ENDOQUATTM

DISINFECTANT AND SANITIZER

HEALTHHEALTH
TECHNOLOGY
TECHNOLOGYASSESSMENT SECTION
ASSESSMENT SECTION
MEDICAL DEVELOPMENT DIVISION
MINISTRY OF HEALTH MALAYSIA
MEDICAL DEVELOPMENT DIVISION
SERIAL NO 008/13

MINISTRY OF HEALTH MALAYSIA

008/2013
DISCLAIMER

Technology review is a brief report, prepared on an urgent basis, which draw on

restricted reviews from analysis of pertinent literature, on expert opinion and / or
regulatory status where appropriate. It has been subjected to an external review
process. While effort has been made to do so, this document may not fully reflect all
scientific research available. Additionally, other relevant scientific findings may have
been reported since completion of the review.

Please contact: htamalaysia@moh.gov.my, if you would like further information.

Health Technology Assessment Section,

Medical Development Division
Ministry of Health Malaysia
Level 4, Block E1, Precinct 1
Federal Government Administrative Centre
62590 Putrajaya

Tel: 603 88831246

Fax: 603 8883 1230

Available at the following website: http://www.moh.gov.my

ii
Prepared by:
Dr. Roza binti Sarimin
Senior Principal Assistant Director
Health Technology Assessment Section
Ministry of Health Malaysia

Reviewed by:

Datin Dr. Rugayah binti Bakri

Deputy Director
Health Technology Assessment Section
Ministry of Health Malaysia

Dr. Izzuna Mudla Mohamed Ghazali

Senior Principal Assistant Director
Health Technology Assessment Section
Ministry of Health Malaysia

External reviewer:

Dr. Ker Hong Bee

Consultant Infectious Disease Physician
Hospital Raja Permaisuri Bainun, Ipoh, Perak

DISCLOSURE
The authors of this report have no competing interest in this subject and the preparation
of this report is totally funded by the Ministry of Health, Malaysia.

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EXECUTIVE SUMMARY
Introduction
Disinfection is a thermal or chemical process that eliminates many or all pathogenic
microorganisms on inanimate objects, which is classified by product label claims
(USEPA) and by germicidal activity (USCDC/USFDA). Sanitizer is an agent that
reduces the number of bacterial contaminants to safe level as judged by public health
requirements and registered by USEPA for public health uses. The active ingredient of
EndoQuatTM Disinfectant and Sanitizer was Quartenary Ammonium compounds (fourth
generation), a low-level disinfectant which can be used in ordinary environmental
sanitation of non-critical surfaces, as classified by USCDC. EndoQuatTM Disinfectant
and Sanitizer was claimed effective to be applied as surface disinfectant however its
claim remains uncertain. This review was requested by the Senior Principal Assistant
Director, Disease Control Division, Ministry of Health Malaysia to review the evidence
on EndoQuatTM Disinfectant and Sanitizer to be used as surface disinfectant in the MOH
hospitals and healthcare facilities following a proposal from a company to introduce
them in the MOH facility.

Aims/Objectives
To assess the eficacy, safety and cost effectiveness of EndoQuatTM Disinfectant and
Sanitizer to be used as surface disinfectant in the MOH hospitals and healthcare
facilities.

Results and conclusion

There was no retrievable published evidence on the efficacy, safety and cost
effectiveness of EndoQuatTM Disinfectant and Sanitizer. Only limited unpublished low
quality evidence and certification document provided by the manufacturer was available.
Nevertheless, it showed that the EndoQuatTM Disinfectant and Sanitizer was effective
against bacteria, fungi, spore, tubercle bacilli and virus. It also possessed
tuberculocidal activity which can be classified as intermediate-level disinfectant
according to the USCDC. EndoQuatTM Disinfectant and Sanitizer was also registered
with the USEPA (Registration Number 1839-83), and gained recognition from DEFRA.

