We are currently tossing around the idea of irradiating our own units in house.  Does anyone do this?  What are your volumes that you are irradiating?  Currently we are ordering anywhere from 40-60 irradiated products a month from our blood supplier, and we are trying to figure out if it is more cost effective to perform this task in house.  I know it will be a nightmare (or learning experience) to bring in, but I guess it is worth a look. 

Please remember, no one is allowed to divulge their irradiator security information!

 

That being said, I recommend against doing this for your volume.  The devices themselves cost between $150,000 and 200,000.  Then you need an enormous amount of security dedicated to them.  For the volume you are doing I suspect it would be far from cost effective.

We use our cancer center do it for us on their Linear Accelerators

We also had our cancer center do it for us, but they had trouble keeping up with the regulations for blood products and decided to stop providing that service.

The X-ray irradiators (one manufacturer is Best Theratronics of Canada) don't require the same level of security as the gamma irradiators.  They are not an active " radioactive source" that could be stolen, like the gamma sources are.  Security requirements on gamma irradiators are very extensive. 

 

Both are very expensive (>$200,000) and the x-ray irradiators have a very expensive maintenance contract also.  Both are easy to run and easy to train on.  Both are very heavy and require proper floor support (if you are not on ground level).  The x-ray irradiator from Best Theratronics requires a good, cool water supply for cooling also.  There may be another x-ray unit out there by now that doesn't need the water cooling, but I don't know the manufacturer. 

 

We have the Best Theratronics x-ray unit - Raycell - and irradiate approx 100+ units a month.  We are barely breaking even on the investment, so don't know if you could manage it with your current volumes.  No way to tell where the volumes are going on this either.  We have a new set of oncologists here who hardly irradiate anything for their patients.  They are following different guidelines, I guess.

 

In the US, if nothing else qualifies you for it already, the step of irradiating your own units makes you a manufacturer and the FDA will start to visit.  That makes for it's own set of headaches. 

 

I would recommend a lot of research first - and a good look at what your blood distributor does - they should have good, current information on the topic.  Good luck - it is a complex choice.

We also have an X-ray irradiator. We irradiate anywhere from 80-120 unit per month, plus platelets (45?). Our BB is on the 3rd floor and  the irradiator is fine - comes on wheels too. There is the water cooling factor, but it works for us. We have 2 very active hem/onc offices and the hospital is building a cancer center 4 miles away. We are nearly 2 hours from the blood supplier. Between the $$ saved on not ordering irradiated products and the time that is saved for the patients (especially those that drop in after a doctor appointment) our irradiator is going to pay for itself in just a few years and it keeps the doctors happy. Delay in treatment is something to think about if you are not close to your blood supplier.

Liz

We also are fortunate to have a cancer treatment center at our hospital that can do this for us when necessary.  In fact, we serve as the back up for our local blood supply center when their irradiator is down!

 

scott

I have previously used Cesium Irradiators; but in large Medical Centers with complex patients such that we utilized a lot of Irradiated Products (so we could justify the cost). Also, if you do decide to purchase an Irradiator, I am told that the Cesium Irradiators have less downtime than X-Ray. That being said, I am currently in the process of moving to a new Hospital where I am at, and we have purchased the Raycell Irradiator because you don't have to have all of the safety bells and whistles. When I started here (and still in place, though we have been trying to transition for 8 months; just still trying to get correct Orders on patients), they had been giving 100% Irradiated. That would certainly justify an Irradiator. Per my calculations, once we only give Irradiated to patients who require it by diagnosis, that will be approx. 40-45% of our patient population (as we have a Cancer Center). We currently pay an additional $30/unit for the Donor Center to Irradiate. While we will eventually have paid off the cost of the purchase of the Irradiator in the savings, the monthly energy costs and Rad-Sure Labels may not result in a cost savings at all.....we will see. So all things to consider.

Brenda Hutson

We have units irradiated in our radiation oncology center on their linear accelerators.  It always flummoxes inspectors because they are used to the free-standing irradiators and don't understand the differences in dose-mapping etc.

The X-ray irradiators (one manufacturer is Best Theratronics of Canada) don't require the same level of security as the gamma irradiators.  They are not an active " radioactive source" that could be stolen, like the gamma sources are.  Security requirements on gamma irradiators are very extensive. 

 

Both are very expensive (>$200,000) and the x-ray irradiators have a very expensive maintenance contract also.  Both are easy to run and easy to train on.  Both are very heavy and require proper floor support (if you are not on ground level).  The x-ray irradiator from Best Theratronics requires a good, cool water supply for cooling also.  There may be another x-ray unit out there by now that doesn't need the water cooling, but I don't know the manufacturer. 

 

We have the Best Theratronics x-ray unit - Raycell - and irradiate approx 100+ units a month.  We are barely breaking even on the investment, so don't know if you could manage it with your current volumes.  No way to tell where the volumes are going on this either.  We have a new set of oncologists here who hardly irradiate anything for their patients.  They are following different guidelines, I guess.

 

In the US, if nothing else qualifies you for it already, the step of irradiating your own units makes you a manufacturer and the FDA will start to visit.  That makes for it's own set of headaches. 

 

I would recommend a lot of research first - and a good look at what your blood distributor does - they should have good, current information on the topic.  Good luck - it is a complex choice.

The FDA point alone would put an end to my speculation. 

 

I worked in a lab where we irradiated our own products.  We did a higher volume than you.  We already qualified as a manufacturer under FDA because we washed products.  It was worth it for us. 

Mabel, I agree, sat with the FDA inspector for over 4 hours with the Cancer Center personnel going over the differences. This lady was very new.

We have units irradiated in our radiation oncology center on their linear accelerators.  It always flummoxes inspectors because they are used to the free-standing irradiators and don't understand the differences in dose-mapping etc.