Biological Products

[TStec]

I have been transplanted from Transfusion QA to Surgical Services. Every day I find out about products derived from non human/ non cellular. We only thought about human tissues to humans but at AABB in Montreal at Assessor training, I learned that all biological products regardless of source should be assessed it the Medical Director was indicated is "tissue oversight". Our Transfusion Committee has a Tissue Focus group and the chair of the Transfusion Committee is the Transfusion Medicine Service Medical Director. We though we were on top of things but this woke us up. The first wake up call was qualification of suppliers documentation. The sales representatives tell surgeons that this product is not a Joint Commission tissue and convince them to trial the product. RIGHT! So I now qualify suppliers and require a package insert. One product was derived from human plasma and quoted 21 CFR requirements. What surgeon or nurse would be familiar with 21 CFR???? These are FDA biological products. Think about it, the FDA is concerned about tracking and tracing in adverse events. The FDA has biological products and medical devices, both are found in your surgical suites and most are probably not controlled or tracked unless you have complete barcode supply chain control.
Our institution is way ahead in the BIOVIGILANCE movement. We are setting up a Biovigilance Program for biological products from tissues, breast milk, albumin and perioperative products. First I designed a Biological Product Qualification process & document. Any product derived from human, bovine, porcine or other is sent to me. And I can tell you that I give those representatives something to think about. I have call manufacturers of autotransfusion devices to ask why they do not put base labels on the transfusion bags? Would any blood banker buy a bag without a base label, where would we put our ISBT128 label!
Some of the requirements are FDA registration number for biologic or medical device, AATB accreditation for tissue and Quality Program documentation with a responsible head contact.
The last surprise was a plant extract collagen, non-cellular product. The last process I had to create was to send an autologous craniotomy bone flap for a trauma patient who was transferred to another facility.
We are hoping to implement Tissue TrackCore to track all biologics in the near future. It is a whole new world for this Blood Banker! My next step will be to introduce AABB Quality System Essentials to Perioperative Services.

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[RR1]

Sounds like really good stuff Tstec. We have an equivalent Haemovigilance program in the UK/ SHOT

[karlaj]

How are people defining tissue for the purpose of tracking: does it have to be of human origin for you to track it, or are you also tracking bovine, pig, etc products?? What about metalic implements? Where do you draw the line?
We have previously drawn the line at human origin, but am now wondering if that is correct?

[TStec]

I still struggle with a working definition of tissue. We call them allograft and we track all biological products regardless of source.
As an AABB Assessor, I learned in Montreal last year that AABB may assess any biologic regardless of the source if the Blood Bank medical director has oversight for tissues. Before that, we also thought only human source tissue was the requirement. We track one product that is produced from Chinese hamster ovaries to create a recombinate product!

[christian]

Dear TStec:
I have read your posts and understand your issue. THere is much ambiguity in definitions and also on compliance rules. I have researched the subject and you're correct to track all biological products regarless of source. Are you going to install Tissue Track core and are you looking also looking to track metal implants and medical devices?

Happy New Year Christianstian