Methods
Literature were searched through electronic databases which included PubMed,
Medline, Cochrane Database of Systematic Reviews, Cochrane Database of Controlled
Trial, Health Technology Assessment, National Horizon Scanning, other websites;
INAHTA, ASERNIP-S, CADTH, FDA, MHRA and general databases such as Google.
Additional articles retrieved from reviewing the bibliographies of retrieved articles or
contacting the authors. A critical appraisal of all relevant literature was performed using
Critical Appraisal Skills Programme (CASP) checklists and the evidence graded
according to the US/Canadian Preventive Services Task Force Level of Evidence
(2001).

iv
ENDOQUATTM DISINFECTANT AND SANITIZER

1.0 INTRODUCTION
Disinfection is a thermal or chemical process that eliminates many or all pathogenic
microorganisms on inanimate (nonliving) objects. In contrast to sterilization,
disinfection is not sporicidal.1 A few disinfectants will kill spores with prolonged
exposure times (3 to 12 hours); which are called as chemical sterilants. Disinfectants
are classified by product label claims of “limited”, “general” or “hospital disinfection”
[US Environmental protection Agency (USEPA)]2 and by germicidal activity [(US
Centre for Disease Control and Prevention USCDC/US Food and Drug
Administration (USFDA)]1,3 as described in Appendix 1.

Disinfection is classified by its germicidal activity as below:

High level disinfection (at similar concentrations with chemical sterilant but with
shorter exposure periods which expected to destroy all microorganisms except
large numbers of bacterial spores);
Intermediate-level disinfectants (might be cidal for mycobacteria, vegetative
bacteria, most viruses, and most fungi but do not necessarily kill bacterial spores)
and
Low-level disinfectants (can kill most vegetative bacteria, some fungi, and some
viruses in a practical period of time (<10 minutes)).1

The USFDA definition of high level disinfection is a sterilant used for a shorter
contact time to achieve a 6-log10 kill of an appropriate Mycobacterium species.3

The European Norm (EN) test requirement for bactericidal activity is a ≥5.0 log10
reduction, for virucidal and fungicidal activity is ≥4.0 log10 reduction and for sporicidal
activity a is ≥3.0 log10 reduction.4

Methods of sterilization and disinfection of medical devices by levels of germicidal

activity and categorization of items for patient care (critical, semi-critical and non-
critical based on degree of risk to patient safety) has been described (in Appendix
2). The methods should be followed to ensure disinfection is adequate in providing a
safe patient environment.1

The USFDA further divided these products into two categories:3

Liquid chemical sterilants/high level disinfectant for processing critical and
semicritical devices which is regulated by the USFDA
General purpose disinfectants that include intermediate and low level disinfectant
for processing noncritical devices and medical equipment surfaces, which are
regulated by the USEPA. The USEPA uses the term ‘hospital disinfectant’ which
is equivalent to a low level disinfection claim; and ‘hospital disinfectant with
tuberculocidal activity’ which is equivalent to an intermediate level disinfection
claim.
The use of disinfectant for noncritical environmental surface has been justified
following few factors such as surfaces may contribute to transmission of
epidemiologically important microbes (e.g., vancomycin-resistant Enterococci,
methicillin-resistant S. aureus, viruses), disinfectants are needed for surfaces
contaminated by blood and other potentially infective material, disinfectants are
more effective than detergents in reducing microbial load on floors and disinfection
of noncritical equipment and surfaces is recommended for patients on isolation
precautions by the USCDC.1

According to USCDC, sanitizer is an agent that reduces the number of bacterial

contaminants to safe level as judged by public health requirement.1 The test result
for a product must show a reduction of at least 99.9% in the number of each test
microorganism compared to untreated surface within 5 minutes, to be registered as
sanitizer for inanimate non-food contact surface.2

Many factors affect efficacy of both disinfection and sterilization processes, such as
organic and inorganic load present; type and level of microbial contamination;
concentration of and exposure time to the germicide; physical nature of the object
(e.g., crevices, lumens); presence of biofilms; temperature and pH of the disinfection
process; and in some cases, relative humidity of the sterilization process (e.g.,
ethylene oxide).1,5,6

This review was requested by the Senior Principal Assistant Director, Disease
Control Division, Ministry of Health Malaysia to review the evidence on EndoQuatTM
Disinfectant and Sanitizer to be used as surface disinfectant in the MOH hospitals
and healthcare facilities following a proposal from a company to introduce them in
the MOH facility.

2.0 OBJECTIVES

To assess the safety, effectiveness and cost effectiveness of EndoQuatTM

Disinfectant and Sanitizer to be used as surface disinfectant in the MOH hospitals
and healthcare facilities.

