Location via proxy:   [ UP ]  
[Report a bug]   [Manage cookies]                

AMG Brochure R4

Download as pdf or txt
Download as pdf or txt
You are on page 1of 20

KILLS UP TO

99.999%
MICROBES
to help prevent healthcare-associated Infections

• World’s 1st non-leaching antimicrobial gloves


• Kills up to 99.999% microbes
• Provides active protection against HAIs
• Tested non-sensitising on skin
WHAT ARE
HEALTHCARE-ASSOCIATED
INFECTIONS (HAIs)?
Healthcare-associated infections are infections that develop as a result
of medical care in a hospital or other healthcare facilities, which were
neither present nor incubating at the time of transmission. It includes
infections acquired by patients in the medical facility but emerging after
discharge, as well as occupational infections among staff.

WHAT ARE THE ADVERSE


EFFECTS OF HAIs?
Every year HAIs cause unnecessary suffering and higher medical
cost for hundreds of millions of patients and their families around
the world. These infections prolong hospital stay, increase the risk of
post-operative complications and disabilities, increase resistance to
antimicrobials and even result in unnecessary deaths and massive
financial losses to the healthcare system.

2
USA
Affected Patients 1.7 million
Deaths 99,000
Cost approx. USD 6.5 billion

EU
Affected Patients 4.1 million
Deaths 37,000
Cost approx. EUR 7 billion

Figure 1. Annual Impact of HAIs in the USA and Europe


Source : Adapted from World Health Organization, Healthcare-Associated Infections Fact Sheet1.

3
HOW DO HAIs OCCUR?
Infections occur when microbes enter the body, breed and
cause a reaction to the body.

3 things lead to an infection:

i. Source iii. Transmission

A source is one within which an infectious agent, Transmission refers to the route or method by which
such as a virus, bacterium or other microbe thrive microbes are transferred from the source to the
and reproduce. In healthcare settings, people such susceptible person. In healthcare settings, microbes
as patients, healthcare workers, visitors and family travel via several ways - physical contact (touching),
members can be a source of infection. Other source sprays and splashes, inhalation, and sharps
includes the healthcare environment where microbes injuries, i.e. when a needle, scalpel or other medical
can live and breed such as on dry and wet surfaces, instruments penetrate the skin. Among these routes,
dust or decaying debris, moist areas and indwelling physical contact is the main mode of transmission in
medical devices. the healthcare setting.2

ii. Susceptible Person

A susceptible person is someone who is not vaccinated


or otherwise immune, or person with a weakened
immune system of which once exposed, provides a way
for the microbe to enter the body. For an infection to
take place, the microbe must first enter a susceptible
person’s body and attack the tissues, multiply and
cause a reaction.

4
Means of
Source Susceptible
Transmission
(Reservoir) Person
(Vehicle)

People, Physical contact, Non-vaccinated,


environment droplets, air and weakened
sharps injuries immune system

Figure 2. Chain of Infection

5
THE ROLE
OF MEDICAL GLOVES
The World Health Organization (WHO) recommends
wearing medical gloves to reduce the risk of:

i. Blood and body fluid contamination of healthcare


workers’ hands.
ii. Microbial dissemination in the environment,
microbial transmission from healthcare workers
to the patients and vice versa, as well as among
patients.

Several clinical studies have confirmed the role


of medical gloves in preventing contamination,
dissemination and transmission of pathogens in
healthcare settings. Thus, gloves should be worn as
precautions throughout patient care activities that may
involve exposure to blood and body fluids and during
outbreak situations.

Nonetheless, inappropriate glove storage, and


inappropriate techniques for glove donning and
removing, may result in microbial transmission.
Once contaminated, gloves can become a source for
spreading infectious agents to healthcare workers,
patients and environmental surfaces.

6
ANTIMICROBIAL GLOVE :
AN ACTIVE APPROACH IN
PREVENTING HAIs
Contrary to conventional medical gloves that serve only as
a passive barrier between microbes and your hands, AMG
antimicrobial gloves can play an active role in reducing the
spread of infections by using its killing mechanism.

The AMG glove is designed to kill microorganisms on the


external side of the glove quickly upon contact. The active
ingredient on the glove is a photosensitiser which generates
singlet oxygen when exposed to light. This singlet oxygen
oxidises the bacteria’s protein and lipid, thus leading to the
death of microbes. [Figure 3]

Ultimately, AMG antimicrobial glove helps reduce the risk of


transmission from an infection source to a susceptible patient.*
* The use of AMG glove does not replace hand hygiene protocol which is required
before donning and removing of gloves.

