Data logger advice

[Mabel Adams]

We need to monitor remote storage of room temp. tissues. We are thinking of getting some data loggers for this that we bring back once a week or month to download the temp data. Are there any issues I need to consider in choosing which one and which features I need? I assume we still need a human to record the temp daily also at these sites.

Eventually we would like to get an integrated system that collects data wirelessly into a computer from many fridges, freezers and RT storage areas, but the money isn't available right now for anything that big.

[Alternatives]

Hello Mabel. I do not suggest you to use some data loggers but real time sensors. First, because data loggers are much more appropriate for transportation monitoring or validation project (mapping for example or coolers validation). The reason is data loggers operate on a limited and specified range of time, with a beginning and a previous end. They are passive, that is to say you will not be alerted in case of temperature excursion; you will see it after, and it will be too late. Real time monitoring system are dedicated to storage of sensitive's products, and as a real time solution, you could always have access to recorded data. Also, those kind of systems could alert you as soon as you will be out of range, and the more important before any excursion, so that you could react and save your products before beeing out of range.

Whatever the system you are going to choose, select one with yearly calibrated sensors, and CFR Part 11 compliant one (it includes audit trail option, security access...etc). A system which could be qualify is also required.

You will find different solutions on the market, wireless, wired (it often depends of the type of equipment and temperature range). For your budget, depending of the number of equipments you have, companies could host the system and give you full access to functionalities; prices are much more cheaper. If you have different locations to monitor, web based monitoring solution should be a good solution for you as they could be upgraded in time, with your allowed budget.

I hope it will help,

Benoît

[Eoin]

Hi Mabel,

I concur with Benoit. Dataloggers (we use Thermoscan) are only useful for short time monitoring (e.g. transport boxes or refrigerators. Also are you not required to have an alarm on the fridge?

The Wireless system such as REES Centron is far more suitable (can be fed through intranet also, so is quite flexible). It can easily be expanded as you grow. It also can alarm on any phone (as well as audible on the main PC). You can inhibit or reset alarms over the phone, when you have someone check that the fridge is OK. We use it on all stuff - Stock Fridge, Issue Fridges, Incubator block, room air, reagent fridges, freezer, incubators etc. We have it in for a couple of years now, and it suits the purpose very well. There are other brands out there equally as good. We also have pharmacy fridges around the hospital on the system (OR, Pharmacy, Oncology etc). They log in on their own PC. It really would be worth putting pressure on yur managers to buy in such a system. It is also very user friendly.

Regards

Eoin

[Alternatives]

If you go in the product review section, you will find some solutions both for data loggers management and monitoring systems, from several companies. Experience from people in this forum could also help you, as some specific topics have been already post on this subject.

A good friday to you!

Benoît

[marvy1]

Mabel,

I use a datalogger for a remote room temp storage site. Its cheap and easy to use (download data once a month). I agree for fridges and other alarmed equipment that dataloggers are not the best solution. However, for room temp monitoring, I find it works as an acceptable, inexpensive alternative to having an integrated temp control system. Mine is from Extech and it records temp and humidity every 4 minutes for over a month (greater than 60,000 data points). I can then print graphs and tables when I download. It also has a visible alarm when it goes out of defined temp range that I have the nursing staff monitor once a day.

[John C. Staley]

Another option would be a simple chart recorder linked to a room temp sensor. I've seen some in the past and they worked pretty well. If all you need to do is confirm the room temp did not exceed or drop below certain levels a paper chart would be sufficient.

This proabably sounds odd coming from a confirmed technophile!

[Alternatives]

Like in a lot of cases, regulatory is sometimes different when it's time to edit guidelines!

If you read JCAHO, you will see that for storage of ambiant tissue only, you have to "maintains daily records to demonstrate that tissues requiring a controlled environment are stored at the required

temperatures", but "for tissue stored at room temperature, continuous temperature monitoring is not required" nor "alarms system".

All others like COMPLIANCE PROGRAM GUIDANCE MANUAL Inspection of Human Cells, Tissues, and Cellular and Tissue-Based Products, 21 CFR, FDA CBER Chapter 41, FDA CFR 606...etc, all applicable for blood banks have a diferent point of view, without any distinguation between room temp and others range of temp and monitoring + alarm is required.

As far as i am concerned, i would recommend you to manage them as if it was frozen or other range of temp. I consider that a room temp product is as temperature sensible than a refrigerated or frozen one. they have a range of temp, and if it's easier at room temp while within your facility, that's another challenge if you have to ship them outside.

What do you think?

[heathervaught]

We use a centralized monitoring system when possible. When that's not possible, we use min/max thermometers that are read and reset daily. The problem with a "monthly" download is...what would you do if you found a temperature out of range the day after your last download?

[marvy1]

We use a centralized monitoring system when possible. When that's not possible, we use min/max thermometers that are read and reset daily. The problem with a "monthly" download is...what would you do if you found a temperature out of range the day after your last download?

We use dataloggers that have a visible alarm (flashing light) that displays when the logger is out of the user-determined limit. I have the remote site read and record the temp daily and also have them document if the alarm light is (or is not) flashing.

[Mabel Adams]

John, we were using chart recorders but they seem to get out of adjustment or the charts aren't changed on time.

I also just learned that the FDA considers Floseal and Tisseal to be blood products, not tissues, even though floseal is RT storage! I emailed "matt " and got the official word. Now I hope we can turn them over to pharmacy like Factor VIII etc. but if not I suppose we have to deal with both the continuous monitoring and the alarm! Of course, they want to store these all over the hospital.

The long-term solution is a centralized system, but we might need something in the interim.

Sigh.

Thanks for all the ideas.