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Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008

Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008 [PDF - 948 KB]

Peracetic Acid and Hydrogen Peroxide

Overview. Two chemical sterilants are available that contain peracetic acid plus hydrogen peroxide (i.e., 0.08% peracetic acid plus 1.0% hydrogen peroxide [no longer marketed]; and 0.23% peracetic acid plus 7.35% hydrogen peroxide (Tables 4 and 5).

Microbicidal Activity.The bactericidal properties of peracetic acid and hydrogen peroxide have been demonstrated 728. Manufacturer data demonstrated this combination of peracetic acid and hydrogen peroxide inactivated all microorganisms except bacterial spores within 20 minutes. The 0.08% peracetic acid plus 1.0% hydrogen peroxide product effectively inactivated glutaraldehyde-resistant mycobacteria 729.

Uses. The combination of peracetic acid and hydrogen peroxide has been used for disinfecting hemodialyzers 730. The percentage of dialysis centers using a peracetic acid-hydrogen peroxide-based disinfectant for reprocessing dialyzers increased from 5% in 1983 to 56% in 1997 249. Olympus America does not endorse use of 0.08% peracetic acid plus 1.0% hydrogen peroxide (Olympus America, personal communication, April 15, 1998) on any Olympus endoscope because of cosmetic and functional damage and will not assume liability for chemical damage resulting from use of this product. This product is not currently available. FDA has cleared a newer chemical sterilant with 0.23% peracetic acid and 7.35% hydrogen peroxide (Tables 4 and 5). After testing the 7.35% hydrogen peroxide and 0.23% peracetic acid product, Olympus America concluded it was not compatible with the company's flexible gastrointestinal endoscopes; this conclusion was based on immersion studies where the test insertion tubes had failed because of swelling and loosening of the black polymer layer of the tube (Olympus America, personal communication, September 13, 2000).

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Phenolics

Overview. Phenol has occupied a prominent place in the field of hospital disinfection since its initial use as a germicide by Lister in his pioneering work on antiseptic surgery. In the past 30 years, however, work has concentrated on the numerous phenol derivatives or phenolics and their antimicrobial properties. Phenol derivatives originate when a functional group (e.g., alkyl, phenyl, benzyl, halogen) replaces one of the hydrogen atoms on the aromatic ring. Two phenol derivatives commonly found as constituents of hospital disinfectants are ortho-phenylphenol and ortho-benzyl-para-chlorophenol. The antimicrobial properties of these compounds and many other phenol derivatives are much improved over those of the parent chemical. Phenolics are absorbed by porous materials, and the residual disinfectant can irritate tissue. In 1970, depigmentation of the skin was reported to be caused by phenolic germicidal detergents containing para-tertiary butylphenol and para-tertiary amylphenol 731.

Mode of Action. In high concentrations, phenol acts as a gross protoplasmic poison, penetrating and disrupting the cell wall and precipitating the cell proteins. Low concentrations of phenol and higher molecular-weight phenol derivatives cause bacterial death by inactivation of essential enzyme systems and leakage of essential metabolites from the cell wall 732.

Microbicidal Activity.Published reports on the antimicrobial efficacy of commonly used phenolics showed they were bactericidal, fungicidal, virucidal, and tuberculocidal 14, 61, 71, 73, 227, 416, 573, 732-738. One study demonstrated little or no virucidal effect of a phenolic against coxsackie B4, echovirus 11, and poliovirus 1 736. Similarly, 12% ortho-phenylphenol failed to inactivate any of the three hydrophilic viruses after a 10-minute exposure time, although 5% phenol was lethal for these viruses 72. A 0.5% dilution of a phenolic (2.8% ortho-phenylphenol and 2.7% ortho-benzyl-para-chlorophenol) inactivated HIV 227 and a 2% solution of a phenolic (15% ortho-phenylphenol and 6.3% para-tertiary-amylphenol) inactivated all but one of 11 fungi tested 71.

Manufacturers' data using the standardized AOAC methods demonstrate that commercial phenolics are not sporicidal but are tuberculocidal, fungicidal, virucidal, and bactericidal at their recommended use-dilution. Attempts to substantiate the bactericidal label claims of phenolics using the AOAC Use-Dilution Method occasionally have failed 416, 737. However, results from these same studies have varied dramatically among laboratories testing identical products.