Photodynamic
Reaction
ACTIVATED
PHOTOSENSITISER

1
O2

PHOTOSENSITISER
3
O2

MICROBES
CELL DEATH
LIGHT

Figure 3. Photodynamic Reaction Leading to Cell Death

7
THE BENEFITS OF AMG
Effective against a wide
range of bacteria Biocompatible

Unlikely development of
Quick kill bacteria resistance

Uncompromised
Non-leach technology glove properties

EFFECTIVE AGAINST A WIDE RANGE OF BACTERIA


Refer to Table 1.

Average % Bacteria Killed


QUICK KILL Microbe Type
5 mins 10 mins 15 mins 20 mins
Based on ASTM D7907 Standard
Enterococcus faecalis
Test Methods for Determination of Gram-positive 99.982 99.996 - 99.968
(VRE)
Bactericidal Efficacy on the Surface
of Medical Examination Gloves, AMG Enterococcus faecium Gram-positive 99.991 99.991 99.996 -
is effective in killing superbug MRSA
and VRE. MRSA Gram-positive 99.988 99.998 99.999 99.997

Test data has shown that AMG


Staphylococcus aureus** Gram-positive 99.999 99.993 - 99.994
can kill up to 99.999% of selected
microbes such as Staphylococcus
Streptococcus pyogenes Gram-positive 99.946 99.970 99.988 99.996
aureus as quickly as 5 minutes.
Further testing was conducted at a
Escherichia coli Gram-negative - - 99.030 -
shorter contact time with kill rate
recorded at 99.989% in 1 minute Klebsiella pneumoniae Gram-negative - 96.471 - 97.747
and 99.998% in 2 minutes.
Table 1. AMG Antimicrobial Glove Test Results for Bacteria Kill.

** Further testing was conducted on Staphylococcus aureus at shorter contact time.


Bacteria kill rate (%) results recorded: 99.989% (1 min), 99.998% (2 mins) & 99.999% (5 mins)

8
NON-LEACH TECHNOLOGY
AMG is the world’s first non-leaching
antimicrobial examination glove. The active
has been tested for non-migration with the
following medium:

i. Water ii. Hot Water (45 degrees Celcius)


iii. Sweat iv. Saliva
v. Ethanol

All extracts were analysed at Intertek using


validated analytical techniques to detect
the active. Results conclude that no active
could be found in any of the extracts from
neither the inner nor the outer glove surface.
Although the active is proven safe, AMG has
been designed to further ensure that it does
not leach and transfer to the patients.

UNLIKELY DEVELOPMENT OF
BACTERIA RESISTANCE
Singlet oxygen technology employed has been assessed
as low in regards to bacteria resistance. This is attributed
to the non-specific nature of the glove’s bacteria-killing
mechanism.

Generally, oxidative antimicrobials such as the AMG


technology has been viewed as low probability
for development of resistance by the EU Scientific
committee.3

9
BIOCOMPATIBLE
AMG glove is suitable for different applications as it has been tested safe for use against various contacts such as
skin and oral contact. Some of these tests confirm that the AMG glove is:
• Non-irritating • Non-toxic • Non-sensitising & low dermatitis
It does not cause primary skin irritation like No toxic effects occurring following potential
redness (erythema) or slight swelling (edema). oral administration. Modified Draize Test shows the gloves
do not cause allergic reaction in normal
• Non-sensitising • Non-cytotoxic tissue after exposure.
It does not contain any substance that will It does not display destructive action
induce skin allergy. on cells.

No. Test Method Purpose of Testing Result Summary

1 Modified Draize- FDA To determine whether gloves contain residual chemical No sensitiser detected
95 Test additives at a level that may induce Type IV allergy.

2 Acute Toxicity Oral ISO 10993-11 To evaluate toxic potential of substance that leaches out No toxic effects
of gloves by determining adverse effect occurring within
short term exposure via oral route.

3 Cytotoxicity Test ISO 10993-5 To determine if gloves contain significant quantities Non-cytotoxic at 10%
of harmful extractables and their effect on cellular extract
components.

