The Food and Drug Administration confirmed last week that it continues to investigate the deaths of three patients last July at an outpatient kidney dialysis center operated by the University of Chicago Hospitals, MODERN HEALTHCARE has learned.
On July 16, three women died and several other patients were hospitalized hours after they received dialysis treatment at the hospital's freestanding clinic. The women, whose ages were 56, 78 and 80, suffered from end-stage renal disease and were considered in poor health, hospital officials said (July 26, 1993, p. 26).
A preliminary investigation conducted by the national Centers for Disease Control and Prevention and the Illinois Department of Public Health initially determined that the deaths were caused by unusually high amounts of fluoride in the water used during the dialysis treatment.
However, an FDA Safety Alert obtained by MODERN HEALTHCARE issued one month after the incident said the FDA was investigating whether the safety lights on the clinic's de-ionizer-a machine used to remove fluoride and other contaminants from its water system-adequately warned hospital staff that the machine's tanks had become exhausted.
"The newer de-ionizer model recently installed at the facility used a different style warning system with two lights: a green one to indicate that the system is functioning normally and an amber one to indicate that it needs recharging," the report said. "The change could have caused confusion and contributed to the problem."
An FDA spokeswoman confirmed that the case remains open and under investigation. She declined further comment. Hospitals are required by law to report to the FDA patient accidents or deaths associated with medical devices, including dialysis equipment.
Susan E. Phillips, the hospital's vice president for public affairs, said the hospital was not aware of the FDA's ongoing investigation of the incident.
"The FDA has not informed us that they have any more questions," she said. She confirmed that the FDA contacted the hospital in November, seeking additional information on the operator of the hospital's water treatment system-Interlake Water Systems of Broadview, Ill. The hospital continues to use the company's water treatment services but has since changed the specific equipment related to the patient deaths, she said.
Executives at Interlake could not be reached for comment.
The outpatient dialysis clinic has since reopened and continues to care for many of the hospital's 250 dialysis patients, Ms. Phillips added.