Infect Dis Clin North Am. 2016 Sep; 30[3]: 609–637. An Overview and Current Issues When properly used, disinfection and sterilization can ensure the safe use of invasive and noninvasive medical devices. The method of disinfection and sterilization depends on the intended use of the medical device: critical items [contact sterile tissue] must be sterilized before use;
semicritical items [contact mucous membranes or nonintact skin] must be high-level disinfected; and noncritical items [contact intact skin] should receive low-level disinfection. Cleaning should always precede high-level disinfection and sterilization. Current disinfection and sterilization guidelines must be strictly followed. Keywords: Disinfection, Sterilization, Health care facilities • All invasive procedures involve contact by a medical device or surgical instrument with patients’ sterile tissue or mucous membrane. • The level of disinfection or sterilization depends on the intended use of the object: critical [items that contact sterile tissue, such as surgical instrument], semicritical [items that contact mucous membranes, such as endoscopes], and noncritical [items that contact only
intact skin, such as stethoscopes] require sterilization, high-level disinfection, or low-level disinfection, respectively. • Cleaning must precede high-level disinfection and sterilization. • Failure to properly disinfect devices used in health care [eg, endoscopes] has led to many outbreaks. • Health care providers should be familiar with current issues, such as the role of the environment in
disease transmission, reprocessing semicritical items [eg, endoscopes], and new technologies [eg, hydrogen peroxide mist].Key points
Introduction
In the United States in 2010 there were approximately 51.4 million inpatient surgical procedures and an even larger number of invasive medical procedures.1 In 2009, there were more than 6.9 million gastrointestinal [GI] upper, 11.5 million GI lower, and 228,000 biliary endoscopies performed.2 Each of these procedures involves contact by a medical device or surgical instrument with patients’ sterile tissue or mucous membranes. A major risk of all such procedures is the introduction of pathogenic microbes, which can lead to infection. Failure to properly disinfect or sterilize equipment may lead to transmission via contaminated medical and surgical devices [eg, carbapenem-resistant Enterobacteriaceae [CRE]].3, 4
Achieving disinfection and sterilization through the use of disinfectants and sterilization practices is essential for ensuring that medical and surgical instruments do not transmit infectious pathogens to patients. Because it is not necessary to sterilize all patient-care items, health care policies must identify whether cleaning, disinfection, or sterilization is indicated based primarily on each item’s intended use, manufacturers recommendations, and guidelines.
Multiple studies in many countries have documented lack of compliance with established guidelines for disinfection and sterilization.5 Failure to comply with scientifically based guidelines has led to numerous outbreaks and patient exposures.6, 7, 8 Because of noncompliance with recommended reprocessing procedures, the Centers for Disease Control and Prevention [CDC] and the Food and Drug Administration [FDA] issued a health advisory alerting health care providers and facilities about the public health need to properly maintain, clean, and disinfect and sterilize reusable medical devices in September 2015.9 In this article, which is an updated and modified version of earlier articles,10, 11, 12, 13, 14 a pragmatic approach to the judicious selection and proper use of disinfection and sterilization processes is presented, based on well-designed studies assessing the efficacy [via laboratory investigations] and effectiveness [via clinical studies] of disinfection and sterilization procedures.