4 Primary Skin ISO 10993-10 To determine whether exposure to gloves may produce Non-irritating
Irritation skin irritation

5 Dermal ISO 10993-10 To assess potential of gloves to cause delayed Non-sensitising


Sensitisation Study hypersensitivity (Type IV) or allergic reaction stimulated
by the immune system.

6 Accelerator Malaysian Rubber To quantify the amount of extractable accelerators in Non-detectable for
Extraction Test Board (MRB) gloves. accelerators
In-House Method

Table 2. List of Biocompatibility Test Results for AMG Antimicrobial Gloves.

UNCOMPROMISED GLOVE PROPERTIES


Apart from medical settings, AMG glove has been proven safe for use in different applications and industries. Its
safety and effectiveness are proven to ensure it befits its intended use.
i. Medical
Tested for impermeability and glove strength, AMG glove is effective in preventing contamination between patient and healthcare practitioner,
as well as for handling various chemotherapy drugs. All tests conducted are in accordance to recognised international standards such as ASTM
D6319, EN 455 and ISO 11193 part 1.

ii. Personal Protective Equipment (PPE)


The glove is tested to protect users from substances and mixtures that are hazardous to health, and harmful biological agents that may cause very
serious consequences or damage to health. Tests conducted are in accordance to the harmonised standard [refer Table 3.] which complies with PPE
Regulation. Some countries may require further registration.

iii. Food Contact


The glove is tested safe for food contact according to the standards of U.S. FDA, BfR XXI German Recommendation and Japan Food sanitation. It is
tested in various types of simulants representing different types of food that are acidic, alcoholic and fatty in content. Some countries may require
further registration with biocidal agencies such as BPR and EPA.

10
No. Test Method Purpose of Testing Result Summary

1 Watertight Test EN 455-1 To detect holes in gloves. Pass


ASTM D5151

2 Physical Property EN 455-2 To determine the tensile strength and elongation at Pass
Test ASTM D6319 break of gloves.

3 Particulate Residue EN 455-3 To determine the amount of residual powder (or filtered- Pass.
Test ASTM D6124-06 mass) found on medical gloves. Less than 2mg/glove

4 PPE Certification PPE (EU) 2016/425 There are several testing methods under PPE -
EN ISO 374-1 certification as shown below:

Chemical ISO 16523-1 To evaluate the resistance to permeation by chemicals. Pass


Permeation Test

Penetration (Air & EN 374-2 To determine penetration resistance of gloves that Pass
Water Leak) Test protect against dangerous chemicals and/or organisms.

Degradation Test EN 374-4 To determine resistance of protective glove materials Pass


to degradation caused by dangerous chemicals with
continuous contact.

Protective Gloves EN 420 Design and Construction: Pass


(pH & PAH) Test To evaluate if gloves can perform hazard related activity
normally while enjoying appropriate protection at
the highest possible level. Testings include sizing and
measurement of hands (hand circumference and hand
length) and sizing and measurement of glove (length).

pH Value : To determine the pH value of glove. Pass

Dexterity : To evaluate the ability to perform its task Pass

Viral Penetration EN ISO 374-5 To measure resistance of gloves used against No penetration
Test penetration by blood-borne pathogens. < 1 PFU/ml

5 Chemical ASTM D6978 To assess resistance of gloves to permeation by All selected drugs meet
Permeation Test potentially hazardous cancer chemotherapy drugs under breakthrough time of more
(Chemotherapy conditions of continuous contact. than 240 minutes
Drugs)

6 Food Contact EC 1935/2004 To evaluate if gloves release their constituents into food Pass according to German
EU 10/2011 at a level harmful to human health. Recommendation BfR XXI

7 Food Contact Japan Sanitation To evaluate if gloves release their constituents into food Pass
Law at a level harmful to human health.

8 Food Contact 21 CFR 177.2600 To evaluate if gloves release their constituents into food Pass
at level harmful to human health.

9 Viral Penetration ASTM F1671 To measure resistance of gloves against penetration by No penetration
Test blood-borne pathogens. < 1 PFU/ml

Table 3. AMG Antimicrobial Glove Performance According to Globally Recognised Standards.

11
3. Why does AMG gloves provide Active Protection
Against HAIs?
The use of medical gloves is intended to prevent cross
contamination between the patient, the user and its
environment.
However, conventional gloves can only provide passive protection
as contaminated gloves caused by inappropriate storage,
inappropriate use and techniques for donning and removing,
may in turn become a vehicle for transmission of microbes.
Conversely, AMG gloves provide an active approach in HAI
prevention as the gloves can continuously and effectively reduce
or inhibit microbial colonisation on the glove surface within a
short amount of time, thus further reducing the risk of cross
contamination.

