The August 11 deadline to comment on revisions proposed for the AABB Standards has prompted a transfusion medicine physician in California to encourage discussion about proposed Standard 5.7.4.2 which addresses Irradiation of blood products. The inquiring colleague has concerns over the proposed new wording of Standard 5.7.4.2 which replaces the requirement for an irradiation indicator with each batch of components that are irradiated with the following statement: "A method shall be used to indicate that irradiation has occurred with each batch."

The wording that he suggests for Standard 5.7.4.2 is "An indicator shall be affixed to every blood component that is irradiated to indicate that irradiation has occurred". In his blood center work over the years, he has always insisted that an irradiation indicator be affixed to each unit of blood to assure the technical staff and every other subsequent handler of the unit that irradiation has occurred. As a new Associate Medical Director at one blood center, he recalls being asked, per the center's SOP, to review the irradiation log and "sign off" on the acceptability of two RBC units to which irradiation indicators had not been affixed, due to the operator's oversight. He refused. To follow up on his refusal, he discussed the case with the other Associate Medical Directors, who supported his decision and agreed to change the local policy which allowed them to "sign off" on this kind of clerical error if the rest of the paper trail looked good. The hospital services staff had some difficulty accepting this change, until he presented a continuing education seminar on TA-GVHD. Some photographs of actual pediatric and adult patients, along with a candid discussion of this painfully fatal disease, brought the hospital services staff around to this patient-centered point of view. He acknowledges that there are safeguards built into the instruments that we use and the procedures that we follow that reduce the need for proof that each unit intended to be irradiated has actually been adequately irradiated, but nothing can be considered failsafe.

The following comments have been received.

ADDENDA August 10, 2004

1. A colleague in Barcelona reports that at his blood center they irradiated 10,000 blood components last year. They used one irradiation indicator with each batch of irradiated blood components (6 RBC units or 6 pooled platelet units). So, only one of these blood components per batch has an irradiation indicator affixed. But their technicians, according to their SOP, use a label with the word "IRRADIATED" that has to be immediately affixed after the irradiation of the blood units. The entire irradiation process is performed in a closed room: only 6 blood components go into the room, the irradiation process begins and the "IRRADIATED" label is affixed after the irradiation. These 6 units can then leave the room and a new process may begin.

2. A transfusion medicine colleague in Boston reports that she has been trying to figure out what the proposed standard 5.7.4.2 really means. She asks "Does it mean that we will be allowed to use data captured by the irradiator as a replacement for irradiation indicators? If so, that would be fantastic!" In her opinion irradiation indicators are not fool proof. She says that in her experience the adhesion to unit of red cells is unreliable, that they can fall off, and sometimes end up adhering to non-irradiated products. She concludes saying "We immediately discard any product when the irradiation status is questioned".

3. A Technical Supervisor of a Blood Bank in Arizona reports that their SOP requires that an indicator is placed on each blood product to be irradiated. Interestingly, their irradiator is an X-ray type, and the indicators only indicate that irradiation has occurred, and not that the dose was adequate. Their irradiator uses two water cooled X-ray tubes to produce an X-ray field to irradiate products contained in a cannister. The following is a link to information describing this category of irradiation equipment: http://www.mds.nordion.com/master_dex.asp?page_id=809.

ADDENDA August 13, 2004

4. A transfusion medicine physician in Sacramento is of the opinion that an indicator should be affixed to EVERY blood component that is to be irradiated to ensure that each and every unit has been irradiated, and this can be documented via the label on it. He believes that it is not appropriate just to put an indicator in with each batch of blood components to be irradiated. He also points out that while the period for written comments on this proposed Standard are closed, emailed ones will apparently be accepted for another week.

ADDENDA August 17, 2004

5. A colleague at a Blood Bank in Kuwait reports that for the last 10 years that they have been placing indicators on every unit that they irradiate to ensure and document adequate irradiation exposure to all units simultaneously. Moreover, to document adequate irradiation, they need evidence that each individual unit was irradiated, which they feel the indicators help to provide. They intend to continue using indicators on each unit irradiated, even if the AABB standards modify the wording for Standard 5.7.4.2.

ADDENDA August 29, 2004

6. The Product Manager of a manufacturer of irradiation indicators submits the following comments. She states that a customer recently called to inform them that one of the radiation indicators (out of a batch of five units of blood irradiated together) did not function properly.  This facility uses one indicator per unit (i.e. one indicator was adhered to each of the five units of blood in the batch).  The incident was written up as a customer complaint and an investigation was conducted. The problem indicator was returned to the manufacturer.  After analysis and testing of the indicator by the manufacturer's technical staff, it was concluded that the indicator had never been irradiated at all. In spite of safe practices and procedures, a blood product thought to have been irradiated was not irradiated at all.  The practice of using one indicator per unit by this facility may have prevented a serious potential problem.

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Ira A. Shulman, MD
CBBS e-Network Forum Editor & Moderator