Part 4 of Five Golden Rants
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OK, enough with the evil secret legislation stories. Let's get back to one of our perennial favorite topics: people saying stupid stuff at public meetings.
Labs Airing RUO Dirty Laundry in Public
I've been to several public meetings this year and am amazed how many Laboratory Directors and other folks involved in CLIA labs have brazenly announced their willingness to purchase and clinically validate products labeled RUO.
RUO stands for "Research Use Only". FDA terminology can be confusing sometimes, but it's difficult to see where the confusion arises in this case. RUO products are appropriate for research use... only.
This shamelessness reached its apex at the Nov. 22nd AMP/ACLU meeting where lab directors complained (at a microphone!) that one reason they can't meet higher standards is the fact that RUO products are impossible to control due to their complexity and the frequency with which they change.
Seriously people, you are making FDA's argument for them. This is the exact reason they want you to stop using RUO products to produce diagnostic results. It's one of the reasons people like me complain that you're operating with lower standards.
I'm tempted to ask which part of "only" they don't understand. But in the spirit of the holidays, it might be more charitable to assume that it's all a big misunderstanding. Maybe they just think RUO stands for something else.
Based on how they're talking about RUO in public, I can only assume they think it might stand for:
- Random Use OK
- Rigid Understanding Optional
- Really Useful Offering
- Regulator Umbrage Opportunity
Seriously, though... RUO is a very broad category that covers everything from materials manufactured under cGMP to stuff some guy mixed up in his bathtub. Are we not at least a little curious what kind of materials are being used to create some most important diagnostics in the land?