AMG 4. Does AMG antimicrobial glove replace the need for

ANTIMICROBIAL
hand hygiene?
Although AMG glove has been found effective against a wide range

GLOVES or microbes, it does not replace the need for hand hygiene. AMG
serves as an extra precaution or tool to help mitigate the spread
of HAI. Protocols for hand rubbing or hand washing should still be

FAQ
performed before donning and after removing gloves.

5. What does it mean by non-leaching? Is it safe?


We designed the antimicrobial gloves to be non-leaching to ensure
the active ingredient does not transfer to the patient. To further
ensure the safety of the active ingredient, the gloves were tested
for biocompatibility. Below illustrates the tests carried out:
i. Tested at Intertek UK, the gloves were extracted using water,
artificial saliva, artificial sweat and alcohol at room and
body temperature. The extracts were analysed by validated
1. What is AMG Antimicrobial glove? analytical techniques to detect the active. No active could be
AMG is the world’s first non-leaching antimicrobial gloves, found extracted from the gloves’ inner or outer surface.
designed to kill microorganisms on the external side of the glove ii. ISO 10993 biocompatibility testing has been conducted on the
quickly upon contact. inside and external surface of the gloves. Results confirm that
the gloves are non-sensitising, non-irritating, non-toxic (oral)
2. What is the purpose of AMG antimicrobial glove? and non-cytotoxic.
Though conventional gloves provide a barrier between healthcare iii. The Modified Draize-95 test was also conducted where both
worker and patient, it does not tackle the problem of transient the inner and outer surfaces of the gloves were tested on
transmission, where microbes get transmitted from one surface human skin. The gloves provided no clinical evidence of
to another. AMG glove is designed to help reduce the spread of inducing allergic reactions. With this test result, U.S. FDA
HAI, as it is proven to kill up to 99.999% of selected microbes. allows a “Low Dermatitis Potential” claim for the gloves.

12
6. What materials are in contact with my skin when using
AMG Antimicrobial gloves?
AMG’s technology is introduced on the external side of the glove. In humans, singlet oxygen generating dyes are used for cancer
The glove user is exposed to the donning side of the glove, which treatment, known as photodynamic therapy, PDT.
is similar to a standard examination glove. The skin of the glove
user is not exposed to this technology. It is also used in dental disinfection prior to procedures like root
canal treatments, in which the dye is rinsed into the patients’
7. How does singlet oxygen work? mouths, a light applied and disinfection occurs safely and rapidly.

In this technology a special dye is used. The dye absorbs visible However, probably the most ubiquitous use is in laundry
light. The dye is thus raised from a ground state to an excited powders, where a singlet oxygen generating dye is washed onto
quantum state, in which an elevation in energy takes place. clothing, and subsequently acts as a photobleach. Many readers
The energy then transfers to a proximal oxygen molecule of this will therefore be unwitting users of singlet oxygen and
found in the air, causing the oxygen molecule to also rise to will be wearing some singlet oxygen generating dye.
an excited quantum state. The ground state of oxygen present
in air, is a triplet electronic configuration, written as 3O2 . Upon
sensitisation by the dye molecule, the electronic configuration
changes and enters the singlet state, 1O2.
This singlet oxygen state is reactive and more oxidative
compared to ground state oxygen and therefore, is able to
kill microbes such as bacteria by oxidising the cells’ protein
and lipid. Using the dye as a catalyst, singlet oxygen can be
generated continuously as it absorbs light and air.

8. What are the advantages of using singlet oxygen


antimicrobial system?
Singlet oxygen is a non-selective system that can react rapidly
against many microbial components. There is not one single
protection mechanism that bacteria can protect itself from
singlet oxygen.4 This is in contrast to antibiotics, which needs
very specific mechanism to treat a patient. As singlet oxygen is
transient, it does not lead to the release of persistent biocides
into the environment.

AMG will as such transform the standard examination glove


from a passive medical device to a medical device with active
protection which will actively reduce or inhibit microbial
colonisation.

