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Recommendation of AAD in HAI-prevention guidelines

Hospital environmental decontamination and HAI guidelines from national and international healthcare organisations rarely reflect the current evidence base
Nicola Petrosillo MD
Director, 2nd Infectious Diseases Division
National Institute for Infectious Diseases
Lazzaro Spallanzani, IRCCS
Rome, Italy
Antje Emmermann
Market Access Director EMEA
Advanced Sterilization Products
Division of Cilag GmbH International
Johnson & Johnson
Norderstedt, Germany
Healthcare-associated infections (HAIs) are a massive burden on both patients and healthcare facilities.(1) For patients, HAIs lead to increased hospitalisation, discomfort and mortality risk,(2–4) while,  for healthcare facilities, the economic burden is huge – approximately €7billion per year within Europe.(3)
The role of the environment as an important source of HAIs is well documented.(5–10) Transfer of pathogens occurs from surfaces to patients (mainly via hand contact)(3,11,12) and pathogens can persist on surfaces for a number of weeks, despite regular cleaning and decontamination.(13–15) A number of studies have revealed that the level of pathogen contamination in the environment is a risk factor for acquisition of HAIs, such that prior exposure of a hospital room to a patient infected or colonised with a pathogenic microorganism increases the risk of a subsequent patient contracting this pathogen.(8,16–19)
Manual cleaning followed by manual decontamination is clearly recommended in a number of international and European guidelines,(20–22) and has been reported to reduce microbial contamination and the incidence of HAIs.(23–26) However, the success of manual decontamination is dependent upon the skill and dedication of the user. This raises a number of issues:
  • It can often be difficult to reach all potentially contaminated surfaces manually(27)
  • The margin for human error may introduce inconsistency and lack of completeness into the decontamination process(28)
  • The burden of manual decontamination in terms of staff time is extensive. This is not limited to the labour time itself, but also extends to the high level of training, maintenance and supervision required to ensure that staff adhere to strict protocols(26,28) 
  • Manual cleaning and decontamination can expose staff to hazardous chemicals(28)  
Overall, these limitations may compromise the effectiveness of manual decontamination. A number of studies have revealed that manual decontamination protocols do not significantly reduce the number of sites of environmental contamination.(13,15) Given this observation, there is a real need for novel technologies that allow automated area decontamination (AAD). These technologies provide a ‘contact-free’ approach to decontamination that is firstly more consistent, due to the removal of human error, but secondly more pervasive.(28) They may also be safer for staff, as exposure to hazardous chemicals is avoided. There are several different types of AAD technology, including systems using hydrogen peroxide (H2O2) and ultraviolet radiation (UV). Although both technologies are effective at reducing colonisation of pathogens,(28–32) H2O2 systems have recently been shown to be superior.(33,34) Therefore, for the scope of this article, the focus will be on H2O2 technologies.
Hydrogen peroxide technologies
H2O2 is effective at killing pathogens in vitro, inactivating a number of bacteria and spores with >4 log reductions within 90 minutes.(28,35-39) Although it is difficult to attribute a real-world reduction in HAIs to a single intervention, the in vitro evidence of effectiveness of H2O2 systems seems to be supported by real-world evidence of pathogen inactivation and HAI reduction in healthcare facilities achieved following introduction of these systems. A number of before-and-after and controlled interventional studies, in addition to reports from routine clinical practice, elegantly detail the effectiveness of automated H2O2-based systems, at both reducing environmental contamination and reducing the incidence and burden of HAIs (Table 1). 
Given the amount of evidence supporting the use of AAD for hospital decontamination, it is surprising that AAD technologies are not more prevalent in the routine and outbreak decontamination protocols of healthcare facilities. We hypothesised that hospital decontamination and HAI prevention guidelines from national and international healthcare organisations, societies and working parties do not reflect the amount of growing evidence supporting the use of AAD, and thus are not currently influencing the utilisation of AAD technologies to reduce the burden of HAIs.
We aimed to review these guidelines to determine how frequently AAD technologies were acknowledged by national and international healthcare organisations and whether specific recommendations were issued for their usage.
A literature review was conducted to identify guidelines on environmental decontamination and prevention of HAIs in healthcare facilities. This literature review considered only international guidelines and national guidelines from European countries that were specifically aimed at preventing HAIs generally, or a specific HAI, in healthcare facilities. Identified guidelines from individual countries outside of Europe were excluded. Secondary and tertiary hospitals for inpatient care were considered as relevant healthcare facilities. Outpatient care facilities, such as doctors’ clinics and hospices, were not deemed relevant for inclusion. 
Identified guidelines were reviewed for their consideration of the following terms, representing different protocols contributing to HAI prevention:
  • AAD
  • Environmental decontamination
  • Manual cleaning
  • Hand hygiene
  • Surface cleaning
  • Education/training
  • Personal protective equipment (PPE)
  • Specific disinfectants.
