FDA Official Says Use Of Phoenix Heart Was Justified
TUCSON, Ariz. (AP) _ Medical circumstances probably justified the implantation of an artificial heart at the University of Arizona Hospital last week without federal approval, a U.S. Food and Drug Administration official said Thursday.
David Johnson, of Seattle, regional medical officer of the FDA, made the remarks after a five-hour meeting with the doctors who performed the surgery and others associated with the incident.
Thomas Creighton was kept alive for 11 hours March 6 by the untried artificial heart, known as the Phoenix Heart, in between two human heart transplants. He died Friday, nearly 36 hours after the second natural heart was transplanted.
″It appears that this is clearly or has been a very unique emergency situation,″ Johnson said.
″First concerns are for the patient, and because it appears that this appears to have been such a unique emergency situation, it may well not have been possible for them to call the FDA,″ he said.
Johnson met Thursday with Dr. Jack G. Copeland, head of the cardio-thoracic surgical tranplant team, who authorized temporary use of the Phoenix Heart; Dr. Cecil Vaughn of St. Luke’s Hospital in Phoenix, who implanted it; Dr. Kevin Cheng, a dentist at St. Luke’s who invented the device; Alethea Caldwell, administrator of the University Medical Center, and other hospital officials and attorneys.
Copeland and Vaughn said last week that they had no time to seek FDA approval before using the Phoenix Heart in Creighton and the first priority was to try to keep him alive.
Johnson said the FDA was seeking additional information about the case, but that the agency would consider a petition from the university for permission to conduct research involving use of artificial hearts and similar devices in humans.
On Monday, the FDA issued a gently worded reprimand advising the medical center that it wanted to be consulted ″if you anticipate implanting artificial hearts in patients in the future.″
John C. Villforth, director of the FDA’s medical devices division, wrote to the hospital to say federal regulations and procedures play a role in safeguarding patients’ rights and in ensuring orderly development of medical devices.
He said the agency understood and sympathized with the desire of surgeons to use the artificial heart in their effort to keep a dying patient alive.
Copeland told reporters last week that he wanted to do all he could to ensure that he would have a temporary artificial implant device - either an entire heart or a partial, pumping assist device - available ″on the shelf″ for future emergencies.