OPTN/UNOS policy 16 prohibits extra vessel use in any procedure other than the implantation or modification of a solid organ transplant because it can pose significant safety risks. Despite this prohibition, in 2012, UNOS received five reports of extra vessels intended for transplantation purposes that were used in other types of surgical procedures. As of October 28, 2013, UNOS received one additional report.
The OPTN strongly encourages transplant hospital management to share this alert with all appropriate personnel. Please help us eliminate this practice and the patient safety risks that go along with it by taking the recommended actions listed below.
- Inform all transplant and surgical staff that there are no exceptions to the policy that forbids using extra vessels in non-solid organ transplant procedures.
- Review OPTN/UNOS policy 16 and the evaluation plan regarding vessel recovery, transplant, and storage with all transplant and surgical staff.
- Review your transplant hospital’s policies and procedures regarding vessel recovery, transplant, and storage.
- Identify and change (if necessary) your safeguards to prevent use of extra vessels in non-solid organ transplant patients.
The management of extra vessels continues to be one of the most frequent areas of noted member non-compliance found during OPTN/UNOS compliance reviews and the Membership and Professional Standards Committee (MPSC) reviews vessel policy cases routinely.
Extra vessels have been reported as being used in non-transplant procedures for the following types of surgical situations: Whipple procedure, vascular surgery, blood loss mitigation, and shunt repair.
Safety risks include potential ABO incompatibility leading to vessel graft failure and the potential for disease transmission as in solid organs. Traceability of vessel use is critically important and patient risk increases when the vessel recipient is not registered as a transplant recipient. Non-transplant patients are not under the purview of the OPTN so they fall outside the extensive data system, which allows for sharing pertinent patient information and timely follow up. User compliance with OPTN policy requirements such as storage of extra vessels for up to 14 days for subsequent use in organ transplantation can only be assured when the vessel recipient is a solid organ transplant recipient.
Extra recovered donor vessels are classified as organs under federal regulation. In 2007, the Food and Drug Administration (FDA) and Health Resources Services Administration (HRSA) issued a recommendation which amended regulations “to include as part of an organ those blood vessels recovered with the organ that are intended for use in organ transplantation and to exclude blood vessels from the definition of human cells, tissues, or cellular or tissue-based products.” Thus, the regulation of these vessels for use in organ transplantation was placed under HRSA; while other non-organ transplant related blood vessels remained under the FDA. This shift in regulatory responsibility reduces duplicate reporting and tracking under two federal agencies, but it did elicit “significant adverse comment” regarding concerns over safety, tracking, and transfer of regulatory responsibility. A final ruling was ultimately issued and became effective on April 11, 2007. It allows for the use of organ donor derived extra vessels to only be used in solid organ transplant procedures.
Given the large number of alternative medical products that could be used in place of donor vessels for emergency procedures, the MPSC does not accept the life-saving measure justification for using extra vessels in non-solid organ transplant procedures. Using extra vessels for any use other than organ transplantation carries serious patient safety risks and violates federal regulation and OPTN policies developed to protect patient safety.