3.0 TECHNICAL FEATURES

EndoQuatTM Disinfectant and Sanitizer consists of a dilute blend of Quaternary

Ammonium Compounds (fourth generation) in aqueous solution which is claimed to
be a highly effective hospital grade blended disinfectant, sanitiser and deodorizer,
effective to be applied as surface and environmental sanitizing and disinfectant
within 10 minutes of application.7

It is also claimed that this product is a high level disinfectant which is able to kill to
log 7 in 3 minutes in dirty condition, as well as can be used as a general purpose
cleaner or disinfectant on any surface at lower concentration.

2
Delivery of EndoQuatTM could be done in 10 minutes using the ultrasonic atomiser
which dispenses the atomized solution to disinfect surfaces without excessive
wetting (Figure 1).

Figure 1: EndoQuatTM delivery using the ultrasonic atomizer

The product is highly adaptable to various delivery systems including aerosols,

topical handwashes and sprays. It can also be formulated into paints and coverings
to prevent mould and mildew, vital in humid conditions.

It is also claimed suitable to be used in hospitals/healthcare setting and in

agriculture, cosmetic and pharmaceutical industry. In medical/healthcare industry its
use as claimed are for sanitation, disease control and personal hygiene safety
management practices.7,8 This blended disinfectant is claimed to be a bactericidal
(greater than 6-log10 in 20 seconds for MRSA, E. Coli, Salmonella and others),
virucidal (enveloped and non-enveloped viruses including Hepatitis C, Polio and
Adenovirus), sporicidal (kills Clostridium spores by 4-log10 in 1 minute), fungicidal,
yeasticidal and tuberculocidal when used as directed and biodegradable.7,8

Mechanism by which it kills the organism is said by stabilizing the organism cell
membrane. Its product range includes hand gel, hand wash and surface wipes using
EnviroCair technology.

4.0 METHODOLOGY

4.1 SEARCHING METHODS

Electronic databases searched through the Ovid interface:

MEDLINE(R) In-process and other Non-Indexed Citations and Ovid
MEDLINE(R) 1948 to present
EBM Reviews - Cochrane Central Register of Controlled Trials – January
2013
EBM Reviews - Database of Abstracts of Review of Effects (1st Quarter
2013)
EBM Reviews - Cochrane Database of Systematic Reviews - 2005 to January
2013
EBM Reviews - Health Technology Assessment - 1st Quarter 2013

3
 NHS economic evaluation database - 1st Quarter 2013

Other databases:
PubMed
Horizon Scanning database (National Horizon Scanning Centre, Australia and
New Zealand Horizon Scanning Network, National Horizon Scanning
Birmingham)
Other websites; FDA, MHRA, INAHTA, ASERNIP-S, CADTH.

General databases such as Google and Yahoo were used to search for additional
web-based materials and information. Additional articles retrieved from reviewing
the bibliographies of retrieved articles or contacting the authors. The search was
limited to articles on human. There was no language limitation in the search.
Appendix 3 showed the detailed search strategies.

The last search was conducted on 15 February 2013. The search was re-run in June
2013. The search strategy used these terms either singly or in various combinations:
EndoQuat OR inorganic chemicals OR organic chemicals OR heterocyclic
compound OR ammonium compounds OR ammonium Chloride OR ammonium salts
OR quaternary ammonium salt OR sanitizer OR disinfectant.

4.2 SELECTION OF STUDIES INCLUDED /EXCLUDED

A reviewer screened the titles and abstracts against the inclusion and exclusion
criteria and then evaluated the selected full-text articles for final article selection.
The inclusion and exclusion criteria were:

Inclusion criteria
Population Hospital, healthcare facilities, clinics, inanimate surface, food
contact, non-food contact
Interventions EndoQuat, Ammonium salt, Quaternary Ammonium
Compounds, sanitizer, disinfectant
Comparators Control
Outcomes Germicidal activity
Bactericidal, virucidal, yeasticidal, fungicidal
Study design Any primary study of acceptable quality
Type of English, full text articles, human studies
publication

Exclusion criteria
Intervention -
Study design Anecdotal, Case series/reports, animal studies
Type of Non-english
publication

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Relevant articles were critically appraised using Critical Appraisal Skills Programme
(CASP) and evidence graded according to the NHS Centre for Reviews and
Dissemination (CRD) University of York, Report Number 4 (2nd Edition) for
diagnostic accuracy studies (Appendix 4). Data were extracted and summarized in
evidence table. The data were not pooled and only qualitative analysis was carried
out.

