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New exception pathway available for heart device recalls

New exception pathway available 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 of OPTN Policy 6.4: Adult and Pediatric Status Exceptions on July 11 that is now in effect. 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

Candidates experiencing these circumstances are not required to be hospitalized in order to be eligible for this exception pathway.

What was the previous policy?

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

How is this new policy different?

This new policy allows transplant programs to submit a 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 or a component within the 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. Read the policy notice.

What you need to do

  • Review the professional educational materials below.
  • Check the new box under the exception criterion for Status 1, 2 or 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 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.

A retrospective public comment period will occur on this policy change from Aug. 3 to Sept. 28. As an emergency policy action, this policy can remain in place for up to 12 months. The OPTN Board of Directors will review the policy proposal during their Dec. 5, 2022 meeting. If approved, this proposal will become a permanent modification to OPTN Policy 6.4.

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 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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