Refrigerator validation

[kpend]

Hi,

I received a call from my OR today that they ordered and received a new refrigerator for storing blood in the room for open hearts and that I need to "get it ready".

What is required to validate a new refrigerator for storage of blood? I have not seen the fridge yet, but I am told it has a chart and alarms.

Thanks!

[Malcolm Needs ☆]

Well, for one thing, it will require temperature mapping - but I'm not very good at this sort of thing, so I am certain there will be other things that need to be done - such as alarm testing, but I'll leave this to a member who actually knows what they are talking about!!!!!!!!!!!!!!!!

[Eagle Eye]

it is very strange that OR would call you after ordering ref. Was this approved by your medical director? do they know that they need continuously monitored ref. with alarm syatem? who wll monitor the ref. for 1) dailt temp. 2) PM 3) storing and returning blood products? who will answer all questions to agencies when you have an inspection?

Sorry--got off track but my QA brain at work!!

[kpend]

Yes, it was very strange I was notified after the fact. The OR already has one, they just wanted one for a second room. It is continuously monitored with an alarm. They are already used to taking daily temps and changing charts. Other maintenance, not so sure. I have requested to see all their records.

I will have to answer to the inspectors...which is why I will make sure it is done correctly. The fridge is in my posession until ready for use.

I cannot find records of validation of the first refrigerator - the previous manager retired right before Christmas. I am hoping the OR has a copy of the validation records.

Can you please explain what temperature mapping is?

[Eagle Eye]

It depends up on the brand of the ref. you have. Most ref. comes with temp. mapping done. As far as know what they do is monitor the temp. over certain period. It will be very cumbersome if you had to do it your own. Ask the company to help you with it. I puchased several Helmer and they comes with mapping.

But still I performed my validation. First write the protocol includung IQ, OQ & PQ. (user guide will be helpful here)

Once you write your protocol perform each step.

1) Install it as per manuf. recommendation, IQ: safety check, check the voltage, clearance surrounding the unit etc. (I usually involve my bio med here)

2) OQ: verify setting and mechanicla function eg. install the chart, install battery, determine the set point

3) PQ: check the performance to see if the unit is performing as per manuf. (testing alarms, taking temp. etc)

Complete the validation, write SOP, sign off validation, train staff and start using it and monitor it.

[Malcolm Needs ☆]

Temperature mapping involves putting temperature probes in various places within the fridge (or freezer) to ensure that there are no places where the temperature is outside the prescribed range (either hotter or colder). If areas are either hotter or colder, temperature critical amterial should not be stored in these areas.

[mgscientific]

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Edited January 15, 2013 by Cliff
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[Whitney]

When you write your PQ do you include testing the maximum number of units that can be stored in the refrigerator or freezer? Currently we monitor empty and then with at least 20 units per shelf. The FDA investigator indicated that we need to validate for the maximum number of products we could store in any one unit. I'm not sure how to tackle this so any advice would be appreciated!

[Eagle Eye]

No. We did not do this. But after we put into use we monitor daily QCs and see any changes in chart recording too.

Sidetrack:::: we had a freezer running nicely at -30F with peak every time the defrost cycle runs. All of a sudden I notice the peak was much smaller (but temparature was still withing range) .....We called the company and the investigation---the door gasket needed replacement....So monitoring QC and charts with eagle eye works!!!!