A rational approach to disinfection and sterilization
Almost 50 years ago, Earle H. Spaulding15 devised a rational approach to disinfection and sterilization of patient-care items or equipment. This classification scheme is so clear and logical that it has been retained, refined, and successfully used by infection control professionals and others when planning methods for disinfection or sterilization.10, 11, 12, 13, 14 Spaulding thought that the nature of disinfection could be understood more readily if instruments and items for patient care were divided into 3 categories based on the degree of risk of infection involved in the use of the items. The 3 categories he described were critical, semicritical, and noncritical. This terminology is used by the CDC’s “Guidelines for Environmental Infection Control in Healthcare Facilities”16 and the CDC’s “Guideline for Disinfection and Sterilization in Healthcare Facilities.”13 These categories and the methods to achieve sterilization, high-level disinfection, and low-level disinfection are summarized in Table 1 . Although the scheme remains valid, there are some examples of disinfection studies with prions, viruses, mycobacteria, and protozoa that challenge the current definitions and expectations of high-level disinfection [HLD] and low-level disinfection.22
Table 1
Methods for disinfection and sterilization of patient-care items and environmental surfaces
Sterilizationa | Destroys all microorganisms, including bacterial spores | High temperature | Steam [∼40 min], dry heat [1–6 h depending on temperature] | Heat-tolerant critical [surgical instruments] and semicritical patient-care items |
Low temperature | Ethylene oxide gas [∼15 h], HP gas plasma [28–52 min], HP and ozone [46 min], HP vapor [55 min] | Heat-sensitive critical and semicritical patient-care items | ||
Liquid immersion | Chemical sterilantsb: >2% glut [∼10 h]; 1.12% glut with 1.93% phenol [12 h]; 7.35% HP with 0.23% PA [3 h]; 8.3% HP with 7.0% PA [5 h]; 7.5% HP [6 h]; 1.0% HP with 0.08% PA [8 h]; ≥0.2% PA [12 min at 50°C–56°C] | Heat-sensitive critical and semicritical patient-care items that can be immersed | ||
HLD | Destroys all microorganisms except some bacterial spores | Heat automated | Pasteurization [65°C–77°C, 30 min] | Heat-sensitive semicritical items [eg, respiratory therapy equipment] |
Liquid immersion | Chemical sterilants/HLDsb: >2% glut [20–90 min at 20°C–25°C]; >2% glut [5 min at 35.0°C–37.8°C]; 0.55% OPA [12 min at 20°C]; 1.12% glut with 1.93% phenol [20 min at 25°C]; 7.35% HP with 0.23% PA [15 min at 20°C]; 7.5% HP [30 min at 20°C]; 1.0% HP with 0.08% PA [25 min]; 400–450 ppm chlorine [10 min at 20°C]; 2.0% HP [8 min at 20°C]; 3.4% glut with 26% isopropanol [10 min at 20°C] | Heat-sensitive semicritical items [eg, GI endoscopes, bronchoscopes, endocavitary probes] | ||
Low-level disinfection | Destroys vegetative bacteria and some fungi and viruses but not mycobacteria or spores | Liquid contact | EPA-registered hospital disinfectant with no tuberculocidal claim [eg, chlorine-based products, phenolics, improved HP, HP plus PA, quaternary ammonium compounds, exposure times at least 1 min] or 70%–90% alcohol | Noncritical patient care item [blood pressure cuff] or surface [bedside table] with no visible blood |
In May 2015, the FDA convened a panel to discuss recent reports and epidemiologic investigations of the transmission of infections associated with the use of duodenoscopes in endoscopic retrograde cholangiopancreatography [ERCP] procedures.23 After presentations from industry, professional societies, and invited speakers, the panel made several recommendations to include reclassifying duodenoscopes based on the Spaulding classification from semicritical to critical to support the shift from HLD to sterilization.24 This change could be accomplished by shifting from HLD for duodenoscopes to sterilization and modifying the Spaulding definition of critical items from “objects which enter sterile tissue or the vascular system or through which blood flows should be sterile” to “objects which directly or secondarily [ie, via a mucous membrane such as duodenoscope] enter normally sterile tissue of the vascular system of through which blood flows should be sterile.”24, 25 Implementation of this recommendations requires sterilization technology that achieves a sterility assurance level of 10−6 of complex medical instruments, such as duodenoscopes. Ideally, this shift would eventually involve not only endoscopes that secondarily enter normally sterile tissue [eg, duodenoscopes, bronchoscopes] but also other semicritical devices [eg, GI endoscopes].24, 25
Critical Items
Critical items are so called because of the high risk of infection if such an item is contaminated with any microorganism, including bacterial spores. Thus, it is critical that objects that enter sterile tissue or the vascular system be sterile because any microbial contamination could result in disease transmission. This category includes surgical instruments, cardiac and urinary catheters, and implants used in sterile body cavities. The items in this category should be purchased as sterile or be sterilized by steam sterilization if possible. If heat sensitive, the object may be treated with ethylene oxide [ETO], hydrogen peroxide [HP] gas plasma, vaporized HP, HP vapor [HPV] plus ozone, or by liquid chemical sterilants if other methods are unsuitable. Table 1 and Tables 2 and 3 list sterilization processes and liquid chemical sterilants and the advantages and disadvantages of each. With the exception of 0.2% peracetic acid [12 minutes at 50°C–56°C], the indicated exposure times for liquid chemical sterilants range from 3 to 12 hours.19 Liquid chemical sterilants can be relied on to produce sterility only if cleaning, which eliminates organic and inorganic material, precedes treatment and if proper guidelines as to concentration, contact time, temperature, and pH are met. Another limitation to sterilization of devices with liquid chemical sterilants is that the devices cannot be wrapped during processing in a liquid chemical sterilant; thus, it is impossible to maintain sterility following processing and during storage. Furthermore, devices may require rinsing following exposure to the liquid chemical sterilant with water that, in general, is not sterile. Therefore, because of the inherent limitations of using liquid chemical sterilants in a nonautomated [or automated] reprocessor, their use should be restricted to reprocessing critical devices that are heat sensitive and incompatible with other sterilization methods.
