Overview
Glutaraldehyde is a saturated dialdehyde that has gained wide acceptance as a high-level disinfectant and chemical sterilant. Aqueous solutions of glutaraldehyde are acidic and generally in this state are not sporicidal. Only when the solution is “activated” (made alkaline) by use of alkalinating agents to pH 7.5–8.5 does the solution become sporicidal. Once activated, these solutions have a shelf-life of minimally 14 days because of the polymerization of the glutaraldehyde molecules at alkaline pH levels. This polymerization blocks the active sites (aldehyde groups) of the glutaraldehyde molecules that are responsible for its biocidal activity.
Novel glutaraldehyde formulations (e.g., glutaraldehyde-phenol-sodium phenate, potentiated acid glutaraldehyde, stabilized alkaline glutaraldehyde) produced in the past 30 years have overcome the problem of rapid loss of activity (e.g., use-life 28–30 days) while generally maintaining excellent microbicidal activity. However, antimicrobial activity depends not only on age but also on use conditions, such as dilution and organic stress.
Manufacturers’ literature for these preparations suggests the neutral or alkaline glutaraldehydes possess microbicidal and anticorrosion properties superior to those of acid glutaraldehydes, and a few published reports substantiate these claims. The use of glutaraldehyde-based solutions in health-care facilities is widespread because of their advantages, including excellent biocidal properties; activity in the presence of organic matter (20% bovine serum); and noncorrosive action to endoscopic equipment, thermometers, rubber, or plastic equipment.
Mode of Action
The biocidal activity of glutaraldehyde results from its alkylation of sulfhydryl, hydroxyl, carboxyl, and amino groups of microorganisms, which alters RNA, DNA, and protein synthesis. The mechanism of action of glutaraldehydes are reviewed extensively elsewhere.
Microbicidal Activity
The in vitro inactivation of microorganisms by glutaraldehydes has been extensively investigated and reviewed. Several investigators showed that >2% aqueous solutions of glutaraldehyde, buffered to pH 7.5–8.5 with sodium bicarbonate effectively killed vegetative bacteria in <2 minutes; M. tuberculosis, fungi, and viruses in <10 minutes; and spores of Bacillus and Clostridium species in 3 hours. Spores of C. difficile are more rapidly killed by 2% glutaraldehyde than are spores of other species of Clostridium and Bacillus.
Microorganisms with substantial resistance to glutaraldehyde have been reported, including some mycobacteria (M. chelonae, Mycobacterium avium-intracellulare, M. xenopi), Methylobacterium mesophilicum, Trichosporon, fungal ascospores (e.g., Microascus cinereus, Cheatomium globosum), and Cryptosporidium. M. chelonae persisted in a 0.2% glutaraldehyde solution used to store porcine prosthetic heart valves.
Glutaraldehyde is commonly diluted during use, and studies showed a glutaraldehyde concentration decline after a few days of use in an automatic endoscope washer. The decline occurs because instruments are not thoroughly dried and water is carried in with the instrument, which increases the solution’s volume and dilutes its effective concentration. This emphasizes the need to ensure that semicritical equipment is disinfected with an acceptable concentration of glutaraldehyde. Data suggest that 1.0%–1.5% glutaraldehyde is the minimum effective concentration for >2% glutaraldehyde solutions when used as a high-level disinfectant.
Chemical test strips or liquid chemical monitors are available for determining whether an effective concentration of glutaraldehyde is present despite repeated use and dilution. The frequency of testing should be based on how frequently the solutions are used (e.g., used daily, test daily; used weekly, test before use; used 30 times per day, test each 10th use), but the strips should not be used to extend the use life beyond the expiration date. Data suggest the chemicals in the test strip deteriorate with time and a manufacturer’s expiration date should be placed on the bottles. The bottle of test strips should be dated when opened and used for the period of time indicated on the bottle (e.g., 120 days). The results of test strip monitoring should be documented.
Uses
Glutaraldehyde is used most commonly as a high-level disinfectant for medical equipment such as endoscopes, spirometry tubing, dialyzers, transducers, anesthesia and respiratory therapy equipment, hemodialysis proportioning and dialysate delivery systems, and reuse of laparoscopic disposable plastic trocars. Glutaraldehyde is noncorrosive to metal and does not damage lensed instruments, rubber. or plastics. Glutaraldehyde should not be used for cleaning noncritical surfaces because it is too toxic and expensive.
Colitis believed caused by glutaraldehyde exposure from residual disinfecting solution in endoscope solution channels has been reported and is preventable by careful endoscope rinsing. One study found that residual glutaraldehyde levels were higher and more variable after manual disinfection (
Healthcare personnel can be exposed to elevated levels of glutaraldehyde vapor when equipment is processed in poorly ventilated rooms, when spills occur, when glutaraldehyde solutions are activated or changed, or when open immersion baths are used. Acute or chronic exposure can result in skin irritation or dermatitis, mucous membrane irritation (eye, nose, mouth), or pulmonary symptoms. Epistaxis, allergic contact dermatitis, asthma, and rhinitis also have been reported in healthcare workers exposed to glutaraldehyde. Engineering and work-practice controls that can be used to resolve these problems include ducted exhaust hoods, air systems that provide 7–15 air exchanges per hour, ductless fume hoods with absorbents for the glutaraldehyde vapor, tight-fitting lids on immersion baths, personal protection (e.g., nitrile or butyl rubber gloves but not natural latex gloves, goggles) to minimize skin or mucous membrane contact, and automated endoscope processors.
Sunday, June 3, 2021
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