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What the Experts Say Benzalkonium Chloride Antiseptic “Environmental cultures revealed that a canister of cotton balls soaked in aqueous benzalkonium chloride and two multiple-dose vials of methylprednisolone previously used by office personnel were contaminated with the epidemic strain of S. marcescens. The canister may have served as a potential reservoir for contamination of sterile solutions and equipment used for joint injections, of skin at the injection site, and of hands of personnel. No further cases occurred after the use of aqueous benzalkonium chloride was discontinued.” “We report here the results of the outbreak investigation, which identified contaminated aqueous benzalkonium chloride as a possible source.” “The available evidence suggested that for the eight patients who developed S. marcescens septic arthritis following joint injections in January 1982, the canister of Zephiran-soaked cotton balls served as a reservoir for the epidemic strain of S. marcescens.” Nakashima A, et al., Epidemic Septic Arthritis Caused by Serratis marcescens and Associated with a Benzalkonium Chloride Antiseptic. Journal of Clinical Microbiology, p1014-1018, June 1987. “Procedures such as catheterization and prolonged antibiotic treatment also tend to predispose a patient to S. marcescens infections. S. marcescens infections have been transmitted hand-to-hand by hospital personnel, via solutions used for medical procedures and by catheterization or need puncture.” “Cultures were taken from 21 benzalkonium chloride sponge pots located in the ICU, surgery rooms, and outpatient clinic areas; 13 were contaminated with S. marcescens. ... All S. marcescens isolates showed multiple resistance to antibiotics. Of the 36 isolates surveyed, 80% (24 of 30) of the catheter isolates and 100% (6 of 6) of the aqueous benzalkonium chloride isolates were resistant to four or more antibiotics. S. marcescens was not isolated from any of the surface areas tested.” “In the present study, an environmental surveillance of the ICU, surgery rooms, and outpatient clinic areas of the hospital revealed a common source of S. marcescens: aqueous benzalkonium chloride solutions used in skin antisepsis before insertion of i.v. catheters. This finding was confirmed by demonstrating that a single S. marcescens biotype was present in most of the i.v. catheters and disinfectant solutions...the contaminated disinfectant was a reservoir of multiply antibiotic-resistant S. marcescens.” “When aqueous benzalkonium chloride becomes contaminated with these organisms, it becomes a potential source of infection or transmission within a hospital.” “Several nosocomial bacterial infections in humans have been attributed to contaminated disinfectants, in particular, to benzaklonium chloride solutions.” “Our findings serve as a reminder of the potential hazards of improper use of disinfectants in a hospital environment, human or veterinary, and particularly, of the hazards of using aqueous benzalkonium chloride solutions stored in containers with cotton sponges.” Fox J, et al., Nosocomial Transmission of Serratia marcescens in a Veterinary Hospital Due to Contamination by Benzalkonium Chloride. Journal of Clinical Microbiology, p157-160, Aug 1981. “Multiple-dose medications and reliance on benzalkonium chloride as a medication preservative provide a mechanism for nosocomial spread of microorganisms, particularly if infection control procedures are not carefully followed.” “Outbreaks of nosocomial infections continue to occur because of the improper use of multiple-dose medication vials and because of reliance on benzalkonium chloride as a medication preservative.” “However, benzalkonium chloride works optimally as a bacteriostatic agent at a neutral or alkaline pH.” “Our results indicate that benzalkonium chloride may not be an appropriate medication preservative because this agent did not provide effective bacteriostasis on numerous occasions.” Hamill R, et al., An Outbreak of Burholderia (Formerly Pseudomonas) cepacia Respiratory Tract Colonization and Infection Associated with Nebulized Albuterol Therapy. Annals of Internal Medicine, 1995;122(10):762-66. “The isolate’s resistance to pure benzalkonium chloride was increased step-wise to a concentration of 16%. ... The results indicate that it is critical that pharmaceutical solutions