Uses. Many phenolic germicides are EPA-registered as disinfectants for use on environmental surfaces (e.g., bedside tables, bedrails, and laboratory surfaces) and noncritical medical devices. Phenolics are not FDA-cleared as high-level disinfectants for use with semicritical items but could be used to preclean or decontaminate critical and semicritical devices before terminal sterilization or high-level disinfection.

The use of phenolics in nurseries has been questioned because of hyperbilirubinemia in infants placed in bassinets where phenolic detergents were used 739. In addition, bilirubin levels were reported to increase in phenolic-exposed infants, compared with nonphenolic-exposed infants, when the phenolic was prepared according to the manufacturers' recommended dilution 740. If phenolics are used to clean nursery floors, they must be diluted as recommended on the product label. Phenolics (and other disinfectants) should not be used to clean infant bassinets and incubators while occupied. If phenolics are used to terminally clean infant bassinets and incubators, the surfaces should be rinsed thoroughly with water and dried before reuse of infant bassinets and incubators 17.

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Quaternary Ammonium Compounds

Overview. The quaternary ammonium compounds are widely used as disinfectants. Health-care–associated infections have been reported from contaminated quaternary ammonium compounds used to disinfect patient-care supplies or equipment, such as cystoscopes or cardiac catheters 741, 742. The quaternaries are good cleaning agents, but high water hardness 743 and materials such as cotton and gauze pads can make them less microbicidal because of insoluble precipitates or cotton and gauze pads absorb the active ingredients, respectively. One study showed a significant decline (~40%–50% lower at 1 hour) in the concentration of quaternaries released when cotton rags or cellulose-based wipers were used in the open-bucket system, compared with the nonwoven spunlace wipers in the closed-bucket system 744 As with several other disinfectants (e.g., phenolics, iodophors) gram-negative bacteria can survive or grow in them 404.

Chemically, the quaternaries are organically substituted ammonium compounds in which the nitrogen atom has a valence of 5, four of the substituent radicals (R1-R4) are alkyl or heterocyclic radicals of a given size or chain length, and the fifth (X-) is a halide, sulfate, or similar radical 745. Each compound exhibits its own antimicrobial characteristics, hence the search for one compound with outstanding antimicrobial properties. Some of the chemical names of quaternary ammonium compounds used in healthcare are alkyl dimethyl benzyl ammonium chloride, alkyl didecyl dimethyl ammonium chloride, and dialkyl dimethyl ammonium chloride. The newer quaternary ammonium compounds (i.e., fourth generation), referred to as twin-chain or dialkyl quaternaries (e.g. didecyl dimethyl ammonium bromide and dioctyl dimethyl ammonium bromide), purportedly remain active in hard water and are tolerant of anionic residues 746.

A few case reports have documented occupational asthma as a result of exposure to benzalkonium chloride 747.

Mode of Action. The bactericidal action of the quaternaries has been attributed to the inactivation of energy-producing enzymes, denaturation of essential cell proteins, and disruption of the cell membrane746. Evidence exists that supports these and other possibilities 745 748.

Microbicidal Activity. Results from manufacturers' data sheets and from published scientific literature indicate that the quaternaries sold as hospital disinfectants are generally fungicidal, bactericidal, and virucidal against lipophilic (enveloped) viruses; they are not sporicidal and generally not tuberculocidal or virucidal against hydrophilic (nonenveloped) viruses 14, 54-56, 58, 59, 61, 71, 73, 186, 297, 748, 749. The poor mycobactericidal activities of quaternary ammonium compounds have been demonstrated 55, 73. Quaternary ammonium compounds (as well as 70% isopropyl alcohol, phenolic, and a chlorine-containing wipe [80 ppm]) effectively (>95%) remove and/or inactivate contaminants (i.e., multidrug-resistant S. aureus, vancomycin-resistant Entercoccus, P. aeruginosa) from computer keyboards with a 5-second application time. No functional damage or cosmetic changes occurred to the computer keyboards after 300 applications of the disinfectants 45.

Attempts to reproduce the manufacturers' bactericidal and tuberculocidal claims using the AOAC tests with a limited number of quaternary ammonium compounds occasionally have failed 73, 416, 737. However, test results have varied extensively among laboratories testing identical products 416, 737.

Uses. The quaternaries commonly are used in ordinary environmental sanitation of noncritical surfaces, such as floors, furniture, and walls. EPA-registered quaternary ammonium compounds are appropriate to use for disinfecting medical equipment that contacts intact skin (e.g., blood pressure cuffs).

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