5.0 RESULTS AND DISCUSSION

The search strategy did not retrieve any evidence from the electronic databases on
EndoQuatTM Disinfectant and Sanitizer.

An unpublished efficacy compliance document consisted of microbiological testing of

this product, certification documents and Material Safety Data Sheet (MSDS) were
provided by the manufacturer.

5.1 EFFICACY

There was no scientific evidence retrieved from the electronic databases on the
efficacy of EndoQuatTM Disinfectant and Sanitizer to be used as surface disinfectant
in hospitals and healthcare facilities.

The efficacy compliance document provided by the manufacturer consisted of

microbiological testing of this product which was summarized as in Appendix 5. The
efficacy summary demonstrated its effectiveness as bactericidal, tuberculocidal,
yeasticidal, sporicidal and virucidal.

Bactericidal
The result from several quantitative surface and suspension testing provided had
showed that EndoQuatTM Disinfectant and Sanitizer is effective against both gram
positive and negative bacteria. It was effective in achieving more than a 7-log10
reduction of Staphylococcus aureus MRSA after 5 minutes contact time. It was also
demonstrated effective in achieving a more than 6-log10 reduction of Klebsiella
pneumonia ESBL, Enterococcus faecium VRE, Salmonella enteritica,
Staphylococcus aureous, Enterococcus hirae, Eschericia coli after 5 minutes contact
time and Pseudomonas aeruginosa after 15 minutes contact time.9

For tuberculocidal activity, EndoQuatTM Disinfectant and Sanitizer was also

demonstrated effective in achieving more than 4-log10 reduction of Mycobacterium
avium and 5-log10 reduction of Mybacterium terrae respectively, after 60 minutes
contact time.10

Yeasticidal
For fungicidal activity, the conducted yeasticidal quantitative surface test has
demonstrated that EndoQuatTM Disinfectant and Sanitizer was effective in achieving
more than a 5-log10 reduction of Candida albicans after 5 minutes contact time.11

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Sporicidal
The conducted sporicidal quantitative suspension test has demonstrated that
EndoQuatTM Disinfectant and Sanitizer was effective in achieving more than a 3-
log10 reduction of Clostridium difficile endospores after 60 minutes contact time.12

Virucidal
For antiviral activity, the conducted virucidal quantitative suspension test has
demonstrated that EndoQuatTM Disinfectant and Sanitizer was effective as virucide
as it possessed virucidal activity against Poliovirus 1LSc-2ab(NIBSC Code
01/528)/HeLa Cells and Bovine Viral Diarrhoea Virus (BVDV) after 60 and 5 minutes
contact time respectively.13

The certification document provided by the manufacturer was from the Hospital
Infection Research Laboratory of University Hospital Birmingham. They reviewed the
test data provided to support EnviroCair surface disinfectant efficacy claims. The
report summarised that it has been shown to comply with the standard requirements
of the EN test standards. The report also stated that the tests carried out by the test
laboratories demonstrated the efficacy of EnviroCair surface disinfectant against
bacteria and viruses when used at 5% concentration with a 5 minute contact time.14

Other certification document provided was from the UK Veterinary Laboratory

Agency, Department for Environment, Food and Rural Affairs (DEFRA) which
approved the use of EnviroCair for Foot and Mouth disease (animal) and it has been
incorporated into the Approved Disinfectant List under the Animal and Health Act
1981.15

According to the USCDC Guideline for Disinfection and Sterilization in Healthcare

Facilities, 2008, the Quartenaries is commonly used in ordinary environmental
sanitation of non-critical surfaces such as floors, furniture and walls. EPA-registered
quartenary ammonium compounds are appropriate to be used for disinfecting
medical equipment that contacts intact skin such as blood pressure cuff. 1

5.2 SAFETY

There was no scientific evidence retrieved from the electronic databases on the
safety of EndoQuatTM Disinfectant and Sanitizer to be used as surface disinfectant in
hospitals and healthcare facilities.