9. Has singlet oxygen technology been used before


commercially?
Whilst it has not received as much attention as traditional
biocides, singlet oxygen has been researched for a wide range
of uses for many years and a number of important commercial
applications are known.5,6,7,8,9

13
10. Are there literature to show potential of resistance
using singlet oxygen antimicrobial system?
Experimental studies have been done and reported in the
literature about singlet oxygen efficacy and resistance.10,11
In these, bacteria were killed to a high extent with singlet
oxygen, typically 99.9% or 99.99%, leaving only the most
robust bacteria. These were then re-cultivated and re-exposed
to singlet oxygen. This cycle is repeated 10 or 20 times, and
the efficacy of killing is measured. In all cases, it was found
that there is no decrease in efficacy and no development in
resistance.
Many of the mechanisms bacteria use to confer resistance
involve processes internal to the cell. In AMG system however,
the singlet oxygen is generated purely exogenously to the cell
– the dye is separated from the bacteria, it does not leach, and
it cannot enter the cells. Other authors in the literature have
noted4,10 that this makes development of resistance especially
difficult, because singlet oxygen is short lived and with a short
length of diffusion – nothing the bacterial cell does internally will
affect the process of oxidation by singlet oxygen.
Furthermore, a review of the potential for resistance to biocidal
materials was done by the EU expert scientific committee. The
report puts biocidal materials into three categories: low risk of
resistance developing, medium risk and high risk. These authors
put oxidative systems as low risk, some traditional biocide
materials such as chlorhexidine and PHMB as medium risk, and
silver as high risk.3

11. What is the amount of light needed to activate the
AMG Antimicrobial Gloves?
Testing of AMG glove has been conducted at general lighting
condition at hospitals of 1000 lux and 500 lux. Results show
that there was no significant difference in bactericidal efficacy.
Further testing at lower light levels are underway.

12. Would differences in lighting type affect the efficacy


of AMG Antimicrobial gloves (for example – LED,
fluorescent, incandescent light bulb)?
No. The AMG is activated by any white light source. It is
specifically activated by light in the 600 - 700 nm region but
all white light sources contain this, otherwise they would be
coloured.

14
13. Will the dye be depleted if the AMG Antimicrobial 18. How about in a clinical environment? Is there a
Gloves are continually exposed to light? survival difference between Gram-positive and Gram-
negative bacteria?
No. As long as there is light and oxygen, the gloves are active.
Heat aged AMG gloves (accelerated aging equivalent to 3 years The pattern of lower survival of Gram-negative bacteria is also
shelf life) did not show significant difference in bactericidal seen in the clinical environment. In Wilson et al study,13 Gram-
efficacy compared to fresh AMG gloves. positive bacteria such as Staph a. were found in numerous
locations in the hospital environment, but Gram-negative
AMG gloves were also exposed to “light” (equivalent to 30 days
bacteria such as E. Coli were not found on any surfaces
in an open box environment). Again, there was no significant
sampled, despite having a number of patients in the ward with
difference in bactericidal efficacy compared to fresh AMG gloves.
E. Coli infections.

14. What are the different classifications of bacteria?


19. Do biocides kill Gram-positive or Gram-negative
Bacteria are classified into Gram-positive or Gram-negative. bacteria easily?
This classification came from a staining property observed by
Hans Gram in 1884. It was observed that some bacteria could All bacteria respond to biocides differently, requiring different
be stained with a dye, and others could not. It was later found contact times and concentrations for inactivation. In general,
that bacteria have different cell wall structure. Gram-positive Gram-negative bacteria are harder to kill with biocides.14
bacteria allow substances to cross the cell wall more easily. The
cell wall of Gram-negative bacteria is multi-layered and so it is 20. How is the bactericidal efficacy of AMG Antimicrobial
harder for substances to cross the cell wall. gloves measured?
15. What are some examples of Gram-negative bacteria? AMG Antimicrobial Glove will start generating singlet oxygen
and start killing bacteria immediately upon exposure to light
Gram-negative bacteria include Esherichia coli, Pseudomonas and oxygen. Based on the requirements of ASTM D7907-14,
aeruginosa, Klebsiella pneumoniae, Acinetobacter baumannii the contact time in which the bacteria have been exposed the
among others. external surface of the glove containing antimicrobial agent
needs to be measured at intervals of 5 mins, 10 mins, 20 mins
16. What are some examples of Gram-positive bacteria? and 30 mins.
Gram-positive bacteria include MRSA, Staphylococcus aureus, At the end of each contact time, the glove is transferred into a
Enterococcus faecium, Streptococcus pyogenes, Enterococcus validated neutraliser to stop the bactericidal activity. This will
faecalis (VRE) among many others. stop the singlet oxygen killing activity on the microbes, which will
in turn allow the calculation of bacteria kill.
17. What type of bacteria survive longer on surfaces,
Additional testing has been conducted at shorter contact times
which allow the possibility of infection transfer?
of 1 min and 2 mins on Staphylococcus aureus with bacteria kill
Based on a study conducted by Hirai,12 which measures the rates of 99.898% and 99.998% respectively.
survival of different types of bacteria on cotton lint, the results
showed that Gram-positive bacteria have longer lifetimes on
surfaces, which may have implications that these bacteria are
available for transfer to cause HAIs. Gram-negative bacteria
are known to die more quickly on surfaces, especially if the
surface is dry.

