Thermometers

[spavlis]

OK, here is the situation. I can't seem to get a straight answer from anyone I know so I thought I would post this question.

We current monitor the room temperature in our donor center by using just a room temperature chart. Soon, the hospital will be using an automated temperature monitoring system that can record the ambient temperature 24 hours a day. So, my question is.. Do I need to have a chart and an automated temperature reading? I know that our blood refrigerators need an internal temperature, monitor temperature, and a chart. But about a room tempearture? Is it good enough to have just the automated room temperature reading and no chart? We currently only use one method for monitoring our ambient temp and that is the chart, so is it unreasonable to just use only the automated monitor temperature ?

Somehow it is the easy questions that no one can answer straight.

[Lcsmrz]

It would depend on the requirements of the donor room. If products are being stored there, then environment would have to meet storage temperature requirements: 20-24 C, continuous monitoring, alarm system, recording every 4 hrs, etc. If not used for storage, then you would have to meet any documented requirements in the QA Plan.

Another issue would be how accurately the automated system reflects the reality of the donor room temperature. Some systems measure only incoming and outgoing air temp, while other sensors were located in an area that did not reflect the actual temperature, such as an interior wall when the storage was next to the windows.

Finally, the automated system has to be validated and sensors and alarams checked periodically according to the QA Plan.

I have seen several places who have successfullly used facility-wide automated monitoring systems in lieu of stand-alone monitors and recording charts.