9.5 Generic protocol for the evaluation of apheresis equipment
This protocol sets out the minimum requirements for new apheresis equipment and, in a generic form, the mechanism for assessing acceptability of the equipment hardware, the software and the associated apheresis sets. The specific validation or trial of apheresis collections from new equipment is covered in Section 9.6. Novel components, as defined in Section 9.1, produced as a result of new equipment will be assessed as detailed in other sections of this chapter.
Minimum requirements
General
Equipment should be CE-marked or the Blood Service should participate to facilitate CE Marking.
Manufacturers must comply with Good Automated Manufacturing Practice (GAMP).
Equipment hardware
Equipment should contain the following:
manual override system
blood flow monitor
in-line air detector
integral blood filter
anticoagulant flow indicator
collection volume preset device
visual audible alarm for procedure completion
automatic standby mode for power failure
power up self-check to include all critical safety and operational procedures.
Equipment software
Software should provide parameters for
accepted total blood volume calculation algorithm
accepted citrate reinfusion rate calculation algorithm
fixed upper limit citrate reinfusion (see Chapter 6)
programmable upper limit total collection volume
must not exceed predetermined fluid reinfusion limits (e.g. citrate, saline)
alarm and prevent use of incorrect set (incongruent) for programmed procedure
prevent procedure where predicted post-collection parameters fall outside programmable safety limits as defined in Chapter 6
for other measures see Chapter 6.
Apheresis sets
Apheresis sets should have
closed system
visual system to minimize risk of transposition of fluid lines
microbial filter on 'spiked' lines
diversion line and pouch for sampling
consideration should be given to the incorporation of a pouch on the final pack to facilitate bacterial contamination testing
for other measures see Chapter 6.
The overall mechanism for equipment acceptance is given in Table 9.6 for reference. Validation, installation qualification, operational qualification and performance qualification would be defined by the Blood Service, taking account of the advice within these Guidelines.
Table 9.6 Generic flowchart of apheresis equipment acceptance