15
21. Does AMG glove has any efficacy on virus? 23. What is the intended use and indication for AMG
Antimicrobial Gloves in the technical file?
We believe AMG can kill viruses apart from bacteria. This is
why we choose to name it Antimicrobial instead of the more The Antimicrobial Nitrile Powder Free Examination Gloves are
limited Antibacterial. However, all our tests are based on ASTM intended to be used in the framework of medical examinations
D7907 Standard Test Methods for Determination of Bactericidal and diagnostic and therapeutic procedures conducted under
Efficacy on the Surface of Medical Examination Gloves. This non-sterile conditions. Furthermore, the use of the device is
test method specified the glove to be tested against 4 specific intended to help prevent cross contamination.
bacteria. As AMG is a new invention, there is no other standard
that we can use to test for viral efficacy. Nevertheless, we are Its indication is stated as “Any medical condition requiring an
working on adapting D7907 to test for viruses. This work will examination, a diagnostic or therapeutic procedure on the
take a longer time to complete. One of the challenge is that intact skin or mucosa under non-sterile conditions”.
viruses only replicate inside the living cells; once expose to the
environment they will be destroyed quickly, therefore making it 24. Does AMG Antimicrobial Gloves require registration by
difficult for us to test. EU Biocidal Regulation?
Meanwhile, we have decided to launch AMG with D7907 test The Biocides Regulation (EU) No. 528/2012 is not applicable
data as we believe most HAIs attributable to hand-surface for medical devices unless they are intended to be used for
contamination are bacteria. Viruses like Hepatitis and HIV other purposes not covered by the medical device directive,
are spread through fecal-oral route or transmission through in which case the Biocides Regulation shall also apply to that
contaminated syringes, needles or sharps, infected blood product insofar as those purposes are not addressed by those
transfusions. The more common flu virus is mainly spread to instruments. In our understanding, this would mean that the
others by droplets made when people with flu, cough, sneeze biocides regulation is only applicable if the gloves are intended
or talk. These droplets can land in the mouths or noses of for other non-medical purposes or if the antibacterial feature
people who are nearby or possibly be inhaled into the lungs. would not be within the original purpose of the medical device.
Less often, a person might get flu by touching a surface or As the gloves’ medical purpose is to prevent infection of the
object that has flu virus on it and then touching their own patient and the antimicrobial feature supports this purpose, we
mouth, nose, or possibly their eyes.15 believe that the biocides regulation is not applicable.16


22. What is the medical device classification for AMG
Antimicrobial Gloves in MDD93/42/EEC?
European Union MDD 93/42/EEC Annex IX:
Class I (Rule 5) includes “All invasive devices with respect to body
orifices, other than surgically invasive devices and which are not
intended for connection to an active medical device…”.
As such, the Antimicrobial Nitrile Powder Free Examination gloves
are an invasive device intended for short transient use (I. Definitions,
1.1) for examinations on intact skin and also involve body orifices (I.
Definitions, 1.2). All other parts of rule 5 do not apply.
Based on rule 5 (III. Classification, section 2, 2.1), the
Antimicrobial Nitrile Powder Free Examination Gloves are
classified as a medical device class I.

