TABLE 5.
Outbreaks and adverse events caused by bacterial and/or endotoxin-associated contamination in water in the dialysis setting within the United States (modified from Arduino et al. 2010 (15)). The 20 events listed below span between 1969 and 2008 (events where reprocessing of dialyzers was a main contributor to the outbreak are noted by an asterisk)
| Contamination | Description; cause | References |
|---|---|---|
| Bacterial | Gram-negative bacteria bloodstream infections in 8 patients (Burkholderia cepecia
complex, Ralstonia sp., Pseudomonas aeruginosa, or Stenotrophomonas maltophilia); Burkholderia cepacia complex found in reverse osmosis water, gram-negative organisms detected in a patient dialyzer and solution distribution system |
(106) |
| Bacteremia episodes (~30) with the main gram-negative organisms being P. aeruginosa, Proteus, and Flavobacterium; bacteria was found in tap water and dialyzer resins, while no chlorine residual was detected after deionizer columns |
(83) | |
|
Pseudomonas cepacia recovered from 10 patients (13 cases of peritonitis); insufficient disinfection of contaminated tap water that was used for cleaning dialysis machines |
(84) | |
| Nontuberculous mycobacterial (NTM) infection (Mycobacterium chelonae subspecies abcessus), 27 cases; detected in water samples |
(85) | |
| Pyrogenic reactions in 14 patients, 2 with bacteremia and 1 death; reverse osmosis water storage tank contaminated with bacteria |
(36) | |
| *Intradialytic sepsis in 9 patients; gram-negative organisms detected in predialysis saline rinse, the source was either the dialysis fluid or water used for rinsing the dialyzers between uses |
(98) | |
| *Bacteremia in 6 patients; likely source(s) of the gram-negative bacteria were the dialysis fluid or water used for rinsing dialyzers prior to reuse, as well as the improper preparation of the new disinfectant |
(86) | |
| *Bloodstream infections of Klebsiella pneumonia in 6 patients; inadequate disinfection of reprocessed dialyzers, as technicians’ gloves were cross contaminating from infected patient |
(87) | |
| Endotoxin | Pyrogenic reaction in 49 patients; untreated tap water used to prepare the dialysate contained high levels of endotoxin |
(107) |
| Pyrogenic reaction in 45 patients; inadequate disinfection of the fluid distribution system |
(89) | |
| *Pyrogenic reactions in 13 patients; bacteria was detected in tap water and water used to prepare the bicarbonate dialysate, endotoxin was detected in the faucet of the reprocessing room and the water-spraying device used for rinsing |
(99) | |
| Pyrogenic reactions in 23 patients (49 episodes); increased endotoxin levels found in the tap water used to prepare the dialysate |
(100) | |
| *Pyrogenic reactions in 3 patients; change in reprocessing methods potentially altered the permeability characteristics allowing endotoxins to pass through membrane |
(96) | |
| *Pyrogenic reactions in 16 patients (18 episodes); endotoxin is the believed cause during reuse of dialyzers, water used to rinse dialyzers and dilute the disinfect was contaminated with high concentrations of endotoxins (>6 ng/ml) and bacteria (>104 CFU/ml) |
(88) | |
|
Combined:
Bacterial & Endotoxin |
Pyrogenic reactions and bacteremia in 5 patients (2 with Klebsiella pneumonia, 1 with K. pneumonia and P. aeruginosa); distribution systems and machines were inadequately disinfected with sodium hypochlorite when a pump failed 2 weeks prior to the outbreak |
(90) |
| Pyrogenic reactions (9 episodes) and gram-negative bacteremia (5 episodes) in 11 patients; water distribution system was not routinely disinfected, machine was not disinfected according to manufacturer’s instructions, poor bacterial assay resolution |
(91) | |
| *Pyrogenic reactions (~20) due to bacteria and/or endotoxins; reverse osmosis water was believed to be the source of contamination |
(92) | |
| *Pyrogenic reactions in 9 and gram-negative bacteremias in 5 patients; inadequate mixing of Renalin disinfectant |
(93) | |
| Nontuberculous mycobacteria | *A total of 27 cases with various infections: bacteremia in 14, soft-tissue infections in 3, and 1 with an access-graft infection, while 9 others had widely disseminated disease. Mycobacterium chelonae ssp. abscessus was identified in 26 isolates and the remaining isolate was a M. chelonae-like organism; the water treatment system showed widespread contamination and the processed dialyzers were contaminated with viable mycobacterium |
(95) |
| *Systemic M. chelonae abscessus infections in 5 patients, 1 patient died during antimicrobial therapy; a hose with a spray device was contaminated with M. abscessus and the Renalin disinfectant concentration was not high enough |
(94) |