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Replacing Cesium-137 Blood Irradiators

Part of Preventing a Dirty Bomb: Radiological Security for Hospitals and Research Centers

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Replacing Cesium-137 Blood Irradiators

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Hospitals and research centers in the United States and around the world are addressing concerns about radiological security, safety and liability by replacing blood irradiators that use radioactive cesium-137 with safe, effective, FDA-approved x-ray technology.

In addition to the important health and safety concerns associated with a radiological attack, hospitals and research centers face considerable liability and reputation risks. Replacing cesium-137 source-based devices with X-ray technology protects those without insurance to cover losses associated with acts of terrorism—losses that easily could cause financial devastation for an institution responsible for paying huge damages in the wake of a dirty bomb explosion using stolen material.

If an institution chooses to continue using cesium-137 devices, those who oversee operations including radiation, health, safety and security department, have an obligation to ensure the devices are used in a safe and secure matter, compliant with state and/or federal regulations. They also must inform senior management about risks associated with the devices. End users, including doctors, technicians, and researchers, also should be informed about security risks and threats, and provided with information about alternative technologies.

In my professional opinion, there is neither a medical reason to delay the transition from cesium-137 blood irradiators to x-ray technology nor an economical reason…there is, however a security imperative to start to phase them out immediately… — Jacob Kamen, Ph.D, ABHP, Chief Radiation and Laser Safety Officer, Mount Sinai Health System

Ready to switch to a safe technology? Here is where to start:

  1. Learn more about available alternative technologies: In 2012, the U.S. Food and Drug Administration approved the use of non-radioactive X-ray devices for sterilizing blood that provide the same medical outcomes as cesium-137 blood irradiators. Three types of these devices on the market are FDA approved–Best Theratronics, Hitachi, RadSource; each costs approximately $270,000 per unit. The X-ray units require far less costly security and shielding, they eliminate liability, and they do not require expensive disposal at the end of the machine’s life-cycle. View a comparison of the available X-ray irradiator technology specs here.
  2. Learn about your local regulations and requirements. Determine who oversees licenses and inspections of radiological devices in your state to find out what steps are necessary to terminate or amend your cesium-137 licenses. Regulators may also be able to inform you about solutions or replacement initiatives in your home state. Information about your local regulator, either at the state or federal level, is available through the U.S. Nuclear Regulatory Commission here.
  3. Find out if you qualify for federal funding help through the Cesium Irradiator Replacement Project. The Cesium Irradiator Replacement Project offered by the National Nuclear Security Administration’s Office of Radiological Security provides incentives for qualified sites to make the switch. These include:
    • Removal and disposal of the cesium-137 irradiator, saving the site approximately $100–$200k per irradiator.
    • A limited financial payment towards the purchase of the new non-radioisotopic device, up to 50% of the purchase price. The payment will be disbursed when the cesium device has been removed and the non-radioisotopic device has been installed.
    • Training, warranty/maintenance agreement costs, and spare part costs are the responsibility of the site.

Learn more about the Cesium Irradiator Replacement Project here. Contact the Office of Radiological Security at [email protected].

More questions? Read on.

Are the alternative X-ray devices effective for blood irradiation?

The reliability of X-ray devices has improved significantly since the machines were first introduced and X-ray irradiators now offer a direct replacement for cesium-137 irradiators. The FDA has certified that x-ray irradiators from two U.S. commercial manufacturers (Best Theratronics and Rad Source Technologies) are “substantially equivalent” to cesium-137 irradiators. X-ray irradiators also have additional benefits and options not available with traditional cesium-137 irradiators. The unique design of the rotator typically allows users to increase their throughput and sterilize more blood products in less time. Other models have self-contained cooling systems and wheels for easy transportation, making the irradiator more ergonomic and easy to use and maintain. Most importantly, all regulatory and security requirements needed for cesium-137 irradiators are eliminated – including license fees—with the transition to X-ray devices, as well as the need to perform additional monitoring for radiation exposure. Click here to get more details about available alternative and emerging technologies.

 

What are the costs associated with replacement?

There are several types of costs to consider, including those associated with: purchasing, facility modification, operating, staff training, technology termination, and liability/insurance. This page provides a detailed overview of lifecycle costs and liability considerations. The worksheet template found within the document can help you decide if replacing cesium-137 irradiators with X-ray technology is the right step for you.

 

How long does the replacement process take?

The length of the replacement process can vary, depending on several factors including: your facility requirements, your local licensing procedures, and the X-ray manufacturer. This chart from the Cesium Irradiator Replacement Project illustrates the potential steps involved in the replacement process. You can use it to help define a timeline for your own site.

 

What do institutions that have replaced their irradiators have to say?

After replacing both their research and blood irradiators with X-ray technology, Mount Sinai Health System in New York says that their transition has been very successful. The X-ray blood irradiators have shown superior capability over their aging cesium-137 counterparts. Click here to read the full story of about Mount Sinai’s experience making the switch to X-ray technology.
Other decision makers in the United States and around the world have taken steps to eliminate the risk of dirty bombs through cesium-137 irradiator replacement. Visit this page to learn more about these leaders who are taking steps to eliminate radiological risks.

For a deeper dive into the details about replacement, watch the presentations from the 2017 workshop hosted by the New York City Department of Health and Mental Hygiene in partnership with NTI and ORS, and the presentations from 2018 workshops hosted by the University of California, also in partnership with NTI and ORS. The University of California (UC) system collected a set of research papers and resources comparing cesium-137 to X-ray irradiators and made them available for review here.

 

Click here to return to the Preventing a Dirty Bomb resources page.

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