Table 2
Summary of advantages and disadvantages of chemical agents used as chemical sterilantsa or as high-level disinfectants
Peracetic acid/HP |
|
|
Glutaraldehyde |
|
|
HP |
|
|
OPA |
|
|
Peracetic acid |
|
|
Improved HP [2.0%]; HLD |
|
|
Table 3
Summary of advantages and disadvantages of commonly used sterilization technologies
Steam |
|
|
HP gas plasma |
| |
100% ETO |
|
|
Vaporized HP |
|
|
HP and ozone |
|
|
In contrast to semicritical items that have been associated with greater than 100 outbreaks of infection,6 critical items have rarely,26 if ever, been associated with disease transmission. For example, any deviation from proper reprocessing [such as crevices associated with the elevator channel] of an endoscope could lead to failure to eliminate contamination with a possibility of subsequent patient-to-patient transmission due to a low or nonexistent margin of safety. This low [or nonexistent] margin of safety associated with endoscope reprocessing compares with the 17-log10 margin of safety associated with cleaning and sterilization of surgical instruments [ie, 12-log10 reduction via sterilization and at least a net 5-log10 reduction based on the microbial load on surgical instruments [2-logs]27 and microbial reduction via a washer disinfector [7-logs]].18
Semicritical Items
Semicritical items are those that come in contact with mucous membranes or nonintact skin. Respiratory therapy and anesthesia equipment, gastrointestinal endoscopes, bronchoscopes, laryngoscopes, endocavitary probes, prostate biopsy probes,28 cystoscopes,29 hysteroscopes, infrared coagulation devices,30 and diaphragm fitting rings are included in this category. These medical devices should be free of all microorganisms [ie, mycobacteria, fungi, viruses, bacteria], although small numbers of bacterial spores may be present. Intact mucous membranes, such as those of the lungs or the gastrointestinal tract, are generally resistant to infection by common bacterial spores but susceptible to other organisms, such as bacteria, mycobacteria, and viruses. Semicritical items minimally require HLD using chemical disinfectants. Glutaraldehyde, HP, ortho-phthalaldehyde [OPA], peracetic acid with HP, and chlorine [via electrochemical activation] are cleared by the FDA19 and are dependable high-level disinfectants provided the factors influencing germicidal procedures are met [see Tables 1 and 2]. The exposure time for most high-level disinfectants varies from 8 to 45 minutes at 20°C to 25°C.19
Because semicritical equipment has been associated with reprocessing errors that result in patient lookback and patient notifications, it is essential that control measures be instituted to prevent patient exposures.7 Before new equipment [especially semicritical equipment as the margin of safety is less than that for sterilization]25 is used for patient care on more than one patient, reprocessing procedures for that equipment should be developed. Staff should receive training on the safe use and reprocessing of the equipment and be competency tested. At the University of North Carolina [UNC] Hospitals, to ensure patient-safe instruments, all staff that reprocess semicritical instruments [eg, instruments which contact a mucous membrane such as vaginal probes, endoscopes, prostate probes] are required to attend a 3-hour class on HLD of semicritical instruments. The class includes the rationale for and importance of high-level disinfection, discussion of high-level disinfectants and exposure times, reprocessing steps, monitoring minimum effective concentration, personal protective equipment, and the reprocessing environment [establish dirty-to-clean flow]. Infection control rounds or audits should be conducted annually in all clinical areas that reprocess critical and semicritical devices to ensure adherence to the reprocessing standards and policies. Results of infection control rounds should be provided to the unit managers, and deficiencies in reprocessing should be corrected and the corrective measures documented to infection control within 2 weeks [immediately correct patient safety issues, such as exposure time to high-level disinfectant].
