Airborne Hydrogen Peroxide€¦ · decontamination: HP vapour devices that vaporise a solution of...
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Version: 1.1
Date: December 2016
Review: December 2019
Literature Review and Practice Recommendations: Existing and emerging technologies used for
decontamination of the healthcare environment
Airborne Hydrogen Peroxide
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Literature Review and Practice Recommendations: Existing and emerging technologies used for decontamination of the healthcare environment: Airborne Hydrogen Peroxide
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DOCUMENT CONTROL SHEET Key Information:
Title: Existing and emerging technologies used for decontamination of the healthcare environment: Airborne Hydrogen Peroxide
Date Published/Issued: December 2016 Date Effective From: December 2016 Version/Issue Number: 1.1 Document Type: Literature Review Document status: Final Author: Name: D. Scott, F. Hansraj
Role: Healthcare Scientists (Health Protection) Division: HPS
Owner: Infection Control Approver: Annette Rankin Approved by and Date: December 2016 Contact Name: Infection Control Team
Tel: 0141 300 1175 Email: [email protected]
Version History:
This literature review will be updated in real time if any significant changes are found in the professional
literature or from national guidance/policy.
Version Date Summary of changes Changes marked
1.1 December 2016 Addition of categories for recommendations. No changes made to the content of the literature review.
1.0 May 2015 Final for publication
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Contents Topic .................................................................................................................................... 4
Background .......................................................................................................................... 4
Aim....................................................................................................................................... 5
Objectives ............................................................................................................................ 5
Research Questions ............................................................................................................ 5
Methodology ........................................................................................................................ 6
Search Strategy ........................................................................................................................... 6
Exclusion Criteria ........................................................................................................................ 6
Screening .................................................................................................................................... 7
Critical Appraisal ......................................................................................................................... 7
Results ................................................................................................................................. 7
Research Questions .................................................................................................................... 8
Discussion ......................................................................................................................... 19
Recommendations for Clinical Practice ..................................................................................... 19
Implications for Research .......................................................................................................... 21
Conclusion ......................................................................................................................... 22
Appendix 1: MEDLINE Search (2014) ............................................................................... 23
Appendix 2: MEDLINE Search (2016) ............................................................................... 24
References ........................................................................................................................ 25
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Topic
The use of airborne hydrogen peroxide (HP) for decontamination of the healthcare environment.
Background
Current microbiological and epidemiological evidence indicates that contaminated surfaces in
hospital settings can contribute to the transmission of nosocomial pathogens.1 In particular, there
appears to be a risk of pathogen acquisition from prior room occupants for methicillin-resistant
Staphylococcus aureus (MRSA), vancomycin-resistant enterococci (VRE), Clostridium difficile and
Acinetobacter baumannii.2 Accordingly, existing research implies that improved surface cleaning
and disinfection can reduce healthcare-associated infections.3
Manual processes for terminal cleaning are frequently sub-optimal, suggesting that automated
decontamination processes might offer an opportunity to improve cleaning efficacy and
consistency.4 There are two major airborne HP systems currently in use for environmental
decontamination: HP vapour devices that vaporise a solution of 30 – 35 % HP, and aerosolised HP
systems that dispense a dry aerosol of 3 – 7 % HP with or without the addition of silver ions.5
Automated mobile airborne HP devices can be placed in patient rooms following discharge as an
adjunct to terminal cleaning. However, airborne HP systems are suggested as a supplement to,
rather than a replacement for, standard discharge cleaning measures due to the requirement of
physical removal of dirt from surfaces.6
The advantages of airborne HP devices include greater laboratory sporicidal activity over UV light
devices, bactericidal effectiveness throughout an enclosed space including surfaces not in direct
line-of-sight (unlike UV light systems), and the lack of need to arrange furniture and equipment pre-
exposure to allow maximal disinfection.7 However, airborne HP systems require a longer
decontamination cycle than UV light systems, necessitating that patients rooms are unavailable to
admission for a longer time period.6 Their main disadvantages also include the requirement to
disable HVAC (heating, ventilation and air conditioning) systems, substantial set-up costs for
equipment, the necessity to remove staff and patients from the room before disinfection, and the
need to physically remove dirt and debris before use.7
It has been reported that airborne HP systems are capable of substantially reducing the number of
environmental C. difficile spores, indicating their applicability for the terminal cleaning of rooms
following the discharge of patients under contact precautions.8 The NHSScotland National Infection
Prevention and Control Manual9 currently recommends the use of a disinfectant solution at a
dilution of 1,000 parts per million (ppm) available chlorine for routine and terminal room cleaning
under transmission-based precautions. This review intends to assess the evidence base on the
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appropriateness of using airborne HP decontamination systems for both routine cleaning and
terminal (or discharge) cleaning in the healthcare environment.
Aim
To review the evidence base for using airborne hydrogen peroxide (HP) for decontamination of the
healthcare environment.
Objectives
• To provide a generic description of airborne HP decontamination systems, including the
proposed or actual mechanism of action and the procedure for use.
• To assess the scientific evidence for effectiveness of airborne HP decontamination
systems.
• To explore practical and safety considerations related to the use of airborne HP
decontamination systems.
• To explore the costs associated with airborne HP decontamination systems.
• To produce a concise evidence summary for airborne HP to assist the Equipment and
Environmental Decontamination Steering Expert Advisory Group in making practical
recommendations on the use of airborne HP decontamination systems for NHS Scotland.
Research Questions
The following research questions will be addressed:
1. Are airborne HP decontamination systems currently in use in UK healthcare settings?
2. What is the actual or proposed mechanism of action of airborne HP decontamination
systems?
3. What is the procedure for using airborne HP decontamination systems?
4. What is the scientific evidence for effectiveness of airborne HP for decontamination of the
healthcare environment?
5. Are there any safety considerations associated with using airborne HP decontamination
systems in the healthcare setting?
6. Are there any practical or logistical considerations associated with using airborne HP
decontamination systems in the healthcare setting?