containing benzalkonium chloride as an antimicrobial preservative be formulated without extraneous carbon and nitrogen sources or be preserved with additional antimicrobial agents.” “This organism was also isolated from benzalkonium chloride solutions by Gilardi. That benzalkonium chloride solutions can support pseudomonas contaminants is well established by the studies of Adair et al.” continued... “The organism was originally recovered from 0.15% N-alkyl dimethyl benzyl ammonium chloride solution that functioned as a cleansing germicidal agent in commercial catheters.” Benzalkonium chloride is “restricted in cosmetics (recommendations or requirements) - use, concentration, or manufacturing restrictions - Use is prohibited and restricted in Canadian cosmetics.” Research Department, Pharmaceuticals Division, CIBA-GEIGY Corp, Summit, New Jersey 07901, Fourteen-Year Survival of Pseudomonas cepacia in a Salts Solution Preserved with Benzalkonium Chloride. Applied and Environmental Microbiology, p505-510, Mar 1979. BZK Health Concerns, available at www.ewg.org/skindeep/ingredient/700674/BENZALKONIUM-CHLORIDE/ “Benzalkonium chloride (BC) continues to be used as an antiseptic and contributes to serious outbreaks of disease.” “At that time, a recommendation was made that BC be used only for environmental disinfection.” “The 4 mycobacteria-positive environmental specimens were linked to BC preparations: BC-soaked cotton ball samples taken from examination rooms 1 and 3, a swab sample from the metal container of the soaked cotton balls from room 3, and a sample of diluted BC that was obtained via a sterile syringe from a container of BC-soaked gauze in room 2. At least 1 culture-positive sample was obtained from each of the 3 examining rooms.” “From 1955 through 1982, the misuse of BC was associated with numerous other outbreaks or pseudooutbreaks of postinjection infection caused by bacterial species. The most common species were aerobic, gram-negative bacilli, including Burkholderia (Pseudomonas) cepacia, Serratia marcescens, and Enterobacter species.” “Our study determined that BC is ineffective against M. abscessus, even when used in accordance with the manufacturer’s instructions, and infection with this organism is a definite risk when BC is used.” “Serratia species are responsible for 1.4% of nosocomial bloodstream infections.” “In a population-based study of Serratia bacteremia, the 7-day and 6-month mortality rates were 5% and 37%, respectively.” Serratia Epidemiology, available at http://emedicine.medscape.com/article/228495overview PROFESSIONAL RECOMMENDATIONS “For general patient care, a plain, non-antimicrobial soap is recommended in any convenient form (bar, leaflets, liquid, powder). Such detergent-based products may contain very low concentrations of antimicrobial agents that are used as preservatives to prevent microbial contamination. If bar soaps are used, small bars that can be changed frequently and soap racks that promote drainage should be used.” American Journal of Infection Control (AJIC), Vol 23, No 4, pp 262, Aug 1995. “The Food and Drug Administration has categorized benzalkonium chloride (BZK) as not generally regarded as safe and effective in antimicrobial soaps.” Food and Drug Administration Federal Register, Vol 43, No 4, OTC Topical Antimicrobial Products, Jan 1978. “Similar to other quaternary ammonium compounds, the limited disinfecting property of BC is even more diminished in the presence of organic material.” Tiwari T, et al., Forty Years of Disinfectant Failure: Outbreak of Postinjection Mycobacterium abscessus Infection Caused by Contamination of Benzalkonium Chloride. Clinical Infectious Diseases 2003;36:954-62 “S. Enteritidis and S. Virchow became increasingly resistant to ERY, BKC and TLN within 6 days of gradual exposure to increasingly higher concentrations of these antimicrobial agents.” “Other gram-negative bacteria have been shown to alter their CSH when challenged by BKC, which might be due to the cationic nature of BKC making it more difficult to penetrate a hydrophobic bacterial cell wall.” Braoudaki M, Hilton A, Mechanisms of resistance in Salmonella enterica adapted to erythromycin, benzalkonium chloride and triclosan. International Journal of Antimicrobial Agents 25 (2005) 31-37. 21776 ©2012 Sage Products, Inc. • 3909 Three Oaks Road, Cary, Illinois, 60013 • 800-323-2220 • www.sageproducts.com