Radiation-Generating Machines

Radiation-Generating Machine Registration Information

MIOSHA maintains a registry that identifies each radiation-generating machine by registration number and exact location.  MIOSHA regulations require that RSS notify them of changes to the registration information including when radiation-generating machines are relocated, sold, or disposed.

RSS needs adequate notice when machine owners/users are changing registration information pertaining to a radiation-generating machine in case the proposed changes proposed require new/updated facility radiation shielding evaluations and plan approvals or new certificates of registration.

TO OBTAIN A NEW CERTIFICATE, RSS NEEDS…	IF YOU ARE…
At least six weeks	Acquiring or relocating any unshielded machines installed in a fixed location (e.g., clinical radiographic or fluoroscopic machines) that may need radiation shielding plan approval by MIOSHA
Two Weeks	Acquiring or relocating self-shielded or low-powered devices (e.g, electron microscopes, portable devices, enclosed x-ray irradiators, and enclosed x-ray diffraction machines)
One week	Disconnecting and sending equipment to Property Disposition for sale or disposal

University of Michigan Health (Michigan Medicine) 

To add or remove a radiation-generating machine at Michigan Medicine, please complete the X-ray Device Registration or Removal Form. Completed forms should be sent to [email protected]. 

Machine Registration Tags

MIOSHA issues a yellow tag for each registered radiation-generating machine.  This tag has an identification number that begins with “X” and RSS will affix the tags to the radiation-generating machine after they’re received from MIOSHA.  DO NOT REMOVE TAGS – contact RSS if a tag becomes illegible, is removed, is lost, or is on a component that must be replaced. RSS will request for a new or replacement tag from MIOSHA.

Additionally, MIOSHA requires that all radiation-producing machines be labeled with a warning that ionizing radiation is produced when the machine is energized.  RSS provides stickers to satisfy this requirement.  DO NOT REMOVE THIS STICKER; contact RSS if a sticker becomes illegible, is removed, is lost, or is on a component that must be replaced.

Certificate of Need

The Michigan Department of Health & Human Services (MDHHS) may require U-M to obtain a Certificate of Need (CON) before some types of radiation-generating machines (e.g, CT Machines or linear accelerators) can be purchased and installed for clinical use.  MIOSHA will not register such radiation-generating machines until MDHHS issues a CON or an exemption.  RSS does not process applications for CONs; clinics and facilities that need a CON should contact University of Michigan Health, Office of the Senior Vice-President and Chief Operating Officer, at (734) 647-1163 for assistance.

Facility Radiation Shielding Plan

MIOSHA may require U-M to submit a facility radiation shielding plan for approval prior to registering a radiation-generating machine.  MIOSHA may also require a revised facility radiation shielding plan when:

• The design of an existing facility changes
• A radiation-generating machine is:
  • Upgraded or replaced
  • Repositioned within a shielded room
  • Relocated to another area

RSS reviews or submits facility radiation shielding plans to MIOSHA on behalf of the machine owners/users- and will work with owners/users (when necessary) 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 required shielding in accordance with the plan
• Hire consultants specializing in shielding plan preparation when the equipment involves complex systems or significant shielding needs

University of Michigan Health (Michigan Medicine)

Medical Physicists in Radiology and Radiation Oncology will review and submit facility radiation shielding plans on behalf of U-M Health.

Modifications, Alterations, Repairs

In most instances, routine repairs by a qualified manufacturer or service representative do 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:

• Output
• Inherent shielding
• Interlock operation
• Warning lights
• Any factor that may implicate safety of:
  • Users
  • Patients
  • Research subjects

In some instances, such changes may require re-registration of the radiation-generating machine or a new facility shielding plan approval by MIOSHA.

Radiation Survey

RSS recommends scheduling a radiation survey after repairs to non-clinical radiation-generating machines or to shielding of self-shielded radiation-generating machines (such as, but not limited to cabinet x-ray machines, irradiators, and diffraction units).  NOTE: Machine owners/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 owners/users should run such tests before returning equipment to routine use.

Safe Use of the Equipment

MIOSHA Inspections

MIOSHA routinely inspects newly registered facilities (within a year of registration) and will re-inspect registered facilities and radiation-generating machines at least once every five years thereafter (annually for mammography).  RSS will contact machine owners/users to schedule inspections when requested by MIOSHA and will try to accommodate user schedules when possible; but users must cooperate in making facilities and machine operators available to ensure a complete and timely inspection.

Training

RSS is responsible for training users how to safety use radiation-generating machines and maintain their occupational radiation doses As Low As Resonably Achievable; owning/operating departments are responsible for training users on the specific operation of a particular machine.  

RSS may develop and/or conduct specialized radiation safety training based on the specific needs of a department or job function, including operators and users of:

• Radiation-generating machines
• X-ray devices and specialized equipment specific or unique to radiological use, such as:
  • Analytical X-ray Machine Safety
  • X-ray Fluoroscopy Safety

• X-ray Fluoroscopy Safety

U-M Health personnel operating or participating in procedures involving radiation-generating machines must complete all U-M Health radiation safety training relevant to their job duties.  The following courses are available through the U-M Health learning management system (Cornerstone Learning):

COURSE	AUDIENCE
RADI-10115: Dosimetry Compliance and Occupational Radiation Safety	Personnel operating or participating in procedures involving radiation-generating machines (e.g., x-ray, fluoroscopy).
RADI-10260: Radiation Doses in CT	Personnel operating or participating in procedures involving computed tomography (CT) machines.
RADI-10100: Fluoroscopy Privileging	Operators of fluoroscopy machines for patient use.

Radiation Dosimetry

RSS will advise radiation-generating machine users of any personnel radiation monitoring (dosimetry) requirements. Machine operators/users should obtain dosimeters through their department/unit dosimetry contact, when required.

In general, any person in the room while a radiation-generating machine is operating is (or may be) required to wear dosimetry.

Removing Radiation-Generating Machines from Service

Machine owners must contact RSS at [email protected] or (734) 647-1143 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 (purposely or 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

PCB Reclamation

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 must complete a Property Disposition Declaration of Surplus form.  In the form, include the following statement:

“This is a radiation-generating machine, State of Michigan Tag No.: X- _____.  Please notify EHS Radiation Safety Service upon sale or disposal of this machine and provide the Tag No., name, address and phone number of buyer.”