. Non-operational devices should be identified, repaired, transferred or disposed within a reasonable amount of time. Additionally, the X-ray Registration Holder will be required to contact Campus Capital Equipment to obtain the proper clearance prior to disposing the devices.
Newer X-ray devices do not contain hazardous materials except beryllium and lead. Generally, beryllium is contained within the X-ray tube and must be removed from the system and disposed of as chemical waste. This important information can be found within the X-ray tube’s manufacture’s manual. It is also commonly indicated on the tube itself. Before the disposal process, the X-ray user must remove the head, being careful not to break the X-ray tube. The tube is under vacuum and, if broken, could splinter and cause injuries and exposure to beryllium. Some X-ray systems have beryllium windows and a “poison” sign on the window unit that warns users that the window unit contains a toxic chemical and must be disposed of properly.
Older X-ray devices may contain hazardous materials including hazardous metals and toxic chemical called polychlorinated biphenyls or PCBs in the transformer oil if the X-ray devices were manufactured before July 1979. Before taking a device out of service you need to be aware of what’s in the device and what needs to be done to dispose of it properly. Contact Radiation Safety for assistance. Radiation Safety and Environmental Protection can help you to determine if your old device contains a hazardous waste regulated by the U.S. Environmental Protection Agency and assist you to properly dispose of it.
Basic Safety Guidelines
X-rays are a type of ionizing electromagnetic radiation similar to gamma radiation. They are distinguished based on their source: X-rays are emitted by electrons, while gamma rays are emitted by the atomic nucleus.
With properly functioning instrumentation and by following the correct safety precautions, the risk of radiation exposure when working with radiation producing devices is minimal. However, it is good to know the signs of an acute exposure to a localized area of the human body.
Be aware that these effects can be caused by contact with the beam for only a fraction of a second depending on what device you are using. Typical primary beam exposures are 100,000 to 400,000 rad per minute. The most common effect of large radiation exposure from a radiation producing device is reddening of the skin (erythema). With a dose of a few hundred rem, the superficial layers of the skin are damaged, and the skin will redden in a fashion similar but more complex than a sunburn. The erythema effect will most often reverse itself within a few weeks.
It is also possible that doses at this level could damage cell division which could temporarily stop hair growth and possibly causes hair loss. Hair growth should return with lower doses.
There could also be damage to the sebaceous glands that produces the oil of the skin, which could cause a temporary decrease in the amount of oil produced.
There are other less common and less transitory responses. If a large area is exposure to a large amount of radiation, there could be changes in the skin pigmentation. This effect may not be reversible and could result in permanent skin changes.
If the exposure is large, the transitory damage to the skin, skin hair, or sebaceous glands could cause skin scarring or lead to radiation dermatitis, chronic radiation dermatitis, or radiation induced skin cancer.
Unintended X-ray radiation exposure
If you think you have experienced an unintended or inappropriate X-ray exposure, contact Radiation Safety immediately.
An incident interview will need to be conducted and an incident report will need to be generated with Radiation Safety to determine the estimated unintended exposure. Besides the description of incident, your name, date and location, type of device, and estimated exposure will all be requested during the interview. Radiation Safety will then complete a dose estimate and let you know if there are any further actions needed.
Good Safety Practices
- Each laboratory should designate a primary responsible user for the radiation producing device. This person will be responsible for the interlock bypass keys, performing the alignments, and manufacturer required maintenance on the radiation producing device(s). This person will also coordinate calibrations, repairs, and modifications of the equipment with the company or manufacturer representative, when appropriate.
Radiation Protection Practices
- Time – The shorter the time spent around a radiation producing device, the lower the radiation dose. X-ray users should minimize their exposures to keep their occupational radiation dose As Low As Reasonably Achievable (ALARA).
- Distance – Radiation levels decrease significantly with increase in distance from the source of radiation. The use of distance is one of the easiest and most effective methods for radiation protection. X-ray users should try to maintain the greatest distance from the X-ray source as possible when working with devices.
- Shielding – Lead or concrete shielding can be used to reduce radiation levels when appropriate. Most devices have built-in shielding. Some will require additional shielding placed around the device or within the room.
To protect yourself from the radiation, consider the following potential sources of radiation exposure:
- The primary beam.
- Primary beam leakage
- Beam penetration through stops and shutters
- Secondary radiations from beam interaction of the primary beam with the sample or shielding
- Radiation released from the diffraction of the beam
If you are exposed to the direct x-ray beam or suspect an exposure, IMMEDIATELY follow these steps:
- Shut off the x-ray beam.
- Remain calm.
- Call the Radiation Safety Officer.
