Useful Industry Links

Preventing a Dirty Bomb: Case Studies and Lessons Learned

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

CFR – Code of Federal Regulations Title 21

CDRH stands for the FDA’s Center for Devices and Radiological Health (CDRH). Performance Standards for Ionizing Radiation Emitting Products.

What is Ionizing Radiation?

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.

How is Ionizing Radiation Generated?

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.

What is Ionizing Radiation Used for?

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.

Why use x-ray versus gamma produced Ionizing radiation?

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.

Does the RS 3400 require external cooling?

No, the RS 3400 uses a self-contained water to air exchange system.

Is the RS 3400 Blood Irradiator cleared by the FDA for GVHD?

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).

How does the RS 3400 differ from other x-ray irradiators?

The RS 3400 is designed to have the blood bags rotate around the Quastar™ x-ray emitter using our patented carousel and therefore delivers superior uniformity.
Unlike other x-ray blood irradiators, the RS 3400 is completely self-contained and requires no external water supply for tube cooling.
The RS 3400 is engineered for extreme reliability as it uses the proven Quastar™ x-ray emitter.
The RS 3400 has only ONE x-ray tube and ONE power supply.

How does the RS 3400 differ from a Cs-137 gamma irradiator??

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.

What does CDRH stands for

What does CDRH stands for?

Recent Posts

Recent Comments

Archives

Categories

Meta

Product Literature & Links

RS 3400 Product Brochure

Please click link below to view brochure.