Can any one tell me the standards, meaning frequency, for disinfecting the RO water system and the water loop?

Sounds like your in need of AAMI standards RD62 (Hemodialysis water system standards). This should assist you, and refer to the water system manufacture requirements, AAMI recommends it. Lastly, most corporate requirements are monthly disinfections. I recommend running the disinfect through the machines and equivalent dwell time, this disinfects the machines incomming hose.

Good luck with all your endeavors/

We/I do monthly treated water loop disinfections and quarterly reverse osmosis high/low pH cleaning followed by 1% peroxyacetic acid disinfection hope this helps

Norton,
We do likewise to biomanh2o's post. Others may not agree with this however, IMHO aggresive monthly disinfecting which isn't warranted by positive bacteria/LAL results only degrades your RO membranes, hence creating problems that would not have existed.

AMEN Mr. Finch, AMEN

AAMI RD52 ways "The frequency of disinfection will vary with the design of the system and the extent to which biofilm has already formed in existing systems, but disinfection should be performed at least monthly." It also says "Routine low-level disinfection of the pipes should be performed to control bacterial contamination of the distribution system."

In talking about the bacteria/LAL action levels, RD62 says "If these action levels are observed in the product water, corrective measures, such as disinfection and retesting, shall be taken promptly to reduce the levels into an acceptable range."

By the way, the CDC recommends disinfecting weekly.

If you purchase any AAMI document, I recommend at least purchasing RD52 since it is written for the user.

can someone post documentation where the CDC recommends weekly disinfection and why we don't do it. This is interesting.

See the following link:

http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5210a1.htm

Go down about 1/3 of the way to "Dialysis Water Quality and Dialysate". Item D says "Disinfect water distribution systems in dialysis settings at least weekly (226--228,231,236). Category IA, IC (AAMI: ANSI/AAMI RD62:2001)"

Category IA means "Strongly recommended for implementation and strongly supported by well-designed experimental, clinical, or epidemiologic studies."

Category IC means "Required by state or federal regulations, or representing an extablished association standard."

This document was published in 2003 (before the release of RD52 which was published in 2004) so it does not reflect the reduced bacteria level for dialysate.

AAMI still says monthly.

A different document from the CDC with the same name says "Routine (i.e., monthly), low-level
disinfection of the pipes can help to control bacterial contamination of the distribution system." (see http://www.cdc.gov/ncidod/dhqp/pdf/guidelines/Enviro_guide_03.pdf - see page 64)

I hope this helps.

So Florian, you seem to be extremely well educated on this info, I bow to you. Can you tell me point blank with all these different rules and regulatons with different "times" ie. weekly, monthly what should be done? Weekly disinfection of the system, monthly. What about cenral ro units versus just portable ro units. This is confusing with AAMI, the CDC what should be done?

Thanks in advance.

As a minimum, I would go with the monthly requirement in AAMI; that is what you will be audited to. AAMI RD52 says "The frequency of disinfection will vary with the design of the system and the extent to which biofilm has already formed in existing systems, but disinfection should be performed at least monthly." To get an FDA 510k, the water vendor manual "should specify the frequency of cleaning/disinfection, monitoring and maintenance procedures." Therefore, a frequency should be listed in your water manual.

It is interesting that there is no disinfection frequency in the Canadian guidelines or the International guidelines. And, the only place where a frequency is listed is in RD52, therefore, a frequency didn't exist before 2004.

Technically, you don't need to disinfect the water system as long as your bacteria and endotoxin levels are acceptable...but, I would never advise someone of that. If the bacteria/endotoxin are not acceptable, then you are not disinfecting enough. RD52 also says "A key concept in ensuring compliance with the requirements of 4.1.2 is that disinfection schedules should be designed to prevent bacterial proliferation, rather than being designed to eliminate bacteria once they have proliferated to an unacceptable level (i.e., above the action level). With this strategy, monitoring levels of bacteria and endotoxin serves to demonstrate that the disinfection program is effective, not to indicate when disinfection should be performed."

So what do you do in a case where GE Osmonics recommends in their books for quarterly disinfection of their portable ro units. Do you only do it quarterly or follow AAMI and do it at a minimum of monthly?

NewGuy, are you sure about the GE recommendations? I thought it was quarterly cleaning and at a minimum monthly disinfection.

I believe that is what I read. If anyone knows differently, please post. 700-800 series ro units

I looked up the disinfection recommendation on the GE Web site. I stand corrected. It does say quarterly. Sorry.

We recently talked about disinfection of portable units in the discussion entitled "need help/advice fast" last posted on November 23. How long can you let a portable unit sit before it is required to be disinfected? Someone quoted a GE spec of 24 hours.

My recommendation is to look at what AAMI says and what your manufacturer says, and do whichever is more frequent. If you do something less frequent, document your reasoning in writing and have your medical director sign it. But, just because you document your reasoning and have your medical director sign it does not mean your auditor will accept it.