In the "ask the FDA" regulatory update recently issued there was a question concerning the need to perform monthly calibration of electronic thermometers used in computerized temperature monitoring systems. FDA responded in the "yea" but would consider alternative procedures if the manufacturer's recommendations are less restrictive. What do you do? We let the manufacturer calibrate the temperature probes annually and that's that! It's impossible to get to the probes on a more routine basis without breaking them.

We have a Rees System (computerized alarm for entire lab). We do alarm checks quarterly in the blood bank where we test the probes for each piece of equipment for both high and low temps and ensure that they alarm on the Rees at the appropriate temps. We also have the Rees company come each year and validate each probe (this does not include alarm checks for each fridge). I have not had any regulatory problems related to this and we were just FDA inspected last month.

We too use the REES system. I contacted REES about this issue a while back, and they feel their temperature monitoring devices do not necessarily fit into the category of electronic thermometers. They are technically thermistors.

We have close to 100 probes in several buildings, it would be impossible (well...) to do anything but allow the probes to do what we paid REES to have them do - monitor the temperature.

We pay a hefty fee to have these calibrated annually. At this point that is all we plan to do. We too have had many FDA inspections and they reviewed our REES data in depth a few years ago.

Cliff,

Thermistors, RTD, Thermocouple, IC sensors are all devices that require a electronics to interprets the change in there outputs. RTD's are the most accurate however if shock i.e. dropped they will change in there resistive output requiring recalibration. They are still the best choice of probe to use. IMO once a qtr. you should do an alarm check and have the system calibrated once a year and if you find that the probe isn't alarming at the correct temperature during your qtr. check, then re-calibrate that probe.

We have Centron. They calibrate the temp probes annually. They do not want anyone else to test them. So, I agree with you.

We have found some manufactures that try to prevent outside calibration companies from calibrating there systems. I one case and I won't mention the manufacture, however they provided the annual calibration and we provided quarterly alarm validations. As a surprise to the blood center a number of there probes were reading incorrectly and this was just days after the manufacture recalibrated the system.

We know that Mack Info Systems doesn't calibrate there own systems, because they believe that it would be a conflict of interest. I am not implying that manufactures would falsify any calibrations, however it certainly is to there advantage to show that there system doesn't drift.