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Radiation Regulations

While many governmental agencies may have regulations that affect your practice, this section deals with radiation safety and the primary agencies that regulate radiation safety. The following information is intended for users of general purpose radiology equipment as opposed to mammography, fluoroscopy or computed tomography equipment.

 

We want to stress that while the following information may seem complex, it is not as difficult as it may first appear. When it comes to x-ray regulatory and safety requirements, our position is very simple: you must be in compliance. No “ands”, “ifs” or “buts”, 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. The following may seem complex but need not be if you have the right assistance.

 

As far as agencies are concerned, you need to comply with federal and state/local regulations. On the federal level, the U.S. Food and Drug Administration’s Radiological Health Program issues regulations regarding radiation producing equipment. (For simplification, we will use the term “FDA” for the remainder of this section.) The FDA’s website (http://www.fda.gov/Radiation-EmittingProducts/default.htm) 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.” Your state/local regulations are patterned after the federal regulations; however, in some instances the state/local regulations can be more stringent that the federal regulations.

 

Specifically, 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, there are documents that your equipment supplier/service provider must submit to the FDA and the FDA has the right to inspect your facility. By complying with the regulations of one level of regulators, you will likely comply with the regulations of the other level. But 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:

  1. Using equipment that meets certain manufacturing standards and approvals

  2. Providing an area where the equipment can be used safely especially by providing certain levels of radiation protection to persons who potentially could be exposed to radiation produced by your equipment

  3. Proper installation, maintenance and upkeep of this equipment

  4. Maintaining records that indicate the radiation exposure caused by equipment to your patients, facility personnel and certain other persons

  5. Allowing inspection of your facility’s documentation, equipment, and records by various regulatory agencies or their designees

In order to meet the above responsibilities, we suggest the following:

  1. 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, there are some products that 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 of those who may take this area lightly or those whose knowledge seems limited.

  2. 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.

  3. 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 insure that you meet all requirements.

  4. 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.

  5. 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 familiar with the specific requirement of your jurisdiction and can be a valuable resource for you.

  6. Comply with the scheduled preventative maintenance and inspections as required by the various governmental agencies.

  7. Overall, be certain that you and your x-ray dealer are familiar and comply with all of the applicable radiation regulations for your area.

Once again, this may seem complex but it need not be if you obtain the proper assistance. Feel free to call Omni at 866-692-1033 if you have any questions.

 

 

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