Audience
- Patient Safety Contacts
- Heart Regional Review Board Members, Heart Regional Review Board Chairs
- Heart Primary Program Administrators, Primary Surgeons, Primary Physicians
- Heart Quality Coordinators, Quality Directors/Managers, TX Physicians, TX Program Clinical Coordinators, TX Program Administrators/Managers, TX Program Directors
Implementation date
Dec. 5, 2022
At-a-glance
The OPTN Board of Directors approved the modification to OPTN Policy 6.4: Adult and Pediatric Status Exceptions to be a permanent part of OPTN policy at their Dec. 5 board meeting. This policy went into effect as an emergency policy change on July 14 and was approved by the OPTN Executive Committee on July 11.
This policy change allows transplant programs to submit an exception request on behalf of an adult heart transplant candidate for assignment at Status 1, 2 or 3 if the following conditions are demonstrated:
- The U.S. Food and Drug Administration (FDA) has recalled the candidate’s implanted mechanical circulatory support device or a component within the device
- The candidate’s medical condition warrants a higher status due to the transplant physician determining that the issue cannot be sufficiently mitigated without replacement of the device or the component within the device
For additional details, read the implementation notice.
Exception requests
Exception requests related to device recalls will follow the existing review process. Heart Regional Review Boards will continue to accept or deny exception requests based on the candidate’s clinical status and medical urgency. Regional Review Boards will review the exception requests retrospectively and, if granted, the status exception will last for 14 days. Candidates experiencing the circumstances listed above are not required to be hospitalized in order to be eligible for this exception pathway.
A retrospective public comment period occurred on this policy change from Aug. 3 to Sept. 28.
Education
Professional education is available on this policy change in UNOS Connect.
- SYS179: Heart Status Exceptions for Implanted Device Recalls
Questions
If you have questions relating to implementation, contact UNOS Customer Service at [email protected], or call 800-978-4334 from 8 a.m. to 7 p.m. ET.
For policy-related questions, contact [email protected].
The Organ Center is available 24 hours a day at 800-292-9537.
