Validation - how long it takes16 Sep 2020 15:29
I've just done a quick Google for information about exactly what is medical device validation & how long it might take. I've not had time to spend ages reading everything & organise links for here. I've been puzzled why there hasn't been the slightest explanation anywhere about this process & what it actually means.
I've also been completely gobsmacked at all the political and media panic mongering about testing and the shambolic, disorganised way the Government has organised it & total lack of honesty in explaining that PCR testing doesn't help much stopping Covid spread because it takes so long to get PCR results - days, even weeks sometimes.
I've also wondered why both media and Government haven't been able to say it looks like we will soon have saliva LFT tests because this new technology has been tested, has been scientifically VERIFIED as actually working, but now simply needs to go through the VALIDATION process which is the final entirely bureaucratic hurdle before it is allowed to be sold & released for universal use.
And all that is now needed to cheer everyone up - the politicians, the media, the business community and above all the general public, is the explanation that this VALIDATION process is purely to take a product that demonstrably works/ functions and absolutely prove beyond any doubt that when used in real life situations it will function exactly as expected every time without hiccups, design flaws, manufacturing quality etc. And that you can only do this by trying out the new LFT device on real life situations just to gather statistical evidence from a large number of times the device has been successfully (or unsuccessfully) used.
VALIDATION simply means using the new medical device (LFT) in a sufficiently large number of people and documenting that the test works reliably exactly as stated & within the various parameters claimed & carefully & precisely documenting that to build a body of irrefutable evidence that the product has now been widely used and is doing exactly what it should do in a completely reliable way.
THEN it is given official validation and allowed to flood the market freely to be used all over the World and allow economies to restart etc.
While it might be wise & appropriate for Awacta to keep very quiet about their stunning achievements so far, that does not prevent other people like the Government or the media to chatter about how bureaucracy makes it take forever (usually many years) to get approval for drugs or medical devices & perhaps sometimes a bit of common sense should be used to bypasses the mindless & plodding nature of bureaucracy when common sense sways it would be reasonably safe and appropriate.
As this saliva test can do no harm at all except theoretically giving incorrect results, common sense might suggest that while the BUREAUCRATIC VALIDATION process can happily blunder on, it can certainly be openly discussed and used really.