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Author: John C. Magee, MD, President, OPTN Board of Directors, May 13, 2026

Dear OPTN Members,

In November, I wrote to the Organ Procurement and Transplantation Network (OPTN) community to share a safety notice regarding the use of normothermic regional perfusion (NRP) and to outline immediate steps members should take to reduce the risk of unintended brain reperfusion. I appreciate the careful attention and professionalism many of you have brought to this issue since that time.

I would like to provide both an update on the work to address NRP through the OPTN policy development process and to reiterate and refine the previous safety notice mentioned above.

At the direction of the Health Resources and Services Administration (HRSA), in October 2025, the OPTN convened an NRP Workgroup. The Workgroup’s charge is to develop proposed policy elements related to NRP, informed by reported safety events, existing OPTN policy, ethical considerations, and current practice across the national system.

The Workgroup has been engaged in a structured and deliberate review process. Its initial focus has been on identifying areas where national policy requirements or standards may be appropriate and drafting plain-language summaries of potential policy concepts for HRSA and OPTN Board review. This work is intended to support careful consideration of issues and ensure that any future policy proposals are grounded in the best available evidence and prioritize patient safety, consistency, and transparency.

As you are aware, in December 2025, the OPTN released a policy proposal addressing refinements to the pre-existing donation after circulatory death (DCD) policy for public comment. This proposal (the Donation after Circulatory Death Policy) aimed to improve safeguards for potential DCD patients and increase the information shared with potential donors and their families. The Donation after Circulatory Death Policy proposal was not intended to address all NRP specific components, though it did include some direction regarding how NRP should be discussed with and explained to potential donors and their families.

During the public comment period for the proposed Donation after Circulatory Death Policy, commenters raised concerns related to NRP. These comments have been shared with the NRP Workgroup and they will endeavor to incorporate this public feedback into the policy development process to ensure that the concerns of the public, especially those related to patient safety, are appropriately addressed. Any policy proposal regarding NRP will proceed through the established steps for policy approval, including a public comment period and ultimately presentation to the OPTN Board for approval.

As this work continues, I would like to reiterate and refine the following recommendations detailed in my November Safety Notice:

1. In abdominal NRP (A-NRP), the aorta should be occluded above the level of celiac origin, either below or immediately above the diaphragm, AND the proximal aorta should be transected cephalad to the occlusion and allowed to drain to the atmosphere or suction prior to the initiation of perfusion. The OPO must document the date and time that the last vessel is reported as transected and vented.
2. In thoraco-abdominal NRP (TA-NRP), the vessels arising from the aortic arch (the brachiocephalic, left common carotid, and left subclavian arteries) should be secured near their origin AND each artery should be transected and allowed to drain to the atmosphere or suction prior to the initiation of perfusion. The organ procurement organization (OPO) must document the date and time that the last vessel is reported as transected and vented.
3. One of the greatest safety concerns in the setting of NRP is the potential for reperfusion of the brain. Transecting and venting the vessels cephalad to the perfusion circuit as detailed above should prevent this from occurring as there would be no pressure gradient to reperfuse the brain. Nonetheless, we must take every step to monitor for evidence of brain reperfusion, and one sign of reperfusion would be return of respiratory drive. Consequently, paralytic agents must not be used in the setting of NRP as they may obscure potential signs of life (e.g., any movement, including of respiratory muscles) that would indicate a failure in securing the cephalad vessels.
4. Ensure that all stakeholders involved in the NRP recovery process (OPO staff, hospital staff, transplant center staff, and third-party procurement and preservation staff) are aware of the need to prevent unintended brain reperfusion, review the methods being used to avoid brain reperfusion, and have a coordinated plan to address and manage concerns that may arise. Central to this plan is the immediate return of the potential donor to their primary care team’s supervision in the event of signs of life.
5. Report all observations of unintended brain reperfusion via the OPTN Patient Safety Reporting Portal. Ongoing vigilance and transparency are essential to maintaining trust in the organ donation and transplantation system.

These recommendations are meant to complement and update the guidance in my November Safety Notice. Although they are not currently formalized in OPTN policy, I strongly suggest that OPTN members incorporate these recommendations in their own policies to ensure patient safety and increase trust in the national organ procurement and transplantation system. In the event of any inconsistency, these recommendations should be followed as the most current guidance.

The NRP Workgroup will continue its drafting and review efforts over the coming months. The OPTN will share additional updates as this work progresses and will communicate next steps as appropriate.

NRP plays an important role in honoring donor intent and supporting organ transplantation. At the same time, it is essential that this practice meets the highest standards of safety and ethical integrity. I appreciate the continued engagement of the OPTN community as we work together to address this issue thoughtfully and responsibly.