7. What costs are associated with using airborne HP decontamination systems in the
healthcare setting?
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8. Have airborne HP decontamination systems been assessed by the Rapid Review Panel?
Methodology
Search Strategy
The following databases and websites were searched to identify relevant academic and grey
literature:
• MEDLINE
• CINAHL
• EMBASE
• NHS Evidence (http://www.evidence.nhs.uk/)
• Health Technology Assessment (HTA) database (http://www.crd.york.ac.uk/CRDWeb/)
• Database of Abstracts of Reviews of Effects (DARE) (http://www.crd.york.ac.uk/CRDWeb/)
• National Patient Safety Agency (NPSA) (http://www.npsa.nhs.uk/)
• National Institute for Health and Care Excellence (NICE) (http://www.nice.org.uk/)
• Medicines & Healthcare products Regulatory Agency (MHRA) (http://www.mhra.gov.uk/)
• Rapid Review Panel (RRP): product evaluation statements
(http://www.gov.uk/government/groups/rapid-review-panel/)
Search terms were developed and adapted to suit each database/website. Initial literature
searches were run between 24/06/2014 and 01/07/2014. For the update, the literature search was
performed on 08/08/2016. Different search strategies were applied in each year. See Appendix 1
for an example of the search run in the MEDLINE database in 2014 and Appendix 2 for an
example of the updated search conducted in 2016.
Exclusion Criteria
Academic and grey literature was excluded from the review on the basis of the following exclusion
criteria:
• Article was released before 2004
• Article was not published in the English language
• Article does not concern airborne hydrogen peroxide (HP) decontamination systems in the
healthcare environment (off-topic)
• Article is an opinion piece, a non-systematic review or a conference abstract
• Article does not present evidence compatible with the McDonald-Arduino evidentiary
hierarchy10
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• Article concerns a study that did not have an appropriate comparison in the form of
standard cleaning methods
Screening
There was a two-stage process for screening the items returned from the literature searches. In the
first stage, the title/abstract was screened against the exclusion criteria by the lead reviewer. Items
that were not excluded at the screening stage progressed to the second screening stage. In the
second stage of the screening process, the full text of remaining items was screened against the
exclusion criteria by the lead reviewer. Items that were not excluded at the second screening stage
were included in the review.
Critical Appraisal
Critical appraisal of the studies included in this review and considered judgement of the evidence
was carried out by the lead reviewer using the Scottish Intercollegiate Guidelines Network (SIGN)
methodology.11 The McDonald-Arduino evidentiary hierarchy was used as a framework for
assessing the evidence.10
Results
The search found 326 articles. After the first stage of screening this was reduced to 90 articles, and
after the second stage there were eight articles to critically appraise.12-19 The update search
retrieved a further 98 articles, of which 21 passed the first stage of screening, and three were
critically appraised.20-22 The 11 included studies used two different types of airborne HP
disinfection: 10 studies used HP vapour13-22 and two studies used aerosolised HP12;22 (one study
compared HP vapour with aerosolised HP22). Four of the 11 studies were conducted in the United
Kingdom (UK),13;16;18;19 three studies took place in the United States of America (USA),14;15;21 two
studies were situated in France,12;22 one study was conducted in the Netherlands,17 and another
study was set in Australia.20
All of the studies included a comparison with terminal cleaning methods. These included the use of
sodium hypochlorite solution at varying concentrations of available chlorine (e.g. 1,000 ppm and
2,000 ppm), quaternary ammonium compound disinfectants or neutral pH detergents. Many of the
studies were funded by the manufacturers of the airborne HP systems and, in a few instances, the
funding bodies were also involved in the design and execution of the projects. It is important to
bear this in mind when evaluating the findings.
Four of the 11 studies monitored the effect of airborne HP on the incidence of healthcare-
associated infections or patient acquisition of nosocomial pathogens.14;15;20;21 By contrast, seven of
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the studies evaluated the impact of airborne HP on the reduction of environmental
bioburden.12;13;16-19;22
There were a range of airborne HP disinfection systems available that exhibited effectiveness
against various comparison groups. Of the four studies that demonstrated greater levels of
effectiveness than terminal room cleaning with hypochlorite solution, two studies used aerosolised
HP disinfection devices12;22 and three studies used HP vapour systems15;17;22 (one study compared
both aerosolised HP and HP vapour systems with hypochlorite solution22). Two other studies
observed that terminal cleaning with hypochlorite solution exhibited similar effectiveness to HP
vapour devices.16;18 Of the five studies that demonstrated greater levels of effectiveness than
terminal room cleaning with quaternary ammonium disinfectants or detergents, all studies used HP
vapour disinfection.13;14;19-21
Research Questions
Are airborne HP decontamination systems currently in use in UK healthcare settings?
There is no mention of airborne HP decontamination systems in the NHSScotland National
Cleaning Services Specification.23 The NHSScotland National Infection Prevention and Control
Manual9 recommends that, should airborne HP decontamination systems be considered for
adoption in NHSScotland, a formal assessment of the cost, benefit, potential hazards and user
safety should be undertaken. The National Patient Safety Agency (NPSA) Revised Healthcare
Cleaning Manual24 and the Association of Healthcare Cleaning Professionals (AHCP) Revised
Healthcare Cleaning Manual25 both feature sections on airborne HP decontamination systems
alongside other new technologies for environmental disinfection. They summarise that the use of
airborne HP systems for disinfection of patient rooms is increasing, although there is currently
insufficient evidence to confirm their cost-effectiveness for routine cleaning.
These findings suggest that airborne HP decontamination systems are not widely in use within UK
healthcare settings.
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What is the actual or proposed mechanism of action of airborne HP decontamination systems?
HP is an oxidising agent, responsible for the production of free radicals that are capable of
damaging microbial DNA and cell constituents.26 There are a number of different methods of
airborne HP decontamination,5 two of the most commonly used being:
• Hydrogen peroxide vapour
• Aerosolised hydrogen peroxide
The HP vapour system manufactured by Bioquell® produces vapour from a 30 % HP solution.
