Is it necessary to take temps up in surgery when tissue products are being used in surgery. I am thinking like if bone putty gets sent to surgery stays up there for awhile and then comes back unused. Do you have to prove that it was kept at room temp while in surgery? I guess the same would go for a skin graft which we stored at refrig temp? How long can it stay out before it can no longer be put back in fridge.

Bonnie

The short answer is "Yes" - you need documentation that the storage temperatures "wherever" you store those products are within acceptable range. Oddly, it seems to be a once per day requirement unlike our blood bank q4 hours requirement.

I agree, but you must check package inserts. Most that I have seen had a wide range for room temperature 15-30°C (59-86°F). OR suites tend to be cold. You could consider a temperature data logger in a cooler that you validate for storage temperature required. These products are very costly. I added the approximate value of products to my tracking form to make them aware.

Good point. Some package inserts will say, literally, "Store at Room Temp" and do not provide a range. In that case room temp is whatever you make it. Some, however, specify specific ranges that are often very broad. If the range is so broad (like the above example), through a data logger out there and just document it once per month (a surgical suite below 65 or about 78 would probably result in screaming surgeons). Keep it simple.

Hello. "Store at Room Temp" means between 15-30C. Controlled Room temp is 20-25C. Always have a look on what the label mentions, as diferent terms are used (do not exceed 25, below 30...etc).

As Franklyn mentionned, keep it simple and easy to implement. Realize on a regular basis (every 3 months) a short documented study with data loggers. A prequalified coolers for exemple could do the job.

Benoît

I had this same question, but it turns out our Surgery department tracks the room temperature on every case (it is in the patient's surgical record.)

I felt that temperature was sufficient (since I can track which patient the item was issued to.)

Also, our Engineering department has records of daily temperature in each surgical suite.

Linda Frederick

If you consider temp room records to justify tissue products are maintained at room temp, does a mapping of the room is required, as you have no evidence of temperature homogeneity in your surgery room, and it depends of where package inserts are located in the room?

My problem with using someone else's temperature readings is that, rarely, can they produce calibration or validation records for the temperature monitoring equipment. If you are using that temp - you need to re-calibrate at least annually. When I mention that to our EVS guys their eyeballs start to spin and smoke comes out of their ears...

A couple of years ago I put everything on wireless temp sensors including the three rooms on OR where tissues are stored. Using this, the temps are continuously recorded on my computer. This has worked out well so far. The only problem I have now is that all of the chemistry/serology/coag refrigerators, freezers, etc,. are recorded on my computer and I have to notify them if a temp falls out. This situation should change with an upcoming software change.