New Biocides Development - ACS Publications - American Chemical

Chapter 2

Disinfection and Sterilization in Healthcare Facilities Martin S. Favero

Downloaded by COLUMBIA UNIV on August 6, 2012 | http://pubs.acs.org Publication Date: September 7, 2007 | doi: 10.1021/bk-2007-0967.ch002

Director, Scientific and Clinical Affairs, Advanced Sterilization Products, Johnson and Johnson, 33 Technology Drive, Irvine, CA 92618

The effective use of proper disinfection and sterilization procedures plays a significant role in preventing healthcare associated infections. The purpose of this chapter is to describe the scientific rationale for disinfection and sterilization strategies used in hospitals and other healthcare facilities with a focus on chemical germicides formulated as disinfectants, and sterilization procedures that have been developed in the past decade, (move stentence up)Chemical germicides used in healthcare facilities include aldehydes, such as glutaraldehyde, ortho-phthaldehyde (OPA) and formaldehyde, peroxygens, which include hydrogen peroxide, peracetic acid and chlorine dioxide. Medical devices for many years have been sterilized by heat - steam autoclaving and dry heat. There are an increasing number of devices that cannot be sterilized by heat and must be sterilized by low temperature sterilization systems or disinfected by liquid chemical germicides. Ethylene oxides gas, and to a limited extent formaldehyde-steam, have been used for sterilization of heat sensitive instruments. Within the past 10 years a number of new low temperature sterilization systems, including hydrogen peroxide gas plasma sterilizers, and new high level disinfectants have been developed to process medical devices. These systems tend to be oxidative in their mode of action, use relatively low concentrations of the sterilizing agent, do not leave toxic residuals, have excellent compatibility with materials of medical devices, and have short process times.

© 2007 American Chemical Society

In New Biocides Development; Zhu, P.; ACS Symposium Series; American Chemical Society: Washington, DC, 2007.

31


32 The purpose of this chapter is to discuss disinfection and sterilization strategies that are used in health care settings to prevent the transmission of infectious agents from contaminated medical devices and environmental surfaces to patients and health care workers. The effective use of antiseptics, disinfectants and sterilization procedures in health care settings is important in the prevention of hospital-acquired infections. Historically, the use of physical agents, such as moist heat in the form of steam autoclaves or dry heat sterilizers, has played the predominant role for sterilizing devices, equipment and supplies in hospitals. In the 1990's there were a number of devices developed that were heat sensitive and had to be sterilized by low-temperature sterilization systems. Ethylene oxide was used for many years but concerns about toxicity to humans and the environment and very long sterilization cycles stimulated the development of a number of sterilization procedures meant to replace ethylene oxide sterilization. These include systems that employ hydrogen peroxide gas plasma, ozone, and in some parts of Europe, steam/formaldehyde. Liquid chemical germicides formulated as sterilants have also been available for many years but primarily are used to disinfect rather than sterilize medical devices (1,2,3) The choice of what sterilization or disinfection procedure or which specific chemical germicide should be used for sterilization, disinfection or antisepsis or for environmental sanitization depends on several factors. No single chemical germicide or sterilization procedure is adequate for all purposes. Factors that should be considered in the selection of a specific sterilization or disinfection procedure include (1) the degree of microbiological inactivation required for the particular device, (2) materials compatibility of the device with the disinfection or sterilization procedure based on the device's nature and physical composition, and (3) the cost and ease of using a particular procedure.

Regulation of Chemical Germicides Chemical germicides used as disinfectants or antiseptics in most countries are regulated by the federal or central government and usually by the Public Health Service or Ministry of Health. In the U S A , chemical germicides are regulated by two governmental agencies: the Environmental Protection Agency (EPA) and the Food and Drug Administration (FDA). Chemical germicides formulated as sterilants or disinfectants had historically been regulated by E P A , but recently the E P A and F D A agreed that sterilants or disinfectants that are used on medical devices (e.g. hemodialysis machines, endoscopes, high-speed dental hand pieces, etc.) will be regulated by F D A . The E P A requires manufacturers of chemical germicides formulated as sanitizers, disinfectants, hospital disinfectants or sterilant/disinfectants (sporicides) to test these products using specific, standardized assay methods for microbicidal potency, stability



