A Survey on Hypersensitivity Reactions in Hemodialysis

This survey was conducted from 1982 through 1984 by a cooperative effort among the Health Industries Manufacturers Association, seven dialyzer manufacturers, and the Food and Drug Administration. This article presents an analysis of the 1982-83 survey data and a summary of the 1984 data. Most of the reactions reported (99%) were associated with hollow-fiber dialyzers. About 50% of these reactions were experienced by patients using a dialyzer model for the first time, and greater than 98% of the reactions were related to new (unused) dialyzers. On average, there were 180 reactions reported per year, with greater than 90% being considered severe, including death, by the reporting center. A plot of the number of reactions versus time from 1982 through 1984 shows periods of 12-15 months in which the reaction rate remained practically constant. During these periods, the rate of reported reactions alternated from 60 to 150% of the average. Analysis of the survey data showed a strong correlation of the number of reactions with the race and age of the patients. Blacks and other minorities experience nearly three times as many reactions as white patients. Also, patients under 29 years of age seem to have nearly twice as many reactions as patients in the 30- to 49-year-old range, whereas patients over 50 years old have nearly half the number of reactions of the 30- to 49-year-old range. The average reactivity of the U.S. hemodialysis patient population was calculated to be 3.3 reactions per year per 1,000 patients exposed to hollow-fiber dialyzers and 0.3 reaction per year per 1,000 patients exposed to flat-plate dialyzers.(ABSTRACT TRUNCATED AT 250 WORDS)