Validate IV infusion pumps used for blood products?

[Mabel Adams]

Our hospital is getting a new IV infusion pump system (download data wirelessly to computer etc.) with a jillion new pumps. They will be using them to give blood products. Has anyone else ever validated infusion pumps? Do we need to? If so, how?

[RR1]

Does the computer control the infusion rate and if the data is being stored does this need to comply with 21 CFR (I may have this wrong- as not completely sure of U.S regs), in which case the validation may need to involve testing computer data storage aspects ?

The supplier should be able to help and advise what minimum testing is required for their products, or at least let you know what could happen in the worst case scenario with the individual pumps. If the FDA has a medical devices section they may also be able to help with validation advice.

If the pumps have heating elements then possibly calibration certificates to traceable standards provided, and check of the over-temperature cut-off function, or just basic check of these devices working properly at different flow rates?

Sorry- not that much help, just hope you don't have to test each one or there won't be much time to do anything else for the next year or so!

Edited March 12, 2011 by RR1
forgot something

[Bill]

One hospital that I worked in the BioMed Dept checked all that at least twice per year. The records they had from the manufacturer were flawless. There were tests to check free-flow prevention. Delivery volumes at low rate and high rate, those with warmers had temp checks with volume load and a specific test for cutoff temp.

[Deny Morlino]

Biomed handles all of this twice yearly at our facility. They have a computer tracking schedule set up for every device they are responsible for the upkeep of, and are flagged when a device is due for a semi-annual check, etc. The reports go to the lab manager and she makes sure everything meets the regs (whew, one less thing for me to worry with).

[Mabel Adams]

So we don't have to validate them in some way specifically related to blood transfusion it sounds like. Good. I will let Bio-Med do their usual and call it good.

[Deny Morlino]

So we don't have to validate them in some way specifically related to blood transfusion it sounds like. Good. I will let Bio-Med do their usual and call it good.

That is my thought. Are you always kept in the loop if a new infusion pump is put into use (i.e. replacement of a failing unit)? I doubt I am. I must rely on the biomed folks to do their part. The best thing I can suggest is to make sure you have a good rapor with this group and make sure both biomed and blood bank are on the same page with the requirements.