33 and toxicity to humans. For chemical germicides intended for use on medical devices (as opposed to environmental or housekeeping surfaces), the F D A requires that manufacturers submit a premarket application that may include additional specific microbicidal activity data, device/chemical compatibility data and detailed instructions to the user regarding the "safe and effective use' of the product. F D A also regulates all sterilization devices such as steam autoclaves, ethylene oxide, ozone, and hydrogen peroxide gas plasma sterilizers, and dry heat ovens. F D A regulates chemical germicides that are formulated as antiseptics, preservatives or drugs to be used on or in the human body or as preparations to be used to inhibit or kill microorganisms on the skin. This type of chemical germicide is categorized basically by use pattern (e.g. antimicrobial handwashes, patient preoperative skin preparations, skin wound cleansers, skin wound protectants and surgical hand scrubs) and is not regulated or registered in the same fashion that E P A regulates and registers a disinfectant. Currently, data are not available to assess accurately the efficacy of many of the antimicrobial antiseptic formulations on the market; consequently, health care workers must make product selection decisions based on information derived from the manufacturer and published studies in the literature. The Centers for Disease Control and Prevention (CDC) does not approve, regulate or test chemical germicides formulated as disinfectants or antiseptics. Rather, the C D C recommends broad strategies for the use of sterilants, disinfectants and antiseptics to prevent transmission of infections in the health care environment.

Definitions The definitions of sterilization, disinfection, antisepsis and other related terms such as decontamination and sanitization are generally accepted in the scientific community, but some of these terms are misused. It is important not only to understand the definition and implied capabilities of each procedure, but also to understand how to achieve and in some cases monitor each state.

Sterilization and disinfection The term sterilization is one that students and professionals have memorized and recited seemingly forever. It can be the simplest and the most complex concept depending on how it is viewed and how it is applied. The definition of sterilization can change depending on the user's vantage point. This term can be viewed somewhat like a hologram and can be defined in die context of: 1. The state of sterilization, 2. The procedure of sterilization, 3. The application of sterilization.


34 Any item, device or solution is considered to be sterile when it is completely free of all living microorganisms. This state of sterility is the objective of the sterilization procedure and, when viewed in this context, the definition is categorical and absolute, i.e. an item is either sterile or it is not. A sterilization procedure is one that kills all microorganisms, including high numbers of bacterial endospores. Sterilization can be accomplished by heat, ethylene oxide gas, hydrogen peroxide gas plasma, ozone, and radiation (in industry). From an operational standpoint, a sterilization procedure cannot be categorically defined. Rather, the procedure is defined as a process, after which the probability of a microorganisms surviving on an item subjected to the sterilization procedures is less than one in one million (10" ). This is referred to as the 'sterility assurance level', and it is this approach that is used by the medical device industry to sterilize large quantities of medical devices. The application of sterilization principles in industry is much more sophisticated and controlled than sterilization procedures used in hospitals. However, steam autoclaves, ethylene oxide gas sterilizers, hydrogen peroxide gas plasma sterilizers, and dry heat sterilization ovens used in health care facilities have operational protocols that are verified by the manufacturer to accomplish sterilization, and all the variables that control the inactivation of microorganisms are either automated or built into simple controls in the devices. In addition, the cycles are routinely monitored with chemical and biological indicators. The application of the sterilization process takes into account additional considerations. This approach involves the strategy associated with a particular medical device (or medical fluid) and the context of its degree of contact with patients. Dr. Earl Spaulding in 1972 ( 1) proposed that instruments, and medical devices be divided into three general categories based on the theoretical risk of infection if the surfaces are contaminated at time of use. Briefly, these categories are: medical instruments or devices that are exposed to normally sterile areas of the body require sterilization; instruments or devices that touch mucous membranes may be either sterilized or disinfected; and instruments, medical equipment or environmental surfaces that touch skin or come into contact with the patient only indirectly can be either cleaned and then disinfected with an intermediate-level disinfectant, sanitized with a low-level disinfectant or simply cleaned with soap and water. These instruments or other medical surfaces are termed 'critical', "semi-critical' or 'non-critical', respectively. Selection of the appropriate disinfecting procedure in the last category (non-critical will include consideration of the nature of the surface as well as the type and degree of contamination. In the context of these categorizations, Spaulding also classified chemical germicides by activity level (Table 1):


