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News / August 27, 2020
In Part III of “How to Properly Disinfect Reusable Medical Devices” (Elmed blog #28) we discussed various disinfectants that are commercially available for use in healthcare facilities along with their intended uses. In Part IV of this series we will continue our look at various FDA approved disinfectants. The goal of this series is to help healthcare reprocessing personnel select appropriate disinfectants for their reusable medical devices and how best to use them in the most efficient way.
“When selecting disinfectants and sterilants, products should have a balance between germicidal efficacy and user safety. Disinfectants and sterilants should be non-toxic, non-irritating and non-sensitizing. Ideally, special ventilation such as fume hoods will not be required. Ideal disinfectants and sterilants will not require detoxification, can be poured safely down the drain, and will not damage the environment upon disposal.” 1
Hydrogen Peroxide. The literature contains several accounts of the properties, germicidal effectiveness, and potential uses for stabilized hydrogen peroxide in the health-care setting. Published reports describe good germicidal activity to hydrogen peroxide and attest to its bactericidal, virucidal, sporicidal, and fungicidal properties (2-4). The FDA website lists all of the FDA approved liquid, high-level disinfectants containing hydrogen peroxide and their cleared contact conditions.
Hydrogen peroxide is active against a wide range of microorganisms, including bacteria, yeasts, fungi, viruses, and spores (5-6). A 0.5% accelerated hydrogen peroxide demonstrated bactericidal and virucidal activity in 1 minute and mycobactericidal and fungicidal activity in 5 minutes. 7
Iodophors. Iodine solutions or tinctures long have been used by healthcare professionals primarily as antiseptics on skin or tissue (i.e., povidone-iodine). Iodophors, on the other hand, have been used both as antiseptics and disinfectants. An iodophor is a combination of iodine and a solubilizing agent or carrier. Iodophors retain the germicidal efficacy of iodine but unlike iodine generally are non-staining and relatively free of toxicity and irritancy. 8, 9
In addition to their use as an antiseptic, iodophors have been used for disinfecting blood culture bottles and reusable medical devices and equipment, such as hydrotherapy tanks, thermometers, and endoscopes. Antiseptic iodophors are not suitable for use as hard-surface disinfectants because of concentration differences. Iodophors formulated as antiseptics contain less free iodine than do those formulated as disinfectants.10
Ortho-phthalaldehyde (OPA). Ortho-phthalaldehyde is a high-level disinfectant that has superior mycobactericidal activity (5-log10 reduction in 5 minutes) to glutaraldehyde. In addition to being fast acting, OPA has several other advantages over glutaraldehyde. It has excellent stability over a wide pH range (pH 3–9), it does not cause irritation to the eyes and nasal passages 11, it does not require exposure monitoring, it is practically odorless and it requires no activation. Additionally, OPA, like glutaraldehyde, has excellent material compatibility.
With respect to disinfectants and sterilants, part of the Center for Disease Control and Prevention (CDC) role is to keep healthcare personnel informed of current scientific evidence pertaining to these FDA approved products. The CDC is a good source of information concerning the safety and efficacy of the commercially available disinfectants and sterilants along with recommending products that are most appropriate or effective for specific microorganisms and settings in your facility.
Another valuable resource for healthcare personnel is the National Institute for Occupational Health and Safety (NIOSH). They can provide specific recommendations on work related regulations and recommended precautions involving the use of sterilants and disinfectants.
“A thorough understanding of a chemical’s safety data sheet is a must, but it doesn’t stop there. It is extremely important to be aware of and compliant with all federal, state, municipal, and industry enforced regulations pertaining to employee exposure to sterilants and disinfectants.” 12
To summarize this four part blog on how to properly disinfect reusable medical devices, it is vital that reprocessing personnel always follow the disinfectant manufacturer’s Instructions for Use (IFUs). It is equally important that reprocessing personnel ensure that those IFUs have been validated by an independent laboratory. In the absence of following validated IFUs from the manufacturer, reprocessing personnel cannot be sure that the disinfectant is actually providing 100% kill on every reprocessing cycle.
1 Nadeau K., Connecting the dots, removing the spots. HPN November 20, 2017
2 Turner FJ. Hydrogen peroxide and other oxidant disinfectants. In: Block SS, ed. Disinfection, sterilization, and preservation. Philadelphia: Lea & Febiger, 1983:240-50.
3 Block SS. Peroxygen compounds. In: Block SS, ed. Disinfection, sterilization, and preservation. Philadelphia: Lippincott Williams & Wilkins, 2001:185-204.
4 Sattar SA, Springthorpe VS, Rochon M. A product based on accelerated and stabilized hydrogen peroxide: Evidence for broad-spectrum germicidal activity. Canadian J Infect Control 1998 (winter):123-30.
5 Rutala WA, Gergen MF, Weber DJ. Sporicidal activity of chemical sterilants used in hospitals. Infect. Control Hosp. Epidemiol. 1993; 14:713-8.
6 Block SS. Peroxygen compounds. In: Block SS, ed. Disinfection, sterilization, and preservation. Philadelphia: Lippincott Williams & Wilkins, 2001:185-204.
7 Omidbakhsh N, Sattar SA. Broad-spectrum microbicidal activity, toxicologic assessment, and materials compatibility of a new generation of accelerated hydrogen peroxide-based environmental surface disinfectant. Am. J. Infect. Control 2006; 34:251-7.
8 Gottardi W. Iodine and iodine compounds. In: Block SS, ed. Disinfection, sterilization, and preservation. Philadelphia: Lea & Febiger, 1991:152-66.
9 Gottardi W. Iodine and iodine compounds. In: Block SS, ed. Disinfection, sterilization, and preservation. Philadelphia: Lippincott Williams & Wilkins, 2001:159-84.
10 Favero MS, Bond WW. Chemical disinfection of medical and surgical materials. In: Block SS, ed. Disinfection, sterilization, and preservation. Philadelphia: Lea & Febiger, 1991:617-41.
11 Cooke RPD, Goddard SV, Whymant-Morris A, Sherwood J, Chatterly R. An evaluation of Cidex OPA (0.55% ortho-phthalaldehyde) as an alternative to 2% glutaraldehyde for high-level disinfection of endoscopes. J. Hosp. Infect. 2003; 54:226-31.
12 Nadeau K., Op. cite.
