Hello Everyone,

Need some guidance on validation of blood warmers.  Recently our clinical engineering bought 24 new blood warmers, same model and brand of what we have already used and validated.  We have just recently validated 6 of the 24 new ones with running blood through them and taking whole blood potassium levels at hourly intervals. 

The question we cannot agree on is do we need to validate every single blood warmer or is the 6 that we have done a sufficient sampling to be able to make a blanket statement that the warmers are ok for patient use.  Anyone have any evidence based answers to this?  At this point I'll take just some good advice!  Thanks in advance.

 

 

I may be opening a can of worms but I would not have done any validation and left it up to biomed to do their function and temp checks according to manufacturer's specs.   Do you validate IV pumps or rapid infusers?  

We do not.  There was a validation done on these 10 years ago when we first received these devices, so we were piggybacking off of that a little bit.  And in us doing that it brought up a lot of discussion.  So far the consensus is we went over and beyond what we should do and biomed checks are sufficient.

I do review an annual summary of blood warmer function checks supplied by my BIOMED guys and gals. 

Thanks for the info!

1 hour ago, R1R2 said:

I may be opening a can of worms but I would not have done any validation and left it up to biomed to do their function and temp checks according to manufacturer's specs.   Do you validate IV pumps or rapid infusers?  

R1R2 basically said what I was going to say, verbatim.

5 hours ago, R1R2 said:

I may be opening a can of worms but I would not have done any validation and left it up to biomed to do their function and temp checks according to manufacturer's specs.   Do you validate IV pumps or rapid infusers?  

I agree.  There is basic function, temp checks, alarm (?) that get verified per protocols provided by the manufacturer.  They should suffice.