Material Safety Data Sheet on EndoQuatTM Disinfectant and Sanitizer provided by

the company offered information on its properties, safety data as well as ways in
handling the substance in a safe manner. EndoQuatTM Disinfectant and Sanitizer is
produced in accordance to European Directive - EC Directive 91/155/EC, a Directive
aimed to provide manufacturing operations with the information on hazard profiles,
risks associated with this substances and preparations in the work place to facilitate
the workers’ health and safety protection.7

EndoQuatTM is also produced in accordance with EC Biocide Directive, meets the

quality requirement standard (BS EN ISO Standards EN 1040 / 1275 / 1276 / 1650),

6
and claimed to be registered with USEPA (Registration Number 1839-83).8 However
its registration with FDA could not be retrieved and CE mark was also not available.

It was also claimed that its product range has gained worldwide recognition and
accreditation from Environmental Protection Agency (EPA), Department for
Environment, Food and Rural Affairs (DEFRA), Medicine and Healthcare Products
Regulatory Agency (MHRA) and World Health Organisation (WHO).8

5.3 COST EFFECTIVENESS

There was no retrievable scientific evidence from the electronic databases on the
cost-effectiveness of EndoQuatTM Disinfectant and Sanitizer to be used as surface
disinfectant in hospitals and healthcare facilities. Its direct cost was also not
available.

5.4 LIMITATION

Our study has several limitations. The selection of studies was done by one
reviewer. Although there was no restriction in language during the search, only
English full text articles were included in this report. Any abstracts without full text
articles were also excluded.

5.5 DISCUSSION

It is claimed that this product is a high level disinfectant which able to kill to log 7 in 3
minutes in dirty condition and can also be used as a general purpose cleaner or
disinfectant on any surface at lower concentration.

The efficacy compliance document provided demonstrated that EndoQuatTM

Disinfectant and Sanitizer was effective against bacteria, fungi, spore and virus. For
tuberculocidal activity, efficacy provided demonstrated that there was a 4-log10
reduction of Mycobacterium avium and 5-log10 reduction of Mybacterium terrae
respectively, after 60 minutes contact time.

According to USFDA, high level disinfectant to be used in hospitals and healthcare

facility, should achieve a 6-log10 kill of an appropriate Mycobacterium species for
tuberculocidal activity efficacy.

6.0 CONCLUSION
There was no retrievable published evidence on the efficacy, safety and cost
effectiveness of EndoQuatTM Disinfectant and Sanitizer. Only limited unpublished
low quality evidence and certification document provided by the manufacturer was
available. Nevertheless, it showed that the EndoQuatTM Disinfectant and Sanitizer
was effective against bacteria, fungi, spore, tubercle bacilli and virus. It also
possessed tuberculocidal activity which can be classified as intermediate-level
disinfectant according to the USCDC. EndoQuatTM Disinfectant and Sanitizer was

7
 also registered with the USEPA (Registration Number 1839-83), and gained
recognition from DEFRA.

7.0 REFERENCES

1. US Centers for Disease Control and Prevention. Department of Health and Human
Services. Guideline for Disinfection and Sterilization in Healthcare Facilities. 2008.
2. US Environmental Protection Agency. Sanitizer test for Inanimate Surfaces. Efficacy data
requirements. Available at http://www.epa.gov/oppad001/dis_tss_docs/dis-10.htm
Assessed on 15 January 2013.
3. US Food and Drugs Administration, Department of Health and Human Services. Code of
Federal Regulation 21. Part 178 Indirect Food Additives: Adjuvants, Production Aids, And
Sanitizers. Assessed online at
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?fr=178.1010 on 15
February 2013.
4. European Committee for Standardization. Chemical disinfectants and antiseptics –
published standards. Available at
http://www.cen.eu/cen/sectors/technicalcommitteesworkshops/CENTechnicalCommittee
Assessed on 15 February 2013.
5. Alabama Department of Health. Cleaning and Sanitizing. Accessed at
http://www.adph.org/environmental/assets/CleanAndSanitize on 20 January 2013.
6. Disinfectant. Available at https://en.wikipedia.org/wiki/Disinfectant Assessed on 15
February 2013.
7. EndoQuatTM. Material Safety Data Sheet
8. EndoQuat. Product Information. Available at URL:
http://www.biohealthsolutions.co.uk/endoquat.php, accessed on 15 December 2012
9. EnviroCair. Expert Report according to DIN EN 13697:2001, DIN EN 1276:2009.
November 2011.
10. Certificate of Analysis.EN 14348 Chemical disinfectant & antiseptic quantitative
suspension test for the evaluation of mycobactericidal activity of chemical disinfectant and
antiseptic used in the medical area.
11. EnviroCair. Expert Report according to DIN EN 1650:2008. November 2011.
12. Test Report according to DIN EN 13704.
13. Test Report according to DIN EN 14476:2005.
14. Hospital Infection Research Laboratory, University Hospital Birmingham.Letter.2012
15. Department for Environment, Food and Rural Affairs (DEFRA). Veterinary Laboratory
Agency Confirmation of Approval.2009

