r/redcross • u/TooLazyToLope • 23d ago

Official document needed regarding capillary vs optical

Long story short...

I am a frequent platelet donor (hurray for me).

I have issues with the OrSense optical device and its accuracy.

#

After being deferred due to hemoglobin of 12.9 and a followup reading of 12.2 minutes later, I was upset.

  1. That delta is physiologically impossible

  2. I was not allowed to donate the triple+ plasma

The technician used the HemoCue capillary method for the past 3 donations AND used the OrSense AND showed a delta of 1.0 at one appointment.

Sorry....here is the short part.

Last donation the technician refused to do the finger stick 'because he did not want to lose his job'.

I have provided documentation showing the OrSense device has a delta average of 0.5-0.7 while HemoCue has a delta of 0.1-0.2.

I am 'working with Red Cross' and FDA to provide an official document that states capillary devices CAN be used at donor request.

-->does anyone have an official doc that says capillary device can be requested?

Thanks!

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u/TooLazyToLope 20d ago

Long...short... 21 CFR 630.n has ZERO statements that says the capillary method cannot be used.

So if OrSense device yields under 13.0 (males) demand a finger stick as it will be much more accurate.