6

1. High-level disinfection. This is a procedure that kills vegetative microorganisms but not necessarily high numbers of bacterial spores. These


35 chemical germicides, by Spaulding's definition, are those that are capable of accomplishing sterilization, that is they kill all microorganisms, including a high number of bacterial spores, when the contact time is relatively long (610 h). As high-level disinfectants, they are used for relatively short periods of time (5-30 min). These chemical germicides are very potent sporicides and, in the U S A , are those registered with the F D A as sterilant/disinfectants http://www.fda.gov/cdrh/ode/germlab.html (Table II).


2. Intermediate-level disinfection. This is a procedure that kills vegetative microorganisms including Mycobacterium tuberculosis, all fungi and most viruses. These chemical germicides often correspond to EPA-approved "hospital disinfectants' that are also 'tuberculocidal'. 3. Low-level disinfection. This is a procedure that kills most vegetative bacteria except M. tuberculosis, some fungi and some viruses. These chemical germicides are often ones that are approved in the U S A by E P A as hospital disinfectants or sanitizers. Spaulding's system for classifying devices and strategies for disinfection and sterilization is quite conservative. There is a direct relationship between the degree of conservatism as expressed by the probability of a microorganism surviving a particular procedure and the microbicidal potency of the physical or chemical germicidal agent. For example, a sterilization procedure accomplished by steam autoclaving, ethylene oxide gas, or hydrogen peroxide gas plasma sterilization, by design and definition, will result in a one-in-one million probability of a surviving microorganism i f the procedure had initially been challenged with 10 highly resistant bacterial spores. The risk of infection resulting from the use of an item that was subjected to this type of procedure, assuming that the procedure had been carried out properly, would appear to be zero. Correspondingly, the probability of contamination and the theoretical probability of infection associated with sterilization or high-, intermediate- or low-level disinfection with liquid chemical agents would increase as the overall germicidal potency of the selected germicidal agent or procedure decreased. A process of liquid chemical sterilization would, at best, be three orders of magnitude less reliable than a conventional heat sterilization procedure. From a practical standpoint, this means that there is a lower level of confidence with such procedures, and i f and when mistakes are made there is a higher chance of failure than with a heat sterilization procedure. When procedural errors are made, the consequences are magnified especially when a procedure of lower overall potency is used. Procedures that contain fewer built-in assurances are procedurally driven and are ones that should be accompanied by very precise protocols, policies and quality assurance monitoring. 6



a

0

e

d

Quaternary ammonium compounds

Iodophor compounds

Phenolic compounds

Alcohols (ethyl, isopropyl)

Glutaraldehyde OrtAo-phthalaldehyde Hydrogen peroxide Formaldehyde Chlorine dioxide Peracetic acid Chlorine compounds

Glutaraldehyde Hydrogen peroxide Formaldehyde Chlorine dioxide Peracetic acid

Procedure - Chemical

0.1-0.2%

30-50 mg/L free io dine; up to 10,000 mg/L avail able iodine

0.5-3%

70%

Low

Intermediate to low

Intermediate to low

Intermediate

High to intermediate High High to intermediate Intermediate to low High High Intermediate to low

Variable

Not applicable

Activity level

0.5% 3-6% 1-8% Variable Variable 500 to 5000 mg/L free/available chlorine

DISINFECTION

b

STERILIZATION Variable 6-30% 6-8% Variable Variable

Concentration

Table I Activity Levels of Selected Liquid Germicides



Only those iodophors registered with E P A as hard-surface disinfectants should be used, and the instructions of the manufacturer regarding proper dilution and product stability should be closely followed. Antiseptic iodophors are not suitable for disinfecting medical instruments or devices or environmental surfaces.

The effectiveness of alcohols as intermediate level germicides is limited, since they evaporate rapidly, resulting in very short contact times, and also lack the ability to penetrate residual organic material. They are rapidly tuberculocidal, bactericidal and fungicidal, but may vary in spectrum of virucidal activity. Items to be disinfected with alcohols should be carefully pre-cleaned and then totally submerged for an appropriate exposure time (e.g., 10 minutes).

Generic disinfectants containing chlorine are available in liquid or solid form, e.g., sodium or calcium hypochlorite. Although the indicated concentrations are rapid acting and broad-spectrum (tuberculocidal, bactericidal, fungicidal, and virucidal), no proprietary hypochlorite formulations are formally registered with E P A or cleared by F D A . Common household bleach is an excellent and inexpensive source o f sodium hypochlorite. Concentrations between 500 and 1000 mg/L chlorine are appropriate for the vast majority of uses requiring an intermediate level of germicidal activity; higher concentrations are extremely corrosive as well as irritating to personnel, and their use should be limited to situations where there is an excessive amount of organic material or unusually high concentrations of microorganisms (e.g., spills of cultured material in the laboratory).

Because of the ongoing controversy of the role of formaldehyde as a potential occupational carcinogen, the use of formaldehyde is limited to certain specific circumstances under carefully controlled conditions, e.g., for the disinfection of certain hemodialysis equipment. There are no F D A cleared liquid chemical sterilant/disinfectants that contain formaldehyde.

This list of chemical germicides centers on generic formulations. A large number of commercial products based on these generic components can be considered for use. Users should ensure that commercial formulations are registered with E P A or F D A .



Manufacturer

Active Ingredient(s)

Sterilant Contact Conditions

High Level Disinfectant Contact Conditions K041984 Acecide™ High Level Disinfectant and Sterilant 8.3% hydrogen Minntech Corp Indication for device sterilization. 5 min at 25°C 5 days Maximum Reuse peroxide 5hrsat25°C Contact conditions established by 7.0% peracetic acid 5 days Maximum Reuse Contact conditions based on A O A C simulated use testing with endoscopes Sporicidal Activity Test only. K041360 Aldahol III High Level Disinfectant Healthpoint L T D 3.4% glutaraldehyde Indication for device sterilization. 1 0 m i n a t 2 0 ° C 14 days Maximum Reuse 26% isopropanol 10hrsat20°C Contact conditions based on A O A C Contact conditions established by Sporicidal Activity Test only. simulated use testing with endoscopes. K012889 Banicide® Advanced for Sterilization and High Level Disinfection Indication for device sterilization. 45 min at 25°C Pascal Company, Inc. 3.5% glutaraldehyde 30 days Maximum Reuse 10hrsat25°C Contact conditions established by 30 days Maximum Reuse Contact conditions based on A O A C simulated use testing with endoscopes. Sporicidal Activity Test only.

Table II. FDA-Cleared Sterilants and High Level Disinfectants with General Claims for Processing Reusable Medical and Dental Devices as of May 13,2005



K032959 Cidex® OPA Concentrate 5.75% orthoNo indication for device phthaldehyde (OPA) sterilization. In-Use solution (0.05% O P A ) passes the A O A C Sporicidal Activity Test in 32 hrs at 50°C. 5 min at 50°C Single use - diluted by system For use in the EvoTech Integrated Endoscope Disinfection System only. Contact conditions established by simulated use testing with endoscopes.

Advanced Sterilization

0.55% orthophthaldehyde

K030004 Cidex® O P A Solution No indication for device Manual Processing sterilization. Passes the A O A C 12 min at 20°C Sporicidal Activity Test in 32 hrs at 14 days Maximum Reuse Products, Johnson & 2 0 ° C a n d 25°C. Johnson Automated Endoscope Reprocessor (AER) 5 min at 25°C 14 days Maximum Reuse (For processing in an A E R only with FDA-cleared capability to maintain solution temperature at 25°C.) Contact conditions established by simulated use testing with endoscopes. K013280 Sterilox Liquid High Level Disinfectant System 10minat25°C Sterilox, Technologies, Hypochlorite No indication for device 650-675 ppm Active sterilization. Passes the Modified Inc. Single use - generated on site free chlorine A O A C Sporicidal Activity Test in Contact conditions established by 24 h r s a t 2 5 ° C . simulated use testing with endoscopes. Continued on next page.

Products, Johnson & Johnson

Advanced Sterilization



Manufacturer



High Level Disinfectant Contact Conditions K003087 Sporicidin Sterilizing and Disinfecting Solution Sporicidin International 1.12% glutaraldehyde Indication for device sterilization. 20 min at 25°C 14 days Maximum Reuse 1.93% phenol/phenate 12 hrs at 25°C Contact conditions established by 14 days Maximum Reuse Contact conditions based on A O A C simulated use testing with endoscopes. Sporicidal Activity Test only. K993042 Rapicide™ High Level Disinfectant and Sterilant 2.5% glutaraldehyde MediVators, Inc. Indication for device sterilization. Automated Endoscope Reprocessor 5.0 min at 35°C 7 hrs 40 m i n a t 3 5 ° C 28 days Maximum Reuse 28 days Maximum Reuse (For processing in an A E R only with Contact conditions established by FDA-cleared capability to maintain simulated use testing with endoscopes and additional the solution temperature at 35°C.) supporting information. Contact conditions established by simulated use testing with endoscopes. K991487 Cidex®OPA Solution High Level Disinfectant Advanced Sterilization 0.55% ortho12minat20°C No indication for device phthaldehyde 14 days Maximum Reuse Contact sterilization. Passes the A O A C Sporicidal Activity Test in 32 hrs at conditions established by simulated Products, Johnson & use testing with endoscopes. 20°C. Johnson K974188 Cetylcide-G® Concentrate and Diluent Concentrate Cetylite Industries, Inc. 3.2% glutaraldehyde Indication for device sterilization. 40 min at 20°C

Table II. Continued.


In New Biocides Development; Zhu, P.; ACS Symposium Series; American Chemical Society: Washington, DC, 2007. iM

28 days Maximum Reuse Contact 10hrsat20°C conditions established by simulated 28 days Maximum Reuse Contact conditions based on A O A C use testing with endoscopes. Sporicidal Activity Test only. K974062 MedSci 3% Glutaraldehyde 3% glutaraldehyde MedSci, Inc. Indication for device sterilization. 25 min at 25°C 28 days Maximum Reuse Contact 10hrsat25°C conditions established by simulated 28 days Maximum Reuse Contact conditions based on A O A C use testing with endoscopes. Sporicidal Activity Test only. K972708 EndoSpor™ Plus Sterilizing and Disinfecting Solution Note: Due to the lack of test strips for monitoring the concentrations of the active ingredients, the reuse period is limited to 14 days. Cottrell Limited 7.35% hydrogen Indication for device sterilization. 1 5 m i n a t 2 0 ° C peroxide 180 m i n a t 2 0 ° C 14 days Maximum Reuse Contact 0.23% peracetic acid 14 days Maximum Reuse conditions established by simulated Contact conditions established by use testing with endoscopes. simulated use testing with endoscopes. K970230 Sporox Sterilizing & Disinfection Solution Reckitt & Colman Inc. 7.5% hydrogen Indication for device sterilization. 30 min at 20°C peroxide 6 hrs at 20°C 21 days Maximum Reuse Contact 21 days Maximum Reuse conditions established by simulated Contact conditions based on A O A C use testing with endoscopes. Sporicidal Activity Test only. Continued on next page.



Cottrell Limited

Cottrell Limited

Cottrell Limited

Minntech Corporation

Manufacturer



High Level Disinfectant Contact Conditions K960513 Peract™ 20 Liquid Sterilant/Disinfectant 1.0% hydrogen Indication for device sterilization. 25 min at 20°C 14 days Maximum Reuse peroxide 8 hrs at 20°C Contact conditions established by 14 days Maximum Reuse 0.08% peracetic acid simulated use testing with Contact conditions established by endoscopes. simulated use testing with endoscopes. K932922 Procide® 14 N.S. 2.4% glutaraldehyde Indication for device sterilization. 45 min at 20°C 14 days Maximum Reuse Contact 10 hrs at 20°C conditions established by simulated 14 days Maximum Reuse Contact conditions based on A O A C use testing with endoscopes. Sporicidal Activity Test only. K932922 Omnicide™ Long Life Activated Dialdehyde Solution 2.4% glutaraldehyde Indication for device sterilization. 45 min at 20°C 28 days Maximum Reuse Contact 10hrsat20°C conditions established by simulated 28 days Maximum Reuse Contact conditions based on A O A C use testing with endoscopes. Sporicidal Activity Test only. K932922 Omnicide™ Plus 3.4% glutaraldehyde Indication for device sterilization. 45 min at 20°C 28 days Maximum Reuse Contact 10hrsat20°C conditions established by simulated 28 days Maximum Reuse* Contact conditions based on A O A C use testing with endoscopes.




Sporicidal Activity Test only. K931592 Metricide Plus 30® Long-Life Activated Dialdehyde Solution Metrex Research, Inc. 3.4% glutaraldehyde Indication for device sterilization. 90 min at 25°C 28 days Maximum Reuse 10hrsat25°C FDA accepted Metricide Plus as 28 days Maximum Reuse Contact conditions based on A O A C identical to Cidex Plus. Sporicidal Activity Test only. F D A accepted Metricide Plus as identical to Cidex Plus. K931052 Metricide® 28 Long-Life Activated Dialdehyde Solution Metrex Research, Inc. . 2.5% glutaraldehyde Indication for device sterilization. 90 min at 25°C 10hrsat25°C 28 days Maximum Reuse FDA accepted Metricide 28 as 28 days Maximum Reuse Contact conditions based on A O A C identical to Cidex Formula 7. Sporicidal Activity Test only. FDA accepted Metricide 28 as identical to Cidex Formula 7. K930284 Metricide® Activated Dialdehyde Solution Metrex Research, Inc. 2.6% glutaraldehyde Indication for device sterilization. 45 min at 25°C 14 days Maximum Reuse 10hrsat25°C FDA accepted Metricide as identical 14 days Maximum Reuse Contact conditions based on A O A C to Cidex. Sporicidal Activity Test only. FDA accepted Metricide as identical to Cidex. Continued on next page.





High Level Disinfectant Contact Conditions K924434 Cidex™ Activated Dialdehyde Solution Advanced Sterilization 2.4% glutaraldehyde Indication for device sterilization. 45 min at 25°C 14 days Maximum Reuse Contact 10hrsat25°C conditions based on literature 14 days Maximum Reuse Products, Johnson & references. Contact conditions based on A O A C Johnson Sporicidal Activity Test only. K924334 Cidex Formula 7™ Long-Life Activated Dialdehyde Solution Advanced Sterilization 2.5% glutaraldehyde Indication for device sterilization. 90 min at 25°C 28 days Maximum Reuse 10hrsat20-25°C Contact conditions based on literature 28 days Maximum Reuse Products, Johnson & Contact conditions based on A O A C references. Johnson Sporicidal Activity Test only. K923744 Cidex Plus™ 28 Day Solution Advanced Sterilization 3.4% glutaraldehyde Indication for device sterilization. 20 m i n a t 2 5 ° C 28 days Maximum Reuse Contact 10hrsat20-25°C conditions based on literature 28 days Maximum Reuse Products, Johnson & Contact conditions based on A O A C references. Johnson Sporicidal Activity Test only.

Manufacturer




STERIS® Corporation

Wave Energy Systems

2.5% glutaraldehyde

K914749 Wavicide®-01 Indication for device sterilization. 45 min at 22°C 30 days Maximum Reuse Contact 10hrsat22°C 30 days Maximum Reuse conditions established by simulated Contact conditions based on A O A C use testing with endoscopes. Sporicidal Activity Test only. K875280 STERIS 2 0 ™ Sterilant Note: Cleared for use with the STERIS System 1™ Processor only. 0.2% peracetic acid Indication for device sterilization. No indication for high level 12 min at 50-56°C disinfection. Single use only. Contact conditions established by simulated use testing with endoscopes and passing a modified A O A C Sporicidal Activity Test.


46


Decontamination Another term often used in health care facilities is decontamination. A process of decontamination is one that renders a device, items or materials safe to handle, i.e. safe in the context of being reasonably free from disease transmission risk. In many instances, this process is a sterilization procedure such as steam autoclaving, and this is often the most cost-effective way of decontaminating a device or an item. Conversely, the decontamination process may be ordinary soap and water cleaning of an instrument, a device, or an area. When chemical germicides are used for decontamination, they can range in activity from sterilant/disinfectants, which may be used to decontaminate spills of cultured or concentrated infectious agents in research or clinical laboratories, to low-level disinfectants or sanitizers when general housekeeping of environmental surfaces are involved.

Antiseptic The term antiseptic is used to describe a substance that has antimicrobial activity and is formulated to be used on or in living tissue to remove, inhibit growth of, or inactivate microorganisms. Quite often the distinction between an antiseptic and a disinfectant is not made. However, the differences between a disinfectant and an antiseptic are very great and applications are significantly different. A disinfectant is a chemical germicide formulated to be used solely on inanimate surfaces such as medical instruments or environmental surfaces, whereas an antiseptic is formulated to be used solely on or in living tissues. Some chemical agents such as iodophors can be used as active ingredients in chemical germicides that are formulated either as disinfectants or antiseptics. However, the precise formulations are significantly different, use patterns are different and the germicidal efficacy of each formulation differs substantially. Consequently, disinfectants should never be used as antiseptics and antiseptics should never be used to disinfect instruments or environmental surfaces.

Factors that Influence Germicidal Activity Microorganisms vary widely in their resistance to sterilants and disinfectants. The most resistant microorganisms are bacterial endospores and few, i f any, other microorganisms approach the broad resistance of these organisms (This sentence is confusing and may need modification). A number of factors, some of which are associated with microorganisms themselves and


47 others with the surrounding physical and chemical environment, can significantly influence the antimicrobial efficacy of chemical germicides. Some factors are more important than others, but all of them should be considered when planning sterilization and disinfection strategies for medical and surgical devices and materials. Briefly, these factors are as follows.


Type of Microorganism Bacterial spores are more resistant than mycobacteria, fungi, vegetative bacteria and viruses. Some types of viruses are more resistant to germicides than others. As a general guide, one should define the state or degree of inactivation needed (i.e. sterilization or various levels of disinfection) and then choose the most appropriate procedure.

Number of Microorganisms A l l other factors being equal, the greater the number of microorganism on a device, the longer it takes to reduce the microbial population. It is for this reason that devices, especially those that are disinfected, should be cleaned prior to being sterilized or disinfected.

Intrinsic Resistance of Microorganisms Although bacterial spores are more resistant to germicides , very few species in the genera Bacillus or Clostridium are actually responsible for hospital-acquired infections. However, organisms such as M. tuberculosis var. bovis and non-tuberculous mycobacteria, as well as naturally occurring Gram-negative water bacteria such as Pseudomonas aeruginosa and other pseudomonads can, under some circumstances, be relatively resistant to chemical disinfectants. Second to bacterial spores, Mycobacterium spp. is considered one of the most resistant classes of microorganisms to germicides. It is for this reason that chemical germicides that have been approved as "tuberculocides" are sometimes recommended for decontamination or disinfection when a higher activity germicide is needed. It is usually not a concern for transmission of M. tuberculosis but rather a definition or specification that can be used to describe a germicide with a relatively broad range of germicidal activity. Resistance of certain non-lipid viruses is similar to that of mycobacteria (Table III) (4).



4

+ +

2 3

-

+'

Mycobacteria

Spores

+ + +

Vegetative cells

1

+ +

Fungi

5

+/+/-

+

Non-lipid, small

+ +

Lipid, medium sized

Vims

4LOW +/1. Includes asexual spores but not necessarily chlamydospores or sexual spores. 2. Plus sign indicates that a killing effect can be expected; a negative sign indicates little or no killing effect. 3. Only with extended exposure times are high-level disinfectants capable of killing high numbers of bacterial spores in laboratory tests; they are, however, capable of sporicidal activity. 4. Some intermediate-level disinfectants (e.g., hypochlorites may exhibit some sporicidal activity; others (e.g., alcohols or phenolics) have no demonstrated sporicidal activity. 5. Some intermediate-level disinfectants, although tuberculocidal, may have limited virucidal activity.

INTERMEDIATE

HIGH

Level of action

Bacteria

T A B L E III. Levels of disinfectant action according to type of microorganism


00

49 Amount of Organic Soil Present on the Item to be Disinfected or Sterilized Blood, feces or other organic soil may contribute to failure of a disinfecting or sterilizing procedure in three ways. Organic soil may contain large and diverse microbial populations, may prevent penetration of germicidal agents or may directly inactivate certain germicidal chemicals. This factor, perhaps even more than others, underscores the necessity of pre-cleaning items thoroughly prior to disinfection or sterilization.


Type and Concentration of Germicide Generally, with all other factors being constant, the higher the concentration of a germicide, the greater is its effectiveness and the exposure time necessary for disinfection or sterilization can be shorter. If a chemical agent is reused over a period of time, the product effectiveness may be reduced due to a variety of factors such as dilution or organic contamination.

Time and Temperature of Exposure With few exceptions, the longer the exposure times to a given chemical agent, the greater is its effectiveness. A n increase in temperature will significantly increase germicidal effectiveness, but deterioration or evaporation of the agent along with an increase in corrosiveness may also occur.

Other Product- or Process-Related Factors The presence of organic or inorganic loads, p H and the degree of hydration of biological material may significantly affect the potency of certain chemical germicides. For these as well as other factors given above, care should be taken to examine closely and follow label instructions of proprietary germicides.

Device-Related Factors The device or item being disinfected or sterilized must be physically and chemically compatible with the chosen procedure to ensure effectiveness and continued function of the device or item. Also, factors such as ease of access and cleaning as well as the size of the device or item are important considerations. The manufacturer of the item being reprocessed is the best source of pertinent information in this regard.


50


Summary The choice of specific disinfectants in association with protocols for cleaning is a decision that is made broadly in heath care facilities. No single chemical germicide procedure is adequate for all disinfection or sterilization purposes, and the realistic use of chemical germicides depends on a number of factors that should be considered in selecting available procedures. These include the degree of microbial killing required; the nature and composition of the surface item or device to be treated; and the cost, safety, and ease of use of the available agents. Strategies for the use of liquid chemical germicides are based on the original suggestions of Dr. Earl Spaulding and consist of two parts. One divides medical devices into categories based on use and risk of infection. The other recommends procedures of (1) sterilization and disinfection: critical device (sees blood or tissue), sterilization; (2) semicritical device (touches mucus membranes), sterilization or at least high-level disinfection; and (3) noncritical devices or surfaces (touches skin or involves environmental surfaces), intermediate or low level disinfection, or detergent cleaning.

References 1. 2. 3.

4.

Rutala, W . A . Am. J. Infect. Control, 1996, 24, 313-342. Rutala, W . A . Infect Control Hosp Epidemiol 1996, 17, 377-384. Favero, M., Bond, W. Disinfection, sterilization and preservation, 5th ed. Lippincott, Williams and Wilkens, Philadelphia, P A , 2001, Chapter 43. pp. 881-917 Prince H N , Prince D L , and Prince R N . Disinfection, Sterilization and Preservation, 4th Ed. Philadelphia, PA: Lea and Febiger, 1991, 411-444.


50


Summary The choice of specific disinfectants in association with protocols for cleaning is a decision that is made broadly in heath care facilities. No single chemical germicide procedure is adequate for all disinfection or sterilization purposes, and the realistic use of chemical germicides depends on a number of factors that should be considered in selecting available procedures. These include the degree of microbial killing required; the nature and composition of the surface item or device to be treated; and the cost, safety, and ease of use of the available agents. Strategies for the use of liquid chemical germicides are based on the original suggestions of Dr. Earl Spaulding and consist of two parts. One divides medical devices into categories based on use and risk of infection. The other recommends procedures of (1) sterilization and disinfection: critical device (sees blood or tissue), sterilization; (2) semicritical device (touches mucus membranes), sterilization or at least high-level disinfection; and (3) noncritical devices or surfaces (touches skin or involves environmental surfaces), intermediate or low level disinfection, or detergent cleaning.

References 1. 2. 3.

4.

Rutala, W . A . Am. J. Infect. Control, 1996, 24, 313-342. Rutala, W . A . Infect Control Hosp Epidemiol 1996, 17, 377-384. Favero, M., Bond, W. Disinfection, sterilization and preservation, 5th ed. Lippincott, Williams and Wilkens, Philadelphia, P A , 2001, Chapter 43. pp. 881-917 Prince H N , Prince D L , and Prince R N . Disinfection, Sterilization and Preservation, 4th Ed. Philadelphia, PA: Lea and Febiger, 1991, 411-444.


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