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Contaminated Povidone-Iodine Solution -- Texas

From December 29, 1988, to January 21, 1989, Pseudomonas cepacia was isolated from peritoneal fluid of four patients and blood of two patients at a children's hospital in Texas. In three of four patients who were receiving inpatient peritoneal dialysis for renal failure, clinical findings were consistent with peritonitis. Two intensive-care unit (ICU) patients, who were not on dialysis, whose blood cultures grew the organism had no clinical findings attributable to P. cepacia bacteremia.

Hospital personnel recovered P. cepacia in pure culture from three previously opened 1-gallon containers of Clinidine, a povidone-iodine solution (Clinipad Corporation, Guilford, Connecticut, Lot #823529, expiration date: September 1991). Solution from this lot was being used by the peritoneal dialysis staff to disinfect tops of multidose vials of dialysis fluid additives, peritoneal fluid administration set connectors, and ports of peritoneal dialysis systems. Clinidine was also being used by ICU staff for antisepsis of skin before venipuncture and to disinfect the tops of blood-culture bottles. In further investigations by CDC and Food and Drug Administration (FDA), P. cepacia was isolated from two unopened bottles obtained from a subdistributor and one opened bottle of the same lot number being used in another health-care facility; both facilities are located in Texas.

On February 6, 1989, FDA initiated an investigation of the manufacturing plant in Connecticut. On February 9, the company initiated a voluntary recall of the implicated lot. CDC and FDA are continuing investigations to determine the source of the outbreak. Reported by: JD Siegel, MD, PN Duer, Children's Medical Center, CE Haley, MD, Dallas County Health Dept, Dallas, Texas. KA Thomassen, MPA, DM Perrotta, PhD, Epidemiology Div, Texas Dept of Health. Southwest Regional Office, Dallas; Hartford Resident Post, Hartford, Connecticut; Epidemiological Investigations Br, Div of Emergency and Epidemiological Operations, Food and Drug Administration. Hospital Infections Program, Center for Infectious Diseases, CDC.

Editorial Note

Editorial note: In this outbreak, three patients developed peritonitis, and three had pseudoinfections associated with probable intrinsic contamination of a povidone- iodine solution. This is the third instance of suspected intrinsic contamination of an iodophor solution ever reported to CDC. In 1980, a cluster of P. cepacia pseudobacteremias in seven northeastern U.S. hospitals was associated with a contaminated povidone-iodine solution (from another manufacturer) used to disinfect the tops of blood-culture bottles before inoculation (1,2). In 1982, a cluster of P. aeruginosa peritonitis cases in peritoneal dialysis patients was associated with a contaminated poloxamer-iodine solution (from a third manufacturer) being used as a peritoneal catheter disinfectant in a hospital (3). Data from the 1980 and 1982 outbreaks suggested that P. cepacia and P. aeruginosa, organisms commonly found in water, could colonize water distribution pipes or filters in plants that manufacture iodine solutions (1,4). Subsequent laboratory studies revealed that, once affixed to the inner surface of polyvinylchloride distribution pipes and pipes of other compositions, P. cepacia and P. aeruginosa could be protected from the bactericidal effect of the iodophor solution, probably by a glycocalyx film (5,6).

Physicians are requested to report P. cepacia infections suspected to be associated with the use of Clinidine through state health departments to the Epidemiology Branch, Hospital Infections Program, Center for Ifectious Diseases, CDC; telephone: (404) 639-3406.

References

  1. Berkelman RL, Lewin S, Allen JR, et al. Pseudobacteremia attributed to contamination of povidone-iodine with Pseudomonas cepacia. Ann Intern Med 1981;95:32-6. 2.Craven DE, Moody B, Connolly MG, Kollisch NR, Stottmeier KD, McCabe WR. Pseudobacteremia caused by povidone-iodine solution contaminated with Pseudomonas cepacia. New Engl J Med 1981;305:621-3. 3.Parrott PL, Terry PM, Whitworth EN, et al. Pseudomonas aeruginosa peritonitis associated with contaminated poloxamer-iodine solution. Lancet 1982;2:683-5. 4.Berkelman RL, Anderson RL, Davis BJ, et al. Intrinsic bacterial contamination of a commercial iodophor solution: investigation of the implicated manufacturing plant. Appl Environ Microbiol 1984;47:752-6. 5.Anderson RL, Holland BW, Carr JK, Bond WW, Favero MS. Effect of disinfectants on Pseudomonads colonized on the interior surface of PVC pipes. In: Proceedings of International Symposium on Water-Related Health Issues. Atlanta: American Water Resources Association, 1987:115-20. 6.Anderson RL, Berkelman RL, Mackel DC, Davis BJ, Holland BW, Martone WJ. Investigations into the survival of Pseudomonas aeruginosa in poloxamer-iodine. Appl Environ Microbiol 1984;47:757-62.



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