- If there is a medical emergency in addition to the exposure, call University Police.
- Arrange for a medical examination. Important: Notify the examining physician that exposure to low energy x-rays may have occurred.
Radiation Safety Officer: 414-430-7507
University Safety and Assurances: 414-229-6339
University Police: 9-911
Signage, Labels and Postings
Entry to Laboratory
The following signage must be placed at the entrance of each X-ray device and easily visible to users as they enter the area:
- Wisconsin Department of Health Services “Notice to Employees”
- Wisconsin Department of Health Services X-ray Facility Registration Permit
Control Panel (if applicable)
The following signage must be placed near the control panel of each X-ray device and readily visible to the operator:
- At least one sign conspicuously posted bearing the radiation symbol and the words “CAUTION RADIATION – THIS EQUIPMENT PRODUCES RADIATION WHEN ENERGIZED,” or words having a similar intent, near any switch that energizes an x-ray tube if the radiation source is an x-ray tube.
Radiation Producing Device (X-ray Equipment)
- Label bearing the words “Caution Radiation This Equipment Produces Radiation When Energized” near the tube activation switch.
- For Analytical or Cabinet X-ray producing devices a label bearing the words “Caution High-Intensity X-ray Beam,” next to each tube-head. The sign must be clearly visible to any person operating, aligning, or adjusting the device or handling or changing a sample.
Recordkeeping and Audits
Certain records are required to be maintained by all X-ray Registration Holder’s and readily available for internal and/or external inspections. All records should be maintained in one central location in the lab. Applicable records needing to be maintained include:
- Equipment manuals
- Installation records (Includes transfers or donations)
- Standard Operating Procedures for each X-ray producing device.
- Calibration, maintenance, and modification records.
- Use logbook – to be filled out each time the device is used. The log shall include, at a minimum, the user’s name, date of use, and settings or description of use. This can be in a digital form, if desired.
Compliance with internal and external regulations is confirmed through inspections and audits carried out by Radiation Safety. You will be contacted by Radiation Safety when your areas audit is due. If items of non-compliance are observed, confirmation should be obtained that the deficient items are corrected immediately at the time of inspection, or for more complicated items through re-inspection.
All individuals using radiation-producing machines shall receive radiation safety training offered by the Radiation Safety Officer or a source approved by the Radiation Safety Officer. Training must be completed prior to using a radiation-producing device. In addition, individuals shall be trained on the operation of the particular radiation producing device he/she will be using and actions to take in the event of an emergency. This use training shall be provided by the Authorized User or other person approved by the Radiation Safety Officer. All individuals who wish to operate diagnostic, analytical, or cabinet X-ray systems shall receive instruction in and demonstrate ability in:
- General properties of ionizing radiation.
- Principles of radiation detection.
- Radiation hazards associated with the use of the equipment.
- Biological effects of ionizing radiation.
- Procedures to minimize exposure.
- UWM’s Safety requirements.
- Emergency procedures.
Ability shall be demonstrated by passing an on-line examination administered by the Radiation Safety Officer. Machine specific hands-on training must be provided by experienced personnel.
In some cases, the Authorized User will give the safety training, with the course content approved by the Radiation Safety Officer.
Exceptions to radiation safety training requirements maybe granted because of pervious training, experience, or education at the sole discretion of the RSO.
Dosimetry is issued if it is believed that greater than 10% of annual dose limits will be received. Radiation Safety will do an assessment to determine if X-ray users will need to be issued dosimetry or not. This is completed by considering the type of device, completing an exposure survey, and reviewing the experimental protocols.
Changes made to the room configuration, such as relocation of x-ray devices or replacement of one type of device with another, may require a new radiation survey or the use of dosimeters to ensure that adequate operating procedures are in place.
More information can be found on this Dosimetry Handout.
Pregnancy Surveillance Program
Under State and Federal law, the whole-body dose limit of a pregnant radiation worker remains at 5,000 mrem (50 mSv) per year until she specifically declares her pregnancy in a written and signed statement directed to the RSO. The declaration is voluntary. Following the RSO’s receipt of a signed pregnancy declaration, the dose limit to the worker’s embryo/fetus is limited to 500 mrem (5 mSv) for the duration of the pregnancy. Upon the receipt of the signed declaration, the RSO will provide monitoring for potential internal and/or external exposure to the embryo/fetus as appropriate.
The RSO recommends that a pregnant radiation worker declare her pregnancy so that her occupational radiation exposure potential can be evaluated to ensure that the dose to the embryo/fetus does not exceed 500 mrem (5 mSv) over the duration of the pregnancy.