FDA Sends Warning Letter to Community Blood Centers of Florida For Not Meeting Guidelines–One Violation States It Takes 87
Posted Aug 15 2012 3:06pm
In today’s information age, 87 days! There better solutions to test potential blood donors by all means out there and I happen to be consulting with a company that has one solution that can do it in 2 minutes. Why do we live with a process taking 87 days? This center though is not the only one on the list for the FDA as earlier this year, look what happened to the Red Cross and this goes on like every year!
Check this process out from LifeSaver as this even beats the socks off the OraQuick FDA approved test and can you imagine how this will change the way we diagnose not only HIV tests, but pregnancy, etc. as they can all use the same technology with a 2 minute wait.
You can visit the website for LifeSaver and read and view additional details here on how this solution would instantly help the blood centers. Also, why stop here and let’s use the process and look for other potential diseases that would conflict with one donating blood. Why not have that Hepatitis B and C test done in 2 minutes as well so the FDA won’t have these issues to resolve with blood centers?
You can read more about the campaign for safe blood at the Red Cross here at the LifeSaver website. This all just makes sense as when contaminated blood is in the system they have to also dispose of it and that’s yet one more expense so why take the blood only to find out later that it may have to be disposed of? I think that’s a real good question when screenings to avoid this can be this simple and easy. Besides that there’s plenty of other work these folks at the FDA could be doing.
If you are an employer that needs to conduct drug and alcohol testing, here we go again, same technology and a much easier way to test with no trips to a lab. I have been hearing a lot with people I am talking to that this is becoming an accuracy nightmare for some and then of course there’s the time to go to the lab. I don’t normally do this but the response for information has been over whelming here with the product that I should mention that they are also establishing distributorships across the US and the world so there’s more information at the website on how that works here.
So again there’s a choice and a chance to save a lot of money and time as 7 tests can be loaded on a Stik and the retail cost would be very affordable. Right now the projected cost of just the HIV test would be around $13 for a Stik. Now that blood levels are reaching all time lows, it would make sense to take the cost out of the testing for this lifesaving donation. BD
On April 27, 2012, the Food & Drug Administration (FDA) sent a warning letter to the Community Blood Centers of Florida, based on an investigation conducted from September 1, 2011 to December 19, 2011, documenting deviations from applicable good manufacturing practices for finished pharmaceuticals and regulations for blood and blood components as spelled out in FDA guidelines.
Some of the deviations were: (1) failure to store red blood cells at the right temperature, (2) mixing up donor records by blood type, (3) taking 87 days to notify a donor who had tested positive for HIV, (4) using a bag of platelets that had not been drained from a biohazard waste bin and adding it to another bag to fulfill an order, (5) on more than one occasion, records for a donor of one blood type were entered over an existing donor of a different blood type, and (6) on more than one occasion, red blood cells were not stored at the proper temperature.