2006N-0051
  

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


  

  

  


  

  
FDA Comment Number : 
  

  
EC2
  



  

  
Submitter : 
  

  
Mr. Jason Livingston
  

  
Date & Time: 
  

  
07/28/2006 12:07:50
  



  

  
Organization : 
  

  
OPTN/UNOS
  



  

  
Category : 
  

  
Other Organization
  



  

  
Issue Areas/Comments 
  


  

  


  

  
GENERAL
  


  

  



  

  
GENERAL
  


  

  



  

  
 UNOS is a Virginia non-profit corporation that operates the Organ Procurement and Transplantation Network (OPTN) under contract with the Health Resources and Services Administration (HRSA), Department of Health and Human Services (HHS), and pursuant to the National Organ Transplant Act of 1984, as amended (NOTA), and associated regulations. Among the duties assigned to the OPTN are responsibilities for developing and operating a national computer system for matching candidates in need of organ transplants with available donor organs and for establishing the medical criteria by which these donor organs are allocated among all candidates who are registered with the national matching system.  UNOS also is tasked with providing input on proposed Federal regulations with potential impact upon the fields of organ procurement and transplantation as deemed appropriate by the OPTN/UNOS Board of Directors.



These OPTN/UNOS comments are submitted in support of the proposed/direct Final Rule entitled, 'Blood Vessels Recovered With Organs and Intended for Use in Organ Transplantation' as published on May 12, 2006, in the Federal Register.



In June 2005, the OPTN/UNOS Board of Directors approved OPTN/UNOS Policy 5.7 (Vessel Recovery, Storage and Transport) to provide guidance for the recovery, use, and storage of deceased donor vascular allografts, with the purpose of minimizing risks to recipients of these allografts.  The policy states that the transplant program will report to the OPTN the disposition of the vessels recovered with a donor organ and will also report the donor ID of the vessels if the vessels are stored and used for the intended recipient or another recipient. Data system changes in early 2006 have enabled the full implementation of this policy.  



The OPTN/UNOS Operations Committee reviewed the proposed Final Rule and unanimously approved a resolution of support, noting that the proposed Final Rule appears to support the opinion of the transplant community that vessels recovered with organs for the purpose of transplantation should stay within the oversight and purview of the OPTN.



Further, representatives of the OPTN/UNOS Organ Procurement Organization (OPO) Committee observed that alternatives to the proposed/direct Final Rule would have been unacceptable:  either leaving the governance of vessels for organs in an unclear state or potentially developing greater FDA jurisdiction. The process now defined by OPTN/UNOS policy does not result in undue burden to the transplant community and is consistent with the provisions of the proposed Final Rule.  Moreover, nothing in this proposed Final Rule seems to require anything additional of the transplant centers and OPOs that current OPTN policies do not presently address, nor does the proposed Rule create any other agency to be involved in oversight.