16
Appendix: Commonly Found Bacteria in Healthcare Facilities that Cause HAI

No. Microbe Type Impact

1 Enterococcus Gram- According to the Centers for Disease Control and Prevention (CDC), Enterococcus
faecalis/ positive faecalis is responsible for approximately 80% of human infections.17 It is one of the
Vancomycin- Bacteria bacteria that is becoming resistant to vancomycin, an antibiotic, and sometimes
resistant other standard therapies. Vancomycin-resistant enterococci (VRE) are leading causes
enterococci (VRE) of nosocomial bacteraemia, surgical wound and urinary tract infections.

2 Enterococcus Gram- Enterococcus faecium has been a leading cause of multi-drug resistant enterococcal
faecium positive infections over Enterococcus faecalis in the U.S. Approximately 40% of medical
Bacteria intensive care units reportedly found that the majority of device-associated infections
were due to vancomycin- and ampicillin-resistant E. faecium.18 The rapid increase of
VRE has made it difficult for physicians to fight infections caused by E. faecium since
not many antimicrobial solutions are available.19

3 Methicillin- Gram- Commonly transmitted through direct contact, open wounds and contaminated
resistant positive hands, MRSA is a type of staph bacteria resistant to many antibiotics. Due to this,
Staphylococcus Bacteria it is sometimes also called a “superbug”. MRSA can cause severe problems such as
aureus (MRSA) bloodstream infections, pneumonia and surgical site infection in healthcare settings
such as hospitals and nursing homes. Every year, MRSA infects about 72,444 people
with 9,194 related deaths in the U.S.20

4 Staphylococcus Gram- According to CDC, about 30% of people carry this microbe in their noses.21 Usually
aureus positive staph does not cause any harm; however in healthcare settings, it can sometimes
Bacteria cause infections that are serious or fatal. These infections include bacteraemia or
sepsis, pneumonia, endocarditis (infection of the heart valves) and osteomyelitis
(bone infection).

5 Streptococcus Gram- It is estimated that 5 - 15% of healthy individuals carry it on the skin or in the
pyogenes positive respiratory tract without showing symptoms of illness.22 It can rapidly colonise and
Bacteria multiply within a host, causing mild infections like “strep throat” or impetigo. When it
becomes invasive, it can destroy fat, skin and muscle tissues, leading to necrotising
fasciitis (flesh-eating disease).

6 Enterobacter Gram- E. cloacae has been reported as a multidrug-resistant opportunistic pathogen infecting
cloacae negative people in hospital wards for the last three decades. These Gram-negative bacteria have
Bacteria been responsible for several outbreaks of HAIs in Europe, particularly in France.23

7 Escherichia Gram- E. coli can cause diarrhoea, urinary tract infections, respiratory illness, bloodstream
coli negative infections, and other illnesses. The types of E. coli that can cause illness can be transmitted
Bacteria through contaminated water or food, or through contact with animals or people.

8 Klebsiella Gram- These bacteria have become resistant to the class of antibiotics called carbapenems.
pneumoniae negative Unfortunately, carbapenem antibiotics often are the last line of defence against Gram-
Bacteria negative infections that are resistant to other antibiotics.24 The bacteria are not spread
through the air, but through physical contact. It can cause pneumonia, bloodstream
infections, wound or surgical site infections, and meningitis.

17
End Notes:

1. World Health Organization. (n.d.). Health Care-Associated Infections 14. McDonnell, G., & Russell, A. D. (1999). Antiseptics and Disinfectants:
[Fact Sheet]. Retrieved from Activity, Action, and Resistance. Clinical Microbiology Reviews, 12(1),
http://www.who.int/gpsc/country_work/gpsc_ccisc_fact_sheet_en.pdf 147–179.

2. Collins, A. (2008). Preventing Health Care–Associated Infections. 15. Centers for Disease Control and Prevention. (2018). How Flu Spreads.
Retrieved from Retrieved from
https://www.ncbi.nlm.nih.gov/books/NBK2683/ https://www.cdc.gov/flu/about/disease/spread.htm

3. SCENIHR (Scientific Committee on Emerging and Newly Identified 16. MDSS Consulting, EU Authorized Representative
Health Risks). (2009). Assessment of the Antibiotic Resistance Effects
17. Huycke, M. M., Sahm, D. F., & Gilmore, M. S. (1998). Multiple-Drug
of Biocides, p. 57.
Resistant Enterococci: The Nature of the Problem and an Agenda for
4. Maisch, T. (2015). Resistance in antimicrobial photodynamic the Future. Emerging Infectious Diseases, 4(2), 239-249. Retrieved from
inactivation of bacteria. Photochemical & Photobiological Sciences, https://wwwnc.cdc.gov/eid/article/4/2/98-0211_article
14(8), 1518-1526.
18. Agudelo Higuita, N.I., & Huycke, M.M. (2014). Enterococcal Disease,
5. DeRosa, M. (2002). Photosensitized singlet oxygen and its Epidemiology, and Implications for Treatment. Retrieved from
applications. Coordination Chemistry Reviews, 233-234, 351-371. https://www.ncbi.nlm.nih.gov/books/NBK190429/

