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One-year monitoring report available for heart recall exception status policy

Published on: Monday, December 4, 2023

The Organ Procurement and Transplantation Network (OPTN) Heart Transplantation Committee released a one-year monitoring report regarding an urgent exception status policy for candidates who have an implanted heart assist device under recall. Mechanical circulatory support devices (MCSD) are commonly used for bridge-to-transplant therapy, as well as temporary bridge-to-recovery therapy and a permanent solution to severe heart failure. If the FDA has recalled their implanted device, transplant programs can submit an exception request on behalf of adult heart transplant candidates for a Status 1, 2 or 3 exception without requiring hospitalization.

While the transplant physician determines if the patient with the recalled device is at risk and which status assignment best represents the candidate’s clinical condition, the policy provides additional transplant access for candidates who may be affected by a patient safety issue with an MCSD.

The key findings of the one-year monitoring report include:

  • Since implementation of this policy, device recall exception submissions have not increased over time
  • Device recall exception submissions accounted for a very small percentage of adult heart registrations, waitlist additions and transplants between July 14, 2022, and July 13, 2023
    • Adult Status 2 represented the largest number of adult heart registrations, waitlist additions, and transplants that submitted a device recall exception.
    • Adult Status 1 represented the smallest number of adult heart registrations, waitlist additions, and transplants that submitted a device recall exception
  • Read the full report, here: OPTN Heart Committee’s 1-Year Monitoring of Heart Policy to Address Patient Safety Following Device Recall (PDF)

Background

In 2022, the OPTN Executive Committee unanimously supported an emergency policy action to address patient safety concerns associated with MCSD’s. The OPTN Heart Transplantation Committee will continue to monitor this policy, and subsequent monitoring reports will be published on the OPTN website on an ongoing basis.