(FDA) An agency of the US federal government established by Congress in 1912 and presently part of the US Department of Health and Human Services. The FDA gives classifications of medical devices according to potential risks and controls the safety of marketed drugs.
For more details please visit the FDA's 'Our Mission and Mandate'.

See also Class I II III Devices and Phase 1 2 3 4 Drug Trials.

Gamma rays are a form of nuclear radiation that consists of photons emitted by radioactive elements from the nucleus. This high energetic light emission is also produced from subatomic particle interaction, such as electron positron annihilation. Gamma radiation, similar to x-radiation can injure and destroy tissue, especially cell nuclei.
Gamma rays have in general very high frequencies, short wavelengths, are electrically neutral and penetrate matter. The interaction of gamma rays with matter depends on the nature of the absorber as well as the energy of the gamma rays; these interactions determine also the type and amount of shielding needed for radiation protection.

See also Radiation Safety, Lead Equivalence, Lead Apron, Leaded Glove, Glove-Box, Radioactive Decay Law and Radiation Worker.

(IAEA) The IAEA is an independent international organization related to the United Nations system today, founded in 1957 ('Atoms for Peace' Agency) as part of the United Nations family. Its mission is to promote and supervise worldwide safe, secure and peaceful nuclear technologies. The IAEA's three main areas of work are 'Safety and Security', 'Science and Technology', and 'Safeguards and Verification'.

Iodinated contrast media contain small amounts of free iodide. Too much free iodide in the blood may cause hyperthyroidism in patients at risk, but contrast medium induced thyrotoxicosis is rare. The free iodide may also interfere with nuclear medicine diagnostic tests and treatment. However, iodinated contrast agents do not affect thyroid function tests (e.g., T3, T4, TSH) in patients with a normal thyroid.
Guidelines were prepared by the 'Contrast Media Safety Committee of the European Society of Urogenital Radiology' and discussed on the Tenth European Symposium on Urogenital Radiology in September 2003.
Tests of thyroid function before the injection of contrast agents may only be indicated in areas with dietary iodine deficiency. Patients with Graves' disease, multinodular goiter with thyroid autonomy, especially elderly and patients who lives in areas of iodine deficiency are at risk to develop thyrotoxicosis after IV contrast medium and should be monitored by endocrinologists after contrast enhanced CT exams. Prophylaxis may offer some protection in selected high-risk individuals but is not generally recommended.
The free iodide of iodinated contrast agents interferes with thyroidal iodide uptake and impedes diagnostic thyroid scintigraphy and radio-iodine treatment of thyroid malignancies for 2 months after administration.

The first-generation contrast agents were all ionic monomers, consisting of a tri-iodinated benzene ring with 2 organic side chains and a carboxyl group. Diatrizoate or iothalamate are common iodinated anions, conjugated with a cation, sodium or meglumine. The ionization at the carboxyl-cation bond makes the agent water soluble.
Ionic monomers have the highest osmolality (high-osmolar contrast media (HOCM) possess an osmolality seven to eight times higher than plasma) of the different groups of contrast agents (CM ratio=1.5) and the lowest viscosity. The osmolality in solutions of ionic monomers ranges from 600 to 2100 mOsm/kg (human plasma = 290 mOsm/kg). These high osmolality is related to some of the adverse reactions. HOCM's have been widely replaced by newer contrast agents with improved tolerability and safety profiles.
Examples of HOCM's are Renografin®-60, Hypaque 76, Hypaque Meglumine, Hypaque Sodium and Conray®.

See also Ionic Contrast Agents.