The X-ray Registration, Inspection and Certification Program exists to assure quality radiographs with a safe x-ray facility environment for both the people of Virginia and the operators of the equipment. The X-ray Program registers approximately 19,000 radiation-producing machines (such as x-ray machines); sets performance criteria for them; and authorizes non-department qualified private inspectors to perform the evaluations and non-department service companies to install and repair the machines.
Medical machines must be inspected within the established frequency of annually. Any x-ray machine that is determined to be unsafe for human use is restricted from use until the x-ray machine is repaired by a service company, and re-inspected by a Virginia Radiological Health Specialist , or permanently removed from service. These regional radiological health specialists audit and monitor private sector inspections and perform compliance inspections of x-ray facilities.
The Medical X-ray machine page will cover the following topics:
- Purchasing an X-ray machine
- Shielding Review
- Registration of facilities;
- Notification of out-of-state machines or for temporary use
- Operational Procedures, Forms and Notices
- Inspection requirements
- FDA compliance inspections
- Nationwide Evaluation X-ray Trends (NEXT)
- Certification of X-ray machines
- Machine disposal/inactivation
- Listing of qualified private inspectors.
- Medical Licensing Board, Professional Societies, Allied Professionals.
Purchasing an X-ray machine
The U.S. Food and Drug Administration regulates the manufacture of diagnostic X-ray machines for human use. X-ray machines manufactured after August 1, 1974 must be federally certified for use. Most components of a certified system must be replaced with certified components. Occasionally VDH will conduct an inspection on behalf of the FDA to ensure new X-ray machines comply with the federal certification requirements. FDA can take enforcement action to require the manufacturer/installer to correct the defect at no cost to the facility.
Before you buy an X-ray machine there are several things to consider in addition to the X-ray machine. Make sure you have adequate space for the machine, operator’s booth, film processor, film processing chemicals, and film storage.
You should consult with a medical physicist (See our Private Inspector list) regarding the X-ray machine specifications and shielding requirements for the X-ray room, and film storage area. You may also need to discuss with your film processor/chemicals sales representative the right chemicals and replenishment rates for the type of film and work load for your facility.
Your medical physicist will need the following information to conduct a shielding review of your facility:
- Distances from X-ray tube to each wall
- General use of room on opposite side of each wall
- Designate which wall the film bucky will be installed on
- Approximate weekly patient work load
- Technique factors for the most commonly used projections (mA and time, or mAS, kVp)
- Location of film storage relative to X-ray machine
- Location of operator’s booth
The X-ray machine installer is required to submit a Report of Assembly, FDA Form 2579, to both the U.S. Food and Drug Administration and to the Virginia Department of Health. The report of assembly will prompt VDH to send a registration form to the facility. The facility may begin operation of the X-ray machine as soon as it becomes operational; however, it is recommended that the machine be registered within 30 days and have the machine’s performance reviewed by a Private Inspector within 30 days of registration. Likewise the operators of the machine should review manufacturer’s operating and safety instructions before patient use.
Note: Installers or Assemblers of X-ray equipment are not required to be registerd with the State; however, they are required to install the equipment so that it meets Virginia’s regulatory requirements.
All X-ray machines owned or possessed in Virginia are required to be registered with the Virginia Department of Health with the following exception:
- X-ray machines in areas of exclusive federal jurisdiction (airports, military and other federal facilities)
- X-ray machines belonging to manufacturers and dealers used for demonstration purposes ( See notification of temporary use requirements)
- X-ray machines from out of state used for less than 180 calendar days (See notification requirements)
Owners of X-ray machines or those having administrative control of an X-ray machine shall submit a registration form to the Department of Health and provide the appropriate information regarding the machine and its intended use. The Registration form may be downloaded Medical Registration Fillable Form Health 04-07-16. VDH will provide the facility a decal to place on the X-ray machine and issue a facility identification number and tube number. VDH will send an invoice annually for the registration fee of $50.00
Unpaid registration fees will be turned over to the Virginia Department of Taxation for collections and will accrue interest and additional penalties. Please also remember to pay the Use Tax, also known as the sales tax on new X-ray machines. The Virginia Department of Taxation has used the VDH X-ray registration database as a tool to recover unpaid use tax on new X-ray machines.
Notification of Out of State or Temporary Use Machines
VDH must be notified in advance whenever an out-of- state X-ray machine or X-ray machine is brought into the state for temporary use. Machines used more than 180 calendar days must be registered with VDH. The individual will give written notice at least two working days prior to use in the state. The notice shall includes:
- Type of radiation machine (Make, Model, Serial Number)
- The nature, duration and scope of use
- The exact location where the machine is to be used
- The State in which the machine is registered along with a current inspection report and
- Contact name and telephone number.
NOTE: X-ray machine operators not affiliated with a hospital must be licensed by the Board of Medicine. For additional information, contact the Board of Medicine and ask about Radiologic Technologist, or Radiologic Technologist Limited at: http://www.dhp.virginia.gov/medicine/medicine_occupations.htm
X-Ray equipment used in the practice of medicine is inspected every year. Ninety (90) days prior to the expiration on the green certificate, a yellow notice is sent reminding the facility that an inspection is due. Your previous inspector’s name and telephone number is provided.