Noncritical Items
Noncritical items are those that come in contact with intact skin but not mucous membranes. Intact skin acts as an effective barrier to most microorganisms; therefore, the sterility of items coming in contact with intact skin is “not critical.” Examples of noncritical items are bedpans, blood pressure cuffs, crutches, bed rails, linens, bedside tables, patient furniture, and floors. In contrast to critical and some semicritical items, most noncritical reusable items may be decontaminated where they are used and do not need to be transported to a central processing area. There is virtually no documented risk of transmitting infectious agents to patients via noncritical items31 when they are used as noncritical items and do not contact nonintact skin and/or mucous membranes. However, these items [eg, bedside tables, bed rails] could potentially contribute to secondary transmission by contaminating hands of healthcare personnel or by contact with medical equipment that will subsequently come in contact with patients.32 Table 1 and Table 4 list several low-level disinfectants that may be used for noncritical items. Table 4 lists the advantages and disadvantages of the low-level disinfectants that are used on noncritical patient care items [eg, blood pressure cuffs] and noncritical environmental surfaces. The exposure time for low-level disinfection of noncritical items is at least 1 minute.
Table 4
Summary of advantages and disadvantages of disinfectants used as low-level disinfectants
Alcohol |
|
|
Sodium hypochlorite |
|
|
Improved HP |
|
|
Iodophors |
|
|
Phenolics |
|
|
Quaternary ammonium compounds [eg, didecyl dimethyl ammonium bromide, dioctyl dimethyl ammonium bromide] |
|
|
Peracetic acid/HP |
|
|
Adapted from Rutala WA, Weber DJ. Selection of the ideal disinfectant. Infect Control Hosp Epidemiol 2014;35:855–65; and Rutala WA, Weber DJ. Disinfection and sterilization in healthcare facilities. In: Han J, editor. SHEA practical healthcare epidemiology. University of Chicago Press.
Current issues in disinfection and sterilization
Reprocessing of Endoscopes
Physicians use endoscopes to diagnose and treat numerous medical disorders. Although endoscopes represent a valuable diagnostic and therapeutic tool in modern medicine, more health care–associated outbreaks have been linked to contaminated endoscopes than to any other reusable medical device.6, 8 Additionally, endemic transmission of infections associated with GI endoscopes may go unrecognized for several reasons, including inadequate surveillance of outpatient procedures, long lag time between colonization and infection, low frequency of infection, and because pathogens are the usual enteric flora. In addition, the risk of some procedures might be lower than others [eg, colonoscopy vs ERCP], whereby normally sterile areas are contaminated in the latter. In order to prevent the spread of health care–associated infections [HAIs], all heat-sensitive endoscopes [eg, GI endoscopes, bronchoscopes, nasopharyngoscopes] must be properly cleaned and, at a minimum, subjected to HLD following each use. HLD can be expected to destroy all microorganisms; although when high numbers of bacterial spores are present, a few spores may survive.
Recommendations for the cleaning and disinfection of endoscopic equipment have been published and should be strictly followed.13, 35, 36 Unfortunately, audits have shown that personnel often do not adhere to guidelines on reprocessing5 and outbreaks of infection continue to occur.3, 6, 8, 37 Additionally, recent studies have suggested that current reprocessing guidelines are not sufficient to ensure successful decontamination.38 In order to minimize patient risks and ensure that reprocessing personnel are properly trained, there should be initial and annual competency testing for each individual who is involved in reprocessing endoscopic instruments.13, 35, 36
In general, endoscope disinfection or sterilization with a liquid chemical sterilant or high-level disinfectant involves 5 steps after leak testing: [1] clean: mechanically clean internal and external surfaces, including brushing internal channels and flushing each internal channel with water and a enzymatic cleaner or detergent; [2] disinfect: immerse endoscope in high-level disinfectant [or chemical sterilant] and perfuse [eliminates air pockets and ensures contact of the germicide with the internal channels] disinfectant into all accessible channels, such as the suction/biopsy channel and air/water channel, and expose for a time recommended for specific products; [3] rinse: rinse the endoscope and all channels with sterile water, filtered water [commonly used with automated endoscope reprocessors], or tap water; [4] dry: rinse the insertion tube and inner channels with alcohol and dry with forced air after disinfection and before storage; and [5] store: store the endoscope in a way that prevents recontamination and promotes drying [eg, hung vertically].
