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Statement to the Radiological Devices Panel of the Medical Devices Advisory Committee

Blood Irradiators

12 April 2012

M. Allene Carr-Greer, Director, Regulatory Affairs

AABB is an international, not-for-profit association representing individuals and institutions involved in the field of transfusion medicine and cellular therapies. The association is committed to improving health by developing and delivering standards, accreditation and educational programs that focus on optimizing patient and donor care and safety. AABB membership consists of nearly 2,000 institutions and 8,000 individuals, including physicians, nurses, scientists, researchers, administrators, medical technologists and other health care providers. AABB members are located in more than 80 countries.

AABB appreciates the opportunity to provide comments as the panel considers the appropriate device classification for blood irradiators. Irradiators, regulated as devices found to be substantially equivalent to predicate devices marketed in interstate commerce prior to May 28, 1976, have been used safely and effectively, to prevent graft versus host disease (GVHD) for more than 30 years.

The Food and Drug Administration has provided a summary of the literature review they performed and the results demonstrate that blood irradiators have had few published problems identified over a long period of time and demonstrate a reasonable assurance of safety. The FDA published a guidance document in 1993 "Recommendations Regarding License Amendments and Procedures for Gamma Irradiation of Blood Products" with recommendations for standard operating procedures, the radiation dosages and validation of the doses, and use of indicator devices, which signal appropriate exposure of the blood product to radiation. Previous to 1993, AABB Standards for Blood Banks and Transfusion Services recommended irradiation of directed blood donations from first degree family members to reduce the risk of GVHD. By 1993 this recommendation had been extended to all blood related donors in a directed donation event. AABB Standards also require that a method is used to indicate that irradiation has occurred with each batch of blood that is irradiated.

AABB believes that additional measures are not needed for use of blood irradiators. Classification should be determined to be class I or class II depending on evaluation of the measures currently in use. All measures listed as general controls for a class I designation are in use for the irradiators. FDA has suggested some special controls that could be considered for a class II designation, some of which are already in place. AABB does not believe it is appropriate to require post-market surveillance and patient registries. Indicators or other methods to indicate that appropriate irradiation of a blood product has occurred are already required by FDA and AABB. Class III designation requiring clinical trials and premarket approval is not appropriate for blood irradiators.