The State of Michigan Ionizing Radiation Rules regulate the possession and use of machines capable of generating ionizing radiation. The rules require that U-M registers all radiation-generating machines with the State of Michigan prior to operating the machines. This can include devices not normally thought of as radiation-generating machines (e.g. electron microscopes) or radiation-generating machines received on loan, on a trial basis, or for demonstration purposes.
Registrations are processed through the Michigan Department of Licensing and Regulatory Affairs (LARA) and certificates of registration are renewed annually. Radiation Safety Services (RSS) is the official liaison on behalf of U-M for all matters involving registrations, applications, approvals, and operation of radiation-generating machines. RSS may recharge the costs of registration and related services to facilities that use radiation-generating machines in association with revenue-generating operations.
Contact RSS for advice and assistance prior to acquiring or installing radiation-generating machines at (734) 764-6200.
LARA maintains a registry that identifies each radiation-generating machine by its registration number and the exact location of the device. LARA regulations require that RSS notify them of changes to the registration information including when the radiation-generating machines are to be relocated, sold, or disposed.
RSS needs adequate notice when users are changing registration information pertaining to a radiation-generating machine in case the changes proposed require new facility radiation shielding evaluations and plan approvals or new certificates of registration.
NOTE: The following time frames are estimates as to how long it takes to obtain a new certificate. For a more accurate time frame in regards to your plans and equipment, contact RSS at (734) 764-6200.
|TO OBTAIN A NEW CERTIFICATE, RSS NEEDS…||IF YOU ARE…|
|Two weeks||Acquiring or relocating self-shielded or low-powered devices (e.g. electron microscopes, portable devices, enclosed irradiators and enclosed x-ray diffraction machines)|
|At least six weeks||Acquiring or relocating any unshielded machines installed in a fixed location (e.g. clinical radiographic or fluoroscopic devices) that may need facility shielding plan design approvals from the State of Michigan|
|One week||Disconnecting and sending equipment to Property Disposition for sale or disposal|
Machine Registration Tags
LARA issues a yellow tag for each registered radiation-generating machine. This tag has an identification number that begins with “X” and RSS will provide and affix the tags to the radiation-generating machine. DO NOT REMOVE TAGS – Contact RSS if a tag becomes illegible, is removed, is lost, or is on a component that must be replaced. We will arrange for a new tag.
Certificate of Need
The Michigan Department of Health and Human Services (DHHS) may require U-M to obtain a Certificate of Need (CON) before some types of equipment can be purchased and installed for clinical use (e.g. CT and dental CT units). LARA will not register such equipment until DHHS issues a CON or an exemption. RSS does not process applications for CONs – Clinics and facilities that may need a CON should contact the University of Michigan Health Systems, Office of the Senior Vice-President and Chief Operating Officer, at (734) 647-1163 for assistance.
LARA may require U-M to submit a facility radiation shielding plan, drawn to scale, for approval prior to registering a radiation-generating machine. LARA may also require a revised facility radiation shielding plan when:
- The design of an existing facility changes
- The radiation generating equipment is:
- Upgraded or replaced
- Repositioned within a shielded room
- Relocated to another area
RSS reviews and submits radiation shielding plans to LARA on behalf of the users, and will work with users to develop a shielding plan for simple installations. Users are responsible for the cost when the facility or unit needs to:
- Be renovated or modified to install the shielding in accordance with the plan
- Hire consultants specializing in plan preparation when the equipment involves complex systems or significant shielding needs
The medical physicists for the Radiology and Radiation Oncology departments will review and submit the radiation shielding plans on behalf of facilities and equipment for the UMHHC.
In most instances, routine repairs by a qualified factory or vendor service representative does not require RSS approval. However, you must obtain approval from RSS prior to modifying or altering radiation-generating machines 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 re-registration of the radiation-generating machine or new shielding plan approvals by LARA.
RSS recommends scheduling a radiation survey after repairs to x-ray generating systems for all non-clinical equipment or to shielding of self-shielded radiation-generating machines such as, but not limited to cabinet x-ray machines, irradiators, and diffraction units. NOTE: Users should always insist that factory service representatives conduct documented tests of all safety systems (e.g. warning lights, interlocks, closure mechanisms) after completing any repair work on a radiation generating machine or users should run such tests before returning equipment to routine use.
Contact RSS if you are unsure about the safety of any equipment.
LARA routinely inspects newly registered facilities in the same year when first registered and will re-inspect registered facilities and radiation-generating machines at least once every five years thereafter. RSS will contact users when inspections are to be scheduled and will try to accommodate schedules when possible; but users must cooperate in making facilities and machine operators available to ensure a complete and timely inspection.
RSS is responsible for training users how to use radiation-generating machines safely; departments are responsible for training users on the specific operation of a particular piece of equipment. RSS training courses are offered on an “as needed” basis. For the sake of efficiency and timeliness, RSS prefers departments request training when they have several machine operators needing training on the same radiation-generating machine. However, always check with RSS if you will need training and we will do our best to accommodate small groups or individuals.
An RSS health physicist will advise users of any personnel radiation-monitoring requirements. Users can arrange to obtain radiation-monitoring dosimeters through their dosimetry contact person when needed.
Authorized users must contact RSS at (734) 764-6200 when they intend to relocate, sell, or dispose of a radiation-generating machine. Radiation-generating machines that will be put into storage, sold, or relocated to Property Disposition must be securely disconnected or permanently rendered inoperable to prevent the device from being used inadvertently. In most instances a radiation-generating machine can be securely disconnected from electrical power for purposes of storage or resale by:
- Removing batteries from a portable radiation-generating machine
- Removing or cutting power cords to the radiation-generating machine
- Removing and securing radiation-generating machine fuses or breakers
- Securing keys to keyed power switches
- Installing locked, tamper-proof covers over power plugs
Older radiation-generating machines and some special purpose or custom units may use cooling oils contaminated with polychlorinated biphenyls (PCBs) to cool parts of the machine such as transformers and x-ray tube heads. PCBs are regulated and the cooling oil may need to be collected for reclamation. Contact EHS HMM at (734) 763-4568 for an evaluation if you intend to sell or dispose of any such radiation-generating machine or are unsure if it contains PCBs.
Property Disposition Declaration of Surplus
When sending equipment to Property Disposition, you will must complete a Property Disposition Declaration of Surplus form. In the form, include the statement:
“This machine is a radiation-generating machine. State of Michigan Tag No.: X _____. Please notify EHS Radiation Safety Service at 764-6200 upon sale or disposal of this unit and provide Machine Tag No., name, address and phone number of buyer.”
Contact RSS for more information if you have questions about preparing radiation-generating machines for storage, sale transfer, or disposal.