These vapour particles are less than 1 micron in size, allowing the vapour to disperse effectively.
At the end of the process, the HP vapour is catalytically broken down into water and oxygen.27
The aerosolised HP system Sterinis® produces a dry mist by aerosolising a solution of 5 % HP,
consisting of < 50 ppm silver ions, < 50 ppm phosphoric acid, < 1 ppm gum arabic, and 95 % bi-
osmotic water. The aerosol is stabilised using silver ions and other chemicals to avoid aggregation
before the drops reach the target.12;28;29 The particles are electrically charged, ranging in diameter
from 8 to 12 microns, and are able to circulate freely in the air as a dry aerosol disinfectant with
access to all surfaces.12 This airborne HP system is alternately referred to as “dry mist” HP.12
Holmdahl et al.29 compared HP vapour and aerosolised HP systems and found that a key
difference was the peak HP concentration, which was twice as high in HP vapour systems than in
aerosolised HP systems, while the total HP concentration was also seen to be higher for HP
vapour.
What is the procedure for using airborne HP decontamination systems?
Airborne HP disinfection systems should only be used as a supplement to standard terminal
cleaning, as biological soiling of surfaces will reduce the effectiveness of decontamination.30 HP is
hazardous to human health, so it can only be used in areas which have been vacated by people
and, in some instances such as the use of HP vapour, properly sealed prior to the disinfection
process.31 This increases the time required for disinfection and the subsequent costs, since
airborne HP must only be applied in rooms that have been vacated. The time required for a cycle
of airborne HP disinfection is proportional to the size of the area to be disinfected.30
The HP vapour system produced by Bioquell® consists of four portable units: a generator unit to
produce HP vapour; an aeration unit to break down the HP vapour catalytically after the exposure
period; an instrumentation module which measures the concentration of HP, as well as the
temperature and relative humidity of the room; and a control computer situated outside the room.13
The generator unit is used to vaporise 30 % liquid HP at 130 oC and the vapour produced is
delivered via a dual axis vapour distribution system that ensures high kinetic energy and even
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distribution throughout the room.13 After decontamination has been completed, aeration units
inside the room catalytically convert the HP vapour into water and oxygen.13;32 The time required to
complete the process depends upon the size of the room, the process typically taking 90 minutes
for a single room.31
The HP vapour system manufactured by Steris® produces an aqueous solution of HP while
controlling the temperature and humidity levels within the room.33 It operates as a dry system,
reducing the relative humidity inside the room so that condensation does not form on surfaces.34
The HP vapour is degraded to oxygen and water in the aeration process, leaving behind no
chemical residues behind.33
The aerosolised HP system Sterinis® consists of a robot that can be pre-programmed to dispense
the required concentration of HP needed for full disinfection.12 The time taken to disinfect a room
depends on the volume of the room. The system uses Sterusil®, a mixture of HP (5 %), silver ions
(< 50 ppm) and phosphoric acid (< 50 ppm).32;35 The device needs to be placed in the corner of the
room as instructed by the user manual. According to the manufacturers, the technology uses the
processes of ionisation and nucleation to allow the small electrically charged droplets, which have
a particle size of approximately 8 to 12 microns, to bond to micro-organisms on surfaces or in the
environment.35 As with other airborne HP systems, disinfection may only take place within vacant
rooms. In the study by Barbut et al.12 it was not deemed necessary to seal the rooms, although the
doors and windows were closed.12;32
What is the scientific evidence for effectiveness of airborne HP for decontamination of the healthcare environment?
One cohort study,14 a cross-over study,22 six before-and-after studies,12;13;15;17;18;21 two interrupted
time series19;20 and a non-randomised trial16 evaluated the efficacy of airborne HP for
decontamination of the healthcare environment. It was demonstrated that this intervention could
reduce environmental surface contamination and decrease the incidence of healthcare-associated
infections.
As detailed in the methodology, the McDonald-Arduino evidentiary hierarchy10 was used as a
framework for assessing the evidence relevant to this research question.
Level V – Demonstration of reduced microbial pathogen acquisition (colonisation or infection) by patients via non-outbreak surveillance testing and clinical incidence:
Manian et al.15 compared standard methods of terminal isolation room cleaning with the use of HP
vapour and its impact on Clostridium difficile infection rates, using a before-and-after study. This
study monitored the number of cases of C. difficile-associated diarrhoea (CDAD) before (using
standard cleaning methods) and during the intervention periods (using HP vapour) and showed a
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37 % reduction in CDAD rates following its introduction. However, it is worth noting that this was a
single-centre study so the findings may not be transferable to other hospitals. It is also worth noting
that this study took place in the USA, where infection control practices may differ to those in the
UK: most notably, the use of quaternary ammonium compounds for terminal cleaning.
Horn and Otter21 undertook a before-and-after study (USA) in which patient room decontamination
was provided using HP vapour on the discharge of all patients with Clostridium difficile infection
(CDI), methicillin-resistant Staphylococcus aureus (MRSA), vancomycin-resistant enterococci
(VRE) or extended-spectrum beta-lactamases (ESBL) producing Gram-negative bacteria. After the
12-month baseline period, in which non-specified standard discharge cleaning was performed,
rates of nosocomial infections were measured over the following 24 months. Over the intervention
period, there was a decrease in CDI from 1.38 to 0.90 cases per 1,000 patient-days (p = 0.009), a
decrease in VRE from 0.21 to 0.01 (p < 0.001), and a decrease in ESBL producing bacteria from
0.16 to 0.01 (p = 0.001). There was also a decrease in MRSA, although this reduction was not
statistically significant (p = 0.188). The authors concluded that using HP vapour for disinfection
was more effective than standard discharge cleaning. However, the standard cleaning practices in
use were not specified and may not represent current practice within NHSScotland. Improvements
in hand hygiene were judged by the authors to be likely to have contributed to the reduction in
infection rates and, therefore, this is a probable confounding factor. One of the authors is employed
part-time by Bioquell®, the manufacturer of a HP vapour system. For this reason, there is the
possibility of investigator bias due to financial interests.
