We have just entered into a contract with a donor service to supply us with tissue on consignment. Since we will only be storing tissue, are we required to register as a tissue bank with the FDA? AORN recommendation is that: Facilities procuring, processing and/or preserving tissue, and facilities storing tissue for potential transfer to a different facility, must register as tissue banks with the FDA.

If the donor service takes the tissue from our freezer to another facility, have we transferred the tissue?

We are the 'Tissue Bank' as well as the Transfusion Service in our hospital. My understanding is that if the tissues you are storing are used in your facility FDA registration is not required. Although, here in California we get to buy a state issued Tissue Bank License.

If you purchase, store and dispense tissue products within you own facility you need not register with the FDA. If, however, you harvest, process, manufacture or transfer products between institutions, you are required to register. If you need to transfer a tissue to another facility, have your vendor help (transfer it back to the vendor and let them transfer it to the other institution. If you think of "tissue" as analogous to blood (I know, a dangerous comment) the registration issues are parallel. Good Luck.

We are being pressured by our OR department to store bone and tissue in our FFP freezer. The freezer only goes to -30'C and I don't think that is cold enough for storage. I am under the impression that we need a -70'C freezer to store tissue. Can anyone give me some help!

Thanks,

John

In order to store frozen tissue product until the full expiration date they must be kept below -40. If they are stored at

-18 to -40 the expiration date is more like 6 mo.

We are being pressured by our OR department to store bone and tissue in our FFP freezer. The freezer only goes to -30'C and I don't think that is cold enough for storage. I am under the impression that we need a -70'C freezer to store tissue. Can anyone give me some help!

Thanks,

John

Look at my thread on Tissue Banking in response to a question in Hot Topics, as well as under the Tissue section (that is, if you want to find a way to NOT have the tissues in your Lab; which in my mind, is not where they belong).

Good Luck!

Brenda Hutson, CLS(ASCP)SBB

Yes, if the tissue leaves your control, you have transferred it. We are the only VA hospital in the Southeast that orders, receives, stores, distributes and tracks tissue used in our facility--only because the OR could not do it.

It is in our policy that we will not transfer or receive tissues from outside facilities(hospitals) as we do not know the control status of these facilities ( even though they are next to us, share physicians in dire emergencies, etc.)

I may be able to help you with your questions as I am a Certified Tissue Banking Specialist and Consultant for the Musculoskeletal Transplant Foundation. A hospital does not need to register with the FDA as a tissue bank if they are only storing for their facility. It is against the FDA's Good Tissue Practices to transfer tissue from one facility to another, as that would make your facility a tissue distributor and require registering with the FDA. I am curious who the donor service organization is that is involved with providing allograft tissues. This is unusual. bob mayes, ctbs

In order to store frozen tissue product until the full expiration date they must be kept below -40. If they are stored at

-18 to -40 the expiration date is more like 6 mo.

Correction! minus 20 degrees C to minus 40 degree C for up to 6 month storage.

We are being pressured by our OR department to store bone and tissue in our FFP freezer. The freezer only goes to -30'C and I don't think that is cold enough for storage. I am under the impression that we need a -70'C freezer to store tissue. Can anyone give me some help!

Thanks,

John

John, you can only keep frozen allograft stored in temps minus 20 to 40 C forup to 6 months. For long term storage minus 70 degrees C required. If you need a freezer, Musculoskeletal Transplant Foundation may provide one at n/c/ call me if I can be of help, Bob Mayes 440-781-4234

I may be able to help you with your questions as I am a Certified Tissue Banking Specialist and Consultant for the Musculoskeletal Transplant Foundation. A hospital does not need to register with the FDA as a tissue bank if they are only storing for their facility. It is against the FDA's Good Tissue Practices to transfer tissue from one facility to another, as that would make your facility a tissue distributor and require registering with the FDA. I am curious who the donor service organization is that is involved with providing allograft tissues. This is unusual. bob mayes, ctbs

Based on the wrangling we've done here to get the tissue issue under control, I would bet large amounts of money that there are all kinds of things going on in ORs across the country in regards to tissues that would make give the FDA fits if they only knew. There are salesmen (who are clueless about tissue handling regs) who tell surgeon customers (who are cluelees about tissue handling regs and don't care, either) that they can provide products on consignment and other little services to make life easy....just do business with ME. When you ask OR if the vendor is qualified, they don't know what you are talking about. When you ask the OR where the tissues come from, they don't have a clue. But that salesman has the best stuff and can get anything! so he says, so they do business. I don't really want the responsibility of tissues, but OR won't take care of a freezer so we are involved.

Ann - Isn't it incredible that some medical personnel can do phenomenal stuff like open heart surgeries and transplants, etc., but they can't do what is considered simple, basic equipment maintenance? We have a small properly monitored blood refrigerator in an intensive care area. Their track record of recording the refrig temp once a day was horrible, so Blood Bank personnel had to take the responsibility of recording the temp by calling them every morning and asking them what the LED temperature is.

What's even more sad is that sometimes their response is "36 degrees" (instead of 3.6 degrees.) Duh!