Guidelines deemed relevant on the basis of their title, scope and area of influence but that did not refer to any of the above terms were not included in the analysis.
Following identification of all relevant guidelines, included guidelines were categorised based on their apparent area of influence as either ‘national’, or ‘international’. Where the target audience was not defined within the guidelines, the official website of the guideline-issuing body was investigated in order to establish the intended reach of the guideline-issuing body.
For each of the considered elements noted above, guidelines were categorised based on the level to which they considered the given element. Categories were defined as follows:
  • ‘Not acknowledged’ – no acknowledgement of a role for the given element of HAI prevention within the guidelines
  • ‘Acknowledged, no recommendation’ – the element of HAI prevention was acknowledged, but no recommendation as to its implementation was provided
  • ‘Acknowledged, with recommendation’ – the element of HAI prevention was both acknowledged and a recommendation as to its implementation was provided.
As part of our literature review, we identified 22 guidelines associated with environmental decontamination and HAI-prevention protocols issued by 20 healthcare organisations, societies or working parties. Of these, four organisations were deemed to have influence at an international level and the remaining 16 were influential at a national level.
As part of our guideline review, we analysed eight decontamination/hygiene protocols: 1. AAD, 2. environmental decontamination, 3. manual cleaning, 4. hand hygiene, 5. surface cleaning, 6. education and training, 7. PPE and 8. use of specific disinfectants. We investigated whether these protocols were acknowledged in the guidelines of healthcare organisations and, provided that they were, determined whether the organisation makes specific recommendations as to the use of the protocol in question as previously described. The results from this review are summarised in Figure 1, while an illustration of these findings stratified by specific healthcare organisations is presented in Figure 2.
In the 22 guidelines that we reviewed, protocols for hand hygiene, PPE and environmental decontamination were all strongly acknowledged [in 91%(20/22), 91% (20/22) and 86% (19/22) of guidelines, respectively]. Where these protocols were acknowledged, specific recommendations for the application of that protocol were also noted to be very common [recommended in 95% (19/20), 80% (16/20) and 84% (16/19) of cases where acknowledged, respectively].
While other protocols were also strongly acknowledged in the guidelines we reviewed, specific recommendations for their use were less frequently observed. For example, surface cleaning, manual cleaning, education and training, and the use of specific disinfectants were also commonly acknowledged [in 95% (21/22), 86% (19/22), 86% (19/22) and 82% (18/22) of guidelines, respectively]. However, the frequency with which specific recommendations on these protocols were made was far lower [recommended in 43% (9/21), 42% (8/19), 47% (9/19) and 50% (9/18) of cases where acknowledged, respectively].
Therefore, for the eight protocols analysed, seven were acknowledged in more than 80% of the guidelines that we reviewed. The only protocol that was not acknowledged to this extent was AAD. Protocols for AAD were acknowledged in only 45% (10/22) of the guidelines we reviewed. Of those that did acknowledge AAD, less than half [40% (4/10)] made specific recommendations for its implementation. 
Our review did identify four examples of guidelines that considered a role for AAD and provided a recommendation on this (Figure 2). In particular, the Italian National Association of Hospital Doctors Management (ANMDO) has recently reviewed the clinical and experimental evidence for AAD and provided a positive recommendation for its use. After deeming that the efficacy of H2O2-based AAD systems is supported by sufficient evidence, the ANMDO updated their hospital decontamination guidelines to include an entire section detailing the use of these automated systems.(62) Ultimately, this new section presents a positive opinion towards the use of AAD, not only in response to outbreaks, but also as part of routine preventative measures. Similarly, the UK National Patient Safety Agency (NPSA),(53) the English Health Protection Agency (HPA)(57) and the Russian Sanitary/Epidemiological Rule and Standard (SanPiN)(66,67) have also made specific recommendations regarding the use of AAD.
To determine the amount of influence behind the recommendations for AAD, we stratified our analysis of the AAD protocol by the size and influence of the issuing healthcare organisations (Figure 3). This indicated that only national healthcare organisations are yet to make specific recommendations. Currently, guidelines with wider influence (on an international level) either do not acknowledge AAD or acknowledge it without making specific recommendations.
Our analysis revealed that healthcare guidelines primarily focus on aspects concerning hygiene of individual healthcare personnel (hand hygiene and use of personal protective equipment). The importance of the need for decontamination of the environment is frequently acknowledged, but in the guidelines we reviewed there is often very little distinction between manual and automated methods of area decontamination. In most cases, explicit recommendations only apply to the former and a general absence of consideration for the use of AAD remains. Overall, our analysis suggests that AAD is under-represented in these decontamination guidelines.