Passaretti et al.14 compared the risk of acquiring multidrug resistant organisms (MDROs) in
patients admitted to a room decontaminated using HP vapour compared to a room disinfected
using standard methods. This was a prospective cohort intervention study comparing acquisition
rates of MDROs. Patients in the HP vapour cohort were significantly less likely to acquire any
MDROs than the patients in the standard cleaning cohort, even after adjustment for confounding
factors; essentially HP vapour used in addition to standard cleaning reduced the risk of MDRO
acquisition by 64 %. This reduction of MDRO acquisition was largely due to patients in the HP
vapour cohort being five times less likely to acquire VRE than the standard cleaning cohort;
reductions in the rates of MRSA, MDR-Gram-negative rods and C. difficile were not statistically
significant. Comparison of the cohorts indicated that over an 18-month period 28 MDRO
transmissions were likely to have been prevented by the use of HP vapour in three units. HP
vapour decontamination also decreased levels of environmental contamination, particularly in
rooms with multiple MDROs. However, it is worth noting that this study took place in a single
institution, so the results are not necessarily amenable to generalisation. It is also significant that
this study was conducted in the USA, which may have led to different infection control practices,
including the use of quaternary ammonium cleaning products as part of a terminal clean. The
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authors also note that there were other infection prevention initiatives ongoing at the time of the
study. In addition, Bioquell® (the manufacturers of a HP vapour system) contributed to the study
design, collection of data and the writing of the report, increasing the risk of investigator bias.
Mitchell et al.20 conducted an interrupted time series in a public hospital (Australia) that introduced
a combination of HP vapour for single rooms (n = 1363) and HP wipes for shared rooms (n = 349),
after discharge of patients either colonised or infected with MRSA. Following a baseline period of
12 months, in which terminal discharge room cleaning was provided using neutral pH detergent (n
= 1917), airborne HP was utilised by in-house hospital cleaning staff for a further period of 24
months. After the intervention was introduced, the incidence of MRSA acquisition reduced from 9.0
to 5.3 per 10,000 patient-days (p < 0.001). Meanwhile the incidence of MRSA bacteraemia also
reduced from 0.16 to 0.11 per 10,000 patient-days, although this change was not statistically
significant (p = 0.58). The authors concluded that using HP vapour and HP wipes in combination
was more effective than detergent cleaning alone. Detergent cleaning is not recommended
practice for discharge cleaning of MRSA-contaminated patient rooms in NHSScotland; thus, it does
not make a suitable comparator. In addition, the study combines multiple intervention components,
so it is not possible to determine whether this impact was solely due to the use of HP vapour or HP
wipes. A number of potential confounders were recognised: additional MRSA screening, changing
antimicrobial consumption, staff feedback on terminal cleaning, and quicker laboratory methods of
MRSA isolation. However, hand hygiene compliance was consistent throughout the study duration.
Level IV – Demonstration of reduced microbial pathogen acquisition (colonisation or infection) by patients via outbreak surveillance testing and clinical incidence:
No evidence identified.
Level III – Demonstration of in-use bioburden reduction that may be clinically relevant:
Otter et al.19 assessed the efficacy of terminal cleaning and HP vapour for the decontamination of
environmental surfaces in the ward side-room of a patient with an extensive history of MRSA,
Gram-negative rods (GNRs) and VRE infection and colonisation. The rate of environmental
recontamination following HP vapour decontamination was also assessed. Terminal cleaning
reduced the number of sites with MRSA from 60 % to 40 % and, for GNRs, from 30 % to 10 %. HP
vapour reduced the number of sites with MRSA to 3.3 % and no GNRs were isolated. VRE was
isolated from 6.7 % of sites before and after cleaning but was not isolated from any sites after HP
disinfection. The patient remained colonised with MRSA during and after both experiments, so HP
vapour decontamination did not lead to the decolonisation of the patient through removal of the
environmental reservoir. This might have been due to the intrinsic colonisation of the patient
leading to recontamination of the environment immediately after cleaning occurs. However, the
GNRs seen in the environment did not match the species infecting or colonising the patient, so it is
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unlikely that the patient was the source of the GNRs. It is worth noting that only 15 sample sites
were used for the environmental sampling and that only one patient was included in the study.
Terminal cleaning was conducted using quaternary ammonium compounds – a product that is not
currently recommended by the NHS in Scotland.
Level II – Demonstration of in-use bioburden reduction effectiveness:
Otter et al.17 compared the effect of a terminal clean using 2,000 ppm hypochlorite solution with the
use of HP vapour to remove environmental reservoirs of multidrug resistant GNRs during an
outbreak. In this study, 10 of 21 areas yielded GNRs after a terminal clean; however, no GNRs
were found after the use of HP vapour. The study also looked at acquisition rates of MDROs and
found no new cases until at least 3 months after HP vapour disinfection had taken place. This
would indicate that HP vapour was more effective at removing GNRs from surfaces than a terminal
clean with hypochlorite solution, and that the chain of transmission was broken during the
outbreak. However, this study used a before-and-after study design, whereas a cohort design
might have allowed a more appropriate comparison to be made. No rationale was provided for the
use of hypochlorite with 2,000 ppm available chlorine over the concentration of 1,000 ppm
currently recommended in NHS Scotland. In addition, there were a limited number of sample sites
used and the study took place on a single site in a hospital in the Netherlands, so the results
cannot be generalised.
Barbut et al.12 compared the efficacy of an aerosolised (or “dry mist”) HP system with a
hypochlorite solution containing 5,000 ppm available chlorine for eradicating C. difficile spores.
