TechNet-21 - Forum

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  1. Larry Schlussler
  2. Cold chain equipment
  3. Wednesday, 06 February 2019
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I was recently looking at a sample print out of a 30 day data logger. The high temperature alarm went off 4 times in a 30 day period. Having this information what does the health worker typically do with the vaccines? Some possibilities are: - Throw away the vaccines. - Ignore the alarms and use the vaccines as if the alarms did not go off. - Issue a notice that the vaccines should be used within a certain period of time. What determines that period? If someone has field experience please let me know how the collected data is typically used. ?
Berlinger & Co. AG Accepted Answer
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Dear all,

The device will not trigger an alarm until it has left the boundaries for the duration that is set in the device. The Fridge-tag series doesn’t work with a cumulative alarm so it will be only triggered if it’s continuously out of bounds. When the temperature deviation is out of the limit while the day changes (a new day starts at the date-change-point at midnight) it can appear that the temperature is in an alarm state for less than the necessary time. For example:

The device is out of range from 13:00 till 02:00 the following day. This case will be visible in your file as following if there were no other alarms on these days:

Duration out of range                                     Alarm trigger time

11h                                                                         23:00h

2h                                                                           00:00h

Since the device is still in an alarm state when the next day starts the Alarm trigger time will be instantly set.

 

Also, we can confirm that for your device the alarm settings are:

for the upper alarm the device has to be above 8 degrees Celsius for 10 hours and

for the lower alarm it has to be below -0.5 degrees Celsius for 1 hour.

 

Best regards

Berlinger & Co. AG

  1. more than a month ago
  2. Cold chain equipment
  3. # 1
Alain Claude BILOA Accepted Answer
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Dear Larry and Bnaventura,

It's a very good topic that your raised here. From my humble experience on the use of fridge tag, I totally agree with what Bonaventura said. For a given CCE, a high alarm occurs when the temperature goes above +8°C during 10 hours. When this happen you need to check the VVM of the vials in this CCE, if the VVM are still good, it is advice that vaccines must be used. Even if this happen several times a month, the VVM is the witness that tells us if the vaccines is usable or not. 

I suggest also that you need to check the defferrent events when the temperature went off. Where there elctricity? Did the door be closed? And which kind of CCE do you have?Can you downloaded the recorded temperature form for this month and sen it to us, so that we can analyse the problem.

Best regards

Alain

  1. more than a month ago
  2. Cold chain equipment
  3. # 2
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Dear Umit and colleagues,

Attached is my observation on the Fridge-tag2 temperature monitoring devices used at health facilities. Can anyone clarify this based on the information provided that for a high temperature alarm to be recorded the vaccine refrigerator has to be exposed to temperatures above +8 Centigrade for 10 hours consecutively?

 

Attachments (1)
  1. more than a month ago
  2. Cold chain equipment
  3. # 3
Umit Kartoglu Accepted Answer
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Dear All,

Agree with Bonaventura that the answer is in the VVM reading.

First of all, the 30-day electronic temperature logger gives alarm on the performance of the refrigerator. So all alarms should be dealt with accordingly to understand the reason and take measures to correct it to prevent further occurrence of such similar alarms. When it comes what needs to be done with the vaccines, you need to refer to VVM readings. If you have a vaccine with no VVM on them since you have no idea what has happened cumulatively to that particular vaccine before it has reached you, you cannot take any risks and preferably these vaccines should be discarded (this is why we say VVM prevents wastage of vaccines).

One issue in Bonaventura's reply caught my attention, the claim of some devices triggering an alarm when the duration of exposure was less than 10 hours. I am wondering how do we know that the exposure was less than 10 hours - unless someone is in the fridge and continuously checking the time when the temperature hits above 8 deg C :) You should take note that Fridge tag device measurement accuracy of the time is +/- 30 minutes/year. In this sense, I do not expect these devices to trigger an alarm with the situations you describe. And if it ever happened (with the proof that it was less than 10 hours - and I wonder how you would verify this) you should return this device for quality check.

Hope this helps,

UMIT

Extensio et Progressio

  1. more than a month ago
  2. Cold chain equipment
  3. # 4
Thato Accepted Answer
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I also think that everytime there is an alarm trigger the health worker should implement the contingency plan which outlines what should happen when there is cold chain failure either being high or low temperature alarms.

  1. more than a month ago
  2. Cold chain equipment
  3. # 5
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Dear Larry and Chandralal,

This is a very interesting topic in vaccine storage temperature monitoring at stores and facilities.

From my understanding, temperature alarms in a 30-day temperature loggers indicate a deviation of storage temperature outside the recommended range of +2 to +8 centigrade.

Based on the 4 high temperature alarms you observed, a health workers should understand that a 30-day device has recorded the storage temperature in a CCE went 4-times out of the recommended range. This means that, there was four incidences wherer vaccines were expoused to high temperatures (above +8 Centigrade).

According to the manufacturer, the high temperature alarm triggers when the CCE records an exposure of vaccine to +8 Centigrade for duration of +10 hours consecutively. The low temperature alarm is triggered when the temperature is -0.5 Centigrade for +60 minutes consecutively. However, I personally had observation of some devices which recorded an alarm when the exposure duration has not reached +10 hours!!!

From my understanding, the health worker doesn't need to throw away the vaccine unless the Vaccine Vial Monitor(s) (VVM) sticker on a vaccine vial(s) has reached the discard point. In addition, the alarm should equally be taken into consideration for interpretetion to determine issues like duration of exposures, times of exposure etc.

If there a frequency of repeated exposures, a health worker should have a plan to move vaccines to other facilities so as to minimize or avoid wastages. 

Regards,

Bonaventura

  1. more than a month ago
  2. Cold chain equipment
  3. # 6
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Thanks Larry for posting this. I also need this information. Hoping to hear experiences from experts.  

  1. more than a month ago
  2. Cold chain equipment
  3. # 7


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