X-Ray Regulations
When it comes to x-ray regulatory and safety requirements, our position is very simple: you must be in compliance.
There are no compromises with respect to these requirements.
A competent and experienced x-ray dealer can assist you and help make compliance a routine matter.
Companies like Omni Imaging work with these regulations on a daily basis and routinely interact with regulatory agencies.
Agencies that regulate X-Ray:
U.S. Food & Drug Administration (FDA)
The FDA’s Radiological Health Program issues regulations regarding radiation producing equipment.
The FDA’s website states the following:
“The mission of the FDA’s radiological health program is to protect the public from hazardous or unnecessary radiation exposure from radiation-emitting electronic products.”
The FDA regulates the x-ray equipment you use, how the equipment is used, and the radiation protection and monitoring used in your practice.
The FDA works closely with state and local agencies that also regulate the use of x-ray generating equipment.
Most of your facility’s registration, submissions, approvals and inspections will be done at the state or local level. However, in most cases there are documents that your equipment supplier/service provider must submit to the FDA and the FDA has the right to inspect your facility
State & Local Regulations
State and Local Regulations can vary greatly depending on the location of your practice.
Your state/local regulations are patterned after the federal regulations; however, in some instances the state/local regulations can be more stringent than the federal regulations.
By complying with the regulations of one level of regulators, you will likely comply with the regulations of the other level. However, this is not an absolute. As the operator of a facility with x-ray equipment you are responsible to meet all regulations
In addition to accepted standards of medical care, you are generally responsible for the following:
You should verify with your supplier that the equipment you are purchasing meets the FDA’s requirements for your type of practice.
While most equipment is certified for use with humans, some products are restricted to veterinary or other non-human use.
While sellers of x-ray equipment recommend certain brands or models, you are ultimately responsible for the selection of properly approved equipment. Ask your potential supplier about these FDA issues.
Avoid working with those who seem to take this area lightly or those whose knowledge seems limited.
There are very stringent design requirements for your x-ray room.
In addition to complying with various building codes, your x-ray room has to be designed to in accordance with the requirements of the National Council on Radiation Protection & Measurements (NCRP), an organization chartered by the United States Congress.
These design requirements deal primarily with radiation shielding and other matters that affect the radiation protection of your patients, employees and others.
You should consult with someone who is qualified to ensure that requirements of the FDA, your state and local government, and the NCRP are met.
Each state and/or local jurisdiction has their own standards for the qualifications of these persons.
Many times, companies such as Omni Imaging are considered by various government agencies to be qualified to do such design work.
While we think it best to deal with an equipment supplier who is qualified to do this design work, at a minimum your supplier should assist you in finding someone who is permitted to do this work.
If you are told by a supplier that they do not get involved in this area, you may want to change to another supplier who does.
Register your x-ray facility and equipment with appropriate governmental agencies.
Usually there are at least two steps to this process.
Appropriate agencies should be notified prior to construction of your facility; when completed additional notification should be made.
You should determine the applicable regulations for your area to ensure that you meet all requirements.
Comply with all radiation monitoring requirements.
These are intended to provide current and historical data for persons who may receive certain threshold radiation exposure by virtue of the operation of your x-ray equipment.
Your x-ray dealer can provide you with list of companies that provide monitoring services.
Various items, notices and records must be maintained and/or posted in your facility (e.g. facility registration certificate, pregnancy warning, technique charts, radiation monitoring results, etc.).
You can find these requirements in the various governmental regulations.
Your x-ray dealer should be able to assist you in determining the specific requirements of your jurisdiction and can be a valuable resource for you.
Comply with the scheduled preventative maintenance and inspections as required by the various governmental agencies.
Overall, be certain that you and your x-ray dealer are familiar and comply with all of the applicable radiation regulations for your area.