I currently use Blood Bank Refrigerator Certified thermometers in my blood storage refrigerators. These thermometers come with a Certificate of Conformance and Accuracy and are "NIST-traceable". They do not have a calibration expiration date. My question is this, Do i need to calibrate these thermometers annually or are they covered by the certificate? When I read the technical manual, the verbage uses "should be", not must. Is there an AABB standard requiring annual or periodical calibration of this type thermometer?

Thank you,

Lisa

It's an FDA reg; was cited once for this. So now I send out my certified thermometer annually to get re-calibrated and they give me a lovely certificate to show inspectors. I use Essco Calibration Laboratory (www.esscolab.com), they are very reasonable.

Hi Terri,

I am having a hard time finding that CFR reference about thermometers. Do you know the exact number?

Tanks

JB

When they cite Blood Banks, they use 21 CFR 606.60, but it doesn't really specify how often for NIST (reference) thermometers. But they cite anyway, because they are the FDA and they can, I guess.

Since we check all thermometers against the NIST one annually, the inspector asked how often we check the NIST. We showed her the certificate, which does not state an expiration of the calibration. So she cited us for not also checking that annually; I asked her if it could be accomplished by verifying it with another NIST thermometer in the Lab, she said not unless it had been purchased (or sent out for calibration verification) during that year.

:angered:Has anyone used a calibration lab other than Essco? I sent ours to them and they said the fluid seperated and they are returning it. I don't want to use them again. I will have to buy a new one. Since they havd had it for 2 weeks, I wonder if it arrived seperated or.............

I have been trying to find a thermometer to keep in house for calibrations, and the only NIST standard thermometers I can find are either mercury (which we have eliminated from our facility), or very, very expensive. Any suggestions?

CardninalHealth sells red spirit filled NIST thermometers.

Yes, we use Spectrum labs for our calibrations.

We use INNOCAL out of Vernon Hills, IL, annually.

I have a traceable digital thermometer from Allegiance (SP) that I believe was less than $100 (several years ago) and works fine for the yearly cal of the lab thermometers. We have a company that comes in yearly to recal the reference thermometers, tachometers etc. AABB and CAP have been fine with this. It's handled through our clinical engineering dept. Your clinical engineering dept might also let you borrow one when needed. (I use one of theirs with a fine wire-type probe for checking the temps in a few odd places where the shishkabob probe on mine has trouble getting to.) Go digital: you avoid mercury, columns seperating, and having to walk around carefully holding the thermometer in its padded box like you were presenting the crown to the king.

I have used Control Company, Innocal, and Fluke.

Sarah