An epidemic of corneal destruction caused by plasma gas sterilization. The Toxic Cell Destruction Syndrome Investigative Team.

BACKGROUND: Toxic endothelial cell destruction (TECD) syndrome after intraocular ophthalmic surgery is rare and can result from exposure to a variety of toxins. During January 8 to 14, 1998, 6 patients developed TECD with corneal edema associated with unreactive or dilated pupils at Hospital A. METHODS: A case patient was any Hospital A patient with TECD within 24 hours after surgery during January 5 to 14, 1998 (epidemic period). A control was any hospital A ophthalmic surgery patient without TECD during the epidemic period. The medical records of hospital A ophthalmology surgery patients during the pre-epidemic (ie, September 1, 1997-January 4, 1998) and epidemic periods were reviewed. Inductively coupled plasma atomic emission spectrometry was used to detect trace inorganic elements on sterilized surgical instruments. Cannulated surgical instruments and laboratory rinsates were perfused directly to the corneal endothelium of isolated rabbit and human corneas. Corneal endothelial ultrastructure and swelling were assessed. RESULTS: The rate of TECD at hospital A was higher during the epidemic than pre-epidemic period (6/12 vs 0/118, P<.001). The only change during the periods was the introduction, on November 5, 1997, of a new sterilization method, AbTox Plazlyte, for sterilization of ophthalmic surgery instruments. Findings from spectrometry revealed that copper and zinc residues were higher in instruments sterilized with Plazlyte than in those sterilized with ethylene oxide (median copper value, 7.64 mg/L vs 0.14 mg/L, respectively, P =.02; median zinc value, 5.90 mg/L vs 1.35 mg/L, respectively, P =.2). Corneal endothelial perfusion of Plazlyte sterilized-instrument rinsates or laboratory solution with copper and zinc produced irreversible damage, similar to toxic corneal endothelial destruction, to rabbit and human corneas. CONCLUSION: A new sterilization method degraded brass to copper and zinc on cannulated surgical instruments resulting in TECD of the cornea. Arch Ophthalmol. 2000;118:1167-1176

Multistate outbreak of hemolysis in hemodialysis patients traced to faulty blood tubing sets.

BACKGROUND: Hemolysis associated with hemodialysis is rare. The most frequent causes of hemodialysis-associated hemolysis are chemical contamination, heat, or mechanical injury of erythrocytes from occluded or kinked hemodialysis blood lines. When patients in three states developed hemolysis while undergoing hemodialysis between May 13 and 23, 1998, an investigation was initiated. METHODS: A case-patient was defined as any patient at healthcare facilities A (Nebraska), B (Maryland), or C (Massachusetts) during May 13 through 23, 1998 (epidemic period), who had hemolysis diagnosed > or =48 hours after undergoing hemodialysis. To identify case-patients and to determine background rates, the medical records of patients from facilities A, B, and C who were undergoing hemodialysis during the epidemic and pre-epidemic (that is, May 5 through 19, 1998) periods were reviewed. Experiments simulating hemodialysis with the same lot numbers of hemodialysis blood tubing cartridge sets used on case- and control-patients were conducted. RESULTS: The rates of hemolysis among patients at facilities A, B, and C were significantly higher during the epidemic than the pre-epidemic period (13 out of 118 vs. 0 out of 118, P < 0.001; 12 out of 298 vs. 0 out of 298, P = 0.001; and 5 out of 62 vs. 0/65, P = 0.03, respectively). All case-patients had hemolysis. Twenty (66%) had hypertension. Eighteen (60%) had abdominal pain, and 10 (36%) were admitted to an intensive care unit. There were two deaths. The only commonality among the three outbreaks was the use of the same lot of disposable hemodialysis blood tubing from one manufacturer. Examination of the implicated hemodialysis blood tubing cartridge sets revealed narrowing of an aperture through which blood was pumped before entering the dialyzers. In vitro experiments with the hemodialysis blood tubing revealed that hemolysis was caused by increased pressure on erythrocytes as they passed through the partially occluded hemodialysis blood tubing. CONCLUSIONS: Our investigation traced the multiple hemolysis outbreaks to partially occluded hemodialysis blood tubing produced by a single manufacturer. On May 25, 1998, the manufacturer issued a voluntary nationwide recall of the implicated lots of hemodialysis blood tubing cartridge sets.