Sincerely,

John C. Magee, MD

President, OPTN Board of Directors

Author: John C. Magee, MD, President, OPTN Board of Directors, May 13, 2026

Dear OPTN Members,

In November, I wrote to the Organ Procurement and Transplantation Network (OPTN) community to share a safety notice regarding the use of normothermic regional perfusion (NRP) and to outline immediate steps members should take to reduce the risk of unintended brain reperfusion. I appreciate the careful attention and professionalism many of you have brought to this issue since that time.

I would like to provide both an update on the work to address NRP through the OPTN policy development process and to reiterate and refine the previous safety notice mentioned above.

At the direction of the Health Resources and Services Administration (HRSA), in October 2025, the OPTN convened an NRP Workgroup. The Workgroup’s charge is to develop proposed policy elements related to NRP, informed by reported safety events, existing OPTN policy, ethical considerations, and current practice across the national system.

The Workgroup has been engaged in a structured and deliberate review process. Its initial focus has been on identifying areas where national policy requirements or standards may be appropriate and drafting plain-language summaries of potential policy concepts for HRSA and OPTN Board review. This work is intended to support careful consideration of issues and ensure that any future policy proposals are grounded in the best available evidence and prioritize patient safety, consistency, and transparency.

As you are aware, in December 2025, the OPTN released a policy proposal addressing refinements to the pre-existing donation after circulatory death (DCD) policy for public comment. This proposal (the Donation after Circulatory Death Policy) aimed to improve safeguards for potential DCD patients and increase the information shared with potential donors and their families. The Donation after Circulatory Death Policy proposal was not intended to address all NRP specific components, though it did include some direction regarding how NRP should be discussed with and explained to potential donors and their families.

During the public comment period for the proposed Donation after Circulatory Death Policy, commenters raised concerns related to NRP. These comments have been shared with the NRP Workgroup and they will endeavor to incorporate this public feedback into the policy development process to ensure that the concerns of the public, especially those related to patient safety, are appropriately addressed. Any policy proposal regarding NRP will proceed through the established steps for policy approval, including a public comment period and ultimately presentation to the OPTN Board for approval.

As this work continues, I would like to reiterate and refine the following recommendations detailed in my November Safety Notice:

1. In abdominal NRP (A-NRP), the aorta should be occluded above the level of celiac origin, either below or immediately above the diaphragm, AND the proximal aorta should be transected cephalad to the occlusion and allowed to drain to the atmosphere or suction prior to the initiation of perfusion. The OPO must document the date and time that the last vessel is reported as transected and vented.
2. In thoraco-abdominal NRP (TA-NRP), the vessels arising from the aortic arch (the brachiocephalic, left common carotid, and left subclavian arteries) should be secured near their origin AND each artery should be transected and allowed to drain to the atmosphere or suction prior to the initiation of perfusion. The organ procurement organization (OPO) must document the date and time that the last vessel is reported as transected and vented.
3. One of the greatest safety concerns in the setting of NRP is the potential for reperfusion of the brain. Transecting and venting the vessels cephalad to the perfusion circuit as detailed above should prevent this from occurring as there would be no pressure gradient to reperfuse the brain. Nonetheless, we must take every step to monitor for evidence of brain reperfusion, and one sign of reperfusion would be return of respiratory drive. Consequently, paralytic agents must not be used in the setting of NRP as they may obscure potential signs of life (e.g., any movement, including of respiratory muscles) that would indicate a failure in securing the cephalad vessels.
4. Ensure that all stakeholders involved in the NRP recovery process (OPO staff, hospital staff, transplant center staff, and third-party procurement and preservation staff) are aware of the need to prevent unintended brain reperfusion, review the methods being used to avoid brain reperfusion, and have a coordinated plan to address and manage concerns that may arise. Central to this plan is the immediate return of the potential donor to their primary care team’s supervision in the event of signs of life.
5. Report all observations of unintended brain reperfusion via the OPTN Patient Safety Reporting Portal. Ongoing vigilance and transparency are essential to maintaining trust in the organ donation and transplantation system.

These recommendations are meant to complement and update the guidance in my November Safety Notice. Although they are not currently formalized in OPTN policy, I strongly suggest that OPTN members incorporate these recommendations in their own policies to ensure patient safety and increase trust in the national organ procurement and transplantation system. In the event of any inconsistency, these recommendations should be followed as the most current guidance.

The NRP Workgroup will continue its drafting and review efforts over the coming months. The OPTN will share additional updates as this work progresses and will communicate next steps as appropriate.

NRP plays an important role in honoring donor intent and supporting organ transplantation. At the same time, it is essential that this practice meets the highest standards of safety and ethical integrity. I appreciate the continued engagement of the OPTN community as we work together to address this issue thoughtfully and responsibly.

