Radiation Regulations
Omni Imaging has extensive experience in working various radiation regulatory agencies. While we are not attorneys and do not claim to have legal expertise, we may be able to assist you with questions about regulatory matters.The following is an overview of some of the radiation regulations and is intended to give you some background information and general guidance. You should work with someone who is familiar with the specific regulations and requirements that pertain to your type of practice and the jurisdiction in which your practice is located.
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 basic radiology equipment as opposed to mammography, fluoroscopy or computed tomography equipment.
We want to stress that while meeting radiation requirements 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, let’s start at the top: the U.S. Food and Drug Administration’s Radiological Health Program. (For simplification, we will use the term “FDA” for the remainder of this section.) 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.”
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:
- using equipment that meets certain manufacturing standards and approvals
- 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
- the proper installation, maintenance and upkeep of this equipment
- maintaining records that indicate the radiation exposure caused by equipment to your patients, facility personnel and certain other persons
- allowing inspection of your facility’s documentation, equipment, and records by various regulatory agencies or their designees
- With respect to x-ray equipment, 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. It is true that most
sellers of x-ray equipment recommend certain brands or models; however, 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.
- 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 amount of radiation of your patients and others who may potentially be exposed to radiation by your x-ray equipment. 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 a supplier tells that they do not get involved in this area, you may want to change to another supplier who does.
- Radiation protection involves not only the safety afforded by the equipment itself, but also protection for patients, facility personnel and all other persons who may potentially be exposed to the radiation produced by your equipment. These other persons include all others who are in your office and all others who may be outside of your facility but are in areas that potentially could receive exposure to radiation from your equipment. You should familiarize yourself with 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 familiar with the specific requirement of your jurisdiction and can be a valuable resource for you.
If this seems like a great deal to absorb or if you need some help, call Omni Imaging at 866-692-1033 or email us at sales@omiimaging.com.