The use of hand hygiene as a method for preventing the spread of HAIs is supported by a wealth of evidence(68,69) and it is pleasing to note that this is reflected in the guidelines, with this practice being heavily recommended. As a result, it is likely that hospitals and healthcare facilities, which often use these guidelines to determine their own local protocols and standards, will heavily promote the use of hand hygiene to help prevent and control HAIs. Given the increasing amount of evidence supporting the importance of use of automated systems for area decontamination, it is surprising that guidelines on this practice remain to be similarly updated to align with the evidence.
Some of the methods of AAD that are supported by evidence include H2O2 and UV systems. Both of these systems have shown strong efficacy in controlled laboratory studies(28–32,36–38,70) and have demonstrated a real-world impact following observations of reduced incidences of HAIs following their implementation.(45-47,71) H2O2 may be the more favorable technology in the healthcare setting due to its higher efficacy(33,34) (especially on objects that lie outside of its line-of-sight). Furthermore, technologies based around low concentration H2O2 may be particularly suitable, as they minimise concerns regarding safety and corrosiveness that could be associated with systems utilising high concentration H2O2.(72)
To date, a number of studies have demonstrated the efficacy of H2O2 against a range of healthcare-associated pathogens, including S. aureus (including methicillin-resistant S. aureus (MRSA), E. coli, P. aeruginosa, C. difficile and vancomycin-resistant enterococcus (VRE).(28,33,36–39,70) Accordingly, efficacy studies, including several randomised controlled trials, have now been performed in situ and have provided compelling evidence supporting the use of AAD technologies as a method for limiting HAIs (MRSA, C. difficile and norovirus) in routine and outbreak circumstances.(28,45–47) 
Recently, a panel of expert scientists from Germany reviewed the role of surface decontamination in HAI prevention.(9) They reported that contaminated surfaces pose a significant infection hazard. In particular, the panel highlighted that environmental and surface cleaning is a holistic process, needing manual cleaning and surface decontamination, and acknowledged the efficacy and safety values of automated H2O2-based decontamination systems.(9)
The lack of alignment between the evidence base for AAD and the representation of AAD in the guidelines highlights a clear concern for those responsible for setting standards at the hospital level; without updated guidance that accurately reflects the level of evidence for AAD technology, hospitals need to conduct independent reviews of the evidence in order to determine the suitability of AAD for decontamination of their facilities. These reviews are costly, and considerable time and expense could be saved if clear guidelines that align with the evidence existed.
Given the large evidence base supporting AAD, it remains unclear as to why current guidelines remain unrevised, especially as the burden of HAIs is so great to both patients and healthcare facilities, and continues to remain unresolved. One explanation for this discrepancy may be a delay between obtaining sufficient evidence and the guidelines being updated accordingly. In the UK, a phenomenon observed primarily with pharmaceutical products and clinical guidelines, commonly known as ‘NICE Blight’, refers to the delay in hospitals adopting new treatments or implementing protocols until the National Institute for Health and Care Excellence (NICE) produces the requisite guidance. This idea provides a clear example of why hospitals might wait for new technologies, despite the availability of scientifically proven success. Of the 22 guidelines we reviewed, only four make recommendations to the use of AAD. It was interesting that those that have already made recommendations for AAD all only have influence at the national level. 
Based on the guidelines we have reviewed, the median year of publication or most recent update is 2009 (range 2000–2012). The majority of these guidelines have never been updated; however, in cases where guidelines were updated, the time between publication and revision was approximately seven years. The WHO guidelines on infection control have not been updated in 11 years, since the last revision in 2002.(49)
Overall, more than one-half of the guidelines we reviewed had been either updated or published within the previous four years. These observations may explain why so few guidelines currently recommend the use of AAD in environmental decontamination. Worryingly, these data suggest that updates to many infection control guidelines may be several years away from completion.
Given the lack of a comprehensive solution to the detrimental effects HAIs have on patient health and hospital budgets, there remains both a moral and financial urgency to identify and implement novel approaches and technologies to combat pathogenic bioburden in hospitals. Overall, the research presented here has highlighted a clear misalignment between the available evidence supporting the use of AAD technologies in preventing transmission of HAIs, and the guidance issued by the advisors and regulators of clinical standard organisations.
Particularly in an area of such unmatched burden, there is a clear need for an update of guidelines to facilitate adoption of the latest beneficial, safe and effective technologies to help combat HAIs and avoid delays that are directly detrimental to patient health. Our analysis should encourage those responsible for creating future guidelines to align the recommendations given to AAD with the available evidence supporting its utilisation. The provision of accurate, evidence-based guidance may influence hospitals and healthcare facilities to utilise AAD technologies as part of their decontamination protocols and help reduce the burden and mortality caused by HAIs.
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