Sincerely,

John C. Magee, MD

President, OPTN Board of Directors

Author: John C. Magee, MD, President, OPTN Board of Directors, May 13, 2026

Dear OPTN Members,

In November, I wrote to the Organ Procurement and Transplantation Network (OPTN) community to share a safety notice regarding the use of normothermic regional perfusion (NRP) and to outline immediate steps members should take to reduce the risk of unintended brain reperfusion. I appreciate the careful attention and professionalism many of you have brought to this issue since that time.

I would like to provide both an update on the work to address NRP through the OPTN policy development process and to reiterate and refine the previous safety notice mentioned above.

At the direction of the Health Resources and Services Administration (HRSA), in October 2025, the OPTN convened an NRP Workgroup. The Workgroup’s charge is to develop proposed policy elements related to NRP, informed by reported safety events, existing OPTN policy, ethical considerations, and current practice across the national system.

The Workgroup has been engaged in a structured and deliberate review process. Its initial focus has been on identifying areas where national policy requirements or standards may be appropriate and drafting plain-language summaries of potential policy concepts for HRSA and OPTN Board review. This work is intended to support careful consideration of issues and ensure that any future policy proposals are grounded in the best available evidence and prioritize patient safety, consistency, and transparency.

As you are aware, in December 2025, the OPTN released a policy proposal addressing refinements to the pre-existing donation after circulatory death (DCD) policy for public comment. This proposal (the Donation after Circulatory Death Policy) aimed to improve safeguards for potential DCD patients and increase the information shared with potential donors and their families. The Donation after Circulatory Death Policy proposal was not intended to address all NRP specific components, though it did include some direction regarding how NRP should be discussed with and explained to potential donors and their families.

During the public comment period for the proposed Donation after Circulatory Death Policy, commenters raised concerns related to NRP. These comments have been shared with the NRP Workgroup and they will endeavor to incorporate this public feedback into the policy development process to ensure that the concerns of the public, especially those related to patient safety, are appropriately addressed. Any policy proposal regarding NRP will proceed through the established steps for policy approval, including a public comment period and ultimately presentation to the OPTN Board for approval.

As this work continues, I would like to reiterate and refine the following recommendations detailed in my November Safety Notice:

1. In abdominal NRP (A-NRP), the aorta should be occluded above the level of celiac origin, either below or immediately above the diaphragm, AND the proximal aorta should be transected cephalad to the occlusion and allowed to drain to the atmosphere or suction prior to the initiation of perfusion. The OPO must document the date and time that the last vessel is reported as transected and vented.
2. In thoraco-abdominal NRP (TA-NRP), the vessels arising from the aortic arch (the brachiocephalic, left common carotid, and left subclavian arteries) should be secured near their origin AND each artery should be transected and allowed to drain to the atmosphere or suction prior to the initiation of perfusion. The organ procurement organization (OPO) must document the date and time that the last vessel is reported as transected and vented.
3. One of the greatest safety concerns in the setting of NRP is the potential for reperfusion of the brain. Transecting and venting the vessels cephalad to the perfusion circuit as detailed above should prevent this from occurring as there would be no pressure gradient to reperfuse the brain. Nonetheless, we must take every step to monitor for evidence of brain reperfusion, and one sign of reperfusion would be return of respiratory drive. Consequently, paralytic agents must not be used in the setting of NRP as they may obscure potential signs of life (e.g., any movement, including of respiratory muscles) that would indicate a failure in securing the cephalad vessels.
4. Ensure that all stakeholders involved in the NRP recovery process (OPO staff, hospital staff, transplant center staff, and third-party procurement and preservation staff) are aware of the need to prevent unintended brain reperfusion, review the methods being used to avoid brain reperfusion, and have a coordinated plan to address and manage concerns that may arise. Central to this plan is the immediate return of the potential donor to their primary care team’s supervision in the event of signs of life.
5. Report all observations of unintended brain reperfusion via the OPTN Patient Safety Reporting Portal. Ongoing vigilance and transparency are essential to maintaining trust in the organ donation and transplantation system.

These recommendations are meant to complement and update the guidance in my November Safety Notice. Although they are not currently formalized in OPTN policy, I strongly suggest that OPTN members incorporate these recommendations in their own policies to ensure patient safety and increase trust in the national organ procurement and transplantation system. In the event of any inconsistency, these recommendations should be followed as the most current guidance.

The NRP Workgroup will continue its drafting and review efforts over the coming months. The OPTN will share additional updates as this work progresses and will communicate next steps as appropriate.

NRP plays an important role in honoring donor intent and supporting organ transplantation. At the same time, it is essential that this practice meets the highest standards of safety and ethical integrity. I appreciate the continued engagement of the OPTN community as we work together to address this issue thoughtfully and responsibly.

Sincerely,

John C. Magee, MD

President, OPTN Board of Directors

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