There were 31 rooms included in this study; 15 rooms were treated with HP and 16 rooms were
treated with hypochlorite. Before cleaning, C. difficile spores were detected in 21 % of surface
samples and 74 % of rooms. After disinfection, the percentage of samples showing environmental
contamination decreased in both arms; spores were detected in 12 % of samples from the
hypochlorite-treated rooms and 2 % of the HP-treated rooms. The decrease in the percentage of
contaminated samples was significantly greater in the HP group (91 %) than in the hypochlorite
group (50 %). The percentage of rooms with at least one sample positive for C. difficile in the
hypochlorite disinfection arm was 69 % before treatment and 50 % after treatment. In the HP
disinfection arm, the percentage of rooms with at least one sample positive for C. difficile was 80 %
before treatment and 20 % after treatment. This demonstrates that the aerosolised HP system had
a greater efficacy for the removal of C. difficile than 5,000 ppm hypochlorite. This study took place
in two university hospitals in France. The study was financially supported by Sterinis® (the
manufacturer of the HP system used). The company also provided the reagents, equipment and
contributed to the costs of consumables, potentially leading to a conflict of interest. No rationale
was provided for the use of hypochlorite with 5,000 ppm available chlorine rather than the
concentration of 1,000 ppm currently recommended in NHSScotland.
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French et al.13 compared terminal cleaning and HP vapour decontamination of a hospital
environment using the presence of MRSA as an outcome measure. Using matched sites, 90 % of
248 sites had MRSA before terminal cleaning and 66 % had MRSA after terminal cleaning. 72 % of
85 sites had MRSA before HP vapour disinfection and 1.2 % of sites had MRSA after HP
disinfection. These results indicated that HP vapour was more effective at removing environmental
MRSA than standard terminal cleaning. However, a few points are important to bear in mind: firstly,
this study took place in 2004 and HP vapour technology has changed significantly since then, in
terms of the equipment available and the time taken for decontamination to take place. Secondly,
standard terminal cleaning used a solution of detergent sanitiser containing 5 – 15 % non-ionic
surfactant and 5 – 15 % cationic surfactant, diluted at a ratio of 1:500, which is not in line with
current guidance in Scotland. The study was funded by Bioquell®, a company that also declares
an involvement in the conception, design and execution of the project. There is no mention of the
rooms being cleaned before HP vapour decontamination took place, despite current guidance
stating that this could impact on the results observed.
Doan et al.16 investigated and compared the effectiveness of HP vapour with standard hypochlorite
cleaning using 1,000 ppm available chlorine to decontaminate rooms contaminated with C. difficile
027. The clinical effectiveness was measured using standardised median log10 reductions in colony
counts and, based on this measurement, the chlorine releasing agent was found to be as effective
as HP vapour. However, despite standardised techniques, each room started at different baseline
counts of C. difficile spores and, even with a standardised inoculation density, it was not possible
to control how many C. difficile spores germinated and how many bacteria grew. This variability in
results was compensated for in the statistical analysis by using median values and standardised
reduction.
Blazejewski et al.22 embarked upon a randomised cross-over study in a university hospital (France)
that randomly allocated patient rooms to either HP vapour (n = 93) or aerosolised HP/peracetic
acid (n = 89) for disinfection, after standard terminal cleaning using quaternary ammonium
compounds, detergent and a sodium hypochlorite solution. A total of 24 environmental
microbiological samples were collected per room, from eight high-touch surfaces, at three time
points: after patient discharge, after standard cleaning, and after HP disinfection. Standard terminal
cleaning reduced environmental bacterial load (p < 0.001) without affecting MDRO contamination
(p = 0.371). But HP reduced environmental MDRO contamination from 6 % to 0.5 % (p = 0.004),
although no significant difference was found between HP vapour and aerosolised HP/peracetic
acid. The authors concluded that both HP systems were more effective at reducing environmental
contamination than standard terminal cleaning. The prevalence of MDRO within the patient rooms
was relatively low (8%); therefore, the sample size (which was calculated assuming a prevalence
of 30 – 40 %) may not have been large enough to detect a statistically significant difference
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between the two HP systems. In addition, Bioquell® and Anios® donated the airborne HP systems
for the trial. Although neither company had any role in the data analysis or reporting, Bioquell® did
contribute to the study design. This raises the possibility of investigator bias due to financial
interests.
Level I – Laboratory demonstration of bioburden reduction efficacy:
Lawley et al.18 used C. difficile spores as an outcome measure to evaluate hypochlorite solution
with 10,000 ppm available chlorine in relation to 3 % and 10 % HP vapour provided by Sigma®
and Bioquell®. They demonstrated that C. difficile spores were inactivated by 10,000 ppm
hypochlorite as well as 10 % HP vapour. They also investigated the time dependency involved in
the use of HP vapour, demonstrating that prolonged exposure was required to achieve a six-log
reduction of bacterial spores (20 minutes at 10 %).
To summarise the evidence, it can be concluded that there is low- to moderate-quality evidence to
support the use of airborne HP decontamination as an adjunct to standard cleaning procedures in
the healthcare environment. In accordance with SIGN methodology, the cohort study constituted
level 2+ evidence (well-conducted controlled analytic studies with a low risk of confounding, bias,
or chance and a moderate probability that the relationship is causal). In contrast, the cross-over
studies, before-and-after studies and interrupted time series were all designated level 3 evidence
(uncontrolled analytic studies).
Are there any safety considerations associated with using airborne HP decontamination systems in the healthcare setting?
Chlorine-releasing agents are considered easy-to-use and the least expensive environmental
disinfection method available. However, they do feature a number of limitations such as the
release of irritating vapours and toxic gases which may affect the eyes and respiratory tracts of
healthcare workers at high concentrations (i.e. 10,000 ppm available chlorine), and personal
protective equipment is recommended for this reason. Sodium hypochlorite-based products can be
corrosive to various materials and potentially cause damage to environmental surfaces. In addition,
the disinfection process must be performed manually, which can be time-consuming, with the
quality of disinfection depending on the staff member performing the procedure. This has led to a
renewed interest in alternative methods of environmental decontamination.12;16;36
HP appears to have low levels of toxicity and, as it degrades into oxygen and water, it is
compatible with most materials. Monitoring units are able to measure the residual concentrations of
HP and ensure that exposure is appropriate.12;30 Johnston et al.37 found HP vapour to be safe and
environmentally-compatible for decontaminating areas such as biological safety cabinets and
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microbiology containment laboratories. Passaretti et al.14 have also reported no safety, equipment,
or material compatibility concerns.