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9.0 APPENDIX
9.1 Appendix 1

SUMMARY OF DISINFECTANT CLASSIFICATION USED BY VARIOUS AGENCIES

Agency Disinfectant classification

USEPA Classify disinfectants by product label claims of “limited”, “general” or
”hospital” disinfection.
Limited : disinfectant registered for use against a specific major group
of organisms (gram-negative or gram-positive bacteria). Efficacy has
been demonstrated in laboratory tests against either Salmonella
choleraesuis or Staphylococcus aureus bacteria.
General : EPA-registered disinfectant for use against both gram-
negative and gram-positive bacteria. Efficacy is demonstrated against
both Salmonella choleraesuis and Staphylococcus aureus. Also called
broad-spectrum disinfectant.
Hospital : disinfectant registered for use in hospitals, clinics, dental
offices, and any other medical-related facility. Efficacy is demonstrated
against Salmonella choleraesuis, Staphylococcus aureus, and
Pseudomonas aeruginosa.
EPA has registered approximately 1,200 hospital disinfectants.

USCDC Disinfection process can be classified as:

high level disinfectants
agent capable of killing bacterial spores when used in sufficient
concentration under suitable conditions. It is expected to kill all other
microorganisms. At similar concentrations with chemical sterilant
but with shorter exposure periods is expected to destroy all
microorganisms except large numbers of bacterial spores
intermediate-level disinfectants
agent that destroys all vegetative bacteria (including tubercle
bacilli), lipid and some nonlipid viruses, and fungi, but not bacterial
spores
low-level disinfectants
agent that destroys all vegetative bacteria (except tubercle bacilli),
lipid viruses, some nonlipid viruses, and some fungi, but not
bacterial spores (<10 minutes)).

USFDA The FDA definition of high level disinfection is a sterilant used for a shorter
contact time to achieve a 6-log10 kill of an appropriate Mycobacterium species.

9
9.2 Appendix 2

METHODS OF STERILIZATION AND DISINFECTION 1

Sterilization Disinfection
Critical items (will enter tissue or High-level (semicritical Intermediate-level Low-level
vascular system or blood will flow items; [except dental] will (some semicritical (noncritical items;
through them) come in contact with items1 and noncritical will come in
mucous membrane or items) contact with intact
Object nonintact skin) skin)

Procedure Exposure time Procedure (exposure time Procedure (exposure Procedure

12-30 min at ≥200C)2,3 time > 1 m) 9 (exposure time >
1 m) 9

Smooth, hard A MR D K K
surface 1,4 B MR E L5 L
C MR F M M
D 10 h at 20-250C H N N
F 4. h I6 O
G 12 m at 50-560C J
H 3-8 h
Rubber tubing and A MR D
catheters 3,4 B MR E
C MR F
D 10 h at 20-250C H
F 4. h I6
G 12 m at 50-560C J
H 3-8 h

Polyethylene tubing A MR D
and catheters 3,4,7 B MR E
C MR F
D 10 h at 20-250C H
F 4. h I6
G 12 m at 50-560C J
H 3-8 h

Lensed instruments 4 A MR D
B MR E
C MR F
D 10 h at 20-250C H
F 4. h I6
G 12 m at 50-560C J
H 3-8 h

Thermometers (oral K8
and rectal) 8 (Hinged A MR D
instruments) 4 B MR E
C MR F
D 10 h at 20-250C H
F 4. h I6
G 12 m at 50-560C J
H 3-8 h

