Freezer temperature monitoring

[MEG]

Recently, in my facility I had an issue with freezer temperature monitoring. One of our freezers that contains FFP had the temperature chart quit working. For six days the daily temperature of the chart was documented(written on the daily log) for a chart that was not working. So I had no temperature chart for 6 days. I discarded the FFP as I could not provide continuous temperature monitoring for that freezer. One of the techs involved felt that I should not have discarded the units. The reason being that in the AABB technical manual it states that if continuous temp monitoring of FFP during storage is not possible, the FDA requires that the component be stored in such a manner as to allow detention of thawing. Then is goes on to explain how to track the air bubble in the plasma. I interpreted this to me a couple things.

1. Even if I can not continuously monitor I am required to monitor every 4 hours correct? We only documented every 24(I don't believe that was correct because different temps were written down for a chart that was not recording the temp).
   
2. I do not have a policy for reviewing plasma that may have or have not thawed because of freezer malfunction.
   
3. The air bubble is covered by my label, and I could not feel it on some of the units.
   
4. Even though the freezer alarm can be heard 24/7, I have documentation in the past were my techs have not documented the alarm sounding.
   

I am just wondering if I am off base in my thinking or is my interpretation correct? Any input is greatly appreciated as this is the 3rd time this has occurred and I keep getting the same questions from the FDA: Provide dates and temperatures( I only have one for every 24 hour period. Provide an SOP for re qualifying the units(I don't have one).

[SMW]

You are correct that you would need to be recording the temperature at least every 4 hours during the period when you did not have continuous monitoring available to be able to use the products. Be careful what you're considering to use as a "thaw indicator". Since most large blood centers use continuously monitored storage devices, most no longer manufacture frozen products with an indicator such as an air bubble in a specific position or indentation.

Since you mention the FDA, I'm assuming you are aware that you must file a Biological Product Deviation (BPD) with the FDA for any products that were thawed and issued during the period when the temperature was not being monitored as well as perform a market withdrawal/recall for each product issued.

[and please remember, the AABB Technical Manual is a textbook and does not constitute Standards, rules or regulations]

[MEG]

You are correct that you would need to be recording the temperature at least every 4 hours during the period when you did not have continuous monitoring available to be able to use the products. Be careful what you're considering to use as a "thaw indicator". Since most large blood centers use continuously monitored storage devices, most no longer manufacture frozen products with an indicator such as an air bubble in a specific position or indentation.

Since you mention the FDA, I'm assuming you are aware that you must file a Biological Product Deviation (BPD) with the FDA for any products that were thawed and issued during the period when the temperature was not being monitored as well as perform a market withdrawal/recall for each product issued.

[and please remember, the AABB Technical Manual is a textbook and does not constitute Standards, rules or regulations]

Thank you so much for your reply. Yes, I did file the BPD and do my Market withdrawal which was quite lengthy. Thanks again

[Mabel Adams]

Might want to add a requirement to your daily temps that they make sure the chart is recording too. Then you could catch it within 24 hrs. at least.

[Eagle Eye]

I believe you did the right thing by discarding FFPs(unless your medical director was going to write justification to FDA). Do you record temp. from chart everyday? if not add that to your QC? For somne reason our chart stops working, we start taking temp. every 4 hrs. and monitors alarm.

[QCDan]

Do you only record the chart temperature on a daily basis ? What about an internal temperature (with a manual thermometer) or the digital temperature (probe in glycol) from the freezer ?

In the end it's a really good teaching tool to the rest of your tech about how to approach temperature monitoring and alarm notifications.

[tbostock]

We have a check on our daily QC sheet that the techs check the chart to make sure it is functioning and on the correct day/time/temp. Because the same thing happened to me many years ago; the techs weren't really looking at the chart.