Ernstgard et al.38 tested the effects of exposure to HP vapour in humans. The key limitation of this
study was that only 11 people were included. In this study, no exposure-related effects on
pulmonary function were observed. Similarly, there were no exposure-related effects on markers of
inflammation or coagulation. Mild irritation of the upper respiratory airways was observed when
people were exposed to HP vapour at 2.2 ppm, though no effects were observed at 0.5 ppm.
There were no effects on lung function or inflammatory markers at either exposure level.
Manian et al.15 state that they found HP vapour to be safe with no instances of vapour leaking
outside the sealed rooms during the decontamination process. During their intervention, there were
no significant adverse reactions attributed to HP vapour in either patients or healthcare workers.
Barbut et al.12 compared an aerosolised HP disinfection system with a hypochlorite clean and
found that the HP-based formulations had greater material compatibility, while also being less toxic
to human beings and the environment. The aerosolised HP system also had an advantage over
HP vapour systems in that, while disinfection still needs to take place in a vacant room, there is no
need to seal the room.
Are there any practical or logistical considerations associated with using airborne HP decontamination systems in the healthcare setting?
Airborne HP decontamination offers a number of benefits compared to standard cleaning with
hypochlorite. Automated HP systems are not subject to user error in the way that manual cleaning
may be. The quality of manual cleaning can vary and has been shown to be suboptimal, not least
because manual cleaning is limited to areas that are easily accessible.32;39 Airborne HP can reach
sites that would be inaccessible for cleaners, such as cracks, crevices or other hard-to-reach
surfaces.30;39;40 Airborne HP can also be used to decontaminate electrical equipment which may be
damaged by the use of cleaning liquids.40 Equipment that may be missed in standard
decontamination can be collected together in a room and effectively decontaminated at the same
time using airborne HP.16
HP systems are able to ensure adequate contact times between the disinfectant and
environmental sites, ensuring the application of correct disinfectant concentrations. These are key
issues for the effectiveness of the disinfection process, and can be achieved more successfully by
using pre-programmed robots rather than relying on cleaning personnel.30;39;40
There a number of practical and logistical considerations with using airborne HP systems. One key
limitation is the need to remove debris and organic matter from all surfaces so that the HP is not
prevented from accessing micro-organisms.40 Pottage et al.34 found that biological soiling reduced
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the efficacy of airborne HP decontamination. Their study demonstrated that the presence of
organic matter resulted in a slower inactivation of bacteriophage using HP vapour decontamination
and that this was exacerbated as the concentration of organic matter increased. This highlights the
importance of effective cleaning prior to gaseous disinfection especially in the hospital setting
where infective agents are likely to be suspended in body fluids. Therefore, it is recommended that
surfaces are manually cleaned with appropriate disinfectants prior to the deployment of airborne
HP decontamination.
The use of all airborne HP decontamination systems require the area to be vacated for the duration
of the decontamination process.14 If a hospital ward needs to be decontaminated, then the whole
ward needs to be moved to alternative accommodation which is a major undertaking and depends
on the availability of additional space.40;41 If HP vapour is used then all heating, ventilation and air
conditioning ducts in the area to be decontaminated must be sealed, along with any doors.14;42 The
airborne HP systems require a team of trained personnel to operate the specialised machinery.16;41
Airborne HP decontamination is relatively time-consuming, even if it is limited to rooms rather than
wards. This is due to the need for an effective initial clean, followed by the use of airborne HP
decontamination and aeration processes, and then monitoring of the environment to ensure that it
is safe to re-enter. This entails a longer process than a standard clean.40;41 If it could be applied
without the need to wait for a deep clean to take place, the process would be easier, less time-
consuming and more cost-effective for healthcare use.41
Another key issue to be considered when using airborne HP decontamination is the rapid rate of
recontamination with pathogens that occurs as soon as patients are readmitted.27 Best et al.40
highlighted this issue in their study investigating the effectiveness of airborne HP against C. difficile
infection (CDI). They found that the rate of CDI influenced how long the enhanced antimicrobial
effectiveness of airborne HP lasted, and depended on whether the ward it was used in was in an
outbreak or non-outbreak setting. Their results demonstrated that airborne HP may be a useful
decontamination method for a hospital ward with a high incidence of CDI.
What costs are associated with using airborne HP decontamination systems in the healthcare setting?
Airborne HP systems are significantly more expensive than the hypochlorite solutions used in
standard cleaning. Doan et al.16 compared the cost-effectiveness of HP vapour and a chlorine-
releasing agent. Their studies demonstrated that the chlorine-releasing agent cost £14.14 per use
and £149.65 per month, compared with £108.96 per use and £1,154.98 per month for HP vapour.
They concluded that HP vapour was more effective at reducing spore counts than the chlorine-
releasing agent but was also more expensive. They found that there was insufficient evidence for
the cost-effectiveness of HP over traditional hypochlorite based cleaning.
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Best et al.40 report that the cost of using airborne HP amounted to about £7,000 per ward, including
staff costs and materials, and therefore may only be justifiable in some cases, e.g. following an
outbreak. The requirement for areas to be vacated while they are being decontaminated using
airborne HP systems incurs additional costs and can potentially lead to delays in bed availability.14
Another factor to consider in terms of the cost of airborne HP decontamination is the rapid rate of
recontamination seen to take place.41
Have airborne HP decontamination systems been assessed by the Rapid Review Panel?