6. Wainwright, M. (2004). Photoantimicrobials - a PACT against 19. Willems, R., Top, J., van Santen, M., Robinson, D., Coque, T. M.,
resistance and infection. Drugs Of The Future, 29(1), 85-93. Baquero, F....Bonten, M. (2005). Global Spread of Vancomycin-resistant
Enterococcus faecium from Distinct Nosocomial Genetic Complex.
7. Babilas, P., Schreml, S., Landthaler, M., & Szeimies, R. (2018). Emerging Infectious Diseases, 11(6), 821-828. Retrieved from
Photodynamic therapy in dermatology: state-of-the-art. https://dx.doi.org/10.3201/eid1106.041204
8. Juarranz, Á., Jaén, P., Sanz-Rodríguez, F., Cuevas, J., & González, 20. Centers for Disease Control and Prevention. (2014). Active Bacterial
S. (2008). Photodynamic therapy of cancer. Basic principles and Core Surveillance Report, Emerging Infections Program Network,
applications. Clinical And Translational Oncology, 10(3), 148-154. Methicillin-Resistant Staphylococcus aureus, 2014. Retrieved from
https://www.cdc.gov/abcs/reports-findings/survreports/mrsa14.html
9. Khan, A. (1991). The discovery of the chemical evolution of singlet
oxygen. Some current chemical, photochemical, and biological 21. Centers for Disease Control and Prevention. (n.d.). Staphylococcus
applications. International Journal Of Quantum Chemistry, 39(3), 251-267. aureus in Healthcare Settings. Retrieved from
https://www.cdc.gov/hai/organisms/staph.html
10. Giuliani, F., Martinelli, M., Cocchi, A., Arbia, D., Fantetti, L., & Roncucci,
G. (2009). In Vitro Resistance Selection Studies of RLP068/Cl, a New 22. Professional and Technical Services (PTS). (n.d.). Streptococcus
Zn(II) Phthalocyanine Suitable for Antimicrobial Photodynamic pyogenes Fact Sheet, Retrieved from
Therapy. Antimicrobial Agents And Chemotherapy, 54(2), 637-642. http://www.infectionpreventionresource.com/files/Streptococcus%20
pyogenes.pdf
11. Tavares, A., Carvalho, C., Faustino, M., Neves, M., Tomé, J., & Tomé, A.
et al. (2010). Antimicrobial Photodynamic Therapy: Study of Bacterial 23. Davin-Regli, A., & Pagès, J.-M. (2015). Enterobacter aerogenes and
Recovery Viability and Potential Development of Resistance after Enterobacter cloacae; versatile bacterial pathogens confronting
Treatment. Marine Drugs, 8(1), 91-105. antibiotic treatment. Frontiers in Microbiology, 6, 392. Retrieved from
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4435039/
12. Hirai, Y. (1991). Survival of bacteria under dry conditions; from a
viewpoint of nosocomial infection. Journal Of Hospital Infection, 19(3), 24. Centers for Disease Control and Prevention. (n.d.). Klebsiella
191-200. pneumonia in Healthcare Settings. Retrieved from
https://www.cdc.gov/hai/organisms/klebsiella/klebsiella.html
13. Moore, G., Muzslay, M., & Wilson, A. (2013). The Type, Level, and
Distribution of Microorganisms within the Ward Environment: A Zonal
Analysis of an Intensive Care Unit and a Gastrointestinal Surgical
Ward. Infection Control & Hospital Epidemiology, 34(05), 500-506.

18
Hartalega Sdn Bhd
C-G-9, Jalan Dataran SD1,
Dataran SD PJU 9,
Bandar Sri Damansara,
52200 Kuala Lumpur, Malaysia.
Tel : +603 - 6277 1733
Email : info@hartalega.com.my

hartalega.com.my H-AMG-V1-R4

You might also like