Calibration of Blood Pressure cuffs and Vital Signs Monitors

[DFields]

What are others doing for calibration of manual blood pressure cuffs?

What about calibrating vital signs monitors (electronic)?

[David Saikin]

It's catch 22 . . . the standard is the mercury manometer - we are not allowed liquid mercury in our hospital. The FDA had no problems with this scenario (as a licensed operation): 1) verify that the gauge is "zeroed"; 2)verify that there are no cracks in the tubing; and 3) pump the gauge up to 40-50 mm and verify that it maintains pressure. I do believe that BioMed can validate your anaeroid cuffs (at some places anyway) . . . some device can do it, I do not have that info.

[Lcsmrz]

What are the manufacturer's recommendations?

[ar_confederate]

We use the SPOT vital signs and calibrate them annually using a certified digital pressure gauge (Digimano 1000) and the temperature block obtained from the manufacturer. Our SOP calls for 4 points; 0, 50, 100 and 150 mm Hg and we have to be + 3 mm Hg agreement. I don't recall the temperature points that we check. Those are set by the temp. block.

[GGEHRKE]

We are a hospital based Donor Center. Our Bio-Med department does not calibrate manual B/P Cuffs since the rest of the hospital uses the electronic type. We too were in the same situation with having to get rid of all mercury cuffs.

To satifsfy the requirement of annual calibration, I contacted the Manufacturer of the Sphygmomanometer. They have a service whereby for a fee they will calibrate the units and send a certificate of calibration good for one year. The company is American Diagnostics and they will do this for any of the cuffs they manufacture. The cost is $50 per unit. That is high considering that to buy a new one (if the present one is not a zero) is much less.

The company did indicate to me that if we wanted to do it ourselves there is a company called Yokogawa that sells a digital reference unit (MT-10). But that unit will require annual calibration by a third party such as MCS calibration in Holbrook, NY. There may be other companies like MCS which many come to your facility for a fee (of course) to do onsite calibration.

I am hopeful this will satisfy the FDA requirements.

I would like to know though, since it is less costly to purchase a new sphygmomanometer if the one you use does not register at zero when not in use, if you keep a log of serial numbers and in and out dates (for one year) if that would be acceptable. Does anyone do similar?

[Kiki Zeleke]

We are currently using manual blood pressure cuffs and microlife blood pressure measuring equipment for our vitals.Is it possible for you to share with me what you guys do for monthly QC on these equipments.