Errors in the maintenance of a water treatment system used in the care of kidney dialysis patients were the principal causes of a deadly outbreak of fluoride poisoning at a University of Chicago Hospitals outpatient dialysis clinic, a new study says.
The findings, released in the September issue of the Annals of Internal Medicine, concluded that faulty maintenance of a deionization system, which is used to remove fluoride and other contaminants from the patients' dialysis solution, was a key factor in the July 1993 poisoning deaths of three dialysis patients and the acute illnesses of nine others (July 26, 1993, p. 26).
The study, which was conducted by researchers at the University of Chicago Hospitals and the national Centers for Disease Control and Prevention in Atlanta, also said that the hospital's dialysis clinic was under renovation and had been using a temporary deionization system for its dialysis units when the poisonings occurred.
Follow-up investigations by HHS suggested that the clinic's staff may have been inadequately trained to recognize problems with the water treatment system. An HHS report in August 1993 recommended additional staff training to prevent similar accidents in the future.
In addition, an FDA Safety Alert obtained by MODERN HEALTHCARE in January said the FDA was investigating whether the safety lights used on the clinic's deionizer system adequately warned hospital staff that the system needed recharging (Jan. 31, p. 14).
This month's findings in the Annals of Internal Medicine concluded that "awareness of the potential hazards of deionization systems and of appropriate safety practices is important because of the widespread use of these systems for hemodialysis and the lethal consequences when deionization systems fail."
In addition to the report, MODERN HEALTHCARE has learned that the families of Belauh Wynn and Mattie Lee-two of the three deceased patients-have since filed wrongful-death lawsuits against the University of Chicago Hospitals; two clinic staff members; Interlake Continental Water Systems of Broadview, Ill.; and Cobe BCT, a Swedish manufacturer of dialysis equipment.
The family of Ms. Wynn is seeking $430,000 in damages, while the complaint involving the death of Ms. Lee seeks unspecified damages. Both lawsuits are pending.
A University of Chicago Hospitals spokesman declined comment on the suits. The other defendants couldn't be reached for comment.
The dialysis clinic has reopened and has treated patients without further incident, the hospital said.-