New Refrigerator

[bldbnkr]

Does anyone know if there is a minimum time that a new refrigerator has to be set up and monitored before I can switch the blood over from the old (to be decommissioned) refrigerator? Would 24 hours be adequate?

Thanks,

Maryann

[L106]

I am not aware of any minimum time limit before you can use it. My opinion is that letting it run for 24-48 hours should be adequate. Then, of course, check the alarm systems and the chart recorder to ensure that they are functioning properly before moving the donor blood into the refrig.

Donna

[Malcolm Needs ☆]

I am sure Donna is correct, but in the UK we have to temperature map the d**n thing for about a week before we can put anything in there!

[David Saikin]

I let knew refs run for 24 hours, check the alarms and charts then . . . stock up.

[Deny Morlino]

We had an issue when we put our last fridge in several years back. It was not consistently holding temps. It might hold them for a few days and then temps would go out of range. We monitored it after each corrective service the manufacturer provided for at least a week before beginning to consider it "fixed". After 3 months of this the manufacturer finally switched the unit out. The replacement unit has been stable for years. My point is that there is not a written standard that I am familiar with. It is entirely up to your own comfort level as to how long to monitor the unit prior to use. I would recommend keeping a close eye on how the temperature fluctuates when a sizable number of units are loaded into the fridge. As Donna stated the inspector will want to see that validation of the alarm system occurred before placing the new fridge into use.

[bldbnkr]

Thanks everyone

I think I'll monitor it for 24-48 hours and switch the blood over after I validate the alarms but still keep a close eye on it for a few months. Hopefully it won't have the problems that Deny's had.

Maryann

[clmergen]

I think the last refrigerator I installed, I let "equilibrate" for about 24 hours and then did the alarm checks, etc after that period. Then we loaded it up.

[ColleenA]

Not sure where you are and who you are inspected by but if AABB or FDA come and visit you may need a validation plan that has been approved and signed off prior to actually putting the equipment into use. This should include IQ (Installation Qualification) appropriate plug, room for ventilation, door that has room to open, OQ (Operational Qualification) make sure that the temperature is set correctly and that the alarms are working as expected and PQ (Performance Qualification) make sure that it runs for specified period of time and is monitored (we check ours every 4 hours for 24 hours) usually checked empty and then filled.

[Eagle Eye]

Ditto......I follow same for all equipment...

[Eoin]

Wow, I am coming over there. Here we have a full validation protocol to follow (IQ,OQ,PQ) - electrical safety certs, calibration certs, mapping unloaded and loaded, hook up temp recorder, then validate that. Takes about 1-2 weeks usually. Then have to write up an executive summary, with all participating signing off & then goes into active service.

Cheers

Eoin

[adiescast]

As stated earlier, AABB and FDA like to see a validation plan (IQ, OQ, and PQ) followed, documented, and signed off before any equipment goes into use. Temperature mapping is a good idea; alarm checking is imperative. The important thing is to make sure the equipment is set up properly and functions as expected under the range of operating conditions possible. You have to decide what that looks like and state that it happened.

We had a refrigerator that failed validation because the design required the compressor to shut down when the unit went into alarm state. Who knew that someone would think that was a good design for a blood bank refrigerator? We would not have known if we hadn't performed the validation.

[clmergen]

I didn't mean to imply that I didn't have a complete validation plan, I did. But I only monitored the refrigerator for 24 hours before it was approved to be used and that was written into my validation plan.

[blarney]

I checked with our blood supplier since we are not billed for the products until they are transfused. They wanted us to monitor the temp every 4 hours for two weeks as that is the standard procedure they follow for new equipment at the blood center.

[Likewine99]

To keep your regulatory agencies happy I would suggest a validation plan including IQ, OQ and PQ as Eoin mentioned above

[Tadpole]

I would qualify a refrigeration unit IQ, OQ - no requirement for PQ - it is equipment and simple equipment at that- but definitely temperature map full and empty as you have to know where to put the probes and won't know that without mapping.

This is with the mindset that you qualify equipment, validate a process.