A, Heat sterilization, including steam or hot air (see manufacturer’s recommendations, steam sterilization processing time
from 3-30 minutes)
B, Ethylene oxide gas (see manufacturer’s recommendations, generally 1-6 hours processing time plus aeration time of 8-12
hours at 50-600C)
C, Hydrogen peroxide gas plasma (see manufacturer’s recommendations for internal diameter and length restrictions,
processing time between 45-72 minutes).
D, Glutaraldehyde-based formulations (>2% glutaraldehyde, caution should be exercised with all glutaraldehyde formulations
when further in-use dilution is anticipated); glutaraldehyde (1.12%) and 1.93% phenol/phenate. One glutaraldehyde-based
product has a high-level disinfection claim of 5 minutes at 350C.
E, Ortho-phthalaldehyde (OPA) 0.55%
F, Hydrogen peroxide 7.5% (will corrode copper, zinc, and brass)

10
G, Peracetic acid, concentration variable but 0.2% or greater is sporicidal. Peracetic acid immersion system operates at 50-
560C.
H, Hydrogen peroxide (7.35%) and 0.23% peracetic acid; hydrogen peroxide 1% and peracetic acid 0.08% (will corrode
metal instruments)
I, Wet pasteurization at 700C for 30 minutes with detergent cleaning
J, Hypochlorite, single use chlorine generated on-site by electrolyzing saline containing >650-675 active free chlorine; (will
corrode metal instruments)
K, Ethyl or isopropyl alcohol (70-90%)
L, Sodium hypochlorite (5.25-6.15% household bleach diluted 1:500 provides >100 ppm available chlorine)
M, Phenolic germicidal detergent solution (follow product label for use-dilution)
N, Iodophor germicidal detergent solution (follow product label for use-dilution)
O, Quaternary ammonium germicidal detergent solution (follow product label for use-dilution)
MR, Manufacturer’s recommendation
NA, Not applicable

4. See text for discussion of hydrotherapy.

2 The longer the exposure to a disinfectant, the more likely it is that all microorganisms will be eliminated. Follow the FDA-
cleared high-level disinfection claim. Ten-minute exposure is not adequate to disinfect many objects, especially those that
are difficult to clean because they have narrow channels or other areas that can nglish organic material and bacteria.
Twenty-minute exposure at 200C is the minimum time needed to reliably kill M. Tuberculosis and nontuberculous
mycobacteria with a 2% glutaraldehyde. Some high-level disinfectants have a reduced exposure time (e.g., ortho-
phthalaldehyde at 12 minutes at 200C) because of their rapid activity against mycobacteria or reduced exposure time due
to increased mycobactericidal activity at elevated temperature (e.g., 2.5% glutaraldehyde at 5 minutes at 350C, 0.55%
OPA at 5 min at 250C in automated endoscope reprocessor).
3 Tubing must be completely filled for high-level disinfection and liquid chemical sterilization; care must be taken to avoid
entrapment of air bubbles during immersion.
4 Material compatibility should be investigated when appropriate.
4. A concentration of 1000 ppm available chlorine should be considered where cultures or concentrated preparations of
microorganisms have spilled (5.25% to 6.15% household bleach diluted 1:50 provides > 1000 ppm available
chlorine). This solution may corrode some surfaces.
4. Pasteurization (washer-disinfector) of respiratory therapy or anesthesia equipment is a recognized alternative to high-level
disinfection. Some data challenge the efficacy of some pasteurization units.
7 Thermostability should be investigated when appropriate.
8 Do not mix rectal and oral thermometers at any stage of handling or processing.
9 By law, all applicable label instructions on EPA-registered products must be followed. If the user selects exposure
conditions that differ from those on the EPA-registered products label, the user assumes liability from any injuries resulting
from off-label use and is potentially subject to enforcement action under FIFRA.

11
9.3 Appendix 3

LITERATURE SEARCH STRATEGY

Ovid MEDLINE® In-process & other Non-Indexed citations and OvidMEDLINE®

1948 to present

inorganic chemicals/ or organic chemicals/ or heterocyclic compounds/ or

1 polycyclic compounds/ or pharmaceutical preparations/ or disinfectants/

or ammonium compounds/ or ammonium salts/ or endoquat

2 limit 1 to ( nglish language and humans)

