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R Woodruff

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  1. Given the issues with X-ray sources (tubes) used in the commercial currently available X-ray source Blood irradiation equipment, the following may be of interest. As you probably know, the indicators (Rad Tag® or Rad Sure®) attached to each blood bag before irradiation only provide qualitative, not quantitative information. That is, they simply indicate whether or not the bag has received radiation and not the total absorbed radiation dose. Rad Tag may be considered semi-quantitive but it does not provide the quantity of the total absorbed radiation dose received by the blood which has been irradiated. A way to have assurance that irradiated blood has received the required total absorbed dose of radiation is through dosimetry. If this is not already being done on a routine basis, I suggest dosimetry mapping using a phantom and dosimeters be provided for the blood bag container (canister). Initially this should be done on a monthly basis. After several months with fairly constant dosimetry data month to month, the dosimetry measurements can be taken every 2 months and then every 3 months. The radiation dosimetry data is taken from a number of locations within the canister and provides data for what is called a "dosimeter map" of the radiation received within the volume of the canister. This radiation data also provides a means of monitoring the radiation output of the X-ray sources (tubes) and will indicate a drop in X-ray source (X-ray tubes and high voltage power supplies). With fairly constant output radiation data, the recommended interval for making this measurement is every 3 months or quarterly.
  2. Thank you, Cliff, for clarification of the advertising.
  3. As stated above, currently, the only source of an X-ray radiation source, blood irradiator in North America is Best Theratronics, Canada. This system is currently designated Raycell. This system was initially designed, manufactured and commercially offered to blood processing laboratories in the U.S. in the 1998-1999 time frame. It was designated as the RS 3000. In 2003, this system was licensed to MDS Nordion at which time it was designated the Raycell by Nordion. In latter 2007, MDS Nordion sold its entire irradiation product line (radioactive sources Cs-137 and Co-60), icluding Raycell, to Best Medical. Other than blood bag canister volume and the addition of an energy reflecting liner? In the canister, Raycell’s design has not changed since the initial design. It lacks a number of features important for current blood irradiation procedure. There is rumoured pricing over the past several years ranging from $146,000. to $250,000. USD with rumoured annual maintance agreements costs ranging from $10,000. to $22,000. USD. The major problem with all X-ray radiation source, blood irradiation equipment, available in North America and in Italy and Japan, lies in the use of X-ray sources (tubes) designed for imaging and not as radiation sources. The basic technology has not changed over the past 100 years. Over time the technology used in these tubes results in non-reliability of the X-ray tubes. Unfortunately, blood processing laboratories have born the brunt of the problem as reflected in the high initial cost of the systems and high maintenance costs. The exorbitant initial cost of the equipment is a result of large company overhead and no competition. The high maintenance cost reflects the use of commercially available, industrial imaging X-ray tubes and their replacement. The exorbitant pricing makes it very difficult for the small to medium size blood processing laboratory to both cost justify the initial cost of the equipment and its on-going maintenance cost. The Irradiation Machines advertisement below your post lists irradiation equipment designed for research and other applications; not for blood irradiation. As such it has no FDA clearance for blood irradiation.
  4. See AABB Weekly Report, dated 10-03-08 for the most current information regarding the subject Title.
  5. You are correct in your comments regarding Raycell. The basic reason for the majority of problems with Raycel (Originally Rad Source Trechnologies RS 3000) is the use of industrial X-ray tubes (2) originally designed for imaging and not designed as irradiation sources. There are inherent problems in using this type of X-ray tube as radiation sources for irradiation applications.
  6. Jim, Currently, the only source in North America for an X-ray source, blood and blood component irradiation system is Best Medical Canada. The system is designated Raycell. It was designed in the 1998 - 1999 time frame, is expensive; $180,000. USD from the last pricing information I received, and reportedly has had reliability problems. If your time frame will allow it, there is at least one new X-ray source blood irradiation system under design and development. Contact me via e-mail if you need or want further details and information. R Woodruff
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