Moving from Cesium 137 Blood Irradiators to X-ray Blood Irradiators

[conwaysbb]

The Nuclear Regulatory Committee is rolling out in the near future even stricter security measures for Cesium 137 Blood Irradiators. The current security regulations are a bear to conform to, but the new regulations are even more onerous to conform to. My Radiation Safety Officer is pulling out his hair right now and with the recent press on the possibility that these irradiators are primary terroristic targets, having the most accessible source of dangerous radioactive material and the the extreme danger that the cesium 137 source material could cause if terrorists do obtain this source, he is recommending that we get rid of the cesium 137 blood irradiator ASAP.

He is actually seeing terrorists coming into our hospital (six terrorists to be exact), kicking down the door, shooting everyone in the room or anyone that responds, pulling the irradiator apart, breaking into the bottom of the lead barrier and taking the actual source out.

The article states that the Defense Science Board is recommending the removal as an overall strategy to reduce the threat to the united states from terroristic activities. It further states "Any one of these 1000 plus sources could shut down 25 square kilometers, anywhere in the United States, for 40 plus years". The article is "Terrorism: Hospitals a Hot Commodity" by Pamela Hess of the Associate Press, if anyone wants to read the whole article.

Is anyone else, who has a cesium 137 blood irradiator, also getting pressure to remove this irradiator or replace it with an x-ray blood irradiator or other equipment that can do the same thing? Does anyone know what companies have this x-ray equipment or equivalent device. What the price tag for anyone of these devices and the differences in actual use of these devices as compared the the cesium blood irradiator.

[Edit by site admin]

I have included the article in our files section.

A word of caution.

The NRC through, my local Department of Public Health, has contacted me regarding posts related to irradiators. I will monitor all posts closely, and will need to edit them if necessary.

Under no circumstances should you post any information related to your facility, the security of your irridiator, or irradiator security policies in general.

Thank you for your understanding.

[heathervaught]

Our blood center uses the MDS Nordion Raycell for all of our irrdiation needs: http://www.mds.nordion.com/products/blood-research-irradiators-b.htm

I have never used a cesium irradiator, but the operation of the Raycell is simple -- place the blood products in the canister, place the canister in the irradiator, close the door of the irradiator, and press the start button. It takes about 6 minutes per cycle. We have dosemapping performed approximately every 6 months to verify adequate dose. In addition, each product is tagged with an indicator to show that it received an adequate dose.

I have attached a copy of our validation.

Raycell validation plan.DOC

Irrad worksheets.doc

[pdavenport]

We've been using the Raycell for over 5 years. The cabinet is approximately 4X5X2 ft. It's lead lined and sits on casters. You need a water line, a drain, and 220 electrical line. The canister will hold two AS-1 RBC or several pheresis platelets. Our cycle is 5 min. The maintenence is minimal and dosimetry checks are not complicated. We have a radiation physicist check for leakage one a year. I think they're going for about $180K, but you'd need to check the current pricing with Nordion.

[mhc]

We are also looking to replace our iradiator with an X-ray type, hopefully to coincide with a move to a new laboratory at the end of 2009. I fear we may be compelled to do it sooner, though, judging from the press. Besides Nordion, does anyone know of any other vendors? Nordion is great, but Canada is a long way from here and the PM/service calls are expensive, even if infrequent.

[shelleyk482]

How often do you need to replace the "bulb" on the x-ray type irradiator? We irradiate approx 1,000 products per month and when we replaced our irradiator a few years ago, our biomed department calculated out the cost & frequency of replacing the "bulb" and determined that it would be cost prohibitive for us to be able to keep an X-ray based machine running with our volume. Are any other large volume facilities using this type of irradiator?

[heathervaught]

We irradiate about 600 units per month. We have had this current machine since 2005 and have never replaced the "bulb". My Technical Director says that we have been using this type of irradiator since 2001 (we upgraded in order to increase capacity several years ago), and she doesn't remember ever changing a "bulb" or x-ray tube of any kind on any of them.

[BloodBank]

Can anyone share what type of quality control done for X-Ray irradiator besides dose map semiannually and irradiaton indication at every use?

[pdavenport]

That's really all there is for QC on the product. We document changing the label and expiration date of red cells when needed.

[Mary]

We use RadSure Blood Irradiation Indicators.

[Franklyn]

I looked at the Nordion very closely at the 2007 AABB Txpo in California. The suitability of the instrument really comes down to your volume. It is relatively large, as a current total volume of 1.5 Liters and a 5 minute cycle time. The instrument uses two X-Ray tubes (top and bottom) and the tubes are each warrantied for 2000 hours of service. The device needs a water feed on a dedicated cooling loop (per code for water cooled devices in our area). The device has a 3 to 5 minute warm up period from a cold start and is not intended for continuous use. So, you have a warrantied period of 24,000 cycles on the tubes but could/should see more. If you average two products per cycle, that is 48,000 products within the warranty period. Your mileage may vary.

Franklyn

[mhc]

I did too, although I wish that there had been other vendors there besides Nordion, just for comparison. I think that in terms of the way we irradiate products at our hospital facility ~ 1000/ month, that the cesium is a more efficient choice. But since we may not have the choice for much longer, the Xray will have to do. Thanks for your input.

[BloodBank]

Does any body know if leak test is required for X-Ray Irradiator? We used to do for Cesium and have continued doing for X-Ray but is it necessary test?

[Franklyn]

You should check with your radiation safety officer, but as there is no "hot" source there is nothing that can leak. My assumption would be that the leak test is not required.

[heathervaught]

If you average two products per cycle, that is 48,000 products within the warranty period. Your mileage may vary.

Franklyn

If you "bought" that irradiation service from your blood supplier at $50 per product, that would be $2.4 million....

