Radiation Control for Health and Safety Act of 1968

Radiation Control for Health and Safety Act of 1968

• Purpose of the law: To protect the public from the hazards of unnecessary radiation exposure resulting from electronic products and diagnostic x-ray equipment
• Established the Center for Devices and Radiological Health (CDRH) under the jurisdiction of the Food and Drug Administration (FDA)
• CDRH is responsible for conducting an ongoing electronic product radiation control program
• Law 90-602 only regulates equipment performance standards, not diagnostic x-ray user practices

Code of Standards for Diagnostic X-Ray Equipment

• Went into effect on August 1, 1974
• Applies to complete systems and major components manufactured after that date

As Low as Reasonably Achievable (ALARA) Concept

• Principle introduced by the NCRP in 1954
• Radiation exposure should be kept "as low as reasonably achievable" with consideration for economic and societal factors
• Described by NCRP as the continuation of good radiation protection programs and practices
• Also known as optimization
• Medical imaging personnel and radiologists share the responsibility to keep occupational and nonoccupational dose limits ALARA
• EfDs and EqDs should be well below maximal allowable levels

Dose Limits

• An EfD limiting system has been incorporated into Title 10 of the Code of Federal Regulations, Part 20
• Rules and regulations of the Nuclear Regulatory Commission (NRC) and fundamental radiation protection standards governing occupational radiation exposure are included in this document
• Basis of the EfD limiting system: concept of radiation exposure and associated risk of radiation-induced malignancy
• Resource for revised recommendations: NCRP Report No. 116 and ICRP Report No. 60
• Future radiation protection standards are expected to continue to be based on risk

Radiation Safety Committee (RSC)

• NRC mandates that an RSC be established for the facility
• Functions of the RSC: provides guidance for the program, facilitates ongoing operation of the program, and selects a qualified person to serve as a radiation safety officer (RSO)

Radiation Safety Officer (RSO)

• An RSO should oversee the program's daily operation, provide for formal review of the program each year
• Typically a medical physicist, health physicist, radiologist, or other individual qualified through adequate training and experience
• RSO has been designated by a health care facility and approved by the NRC and the state
• Responsibilities of the RSO:
  • Develop an appropriate radiation safety program for the facility that follows internationally accepted guidelines for radiation protection
  • Ensure that the facility's operational radiation practices protect people, especially those who are or could be pregnant, from unnecessary exposure
  • Review and maintain radiation-monitoring records for all personnel, be available to provide counseling for individuals
  • Employs proper safety procedures performed by qualified personnel to achieve the ALARA goal

ALARA Concept

• Procedures should be clearly described in a facility's radiation safety program
• Health care facilities usually adopt investigational levels (Level I and Level II) to define ALARA
• A facility's radiation safety program should include a description of procedures to achieve ALARA
• Goal of ALARA can usually be achieved through the employment of proper safety procedures performed by qualified personnel

Model for the ALARA Concept

• An extremely conservative model with respect to the relationship between ionizing radiation and potential risk
• Relationship is assumed to be completely linear and without any threshold
• Risk of injury should be overestimated rather than underestimated

Action Limits

• Personnel dosimeter readings should be well below a tenth of the maximum EfD limits, even for those technologists who receive the most exposure
• Health care facilities establish their own internal action limits, which are set at levels far below the actual limits
• These limits are meant to trigger an investigation that should uncover the reason for any unusually high exposure
• The RSO must be an active participant in an ongoing program designed to prevent personnel from receiving anywhere near the maximum allowed exposures

Radiation Hormesis

• Suggests a beneficial consequence of radiation for populations continuously exposed to moderately high levels of radiation
• There are numerous studies that propose a potential radiation hormesis effect
• Until the radiation hormesis theory is proven, the medical radiation industry will continue to follow the principle of ALARA for radiation protection purposes