AMG Brochure R4
AMG Brochure R4
AMG Brochure R4
99.999%
MICROBES
to help prevent healthcare-associated Infections
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
3
HOW DO HAIs OCCUR?
Infections occur when microbes enter the body, breed and
cause a reaction to the body.
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
4
Means of
Source Susceptible
Transmission
(Reservoir) Person
(Vehicle)
5
THE ROLE
OF MEDICAL GLOVES
The World Health Organization (WHO) recommends
wearing medical gloves to reduce the risk of:
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.
Photodynamic
Reaction
ACTIVATED
PHOTOSENSITISER
1
O2
PHOTOSENSITISER
3
O2
MICROBES
CELL DEATH
LIGHT
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
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:
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.
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.
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
6 Accelerator Malaysian Rubber To quantify the amount of extractable accelerators in Non-detectable for
Extraction Test Board (MRB) gloves. accelerators
In-House Method
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No. Test Method Purpose of Testing Result Summary
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:
Penetration (Air & EN 374-2 To determine penetration resistance of gloves that Pass
Water Leak) Test protect against dangerous chemicals and/or organisms.
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
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.
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.
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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.
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.
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.
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
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
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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