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Statement Before NRC on Additional Requirements for Enhanced Security of CsCl Sources – 9/30/08

Nuclear Regulatory Commission Public Meeting

September 29-30, 2008

 

Security and Continued Use of Cesium-137 Chloride Sources

Issue 4 – Additional Requirements for Enhanced Security of CsCl sources

 

Jed Gorlin, MD, MBA

AABB Board of Directors

 

 

AABB is an international association dedicated to advancing transfusion and cellular therapies worldwide. Our members include more than 1,800 hospital and community blood centers and transfusion and transplantation services as well as approximately 8,000 individuals involved in activities related to transfusion, cellular therapies and transplantation medicine. For more than 50 years, AABB has established voluntary standards for, and accredited institutions involved in, these activities. AABB is focused on improving health through the advancement of science and the practice of transfusion medicine and related biological therapies, and developing and delivering programs and services to optimize patient and donor care and safety. We appreciate the opportunity to comment today on the issue of Security and Continued Use of Cesium-137 Chloride Sources.

 

Blood components are irradiated to prevent transfusion associated-graft-versus-host disease (TAGVHD) from white blood cells in cellular blood components such as red cells or platelets. Once established, TAGVHD is usually untreatable and often fatal. While not all patients require irradiated blood, those whose immune systems are compromised or who are receiving blood from immunologically similar donors, such as family members are at particular risk of this complication. Hence, it is imperative to balance the risks and benefits of phasing out Cesium in favor of alternative strategies. Respondents to the 2007 National Blood Collection and Utilization Survey reported that 2,322,000 blood components were irradiated in 2006. Many of these are concentrated at institutions that take care of cancer patients.

 

On June 5, 2007, the Nuclear Regulatory Commission released Regulatory Issue Summary 2007-14, Fingerprinting Requirements for Licensees Implementing the Increased Control Order and 2007-15, Unescorted Access to Materials for Non-Manufacturer and Distributor Service Providers. All blood establishments that maintain an irradiator will be in compliance with these increased security requirements by the mandated effective date.

 

Subsequently, the Nuclear Regulatory Commission published a Regulatory Issue Summary, Voluntary Security Enhancements for Self-Contained Irradiators Containing Cesium Chloride Sources, dated July 18, 2008 (RIS 2008-17) which supports the voluntary program for security enhancements for self-contained irradiators containing CsCl sources. Additionally, there is already a project currently underway for the hardening of existing cesium source irradiators. It is our understanding that the hardening efforts would increase the time for unauthorized access to the source material to greater than 60 minutes.  In conjunction with the other security measures (e.g. fingerprinting, secure location, monitoring), these measures would significantly increase the safety and security of the source material. The irradiator manufacturers have agreed to perform the hardening activities and will be reimbursed by federal funds.

 

To propose rules/regulations before adequate time has elapsed for an analysis of the effectiveness of the program appears inconsistent with NRC’s support. Achieving the desired outcome from hardening the irradiators may serve to achieve a risk reduction of the same magnitude as eliminating the devices entirely at far less economic hardship for establishments and manufactures while maintaining the continuity of quality healthcare and national security.

 

In conclusion, we recommend that any decision on the discontinuation of cesium source irradiators be delayed until adequate time is allotted for a study to be conducted to evaluate the effectiveness of RIS 2008-17 – installation of hardening measures by manufacturers to current CsCl irradiators.