What does CDRH stand for?
CDRH stands for the FDA’s Center for Devices and Radiological Health (CDRH). Performance Standards for Ionizing Radiation Emitting Products can be found at CDRH 21CFR1020.40
Preventing a Dirty Bomb: Case Studies and Lessons Learned tells the stories of major urban areas and institutions in the United States that have made the decision to remove and replace medical and research devices containing cesium-137 with equally effective alternatives that do not pose the security risks associated with high-activity radiological materials.
Laura S. H. Holgate, Ambassador (ret.)
Vice President, Materials Risk Management
October 1, 2019
CDRH stands for the FDA’s Center for Devices and Radiological Health (CDRH). Performance Standards for Ionizing Radiation Emitting Products.
Why Non-nuclear over Ultraviolet Irradiation?
Ionizing radiation consists of subatomic particles or electromagnetic waves that are energetic enough to detach electrons from atoms or molecules, ionizing them.
Two of the most common forms of ionizing radiation are gamma rays and x-rays. Both forms of ionizing radiation are almost identical with exception to their source of origination.
Ionizing radiation comes from radioactive sources such as cobalt 60 and cesium 137 and non-radioactive sources such as x-ray tubes. Radioactive sources are unstable materials where gamma rays originate from the nucleus. x-rays originate in the electron fields surrounding the nucleus or are machine-produced.
Because of the penetrating properties of ionizing radiation and their ability to kill microorganisms, ionizing radiation is used to sterilize or reduce the microbial load of many different types of products such as medical devices, packaging, cosmetics, foods, and agricultural products. It is also used to alter the properties of many different polymers through recombination, cross-linkage, and cross scission.
Gamma ionizing radiation is produced by radioactive sources such as cobalt 60 or cesium 137 and is dangerous requiring heavy shielding and high levels of security to protect. The unstable material is constantly decaying and cannot be turned off. x-ray ionizing radiation is produced by a x-ray tube therefore it can be turned off when it is not being used and it requires much less shielding. At the end the of unit’s lifecycle, the unit does not have any radioactive source and therefore does not require the expensive disposal costs associated with radioactive sources that continue to degrade over hundreds of years.
Yes, the RS 3400 was cleared by the USFDA for marketing for the irradiation of blood for the prevention of graft verses host disease (GVHD).
The RS 3400 uses a Rad Source patented Quastar™ x-ray emitter and therefore contains NO radioactive isotopes. It can be turned on and off, similar to a light bulb. As a result, there is no Nuclear Site License, Homeland Security issues, or room shielding requirements.
CDRH stands for the FDA’s Center for Devices and Radiological Health (CDRH). Performance Standards for Ionizing Radiation Emitting Products can be found at CDRH 21CFR1020.40