Outbreaks of carbapenem-resistant Enterobacteriaceae infection associated with duodenoscopes: what can we do to prevent infections?
In the past 3 years, multiple reports of outbreaks have led the FDA, the CDC, and national news to raise awareness among the public and health care professionals that the complex design of duodenoscopes [used primarily for ERCP] may impede effective reprocessing. Several recent publications have associated multidrug-resistant [MDR] bacterial infections, especially due to CRE, in patients who have undergone ERCP with reprocessed duodenoscopes.3, 4, 25, 37, 39 Unlike other endoscope outbreaks,6 these recent outbreaks occurred even when the manufacturer’s instructions and professional guidelines were followed correctly.3, 4
The key concern raised by these outbreaks is that current reprocessing guidelines are not adequate to ensure a patient-safe GI endoscope [one devoid of potential pathogens], as the margin of safety associated with reprocessing endoscopes is minimal or nonexistent. There are at least 2 [and maybe 3] reasons for this reprocessing failure and why outbreaks continue to occur. First, studies have shown that the internal channel of GI endoscopes, including duodenoscopes, may contain 107−10 [7–10-log10] enteric microorganisms.40, 41 Investigations have demonstrated that the cleaning step in endoscope reprocessing results in a 2- to 6-log10 reduction of microbes and the HLD step results in another 4- to 6-log10 reduction of mycobacteria for a total 6- to 12-log10 reduction of microbes.40, 41, 42 Thus, the margin of safety associated with cleaning and HLD of GI endoscopes is minimal or nonexistent [level of contamination: 4-log10 [maximum contamination, minimal cleaning/HLD] to −5-log10 [minimum contamination, maximum cleaning/HLD]]. Therefore, any deviation from proper reprocessing [such as crevices associated with the elevator channel] could lead to failure to eliminate contamination with a possibility of subsequent patient-to-patient transmission. This low [or nonexistent] margin of safety associated with endoscope reprocessing compares with the 17-log10 margin of safety associated with cleaning and sterilization of surgical instruments.23
Second, GI endoscopes not only have heavy microbial contamination [107–1010 bacteria] but they are also complex with long, narrow channels, right-angle turns, and difficult-to-clean and disinfect components [eg, elevator channel]. The elevator channel in duodenoscopes is unique to side-viewing endoscopes. It has a separate channel and provides orientation of catheters, guidewires, and accessories into the endoscopic visual field.25 This channel is complex in design and has crevices that are difficult to access with a cleaning brush and may impede effective reprocessing.43 Based on this and other recent studies, it is likely that MDR pathogens are acting as marker or indicator organisms for ineffective reprocessing of the complex design of duodenoscopes, which is an infectious risk to patients.
Third, biofilms could impact endoscope reprocessing failure and continued endoscope-related outbreaks.44 Biofilms are multilayered bacteria plus exopolysaccharides that cement cells to surfaces. They develop in a wet environment. If reprocessing is performed promptly after use and the endoscope is dry, the opportunity for biofilm formation is minimal.45, 46 However, the formation of endoscopic biofilm during clinical practice may be related to reuse of reprocessing methods, such as reuse of detergent, manual cleaning, and incomplete drying.47 Ideally, reprocessing should be initiated within an hour of use; however, there are no evidence-based guidelines on delayed endoscope reprocessing.48 It is unclear if biofilms contribute to failure of endoscope reprocessing.
