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Emergency action: New exception pathway for heart device recalls

Emergency action: New exception pathway for heart device recalls

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

July 14, 2022

At-a-glance

In order to address patient safety concerns, the OPTN Executive Committee approved a modification to OPTN Policy 6.4: Adult and Pediatric Status Exceptions on July 11 that will go into effect on July 14. This policy change will allow transplant programs to submit an exception request on behalf of an adult heart transplant candidate for assignment at statuses 1, 2, or 3 if the U.S. Food and Drug Administration (FDA) has recalled the candidate’s implanted mechanical circulatory support device and the candidate’s medical condition warrants a higher status due to the fact that the issue cannot be sufficiently mitigated without replacement of the device or the component. Candidates experiencing these circumstances will not be required to be hospitalized in order to be eligible for this exception pathway.

What is the current policy?

Current policy requires adult heart candidates to be admitted to the transplant hospital in order to qualify for a Status 1, 2 or 3 exception. OPTN policy does not specifically address how to ensure patient safety, if and when, an implanted heart device is subject to recall by the FDA.

How is the new policy different?

This new policy will allow transplant programs to submit an exception request on behalf of adult heart transplant candidates for a Status 1, 2 or 3 exception without requiring hospitalization if the FDA has recalled their implanted mechanical circulatory support device. The transplant physician is responsible for determining that the recalled device is a risk to patient safety and which status assignment best represents the candidate’s clinical condition. More details will be sent in a separate communication on July 14.

What you need to do

Once the changes to the policy are implemented on July 14:

  • Check the new box under the exception criterion for Status 1, 2 and 3 when you need to document that the request is related to a device recall. When selected, the requirement for the patient to be admitted to the hospital will be suspended.
  • Complete the narrative in which you will include details on the device recalled and the risk to your candidate’s medical condition.
  • Document any materials or information associated with the device recall in the candidate’s medical record.
  • If your candidate’s exception due to device recall is not approved, you should select a status that more accurately reflects their medical urgency.

Additional details

Exception requests related to device recalls will follow the existing retrospective review process. Heart Regional Review Boards will continue to accept or deny exception requests based on the candidate’s clinical status and medical urgency and, if granted, the status exception will last for 14 days.

A retrospective public comment period will occur on this policy change from Aug. 3 to Sept. 28.

Education

Professional education will be available on this policy change in UNOS Connect on July 14.

  • SYS179: Heart Status Exceptions for Implanted Device Recalls

 Questions?

If you have questions relating to implementation, contact UNOS Customer Service at unethelpdesk@unos.org, or call 800-978-4334 from 8 a.m. to 7 p.m. ET.

For policy-related questions, contact member.questions@unos.org

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