Timing of Arm Prep

[DFields]

What timing device do you use for arm scrubs?

Do you calibrate/QC the timing device?

If wrist watch is used is it checked for accuracy?

If wall clock with second hand is used is that checked/how often?

An external auditor is asking us (we had never been asked that before).

[Franklyn]

I have had this question before. We stated a minimum time in our SOP based on the manufacturers insert for the scrub we used. We also stated that the sweep second hand on a wrist watch or wall clock was sufficient and, due to the nature of the step calibration was not required. If you put it in a carefully worded statement that is part of your policy, there is not much to gripe about. There are no regulatory requirements for calibrating this kind of a timer (that I am aware of).

[rcurrie]

I am with Franklyn on this. Quartz watches and clocks are so accurate, that unless it is completely defective, as long as you scrub at least 30 seconds you are good. I had an FDA inspector tell me I needed to do calibration checks on our donor room clocks, and I said "show me where it says this." She was unable to find anything. Case dismissed.

Don't make the mistake of saying that you will scrub for 30 seconds. If your SOP says that and you scrub for 31 seconds, you are not following your SOP.

BC

[BCWTechWriter]

Our collection staff must use the donor room clocks, which are all calibrated monthly.

Our QSD also states that we must scrub for a minimum of 30 seconds.

~T~