title: Acute onset of decreased vision and hearing traced to hemodialysis treatment with aged dialyzers.
abstract: BACKGROUND
  A recent event in which 7 patients at 1 hospital developed decreased vision and hearing, conjunctivitis, headache, and other severe neurologic symptoms 7 to 24 hours after hemodialysis drew attention to the issue of the long-term integrity of dialysis machines and materials.
  
  
  OBJECTIVE
  To determine the cause of the adverse reactions that occurred during this event.
  
  
  METHODS
  Retrospective cohort study of all 9 patients who received hemodialysis at hospital A on September 18, 1996, the day of the outbreak. A case-patient was defined as any hospital A patient with acute onset of decreased vision and hearing and conjunctivitis after dialysis on that day. Non-case-patients were all others who underwent dialysis at hospital A on that day but did not develop adverse reactions. In an attempt to reproduce the conditions of the event, cellulose acetate dialysis membranes of various ages were retrieved from other sources and tested for physical and chemical degradation, and degradation products were identified, characterized, and injected intravenously into rabbits.
  
  
  METHODS
  Clinical signs and symptoms, time to resolution of symptoms, mortality, and dialyzer type and age, for case- vs non-case-patients.
  
  
  RESULTS
  Seven of the 9 patients met the case definition. In addition to diminished vision and hearing, conjunctivitis, and headache, some case-patients had blood leak alarm activation (n=6), confusion/lethargy (n=5), corneal opacification (n=4), cardiac arrest (n=2), or other neurologic signs and symptoms. One case-patient died during hospitalization after the event; 5 of 7 case-patients died within 13 months. Resolution of signs and symptoms varied but persisted more than 3 years or until death in 3 of the 6 patients who survived hospitalization. All case-patients but no non-case-patients were exposed to 11.5-year-old cellulose acetate dialyzers (all of these dialyzers were discarded by the hospital before our investigation). Laboratory investigation of field-retrieved 0- to 13.6-year-old dialyzers of similar type indicated significant chemical degradation in the older membranes. In vivo injection of extracts of membrane degradation products produced iritis and hemorrhages in rabbits' eyes.
  
  
  CONCLUSIONS
  Severe patient injury was associated with exposure to aged cellulose acetate membranes of dialyzers, allowing cellulose acetate degradation products to enter the blood. Clinicians should be aware that aged cellulose acetate membranes may cause severe adverse reactions.
authors.affiliation: Center for Devices and Radiological Health, Food and Drug Administration, Rockville, MD 20852, USA. jch@cdrh.fda.gov
authors.forename: J C
authors.initials: JC
authors.lastname: Hutter
authors.forename: M J
authors.initials: MJ
authors.lastname: Kuehnert
authors.forename: R R
authors.initials: RR
authors.lastname: Wallis
authors.forename: A D
authors.initials: AD
authors.lastname: Lucas
authors.forename: S
authors.initials: S
authors.lastname: Sen
authors.forename: W R
authors.initials: WR
authors.lastname: Jarvis
mesh_terms: D000208:Acute Disease; D000328:Adult; D000368:Aged; D003231:Conjunctivitis / Q000209:etiology; D004196:Disease Outbreaks; D004868:Equipment Failure; D005260:Female; D006261:Headache / Q000209:etiology; D006311:Hearing Disorders / Q000453:epidemiology / Q000209:etiology*; D006761:Hospitals; D006801:Humans; D008297:Male; D008875:Middle Aged; D006435:Renal Dialysis / Q000009:adverse effects* / Q000295:instrumentation*; D012189:Retrospective Studies; D013997:Time Factors; D014786:Vision Disorders / Q000453:epidemiology / Q000209:etiology*