Is there a guideline for RHIG reissue where the RHIG was issued and was not injected into the patient and sent back to Blood Bank? Note the RHIG ( Rhogam, Rhiphylac) was at room temp for hours? What does FDA/ AABB and CAP say besides to the manufacturer's insert?

Thanks,

What does the pkg insert say?  How many hours?  I'd be inclined to toss the product.

20 minutes ago, David Saikin said:

What does the pkg insert say?  How many hours?  I'd be inclined to toss the product.

I agree.  Quite apart from whether or not the immunoglobulin would actually be efficacious after hours out, within reason, the higher the temperature and the longer the immunoglobulin is outwith temperature range, the greater chance that, if there is any bacterial contamination, this will accentuate it, and possibly cause a fatal septicaemia.

similar situation--Rn kept in her pocket for 12 hours after dispense.

I wrote technical service at Rhophylac company--they said no worries--should be fine.!!!

11 minutes ago, LIMPER55 said:

similar situation--Rn kept in her pocket for 12 hours after dispense.

I wrote technical service at Rhophylac company--they said no worries--should be fine.!!!

They said it, or they put it in writing?  If they did put it in writing, was the person who signed the letter senior enough to so do?

I contacted the company and received written guidelines describing storage limits. It was acceptable. 

I believe the manufacture (Kedreon) says 10 hours. That’s what we use

Thank you all!

 

On 6/7/2018 at 12:27 PM, Malcolm Needs said:

I agree.  Quite apart from whether or not the immunoglobulin would actually be efficacious after hours out, within reason, the higher the temperature and the longer the immunoglobulin is outwith temperature range, the greater chance that, if there is any bacterial contamination, this will accentuate it, and possibly cause a fatal septicaemia.

Fatal septicaemia?  The injection is IM not IV.  Malcolm don't you think that a septiceamia is a bit of a stretch.  I would think that a nasty cellulitis is more likely and if left untreated could be very serious or even fatal depending on the bug involved.  

I appear to be feeling just a bit argumentative today, good thing my lovely wife is off visiting family for a few days.   

28 minutes ago, John C. Staley said:

Fatal septicaemia?  The injection is IM not IV.  Malcolm don't you think that a septiceamia is a bit of a stretch.  I would think that a nasty cellulitis is more likely and if left untreated could be very serious or even fatal depending on the bug involved.  

I appear to be feeling just a bit argumentative today, good thing my lovely wife is off visiting family for a few days.   

Fair comment John, not fatal septicaemia, just fatal cellulitis!  My point was though, that it is just not worth taking the risk.

I will go with what the manufacturer states.