When will, or have new AAMI standards for LALs come into affect? I am two days away from the initial state DOH inspection to get my new unit opened and my LALs just came back at 1.0 eu/ml.. after a chemical and ozone disinfect. Should I scramble to disinfect and resample before my inspection, or will 1.0 slide for now to buy me some more time? We will not be running patients for another week after the inspection which will give me time to achieve my desired results. Right now, I just want to satisy the DOH - which, obviously goes by AAMI reccomendations.

[This message has been edited by dfrock (edited 12-03-2001).]

[This message has been edited by dfrock (edited 12-03-2001).]

The new AAMI standards have set the Endo range for water at <0.1-2.0 with an action level at 1.0. You are at the action level so you need to show that you are taking steps to reduce the Endo level. I just had my State Inspection and the Inspector did not have the new regs yet for water.

At the AAMI conference in Baltimore, they estimated 2 years before the new recomendations would be adopted as regulations. The delay is caused by the usual beurocratic red tape of having to go through committee then be voted on by Congress before being entered into the Federal Register. As far as your inspection goes, you're in compliance but there is no reason for you to not start going by the new guidelines even before the Feds do.

Chuck W is correct is saying that it is a good idea to start using the new levels even though they have not been officially adopted. The new regs establish a tougher standard but there is ample evidence that it is a good idea. My question for you is: why do you have such relatively high LAL levels for a brand new unit, even after chemicals and ozone? Sounds like you have to hit it again and re-test.

It is apparent you are not running the system. I assume it is a circulating loop. Open a tap somewhere and let it run at 1.0 gpm (a pencil stream) continual. This will turn the water in storage and work the RO. To keep a system active you should turn water in a storage a minimum of once every four hours. Not standard but one of my rules of thumb. Have seen this situation occur when the RO is put on flush and the loop just keeps on turning. When a UV light is used, the water gets heat from the pump an UV light and away you go.