2006N-0051

Blood Vessels Recovered with Organs and Intended for Use in Organ Transplantation

FDA Comment Number :

EC1

Submitter :

Dr. Arthur Eisenbrey

Date & Time:

05/24/2006 06:05:59

Organization :

Dr. Arthur Eisenbrey

Category :

Health Professional

Issue Areas/Comments

GENERAL

This rule should be cancelled and the current regulatory standards in 21CFR1271 should be enforced for blood vessels ('conduits') recovered from a deceased organ donor and not transplanted with the recovered organs.

The medical decision to accept an organ organ and the associated vessels for one recipient cannot be used to make a blind acceptance of the suitability of the safety of the vessels for a 'third-party' recipient. There are assumptions about safety by the surgeons using these 'third-party' blood vessels that cannot be supported. In addition to the, now well documented, disease transmission risk, there is very good evidence that these vessels also cause HLA sensitization (Goel MC, Flechner SM, El-Jack M, Veniro J, Kingman L, Modlin C, Cook DJ. Salvage of compromised renal vessels in kidney transplantation using third-party cadveric extenders: impact on posttransplant anti-HLA antibody formation. Transplantation 2004; 77:1899-1902). This may seem like a minor issue, but the source of this 'occult' sensitization is not recognized by the surgeons or the rest of the medical team caring for these patients and will have an impact on future transplants in the recipient.

There is no evidence that organ transplant programs have been able to demonstrate appropriate tracking and traceability of these 'third-party' blood vessels. The recent debacle with the national recall of tissue products demonstrates that existing mechanisms for tracking tissues is exceedingly poor. In addition, I have seen no evidence that UNOS has the capability of tracking these as an additional 'organ' when not transplanted with the organs from the same donor (that is, going as a 'third party' transplant). In addition, UNOS has never had mechanisms for tracking the proper storage (not transport) of organs since storage has never been recognized as an issue (who knew this was a wide-spread practice until the rabies cases?).

Patients would be better protected by the existing regulations. The time required to create and validate a new system under UNOS will leave hundreds of recipients unprotected. An unspoken hidden assumption in all of this seems to be that JCAHO standards will cover all the holes left by the HRSA (UNOS) and FDA agreement. Making things easier for transplant surgeons is not an appropriate justification for voiding an appropriate and valid mechanism of ensuring patient safety. The proposed exception to 21CFR1271 should be set aside.