Incidence of hypersensitivity in hemodialysis.

Hypersensitivity reactions in hemodialysis are rare. They have been identified only recently, since the U.S. dialysis patient population became sufficiently large for pattern recognition. These reactions might be the result of a variety of factors, including the manufacturing process and patient characteristics. Some reactions may be due to components of the dialysis system other than the dialyzer, such as the tubing sets. Data collected by the Food and Drug Administration showed that in 1982 there were 3.5 severe hypersensitivity reactions per 100,000 hollow-fiber dialyzers sold. This rate of reaction occurrence does not appear to be appreciably different from that in previous years for which information, though scant, was available. Recently, a significant reduction in the rate of the reactions seems to have occurred after some U.S. manufacturers changed their manufacturing procedures.