Jump to content

Biological Products


Recommended Posts

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.

Link to comment
Share on other sites

  • 6 months later...
  • 2 weeks later...

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?:confused:

Link to comment
Share on other sites

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!

Link to comment
Share on other sites

  • 1 month later...

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

Link to comment
Share on other sites

  • 1 year later...

Since this thread has been silent over a year I wonder if anyone has since found a good definition of what we need to be tracking. We are currently looking at Medtronic's Infuse which is a recombinant protein (no intact cells). It is not a plasma protein so I wouldn't think it would be considered a blood product like Tisseel and Floseal (per FDA). It has no cells like tissues. It is recombinant but is made to resemble a human protein. It seems more like a drug to me--like growth hormone--but its use isn't systemic. Is anyone else tracking it?

Link to comment
Share on other sites

I am using these definitions in my SOP;

Definitions

A. Allograft: The transplant of an organ or tissue from one individual (not an identical twin) to another of the same species with a different genetic makeup. Allografts, also called an allogeneic graft or a homograft, include those items from cadaveric, living related, and living unrelated donors.

B. Autograft: The transplant of tissue from one part of the body to another in the same individual.

C. Xenograft: A surgical graft of tissue from one species to an unlike species, for example porcine or bovine cells, tissues or organs.

D. Tissue: Any human based transplantable and implantable products classified by the U.S. Food and Drug Administration (FDA) as a tissue or a medical device and is subject to the standards of the Joint Commission, Transplant Safety Chapter.

Note: Examples include bone, skin, tendons, fascia, bone marrow, cartilage, blood, and other cellular and tissue based transplant products.

E. Biological Product: A medical device or cellular product implanted into a human recipient manufactured from a biological source, for example human, plant, porcine and/or bovine. Note: Food and Drug Administration (FDA) assures the safety of foods and cosmetics, and the safety and efficacy of pharmaceuticals, biological products and medical devices.

Note: It would not apply to plastic derived synthetic tissue or medical devices.

Link to comment
Share on other sites

Mabel, Infuse is a bone graft material which the rep stated was not a "Joint Commision tissue". This is the recombinant product derived from chinese hamsters. The recombinant part acts like growth factor enhancement of bone grows with this product. I have tracked it from the begining and it is very popular with the Orthopedic surgeons.

The Joint Commision recently added collagen to their listing in the Transplant Safety chapter. This was not highlighted as a change but I noticed it.

Soon we will be tracking all medical devices which will require a unique identifier. Tisseel and Infuse are products that have same lot number/batched production similar to albumin. I use Tissue TrackCore application which assigns a unique barcode ID for every product entered.

Link to comment
Share on other sites

Thanks. Once we get software (next year I hope) I think we will do as you do and track everything biological and probably some hardware with it. It will be easier to do it all than try to figure out what fits and what doesn't. Besides, as a patient, I would want to know that anything they put in me was traceable. If it is bigger than a ***** and not a drug we will track it.

Link to comment
Share on other sites

After many demos we selected Tissue TrackCore (TTC) which is partnered with MTF. We have been live for a year and I am satisfied with my selection. LPiT Solutions is very receptive to customer needs and their support has been awesome. I am able to track tissue, biological products and medical devices. A unique TTC identification barcode number is assigned to every product entered into application. There is a function to inspect shipping container for temperature range and package integrity at point of arrival (warehouse, loading dock mail room or materials management). We implemented (TTC) to comply with the Joint Commission Transplant Safety Chapter, my struggle now is to get OR nurses to be 100% compliant with using the program.

Link to comment
Share on other sites

I guess I should have use the word "pin" or something in my prior post instead of a word for a piece of hardware that would be turned by a screwdriver. Apparently that word is blanked out on BBT with *'s.

We got in some material today that is some mixture of bone matrix and stem cells. There will be no end to this sort of stuff in the future so we probably need to find a robust way to track it. Soon it will be stem cells of every sort.

Link to comment
Share on other sites

Create an account or sign in to comment

You need to be a member in order to leave a comment

Create an account

Sign up for a new account in our community. It's easy!

Register a new account

Sign in

Already have an account? Sign in here.

Sign In Now
  • Recently Browsing   0 members

    • No registered users viewing this page.
  • Advertisement

×
×
  • Create New...

Important Information

We have placed cookies on your device to help make this website better. You can adjust your cookie settings, otherwise we'll assume you're okay to continue.