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Modify Heart Policy to Address Patient Safety Following Device Recall

eye iconAt a glance

Current policy

On July 14, 2022, the Organ Procurement and Transplantation Network (OPTN) implemented an emergency policy to create an exception pathway for non-hospitalized heart candidates who have an FDA recalled mechanical circulatory support device implanted. Previously these candidates had to have been hospitalized to apply for an exception for a Status 3 or above. This emergency policy is being submitted for retrospective public comment. The OPTN Board of Directors will vote on the proposal in December and decide if this policy should be made permanent.

Supporting media

Presentation

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Changes

Add option for status exception for Statuses 1, 2 or 3 for candidates not hospitalized:

  • Must have an implanted mechanical circulatory device (or internal component) that:
    • Is subject to an FDA recall
    • Poses a risk to patient safety
    • Cannot be mitigated without replacement of the device or internal component
  • Exceptions will be retrospectively reviewed by the heart review board
  • Candidates with approved exceptions will remain at status for 14 days
  • After 14 days, programs can apply for a 14 day extension for the candidate, which also must be approved by the review board

Anticipated impact

  • What it's expected to do
    • Promote patient safety for candidates with qualifying recalled devices

  • What it won't do
    • Provide an exception pathway for a status 1, 2 or 3 for all non-hospitalized patients
    • Provide an exception pathway for a status 1, 2, or 3 for all FDA recalls

Terms to know

  • Exception Request: When a candidate does not meet the requirements for a particular status, but their transplant program believes they are at a similar risk of death while waiting for transplant and have a similar potential for benefit after receiving a transplant, they may ask that the candidate be placed at that higher status. These requests are reviewed retrospectively by the review board.
  • Mechanical Circulatory Support Device: A device use to treat end-stage chronic heart failure (ex. Ventricular assist devices (VADs), total artificial hearts (TAH), etc.)

Click here to search the OPTN glossary

Provide feedback

eye iconComments

Anonymous | 08/11/2022

This is an excellent modification and provides appropriate expedited transplant pathways to patients who have a potentially malfunctioning device.