What should we do now? Unfortunately, there is currently no single, simple, and proven technology or prevention strategy that hospitals can use to guarantee patient safety. Of course, we must continue to emphasize the enforcement of evidenced-based practices, including equipment maintenance, and routine audits with at least yearly competency testing of reprocessing staff.13, 35, 36 All reprocessing personnel must be knowledgeable and thoroughly trained on the reprocessing instructions for duodenoscopes. This training includes the new recommendations to use a small bristle cleaning brush and for additional flushing and cleaning steps of the duodenoscope elevator channel [//medical.olympusamerica.com/sites/default/files/pdf/150326_TJF-Q180V_Customer_letter.pdf]. Although these steps were described as validated, no public data are available on the ability of these new cleaning recommendations to yield an ERCP scope devoid of bacteria. But we must do more or additional outbreaks will likely continue. For example, all hospitals that reprocess duodenoscopes should select one of the enhanced methods for reprocessing duodenoscopes. These enhanced methods have been priority ranked with the first providing the greatest margin of safety.25 They include [1] ETO sterilization after HLD with periodic microbiologic surveillance; [2] double HLD with periodic microbiologic surveillance; [3] HLD with scope quarantine until negative culture results are returned; [4] liquid chemical sterilant processing system using peracetic acid [rinsed with extensively treated potable water] with periodic microbiologic surveillance; [5] other FDA-cleared low-temperature sterilization technology [provided material compatibility and sterilization validation testing performed using the sterilizer and endoscope] after HLD, with periodic microbiologic surveillance; and [6] HLD with periodic microbiologic surveillance. These supplemental measures to enhance duodenoscope reprocessing made in May-June 201525 were reinforced by the FDA in August 2015.43 UNC Hospitals has chosen ETO sterilization after HLD with periodic microbiologic surveillance as its primary reprocessing method for duodenoscopes and if the ETO sterilizer is not available, then double HLD with periodic microbiologic surveillance.49
Role of the Environment in Disease Transmission
There is excellent evidence in the scientific literature that environmental contamination plays an important role in the transmission of several key health care–associated pathogens, including methicillin-resistant Staphylococcus aureus [MRSA], vancomycin-resistant Enterococcus [VRE], Acinetobacter sp, norovirus, and Clostridium difficile.50, 51, 52, 53 All these pathogens have been demonstrated to persist in the environment for days [in some cases months], frequently contaminate the environmental surfaces in rooms of colonized or infected patients, transiently colonize the hands of health care personnel, be transmitted by health care personnel, and cause outbreaks in which environmental transmission was deemed to play a role. Importantly, a study by Stiefel and colleagues54 demonstrated that contact with the environment was just as likely to contaminate the hands of health care personnel as was direct contact with patients. Further, admission to a room in which the previous patient had been colonized or infected with MRSA, VRE, Acinetobacter or C difficile has been shown to be a risk factor for newly admitted patients to develop colonization or infection.55, 56, 57
Improving room cleaning and disinfection and demonstrating the effectiveness of surface decontamination in reducing health care–associated infections
Investigators have reported that intervention programs aimed at improving surface cleaning and disinfection reduced HAIs.58 Such interventions have generally included multiple activities: disinfectant product substitutions and interventions to improve the effectiveness of cleaning and disinfection [eg, improved housekeeper education, monitoring the thoroughness of cleaning [eg, by use of ATP assays or fluorescent dyes] with feedback of performance to the environmental service workers, and/or use of cleaning checklists].58, 59, 60, 61 Health care facilities must also allow adequate time for room processing to ensure adherence to all steps recommended by institutional policies and professional organization guidelines. The authors have found that collaboration between infection prevention and environmental services staff, nursing, and management is critical to an effective environmental cleaning program. This collaboration includes ensuring that environmental services staff recognize the significance and relationship of adhering to proper work procedures to reduction of microbial contamination. The assignment of cleaning responsibility [eg, medical equipment to be cleaned by nursing; environmental surfaces to be cleaned by environmental service] is also important to ensure all objects and surfaces in a patient room are decontaminated, especially the surfaces of medical equipment [eg, cardiac monitors]. Improved environmental cleaning has been demonstrated to reduce the environmental contamination with VRE,61 MRSA,62 and C difficile.63 Further, all studies have only focused improvement on a limited number of high-risk objects. Thus, a concern of published studies is that they have only demonstrated improved cleaning of a limited number of high-risk objects [or targeted objects] not an improvement in the overall thoroughness of room decontamination, which is the objective.