The Rapid Review Panel43 (RRP) is a panel of UK experts established by the Department of Health
to review new technologies with the potential to aid in the prevention and control of healthcare-
associated infections. The RRP has reviewed a number of airborne HP disinfection products
between 2005 and 2008:
2005: Sterinis (Related Life Sciences Ltd)
2007: Bioquell Hydrogen Peroxide Vapour System (Bioquell)
2008: Vaporised Hydrogen Peroxide (Steris)
The aerosolised HP system Sterinis® was assessed in 2005 and awarded a recommendation 4
status. The RRP has since altered their recommendation system to encompass 4a and 4b
categories:
“Not a significant improvement on equipment/materials/products already available which claim to
contribute to reducing health care associated infection; no further consideration needed.” (R4a)
“Unlikely to contribute to the reduction of health care associated infection; no further consideration
needed.” (R4b)
A HP vapour system produced by Bioquell® was assessed in 2007 and awarded a
recommendation 1 status:
“Basic research and development, validation and recent in use evaluations have shown benefits
that should be available to NHS bodies to include as appropriate in their cleaning, hygiene or
infection control protocols.” (R1)
A HP vapour system produced by Steris® was assessed in 2008 and awarded a recommendation
2 status:
“Basic research and development has been completed and the product may have potential value;
in use evaluations/trials are now needed in an NHS clinical setting.” (R2)
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Discussion
This systematic review incorporated the results of 11 studies into its findings. The quality of
included studies was predominantly of level 3 (low-quality) evidence; however, there was one
study classified as level 2+ (moderate-quality) evidence. The study design of choice was a
before-and-after study, an interrupted time series or a cohort study. They primarily concerned
either in-use bioburden reduction (level III) or reduced microbial pathogen acquisition in a non-
outbreak setting (level V). The findings identified by the review were used to develop the following
recommendations for clinical practice.
Recommendations for Clinical Practice
This review makes the following recommendations based on an assessment of the extant
professional literature on airborne hydrogen peroxide (HP) systems for environmental
decontamination:
• Airborne HP systems can be used as an adjunct to manual cleaning when performing
terminal room decontamination.
(Grade C recommendation)
• The use of airborne HP systems for environmental decontamination should only be adopted
following completion of a manual clean as residual dirt can reduce efficacy.
(Grade D recommendation)
• Prior to an airborne HP system being considered, an assessment of the area to be
decontaminated must be undertaken to ensure the area can be sealed and the use of HP
made safe.
(Grade D recommendation)
• Airborne HP systems must only be used in an area which has been cleared of all patients
and staff. No entry to the decontamination area is allowed once the decontamination
process has commenced.
(Grade D recommendation)
• Consideration must be given to whether airborne HP will interact with the fire alarm system
and, if so, ensure that local estates are involved to isolate the fire alarm system.
(Grade D recommendation)
• Airborne HP systems in use must be maintained in good working order and a system of
programmed maintenance in place with documented evidence.
(Good Practice Point)
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• Airborne HP may be considered for cleaning of the environment and/or equipment where
ongoing transmission of an organism has occurred and the environment and/or equipment
is considered the route of transmission.
(Good Practice Point)
• Airborne HP systems should not be used for routine cleaning.
(Grade D recommendation)
• If fumigation is the recommended decontamination process (e.g. disinfection of Ebola-
contaminated equipment), then HP should be considered.
(Good Practice Point)
• The use of airborne HP cleaning does not reduce the importance of general cleaning
routinely and between patients.
(Good Practice Point)
• All users of airborne HP systems, whether an NHS Board employee or an external
contractor, must be trained in the product use and potential hazards of the system, and
have assurance of product safety.
(Good Practice Point)
• A Standard Operating Procedure (SOP) must be established and detail processes of when
and how airborne HP cleaning is used regardless of the provision of use by NHS Boards or
external contractors.
(Good Practice Point)
• Validation processes must be in place by NHS Boards and external contractors following
decontamination to ensure the healthcare environment is clean.
(Good Practice Point)
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Implications for Research
The review identified several gaps in the literature in relation to airborne HP decontamination
systems. Many of the relevant studies identified could not be included in this review as they did not
make a suitable comparison in the form of standard cleaning as recommended for NHSScotland in
the National Infection Prevention and Control Manual.9 These studies variously compared the use
of airborne HP disinfection with sodium hypochlorite at a range of concentrations, quaternary
ammonium compound disinfectants, or the use of detergent only. Future studies assessing the
clinical effectiveness of airborne HP systems for decontamination should include suitable
comparison groups to enable the results to be transferable to clinical practice within NHSScotland.
It was also notable that several of the studies combined multiple infection control interventions with
the use of airborne HP disinfection, such as the simultaneous introduction of airborne HP and HP
wipes, the provision of staff feedback on terminal cleaning, and additional screening for colonised
patients. Ideally, studies that evaluate the effectiveness of airborne HP decontamination systems
should exclude other infection control interventions in order to minimise the risk of confounding
factors producing a spurious result.
Finally, very few studies thus far have evaluated the cost-effectiveness of airborne HP
decontamination systems. Of the few that have, the majority have primarily considered the capital
costs of the necessary equipment and the cost of manual labour to operate the devices, in
comparison against the costs of disinfectants used for traditional cleaning. It can be seen from
these studies that a comprehensive cost-effectiveness evaluation for the use of airborne HP
decontamination systems in NHSScotland would be timely.
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Conclusion
The contribution of environmental contamination in healthcare settings to the cross-transmission of
nosocomial infections has been thoroughly demonstrated: firstly, by interventional studies in which
improved surface cleaning has reduced the incidence of HAIs;1 and secondly, by observational
studies which have evidenced the higher risk of pathogen acquisition in patients admitted to rooms
where the prior occupant was known to be infected or colonised.2 Airborne hydrogen peroxide (HP)
decontamination systems provide an example of a novel technology that may supplement standard
cleaning practices and potentially further reduce the transmission of nosocomial pathogens. This
review aimed to provide a concise evidence summary outlining: the evidence of effectiveness for,
the practical and safety considerations of, and the costs associated with, the use of airborne HP
decontamination systems.
The review found that there was a larger quantity of evidence supporting the use of HP vapour
systems than aerosolised HP systems, although this evidence was of low- to moderate-quality.
