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comment_1558

Does anyone use infusion pumps for delivery of blood components? If so, do you perform quality control on the pumps? What tests do you run and how often? AABB Technical Manual states, "...appropriate policies for maintenance and quality control should reduce the chances of damage to transfused components".

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comment_1560

Most places that I assess/inspect use some type of pump. First off, it must be FDA approved for delivering red cells. The manufacturer provides directions for maintenance. It is usually up to the BME people to configure some type of validation that the product does what it says.

comment_1565

My experiences with BioMed people is that they are quite good at the mechanical part of the device, but lack the understanding and documentation necessary for cGMP environments. They get the "deer in the headlights" look if I ask them about clinical measures, such as testing for maximum effluent temp of blood warmers, about post-repair testing procedures, or about the rationale behind their PM schedule or validation.

But I'm the first one to gladly give up blood warmer,etc QC/PM -- with a monthly BB review of their records, of course.

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