To the authors’ knowledge only one study has objectively evaluated what constitutes high-touch objects in a patient room and no study has demonstrated epidemiologically what constitutes a high-risk object. Examples of what the literature refers to as high-touch objects includes bed rails, intravenous [IV] poles, call buttons, door knobs, floors, and bathroom facilities64; however, a study demonstrated high-touch objects in the intensive care unit were the bed rail, bed surface, and supply cart, whereas the high-touch surfaces in a patient ward were the bed rail, over-bed table, IV pump, and bed surface.65 Importantly, the level of microbial contamination of room surfaces was not statistically different regardless of how often they were touched before and after cleaning. Until research identifies which objects and surfaces pose the greatest risk of pathogen transmission, all noncritical surfaces that are touched must be cleaned/disinfected.66
No-touch [or mechanical] methods for room decontamination
As noted earlier, multiple studies have demonstrated that environmental surfaces and objects in rooms are frequently not properly cleaned and these surfaces may be important in transmission of health care–associated pathogens. Further, although interventions aimed at improving cleaning thoroughness have demonstrated effectiveness, many surfaces remain inadequately cleaned and, therefore, potentially contaminated. For this reason, several manufacturers have developed room disinfection units that can decontaminate environmental surfaces and objects. These no-touch systems generally use one of 2 methods: either UV light or HPV/mist.53 These technologies supplement, but do not replace, standard cleaning and disinfection because surfaces must be physically cleaned of dirt and debris.
Ultraviolet light for room decontamination
UV radiation has been used for the control of pathogenic microorganisms in a variety of applications, such as control of legionellosis, as well as disinfection of air, surfaces, and instruments.53, 67 At certain wavelengths, UV light will break the molecular bonds in DNA, thereby destroying the organism. UV radiation has peak germicidal effectiveness in the wavelength range of 240 to 280 nm. Mercury gas bulbs emit UV-C at 254 nm, whereas xenon gas bulbs produce a broad spectrum of radiation that encompasses the UV [100–280 nm] and the visible [380–700 nm] electromagnetic spectra.68 The efficacy of UV radiation is a function of many different parameters such as dose, distance, direct or shaded exposure, exposure time, lamp placement, pathogen, carrier or surface tested, inoculum method, organic load and orientation of carriers [eg, parallel vs perpendicular]. Data demonstrate that several UV systems have effectiveness [eg, eliminate >3-log10 vegetative bacteria [MRSA, VRE, Acinetobacter baumannii] and >2.4-log10 C difficile] at relatively short exposure times [eg, 5–25 minutes for bacteria, 10–60 minutes for C difficile spores].68, 69, 70 The studies also demonstrated reduced effectiveness when surfaces were not in direct line-of-sight.68, 69, 70, 71, 72
Hydrogen peroxide systems for room decontamination
Several systems that produce HP [eg, HPV, aerosolized dry mist HP] have been studied for their ability to decontaminate environmental surfaces and objects in hospital rooms. HPV has been used for the decontamination of rooms in health care.73, 74, 75, 76, 77, 78, 79, 80, 81, 82, 83 Studies have demonstrated that HP systems are a highly effective method for eradicating various pathogens [eg, MRSA, Mycobacterium tuberculosis, Serratia, C difficile spores, Clostridium botulinum spores] from rooms, furniture, and equipment.
Comparison of ultraviolet irradiation versus hydrogen peroxide for room decontamination
UV devices and HP systems have their own advantages and disadvantages [Table 5 ],53 and there is now ample evidence that these no-touch systems can reduce environmental contamination with health care–associated pathogens and reduce HAIs.84 However, each specific marketed system should be studied and its efficacy demonstrated before being introduced into health care facilities. The main advantage of both types of units is their ability to achieve substantial reductions in vegetative bacteria. Another advantage is their ability to substantially reduce C difficile spores, as low-level disinfectants [such as quaternary ammonium compounds] have only limited or no measurable activity against spore-forming bacteria.85 Both systems are residual free, and they decontaminate all exposed surfaces and equipment in the room.
Table 5
Clinical trials using ultraviolet or hydrogen peroxide devices for terminal room disinfection to reduce health care–associated infections
Boyce, 2008 | Before-after [CDI high incidence wards] | Community hospital | HPV [Bioquell] | CDI | 2.28–1.28 per 1000 Pt-days [P = .047] | No | No | NA |
Cooper, 2011 | Before-after [2 cycles] | Hospitals | HPV [NS] | CDI | Decreased cases [incidence NS] | No | No | Yes |
Levin, 2013 | Before-after | Community hospital | UV-PX, Xenex | CDI | 9.46–4.45 per 10,000 Pt-days [P = .01] | No | No | Yes |
Passaretti, 2013 | Prospective cohort [comparison of MDRO acquisition; admitted to rooms with or without HPV decontamination] | Academic center | HPV [Bioquell] | MRSA VRE CDI MDRO-all | 2.3–1.2 [P = .30] 7.2–2.4 [P Chủ Đề |