Nine of the eleven studies demonstrated that using airborne HP systems after standard cleaning
was more effective than standard cleaning alone. For four of these studies, airborne HP was more
effective than hypochlorite while for five of the studies, airborne HP was more effective than
quaternary ammonium disinfectants or detergents. The two other studies showed that airborne HP
systems were similar in effectiveness to hypochlorite solution. However, the studies often lacked a
concurrent control group and frequently combined multiple infection control interventions within a
single study. In addition, the standard cleaning measures adopted did not always reflect current
best practice recommended for use in NHSScotland.
To ensure staff and patient safety, it is recommended that all personnel should be cleared from the
room before use and that the room should be closed to entry for the duration. There is a risk that
airborne HP systems can interfere with the normal operation of heating, ventilation and air
conditioning systems. Consideration should be given to whether airborne HP devices will interact
with these systems and, if so, measures should be implemented to disable them. There has also
been little in the way of cost-effectiveness evaluations of airborne HP systems in the UK.
The Rapid Review Panel (RRP) has evaluated three airborne HP disinfection systems: one that
uses aerosolised HP and two that use HP vapour. Both HP vapour devices were assigned a
recommendation grade of 1 or 2. This classification advises that the product has either shown
benefits that should be available to NHS bodies or that the product may have potential value, and
that in-use evaluations are needed in an NHS clinical setting. The only aerosolised HP device was
categorised with a grade 4: a product that does not show a significant improvement over the
alternatives currently available.
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Appendix 1: MEDLINE Search (2014)
Ovid MEDLINE(R) 1946 to present with daily update
AND
Ovid MEDLINE(R) In-process & other non-indexed citations
Search dates
24/06/2014 and 25/06/2014
1 (all “OR”) 2 (all “OR”) 3 (all “OR”)
Hydrogen peroxide/ hydrogen peroxide.mp. HPV.mp.
AND
Sterilization/ Decontamination/ Disinfection/ Housekeeping, Hospital/ clean*.mp.
AND
Aerosols/ Volatilization/ mist*.mp. fog*.mp. vapo?r*.mp.
Limits
English Language
Publication Year 2004 – 2014 Results: 136
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Appendix 2: MEDLINE Search (2016)
Ovid MEDLINE(R) 1946 to present with daily update
Search dates
08/08/2016
1 (all “OR”) 2 (all “OR”)
(hydrogen peroxide adj2 disinfect*).mp. (hydrogen peroxide adj2 decontaminat*).mp. (hydrogen peroxide adj2 vapo?r*).mp. (hydrogen peroxide adj2 aerosol*).mp.
AND
Sterilization/ Decontamination/ Disinfection/ Housekeeping, Hospital/ clean*.mp.
Limits
English Language
Publication Year 2014 – Current Results: 28
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References
(1) Otter JA, Yezli S, Salkeld JA, French GL. Evidence that contaminated surfaces contribute to the transmission of hospital pathogens and an overview of strategies to address contaminated surfaces in hospital settings. AM J INFECT CONTROL 2013;41:S6-S11.
(2) Mitchell BG, Dancer SJ, Anderson M, Dehn E. Risk of organism acquistion from prior room occupants: a systematic review and meta-analysis. J HOSP INFECT 2015;91:211-7.
(3) Donskey CJ. Does improving surface cleaning and disinfection reduce health care-associated infections? AM J INFECT CONTROL 2013;41:S12-S19.
(4) Carling P. Methods for assessing the adequacy of practice and improving room disinfection. AM J INFECT CONTROL 2013;41:S20-S25.
(5) Boyce JM. Modern technologies for improving cleaning and disinfection of environmental surfaces in hospitals. Antimicrobial Resistance and Infection Control 2016;5(1):10.
(6) Dancer SJ. Controlling hospital-acquired infection: focus on the role of the environment and new technologies for decontamination. Clinical Microbiology Reviews 2014;27(4):665-90.
(7) Weber DJ, Kanamori H, Rutala WA. 'No touch' technologies for environmental decontamination: focus on ultraviolet devices and hydrogen peroxide systems. Current Opinion in Infectious Diseases 2016 Aug;29(4):424-31.
(8) Rutala WA, Weber DJ. Monitoring and improving the effectiveness of surface cleaning and disinfection. AM J INFECT CONTROL 2016;44:e69-e76.
(9) Health Protection Scotland. National Infection Prevention and Control Manual. 2016 http://www.nipcm.hps.scot.nhs.uk/
Accessed:8-8-2016
(10) McDonald LC, Arduino M. Climbing the evidentiary hierarchy for environmental infection control. Clinical Infectious Diseases 2013;56(1):36-9.
(11) Scottish Intercollegiate Guidelines Network. SIGN 50 A guideline developer's handbook. 2015 http://sign.ac.uk/pdf/sign50.pdf
Accessed:8-8-2016
(12) Barbut F, Menuet D, Verachten M, Girou E. Comparison of the efficacy of a hydrogen peroxide dry-mist disinfection system and sodium hypochlorite solution for eradication of clostridium difficile spores. Infection Control and Hospital Epidemiology 2009;30(6):507-14.
(13) French GL, Otter JA, Shannon KP, Adams NMT, Watling D, Parks MJ. Tackling contamination of the hospital environment by methicillin-resistant Staphylococcus aureus (MRSA): A comparison between conventional terminal cleaning and hydrogen peroxide vapour decontamination. J HOSP INFECT 2004;57(1):31-7.
(14) Passaretti CL, Otter JA, Reich NG, Myers J, Shepard J, Ross T, et al. An evaluation of environmental decontamination with hydrogen peroxide vapor for reducing the risk of patient acquisition of multidrug-resistant organisms. Clinical Infectious Diseases 2013;56(1):27-35.
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Literature Review and Practice Recommendations: Existing and emerging technologies used for decontamination of the healthcare environment: Airborne Hydrogen Peroxide
Version 1.1. December 2016 Page 28 of 28
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