Exposure control switches should be permanently mounted outside the operatory to allow the operator to remain in a protected area during the exposure. In this case, dosimetry is not required. Stretch cords are not allowed in new office settings. For existing offices with existing units having stretch cords, the stretch cord should be permanently mounted outside the operatory. In this case, dosimetry is not required. If an existing office has existing x-ray equipment with stretch cords, dosimetry is required. An X-Ray Bulletin dated May 1, 1999 provides additional information on exposure control switches and dosimetry.
Routine cleaning of automatic processor maintains good image quality. Regular changing of processor chemistry, keeps image quality at it’s best. As with any darkroom, white light is a film’s worst enemy. Any light leaks, fog the film, reducing the quality of the image. Make sure your darkroom is light tight!
The following should be posted for each inspection:
- A copy of the Notice to Employees
- A copy of the Radiation Safety Procedures
- A copy of an Operator’s List (RH-F-31)
- The green certificate for each x-ray unit
For medical facilities there is a periodic inspection requirement of once every year that reviews the X-ray machine’s performance and facility’s records pertaining to the machine’s use. The inspection may be performed by any of the Private Inspectors qualified to perform inspections on diagnostic machines. See our Private Inspectors list. Please note that the cost of these machine inspections is set by each individual Private Inspector.
After the facility or the Private Inspector provides VDH the inspection report, VDH will either provide the facility a certificate which should be placed in a conspicuous place near the X-ray machine if there are no items of serious non-compliance, or refer the inspection report to a VDH inspector for follow up of a serious non-compliance.
FDA Compliance Inspection Program
Occassionally VDH inspectors will conduct an inspection of new X-ray machine on behalf of the FDA. This is a FDA compliance inspection conducted on a recently installed x-ray machine (within one year from the installation date). The purpose of this inspection is to provide information to the FDA regarding whether machines and components were manufactured and installed according to federal regulations. There is no fee for the FDA inspection. FDA will ensure the manufacturer or assembler will comply with the federal regulations at their expense and not the owner of the machine.
Nationwide Evaluation X-ray Trends (NEXT)
VDH participates in a national survey to determine the amount of radiation patients are exposed to for various types of X-ray exams. There have been several surveys of various diagnostic projections, which are available at :NEXT
All X-ray machines used in the healing arts must also be certified for patient use. Certification is based on the results of the inspection by a Private Inspector or if needed follow up inspection by a VDH inspector to resolve any outstanding regulatory non-compliance. VDH inspectors will work with the facility to ensure each serious item is corrected and assist the facility to minimize patient dose to radiation and improve the diagnostic quality of the image, or in the case of bone densitometers to ensure accurate diagnostic results.
In those cases when the X-ray machine is not repaired or in some cases no longer repairable, certification will be denied and the machine will be posted and must not be used in the healing arts.
The Board of Medicine is notified when X-ray machine certification is denied. The Board of Medicine may consider continued use of an X-ray machine by any of its licensees as a failure to provide the standards of care and may be subject to disciplinary action by the Board.
Insurance may also deny reimbursement for radiographs produced by an uncertified machine.
The VDH may consider enforcement action against facilities that fail to register its X-ray machines and continue use of uncertified machines.
An X-ray machine may be taken out of service and placed in storage for several reasons such as:
- Machine cannot be repaired or is too expensive to repair
- Does not meet certification requirements
- Replaced by a newer machine
- Facility seeking disposal options
The machine does not need to be inspected unless it is being returned to service; however, it must continue to be registered with VDH and registration fees paid, until permanently disposed or transferred/sold to another individual/facility. Electrical power should be disconnected from the X-ray machine and preferably placed in storage.
The facility should notify VDH when the X-ray machine is transferred to an X-ray repair/installer for disposal; transferred/sold/traded to another individual or facility, or disposed in a landfill. The name and address of person to whom the X-ray machine was transferred should be given so VDH may ensure the X-ray machine is properly registered or the machine is properly removed from our database. Note: Some x-ray installers/repair business will dispose of a machine for you at cost or included in the purchase of a new machine.
Listing of qualified private inspectors.
Facilities may request the services of a Private Inspector to inspect their X-ray machines. Theses indiviudals are not Health Department employees and set their own fees for providing inspection services.VDH certifies these individuals for various types of X-ray equipment. Individuals providing inspection services must be certified to conduct the State’s machine inspection. We also maintain a Private Inspectors list.
Medical Licensing Board, Professional Societies, Allied Professionals
Type of Facility by Practice: Medical
Licensing Board: Board of Medicine- http://www.dhp.virginia.gov/medicine/medicine_occupations.htm
Medical Society of Virginia: http://www.msv.org/
Allied Professionals (X-ray Machine Operator): Radiologic Technologist, or Radiologic Technologist Limited under supervision of a Physcian:
Licensing Board: Board of Medicine- Radiologic Technologist, or Radiologic Technologist Limited under supervision of a Physcian-
Accreditation Services for Radiologic Technologist:
American Registry of Radiologic Technologists: http://www.arrt.org/
Virginia Society of Radiologic Technologists http://vsrt.org/
Joint Review Committee on Education in Radiologic Technology http://www.jrcert.org/
Office of Radiological Health | 109 Governor Street, 7th Floor | Richmond, VA 23219
Telephone (804) 864-8150 | X-ray Fax: (804) 864-8175