3 Disinfection/cl, st [Classification, Standards]

4 Disinfectants/ and Disinfection/

5 2 or 3

6 4 or 5

7 3 and 4

8 Disinfectants/ and Disinfection/

surface disinfectant.mp. [mp=title, abstract, original title, name of

substance word, subject heading word, keyword heading word, protocol

9
supplementary concept, rare disease supplementary concept, unique
identifier]

environmental disinfectant.mp. [mp=title, abstract, original title, name of

substance word, subject heading word, keyword heading word, protocol

10
supplementary concept, rare disease supplementary concept, unique
identifier]

11 9 or 10

12 7 and 11

12
OTHER DATABASES

EBM Reviews –
Cochrane Central
Register of Controlled
Trials
EBM Reviews –
Database of Abstracts of
Review of Effects Similar MeSH, keywords, limits used as per MEDLINE
EBM Reviews – search
Cochrane database of
systematic reviews
EBM Reviews – Health
Technology Assessment
PubMed
NHS economic
evaluation database
INAHTA Disinfectant, ammonium salt, endoquat
FDA Disinfectant, ammonium salt, endoquat

9.4 Appendix 4

HIERARCHY OF EVIDENCE FOR DIAGNOSTIC TEST ACCURACY STUDIES

Level Description

1. A blind comparison with reference standard among an appropriate sample of

consecutive patients

2. Any one of the following Narrow population spectrum

3. Any two of the following Differential use of reference standard

4. Any three or more of the following Reference standard not blind

Case control study

5. Expert opinion with no explicit critical appraisal, based on physiology, bench

research or first principles.

SOURCE: NHS Centre for Reviews and Dissemination (CRD) University of York,
Report Number 4 (2nd Edition)

13
9.5 Appendix 5
ENDOQUAT: SUMMARY OF EFFICACY BY GERMICIDAL (BACTERICIDAL, YEASTICIDAL, TUBERCULOCIDAL, SPORICIDAL & VIRUCIDAL) ACTIVITY

Germicidal activity Exposure time Concentration of

Type of Test Test Organism
(log reduction) (minute) product test solution (%)
Bactericidal activity of EnviroCair – Staphylococcus aureus MRSA >7.16 5 0.50
Quantitative Surface Test based on Klebsiella pneumonia ESBL >6.70 5 2.50
DIN EN 13697:2001
Enterococcus faecium VRE >6.16 5 1.00
Salmonella enteritica 5.22 5 0.50
Bactericidal activity of EnviroCair – Staphylococcus aureus MRSA >5.81 5 0.25
Quantitative Suspension Test based Klebsiella pneumonia ESBL 5.08 5 0.50
on DIN EN 1276:2009
Enterococcus faecium VRE >4.89 5 0.50
Salmonella enteritica >6.00 5 0.50
Bactericidal activity of EnviroCair – Staphylococcus aureus >5.95 5 0.25
Quantitative Suspension Test based Enterococcus hirae >5.50 5 1.00
on DIN EN 1276:2009
Escherichia coli >5.17 5 1.00
Pseudomonas aeuroginosa >5.08 5 1.00
Bactericidal and Yeasticidal activity Staphylococcus aureus >6.92 5 0.50
of EnviroCair – Quantitative Non- Enterococcus hirae >6.95 5 0.50
Porous Surface Test based on DIN
EN 13697:2001 Escherichia coli >6.47 5 0.50
Pseudomonas aeuroginosa 1.85 5 0.50
>6.10 15 2.50
Candida albicans >5.81 5 3.00
3.44 15 0.50
Bactericidal activity of EnviroCair Escherichia coli 6.20 1,3,5 4.00
100% - Quantitative Suspension Test Staphylococcus aureus 6.28 1,3,5 4.00
based on EN 1040
Yeasticidal activity of EnviroCair – Candida albicans >4.67 5 0.50
Quantitative Suspension Test based
on DIN EN 1650:2008
Bactericidal activity of EnviroCair 4% Mycobacterium avium 4.76 60 4.00
- Test based on EN 14348 Mycobacterium terrae 5.19 60 4.00
3
Sporicidal activity of ENV2270- Clostridum difficale endospores >10 60 4.00
Quantitative suspension test based
on EN13704
Virucidal activity of ENVIROCAIR A Poliovirus 1LSc-2ab(NIBSC Code Virucidal activity 60 4.80
6% - based on EN 14476:2005 01/528)/HeLa Cells possessed

Bovine viral diarrhoea virus Virucidal activity 5 4.80

(BVDV) – Modified for Hepatitis C possessed
virus