Looking for information on quarterly alarm testing for blood storage refrigerators/freezers... my new freezer and refrigerator have an automatic alarm test function on the panel boards, is this considered acceptable, or should I also continue performing the manual alarm testing using the water/slush method? Thanks for any help or information!

Continue performing manual testing of the probes/alarms.

I would recommend the manual testing of the probes/alarms at least periodically.

When we get a new refrigerator or freezer (and after any major repair), we do the manual testing of the probes/alarms and the electronic alarm test on the panel board once a month until we have had three consecutive months of consistant satisfactory performance. Thereafter, we do the electronic alarm test at least once a quarter (ie: once every three months) and we still do the manual "water/slush" testing of the probes/alarms at least once a year.

Our policies require daily alarm test from the panel (push button) and probe alarm activation test quarterly

I would not continue to do the manual/slush method quarterly if the new equipment is able to do this function electronically. The key is that you have to validate that it works. Do a validation, prove that it works as expected, and document it for inspectors. If you want, you could still do it manually on an annual basis just to ensure that it still works as designed.

I would not continue to do the manual/slush method quarterly if the new equipment is able to do this function electronically. The key is that you have to validate that it works. Do a validation, prove that it works as expected, and document it for inspectors. If you want, you could still do it manually on an annual basis just to ensure that it still works as designed.

BUT... don't be surprised if some individual inspector/assessor would find this unacceptable. Personally I agree with tbostock and would welcome the "discussion" if it were to occur. To often we get stuck in the we've always done it this way mind set and even when new technology comes along that makes such things obsolete we are slow to embrace the change. Some slower than others.

:bonk:

BUT... don't be surprised if some individual inspector/assessor would find this unacceptable. Personally I agree with tbostock and would welcome the "discussion" if it were to occur. To often we get stuck in the we've always done it this way mind set and even when new technology comes along that makes such things obsolete we are slow to embrace the change. Some slower than others.

:bonk:

Exactly right, John. You and I totally agree on this issue. I guess my argument for inspectors would be...what else that I have fully validated should I not trust? I just validated our new microwave plasma thawer...should I then "thaw them the old way" once in a while? My feeling that if a manufacturer says they can do it, FDA approves it, and I validate it to prove that it can do it...at some point we have to trust that the new technology does indeed work and we can move on to more pressing issues...like patient care.

As an inspector/assessor I want to see that your electonic check actually raises/lowers the temperature of the probe and does not just test the electronics. THEN I am also going to want verificatioin that the thermometer that is being documented (probably the one on your ref/freezer display) is validated vs an NBS standard. Many sales reps harp on the ability of their electronic temp alarm check but in reality all it tests is the electronics. Sorry, I'm from Missouri.

Last time I checked with CAP (and it's been a couple of years) they still wanted the actual physical check and not the electronic check. If you are CAP accrediated, I would definitely check with them before I changed my requirements.