[Franklyn]

If you "bought" that irradiation service from your blood supplier at $50 per product, that would be $2.4 million....

All too true... I am more concerned about downtime and repair time. If you transfuse a lot of irradiated products having the X-Ray machine breakdown can have real patient impact. Cesium source irradiators have (typically) very few downtimes other than scheduled maintenance.

[heathervaught]

All too true... I am more concerned about downtime and repair time. If you transfuse a lot of irradiated products having the X-Ray machine breakdown can have real patient impact. Cesium source irradiators have (typically) very few downtimes other than scheduled maintenance.

We have one of our hospitals qualified as a backup irradiator. We ship them the products, they irradiate them and ship them back (I'm sure we pay them for it, but I don't know how much). Or, you could purchase two up front...since the life of the instrument is a function of the life of the X-ray tube, measured in the number of hours used, it would be easy to justify having two instead of just one (since you would just end up purchasing a second one in a few years anyway).

[Franklyn]

That would be nearly $ 400,000 dollars up front to purchase two units that are about the size of the Galileo. I think that would be a really hard sell and you had better have a big space to put them.

[fairobent]

I am new to this post and am seeking information on the effectiveness of x-ray blood irradiators in irradiating blood vs. Cs irradiators.

What is the capacity of an x-ray unit?

Are x-ray units as effective in sterilizing blood as Cs irradiators?

What is the down time of your x-ray irradiators?

What is the cost for a service visit?

Is your unit reigistered with the state?

Cost to register your x-ray tube?

Thanks you.

[Susan Longley]

Can anyone provide information regarding the amount of downtime that they have experienced with an x-ray irradiator? Is it greater than with cesium irradiators? Also, if film badges are used for calibration, how long does it take to get the results? Can the X-ray irradiator operate while the facility is waiting for results from the film badges?

[Susan Longley]

Is the 3-5 minute warmup period required for each irradiation cycle? (Or is it once per day?)

[THintz]

We have been live with our Raycell since August 2006. We purchased one to get away from having our Cancer Center do irradiation for us using the linear accelerator. We average irradiating about 45 units of RBC's/Plt's per month (low volume). We really like the Raycell a lot and find it very easy to use. Our only problem/downtime happened late in Dec of 2006 when one day the machine just wouldn't start. Long story short...three weeks later we ended up with a new power supply and a new tube (the machine has two of each: upper and lower). Luckily, this was covered under our first year warranty. The Raycell technician never could give us a definitive reason for it, but we have not had trouble since. But as a preventive action, we did re-evaluate our water supply and install a pressure regulator tank. We had been have very slight bumps in pressure but the service technician felt it may have possibly been enough to have a negative impact on the tubes over the long term. You will need to have a very stable water supply (good flow and good pressure). Annually, the only real scheduled downtime is during the annual PM visit. The machine is down for an afternoon. We just prepare ahead of time by irradiating some Group O red cells and a couple platelet products. We do our dose delivery verification each January and July. It's simple and easy to do. We receive a phantom ("plastic cylinder") with imbedded TLD's (little devices that measure the irradiation). You put this in your canister and run a cycle and send the whole thing in. You can run your machine while you wait for the report. Nordion contracts with MD Anderson in Texas and your report is turned around in about 2 weeks. We have a medical physicist review it along with myself (Supervisor) and the Medical Director. Annual maintenance fees are high. Nordion usually presents two options for coverage, depends on if you want tube coverage or not and the number of emergency visits you want covered each year (One of the options is about $22,000.00/yr). To replace a tube is about $25,000. We opt to go out on our own and just pay for one annual PM visit and the two dose delivery verifications annually-no parts, no emergency service (roughly 7,800.00 each year). We know that if something breaks we'll have to pay for service and parts. It was expensive and inconvenient when my machine was down for three weeks as I needed to import all irradiated units from another blood supplier (we have our own donor center-ouch!). I am in North Dakota and our state does require the X-ray tubes to be registered. It runs about $375.00 every 2 or 3 years. We were able to just add a tube to our radiology departments existing license. Regarding warm-up's. We do a warm up cycle (they take 2 minutes) as part of daily maintenance--just to make sure machine runs and then prior to each cycle. If we have back to back cycles less than 30 minutes apart, we don't need to do another warm up. The machine will run without a warm up cycle, but the analogy we received was its like warming up your car in the winter in the North. It just runs better if its been warmed up and there is less stress on the tube. I feel like we have a good irradiation program here. We are AABB/CAP accredited and FDA licensed and have had all here for inspections since we have been live. Our FDA inspector really liked our program and was glad to see us get a Raycell and quit using the linear accelerator. Hope that answers a lot of the questions on the last couple of posts.

[R Woodruff]

See AABB Weekly Report, dated 10-03-08 for the most current information regarding the subject Title.

[HCantrell]

We are currently validating a Raycell CE (thanks, heathervaught for posting your validation cases....I borrowed heavily!) and I have a question. While irradiating red cells, we are noting a temperature increase of 2-3 C after the irradiation. Is this normal? I have only ever worked with "the other kind" of instrument and I don't think I've ever had to document temperatures. I haven't started to research yet, so thought I'd try the easy way first and just ask other users.

[gwendamckee]

We are currently purchaseing one - approximately $250,000.

[BloodBank]

We had Rad source X-Ray irradiator. Lot of problems were encountered. Service (PM) contract is very expensive. Must have very regulated water pressure. We had to replace X-Ray tube which was very expensive. Many down times. In the end power supply was out and company will not repair at any cost. So we are down with nothing. Our Cs irradiator was for running with no problems for many many years. We bought X-Ray when we moved to new Facility. X-Ray irradiator was not even 6 years of usage and was told life span is 10 years. Now we have to buy new which is almost $300,000.