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 registration information, including when radiation-generating machines are relocated, sold, or disposed.

RSS needs adequate notice when machine owners/users are changing registration information in case the proposed changes require new or updated facility radiation shielding evaluations, 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, 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 machine after they are received from MIOSHA. DO NOT REMOVE TAGS – contact RSS if a tag becomes illegible, is removed, lost, or on a component that must be replaced. RSS will request a new or replacement tag from MIOSHA.

MIOSHA also requires all radiation-producing machines to 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, lost, or 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 machines until MDHHS issues a CON or an exemption. RSS does not process CON applications; 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.

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 plan when:

• The design of an existing facility changes
• A radiation-generating machine is upgraded, replaced, repositioned within a shielded room, or relocated to another area

RSS reviews or submits facility shielding plans to MIOSHA on behalf of machine owners/users and will work with owners/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 required shielding
• Hire consultants for 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

Routine repairs by a qualified manufacturer or service representative usually do not require RSS approval. However, you must obtain approval from RSS prior to modifying or altering machines in ways that affect:

• Output
• Inherent shielding
• Interlock operation
• Warning lights
• Any factor affecting the safety of users, patients, or research subjects

Some changes may require re-registration 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 shielding of self-shielded machines (e.g., cabinet x-ray machines, irradiators, diffraction units). NOTE: Machine owners/users should ensure documented tests of all safety systems (warning lights, interlocks, closure mechanisms) are conducted after any repair or 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 re-inspects registered facilities and machines at least once every five years (annually for mammography). RSS will contact machine owners/users to schedule inspections; users must cooperate to ensure timely access.

Training

RSS provides training on safe use of radiation-generating machines and maintaining occupational radiation doses As Low As Reasonably Achievable (ALARA). Departments are responsible for machine-specific operation training.

Specialized training may include:

• Radiation-generating machines
• X-ray devices and specialized radiological equipment:
  • Analytical X-ray Machine Safety
  • X-ray Fluoroscopy Safety

U-M Health personnel must complete all relevant U-M Health radiation safety training via 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 CT machines.
RADI-10100: Fluoroscopy Privileging	Operators of fluoroscopy machines for patient use.

Radiation Dosimetry

RSS will advise users of any personnel radiation monitoring (dosimetry) requirements. Machine operators/users should obtain dosimeters through their department/unit dosimetry contact when required. Anyone in the room during operation 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 intending to relocate, sell, or dispose of a machine. Machines to be stored, sold, or sent to Property Disposition must be securely disconnected or permanently rendered inoperable, which can include:

• Removing batteries (portable machines)
• Removing or cutting power cords
• Removing and securing fuses or breakers
• Securing keys to keyed power switches
• Installing locked, tamper-proof covers over power plugs

PCB Reclamation

Older or custom machines may use cooling oils containing PCBs. PCBs are regulated, and cooling oil may need collection for reclamation. Contact EHS HMM at (734) 763-4568 for evaluation if selling or disposing of any such machine.

Property Disposition Declaration of Surplus

When sending equipment to Property Disposition, complete a Property Disposition Declaration of Surplus form including this 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.”