Validation & QC for SCD

[shelleyk482]

I have used sterile connecting devices for years but I'm now in the position of implementing the use in a facility that has never had one. We purchased the Haemonetics TCD. What have others done in the way of validation prior to implementation & what ongoing QC is done? Are sterility checks necessary before use &/or at periodic intervals? Are just visible weld checks acceptable for the ongoing QC?

Thanks for the input,

Shelley

[John C. Staley]

Shelley, an SCD is basically a simple machine, either it works or it doesn't. Either the weld is intact and everything is fine or the weld leaks. We inspect every weld for leaks. If one leaks the system is considered an open system and treated appropriately. If it does not leak then you've got you closed system and are good to go.

We see one or two leaky welds per year and usually they are due to identifiable operator error. They were in a hurry and didn't place the lines in quite right.

We (the blood bank world) are taking the whole validation idea to heights never imagined by normal people. Don't over complicate this.

My first blood bank supervisor and mentor always subscribed to the KISS principle: Keep It Simple Stupid. I've followed her lead ever since.

[Lcsmrz]

John:

Is it not sacrilege to propose that the Blood Banking community overdoes validation -- or any other thing, for that matter?

"It's for the children ..."

[John C. Staley]

Larry,

I certainly hope so!!

All lemmings need is for at least one to stop and shout, "Hey, wait a minute, do we really want to do this!!"

:ohmygod: