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Infectious proteins:
on the edge of microbiology Prions, as infectious proteins and the causative agents in a groupof diseases known as transmissible spongiform encephalopathies, are notable in their resistance to disinfection and sterilization.1,60,61 Initial studies on the inactivation of prions indicated that aggressive physical (steam sterilization at 134 C for 18 min) and chemical (1N NaOH or 2% available chlorine, in the form of sodium hypochlorite,for 1 h) methodswere required, and thiswas recommended by the World Health Organization in 1999.62 Since this time, these methods have been tested on contaminated surfaces and found to be effective (although associated infectivity is not always removed completely), but damage numerous types of devices.61,63 At the sametime, relatively simple cleaning processes can be effective against prions without broad-spectrum antimicrobial activity.63 Removal of prion contamination is a complicated matter, with studies showing that cleaning chemistries can decrease or even increase the resistance of prion contamination to steam sterilization.61,63 In terms ofthe efficacy of disinfection, moist heat and various disinfection methods are not considered to be effective against prions. Some peracetic acid, phenolic and biocide combination formulations,lower concentrations of alkali (NaOH and KOH), and hydrogen。peroxide gas treatments have significant activity. Indeed, the activity of hydrogen peroxide gas in vacuum-based sterilization processes has been shown to be effective in some cases64,65 but not others,65,66despite similarities in these processes, highlighting the complexity of prion inactivation. It has been suggested that prion decontamination can be considered as being addressed during normal, routine reprocessing of devices when appropriate cleaning formulations and reprocessing methods are used. Considering the long incubationtimes and often sporadic nature of prion diseases, this may be prudent but is still a topic of some discussion. Of further debate is the handling of devices that are known to be or are at high risk of being contaminated with prions, as reviewed elsewhere.63 In some cases, removal of such devices from clinical use is recommended, whileothers suggest reprocessing these devices with cleaning and extended steam sterilization (at 134 C for 18min). Overall, prions may not be highly resistant to reprocessing methods, depending onthe process used, and efficacy against prions does not imply that other micro-organisms have been inactivated.Prion diseases are rare, with themost prevalent being Creutzfeldt- Jakob disease (1e3 cases per million population). However, prion diseases are considered to be representative of other proteinprecipitation-associated diseases 。There is considerable debate about the transmissible nature ofsuch diseases, with growing evidence under experimental conditions for Alzheimer’s disease.69 This suggests, by a similar seeding mechanism to that described for prions, that such diseasescould be transmissible under certain situations, including transfer viacontaminated surfaces. Further research is required to verify thesereports, but if they are confirmed, the impact of current reprocessingstandards, including effects of disinfection, will need to bereconsidered.
ConclusionsDr Earle Spaulding defined a classification system for the safe reprocessing of surgical/medical devices to address the clinical needs of the day; these needs have changed little since 1957 and are equally applicable today. The expectations associated with various different levels of disinfection, and indeed sterilization, are based on the understanding of microbiology, particularly pathogens, and risksassociated with device use on patients. Disinfection and sterilizationclaims are based on passing established test methods, with markerorganisms chosen to represent various types of micro-organisms.With high-level disinfection, for example, the demonstration ofmycobactericidal and some level of sporicidal activity are taken toindicate efficacy against most known types of pathogens. However,this is not always true. Various types of viruses, bacterial strains andprotozoa have been shownto survive existing high-level disinfection/sterilant processes, outside of what would be expected from theSpaulding classification system. Protozoa are rarely considered, andmarker strains of viruses and bacteria may not always reflect disinfectionactivity against groups of micro-organisms. The potentialrisks with atypical transmissible agents such as prions and otherprotein-precipitation-associated diseases are already consideredcompletely outside of such classification systems. It is difficult toestimate the true clinical risks associated with many of these agents.Recent examples with large device-related outbreaks and atypicalmycobacteria that are resistant to high-level aldehyde-based disinfectantsshould be considered as a warning sign. Such high-leveldisinfectants may be labelled as passing a series of tests, but maynot be effective against many types of pathogens. It is expected thatmany other similar device-related infections may occur due toinadequate disinfection/sterilization but are not always identified,investigated or published. One suggestion is that the Spauldingclassification remains the same, but that the required testmethods toconfirm the various levels of disinfection are changed to includemany of the pathogens discussed in this review. As part of this, it issuggested that protozoa (vegetative and dormant forms) should beincluded for high-level disinfection and sterilization claims. Similarly,if certain types of existing high-level disinfectants/sterilants are noteffective against certain types of viruses and mycobacteria, thisshould be recognized as theymay not be applicable for use in certain(such as semi-critical) clinical applications. It should also be considered,especially for sterilization applications, that efficacy againstprions should be required to provide a standard precaution againstthese agents. From this brief review, while the Spaulding classificationsystem is as applicable today as it was in 1957, the expectationsfor the efficacy of various levels of disinfectants, and even sterilants,and how they are determined may need to be reconsidered.
Infectious proteins:
on the edge of microbiology Prions, as infectious proteins and the causative agents in a groupof diseases known as transmissible spongiform encephalopathies, are notable in their resistance to disinfection and sterilization.1,60,61 Initial studies on the inactivation of prions indicated that aggressive physical (steam sterilization at 134 C for 18 min) and chemical (1N NaOH or 2% available chlorine, in the form of sodium hypochlorite,for 1 h) methodswere required, and thiswas recommended by the World Health Organization in 1999.62 Since this time, these methods have been tested on contaminated surfaces and found to be effective (although associated infectivity is not always removed completely), but damage numerous types of devices.61,63 At the sametime, relatively simple cleaning processes can be effective against prions without broad-spectrum antimicrobial activity.63 Removal of prion contamination is a complicated matter, with studies showing that cleaning chemistries can decrease or even increase the resistance of prion contamination to steam sterilization.61,63 In terms ofthe efficacy of disinfection, moist heat and various disinfection methods are not considered to be effective against prions. Some peracetic acid, phenolic and biocide combination formulations,lower concentrations of alkali (NaOH and KOH), and hydrogen。peroxide gas treatments have significant activity. Indeed, the activity of hydrogen peroxide gas in vacuum-based sterilization processes has been shown to be effective in some cases64,65 but not others,65,66despite similarities in these processes, highlighting the complexity of prion inactivation. It has been suggested that prion decontamination can be considered as being addressed during normal, routine reprocessing of devices when appropriate cleaning formulations and reprocessing methods are used. Considering the long incubationtimes and often sporadic nature of prion diseases, this may be prudent but is still a topic of some discussion. Of further debate is the handling of devices that are known to be or are at high risk of being contaminated with prions, as reviewed elsewhere.63 In some cases, removal of such devices from clinical use is recommended, whileothers suggest reprocessing these devices with cleaning and extended steam sterilization (at 134 C for 18min). Overall, prions may not be highly resistant to reprocessing methods, depending onthe process used, and efficacy against prions does not imply that other micro-organisms have been inactivated.Prion diseases are rare, with themost prevalent being Creutzfeldt- Jakob disease (1e3 cases per million population). However, prion diseases are considered to be representative of other proteinprecipitation-associated diseases 。There is considerable debate about the transmissible nature ofsuch diseases, with growing evidence under experimental conditions for Alzheimer’s disease.69 This suggests, by a similar seeding mechanism to that described for prions, that such diseasescould be transmissible under certain situations, including transfer viacontaminated surfaces. Further research is required to verify thesereports, but if they are confirmed, the impact of current reprocessingstandards, including effects of disinfection, will need to bereconsidered.
ConclusionsDr Earle Spaulding defined a classification system for the safe reprocessing of surgical/medical devices to address the clinical needs of the day; these needs have changed little since 1957 and are equally applicable today. The expectations associated with various different levels of disinfection, and indeed sterilization, are based on the understanding of microbiology, particularly pathogens, and risksassociated with device use on patients. Disinfection and sterilizationclaims are based on passing established test methods, with markerorganisms chosen to represent various types of micro-organisms.With high-level disinfection, for example, the demonstration ofmycobactericidal and some level of sporicidal activity are taken toindicate efficacy against most known types of pathogens. However,this is not always true. Various types of viruses, bacterial strains andprotozoa have been shownto survive existing high-level disinfection/sterilant processes, outside of what would be expected from theSpaulding classification system. Protozoa are rarely considered, andmarker strains of viruses and bacteria may not always reflect disinfectionactivity against groups of micro-organisms. The potentialrisks with atypical transmissible agents such as prions and otherprotein-precipitation-associated diseases are already consideredcompletely outside of such classification systems. It is difficult toestimate the true clinical risks associated with many of these agents.Recent examples with large device-related outbreaks and atypicalmycobacteria that are resistant to high-level aldehyde-based disinfectantsshould be considered as a warning sign. Such high-leveldisinfectants may be labelled as passing a series of tests, but maynot be effective against many types of pathogens. It is expected thatmany other similar device-related infections may occur due toinadequate disinfection/sterilization but are not always identified,investigated or published. One suggestion is that the Spauldingclassification remains the same, but that the required testmethods toconfirm the various levels of disinfection are changed to includemany of the pathogens discussed in this review. As part of this, it issuggested that protozoa (vegetative and dormant forms) should beincluded for high-level disinfection and sterilization claims. Similarly,if certain types of existing high-level disinfectants/sterilants are noteffective against certain types of viruses and mycobacteria, thisshould be recognized as theymay not be applicable for use in certain(such as semi-critical) clinical applications. It should also be considered,especially for sterilization applications, that efficacy againstprions should be required to provide a standard precaution againstthese agents. From this brief review, while the Spaulding classificationsystem is as applicable today as it was in 1957, the expectationsfor the efficacy of various levels of disinfectants, and even sterilants,and how they are determined may need to be reconsidered.
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