We are currently standarizing dig therm monthly and would like to move to quarterly or even semi-annually. Who has experience with this type of variance from the FDA? What data did you use to support the request? etc. Thanks for any help.

I check the calibration on my digital thermometers yearly, not monthly or even quarterly. I assume you are referring to the table in 21 CFR 606.60 which defines the frequency of calibration for digital thermometers as monthly. Part of the problem with the CFR is that it hasn't been updated in quite a while and time and technology march on. The manufacture usually has a recommend frequency of calibration with devices of this type and while digital inputs (once upon a time) experienced a lot of drift, such is no longer the case. We did not file for a variance for 21 CFR 606.60, we just made certain our documentation is in place. Our most Recent FDA inspection was in June of this year, our inspector did look at our calibration records for thermometers and refrigerators and we did not receive a 483. Typically, if you can document and validate your process, proving it is in control, there is no issue.

Of course, we are a registered (not licensed) blood bank and transfusion service. That could have an impact as the FDA looks at licensed manufactures a little differently. So your mileage may vary.

We check ours annually also. If you have yours calibrated by Control Company, they will put a re-calibration required in one year label on the thermometer. I send ours off to get it back in time to re-calibrate all our other thermometers in December.

I suspect that tgriffin is referring to the digital thermometer calibration checks required for thermometers used to qualify donors. The regs do require monthly calibration checks for those thermometers.

As the FDA what they require for a variance waiver. That is your best source. That said, I don't know of any donor center that has been given a waiver.

Good luck!

BC

If referring to 21 CFR 606.60( a variance request is no longer needed when following manufacturer's instructions for a digital thermometer. See the link below:

http://www.fda.gov/cber/blood/exceptions.htm

Hope this helps.