Michael Travis’ life lasted less than four days.
But his death has ignited a fierce dispute over whether a widely accepted treatment for prematurely born infants somehow contributed to his death.
Michael, who was delivered Friday night at Cook County Hospital after his mother’s 23rd week of pregnancy, died at 6:04 a.m. Tuesday in Loyola University Medical Center in Maywood. A spokesman for the Cook County medical examiner’s office said the cause of the infant’s death won’t be determined until an autopsy is completed on Wednesday.
The newborn’s family and their lawyers say that a luminescent blanket used to treat the newborn’s jaundice burned the boy’s skin and helped cause his death. The family moved Michael to Loyola on Monday because they said they had lost faith in Cook County Hospital’s ability to care for him after a large blister appeared on the boy’s back.
If investigators do trace Michael’s blister to the device, called a bilirubin blanket, it would be the first time the product has been definitively linked to a serious injury. Despite a handful of somewhat similar incidents reported to the U.S. Food and Drug Administration, the device’s manufacturer and independent groups, experts say the blanket carries few real risks, having been used safely on more than 1 million infants.
“The potential causes for skin lesions like this are numerous,” said Mark Bruley, vice president for accident and forensic investigation at ECRI, a non-profit health services research agency based in Plymouth Meeting, Pa. “It would be far too early to conclude that the bilirubin blanket caused the injury in this case.”
Attorneys for Michael’s parents are exploring every possibility.
Lawyer Robert Clifford filed a motion Tuesday asking Cook County Circuit Chief Judge Donald P. O’Connell to order Cook County Hospital to preserve all the equipment used to treat the baby, including the incubator, thermal lights and any ointments or chemicals that were used.
Clifford conceded Tuesday that a baby with Michael’s low, 600-gram birth weight would have little more than a 50 percent probability of surviving under the best of circumstances. But, he said, experts have told him that the baby’s injuries worsened his chances.
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“This is not a no harm, no foul situation,” Clifford said.
FDA officials said Tuesday that they are investigating whether the blanket played a role in Michael’s death. The blanket’s manufacturer, Ohmeda, and Cook County Hospital are performing their own inquiries.
Bilirubin blankets are a form of phototherapy, which uses light to help infants break down the compound bilirubin. The chemical can cause jaundice in newborns, especially premature infants.
The wandlike light-emitting portion of the blanket is separated from the actual light source by a cable of fiber optics, which conducts light to the patient.
A 1995 study by ECRI found that Ohmeda’s blanket model generated no excess heat above room temperature, Bruley said. That study rated the device as “acceptable,” the agency’s second-highest rating.
Andy Krakauer, president of Ohmeda’s specialty products division, said the company received four reports since the product’s launch in 1992 of skin problems in infants using the blanket. The company had traced each of these reports to sources other than the bilirubin blanket, Krakauer said.
But because the blanket was used in each case as preventive measure, rather than as a treatment for existing jaundice, the company issued a safety alert in January 1996. The alert advised users that the product was to be used only to treat existing jaundice, and that premature infants should not be put on the blanket unless they had signs of jaundice.
“If you have problems with bilirubin, you better be treated because you can die from it,” Krakauer said. “If you don’t have the problem, you shouldn’t use any medical devices to treat it.”
Krakauer said the warning did not mean that the blanket could burn infants. Premature infants should simply be spared any unneeded therapy, he said.
“The pad is not as soft as a mattress, and that’s not good,” he said. “These babies can get pressure sores in less than an hour.”
Dr. Jeremy Marks, a neonatologist at the University of Chicago Hospitals, said the company’s advisory passed through his office unnoticed, because it mandated no change from established procedures.
“This is not a serious warning, it’s a common-sense measure,” he said.
The warning also had little practical effect because most premature babies suffer from jaundice at some point and so would be good candidates for phototherapy, Marks said.
Sharon Snider, an FDA spokeswoman, said the agency had received six reports since 1994 of infants who experienced symptoms similar to Michael’s while they were using the blanket. None of those cases ultimately had been traced to the blanket, and none resulted in a death, Snider said.
ECRI’s Bruley said there are at least seven distinct ways a premature infant such as Michael can suffer reddening of the skin and burnlike symptoms. Each method leaves a distinctive mark on cells when they are viewed under the microscope, he said, and an autopsy should determine the source of the blister.