October 2017, Volume 10 Issue 10ISSN 2380-0429

Surface Disinfection: BioSURF Surface Disinfectant Outperforms All Current Competitors

Gordon’s Clinical Observations: There has been a major void in infection control in the U.S. for several years since Lysol Spray lowered the ethyl alcohol in its formulation. The May 2017 Clinicians Report included an article on pre-wet wipe surface disinfectants that may have frustrated you because of the lack of adequate products. Research just completed by TRAC Research, the human studies division of CR, has identified the plant-based BioSURF disinfectant that has a kill potential similar to the old very potent original formulation Lysol Spray. You, your staff, and your patients will benefit from this very new information.

Current pre-wet disinfectant wipe formulations are convenient, but have been shown to spread rather than kill pathogens contained within complex human proteins always shed during dental procedures (blood, saliva, crevicular fluid, pus, etc). To achieve the thorough, fast microbe

kill expected by patients and clinicians on clinical surfaces, there are three components of surface disinfection that must be present, effective, and compatible with each other. These components are: (1) The disinfectant formulation, (2) The packaging and dispensing, (3) The wipe material. After 40+ years of a worldwide search that includes extensive microbial testing of now 190+ products, one has finally met the necessary essentials in all three surface disinfectant components. The following report describes and lists steps in use of the newest BioSURF environmental surface disinfectant. Continued on Page 2

Bag-in-a-Box dispensing of BioSURF

Products evaluated by CR Foundation® (CR®) and reported in the Gordon J. Christensen Clinicians Report® have been selected on the basis of merit from hundreds of products under evaluation. CR® conducts research at three levels: 1) multiple-user field evaluations, 2) controlled long-term clinical research, and 3) basic science laboratory research. Over 400 clinical field evaluators are located throughout the world and 40 full-time employees work at the institute. A product must meet at least one of the following standards to be reported in this publication: 1) innovative and new on the market, 2) less expensive, but meets the use standards, 3) unrecognized, valuable classic, or 4) superior to others in its broad classification. Your results may differ from CR Evaluators or other researchers on any product because of differences in preferences, techniques, product batches, or environments. CR Foundation® is a tax-exempt, non-profit education and research organization which uses a unique volunteer structure to produce objective, factual data. All proceeds are used to support the work of CR Foundation®. ©2017 This report or portions thereof may not be duplicated without permission of CR Foundation®. Annual English language subscription: US$199 worldwide, plus GST Canada subscriptions. Single issue: $18 each. See www.CliniciansReport.org for additional subscription information.

©2017 CR Foundation®

Course Handout

2Clinicians Report October 2017

Surface Disinfection: BioSURF Outperforms All Current Competitors (Continued from page 1)

1. THE DISINFECTANT FORMULATION: ethyl alcohol and chlorhexidine gluconate chemistryl Since 1976, we have defined “efficacy” of healthcare disinfectants as fast, broad-spectrum kill of poliovirus 1 and Mycobacterium bovis

bacteria (TB) in the presence of at least 10% fresh human whole blood. These test organisms were selected because both are difficult to inactivate with chemicals. Fresh human whole blood was placed in the test system because it is a challenge faced clinically daily. Industry has avoided this challenge because most disinfectants are neutralized by it. Disinfectant companies know their products fail to kill if complex body fluids are present. For years they have put clinicians at high risk by directing to clean before disinfecting. This dangerously places the cleaning personnel in harm’s way.

l It is imperative that disinfectants simultaneously kill and clean. l Over the years, our tests identified original formulation Lysol Disinfectant Spray and GermXtra as products that met the above criteria—

earlier iterations of BioSURF did not. However, Lysol and GermXtra were dispensed as spray-ons which created irritating aerosols, and neither were sold with a compatible wipe, which meant incompatible wipe materials were often chosen unkowningly by staff.

l In January 2017, BioSURF plant-based formulation using a modified production process became available. The graph below compares results of testing this BioSURF dispensed directly from its novel “Bag-in-a-Box” packaging compared to other products tested.

FIGURE 1: Kill potential within 3 minutes of 12 surface disinfectants on poliovirus 1 in the presence of 10% fresh human whole blood.

Summary of Graph:• Only BioSURF Bag-in-a-Box and GermXtra from a freshly opened container killed poliovirus1 in the presence of

10% fresh human whole blood within 3 minutes. BioSURF is EPA registered in the U.S., but GermXtra is not (both are registered in Canada and some other countries). BioSURF active ingredients are 70.5% ethyl alcohol and 0.2% chlorhexidine gluconate by weight, or 84% ethyl alcohol and 0.2% chlorhexidine gluconate by volume at 60°F.

2. THE PACKAGING AND DISPENSING: Bag-in-a-Boxl Kill potential of all disinfectant formulations decreases when exposed to air. Once the

manufacturer’s seal is broken, degradation begins. l Pre-wet wipe dispensing makes no pretense of seal, and pump spray bottles draw in air to

displace the liquid as spray. Once opened, both methods of packaging and dispensing cause gross loss of disinfectant kill potential over time. This degradation problem is overcome by Bag-in-a-Box delivery, which is a system long present in the wine industry to preserve wine chemistry and flavor.

l The efficacy of liquid in Bag-in-a-Box dispensing is maintained because the liquid is sealed within an air-tight bag that collapses on itself as the liquid volume decreases during use.

l For clinicians to obtain full kill potential from BioSURF, they should dispense the disinfectant directly onto a non-interfering wipe material just before each use.

l If clinicians insist on using a pump spray bottle, contents should be fully used then fully replenished each day to maintain kill potential (start with empty bottle each day).

Bag-in-a-Box sealed delivery preserves disinfectant from air exposure degradation. To obtain full kill potential, the liquid should be dispensed dirctly onto a non-interfering wipe before each use.

Pump spray bottle dispensing is less desirable because it draws in air to displace the liquid as spray. This exposes contents to air degradation and decreases kill potential unless contents are fully used and fully replenished each day. BioSURF Bag-in-a-Box 5 liter bag = $59 U.S.

U.S.—order from PureLife Dental at www.purelifedental.comCanada—order from local dental dealers

Q Generally, if a chemical kills 3 log10 (99.9%) of a million organism challenge, it can claim disinfection. Green line indicates 3 log10 kill.

BioSurf (Bag-in-a-Box)

GermXtra QQ

Monarch COEfect BioSonic Wipe Out

Lysol Brand III

ViraCide1 tbMinuteman Cavicide Cetylcide II OptIM Pure

Q

QQ Not available in U.S.

Log 10

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n

4

3

2

1

0

3.4 3.3

2.6 2.62.2

1.9 1.9

1.4

0.30.1 0.0 0.0

3Clinicians Report October 2017

TRAC RESEARCH CONCLUSIONS: BioSURF is the first, and currently only U.S. EPA registered, surface disinfectant with the combination of:(1) 3 minute broad spectrum kill in the presence of fresh human whole blood.(2) Packaging designed to eliminate loss of kill potential due to air exposure by use of the wine industry’s Bag-in-a-Box delivery.(3) Dispensing that prevents aerosol generation.(4) A wipe that does not interfere with the disinfectant’s kill potential.(5) Biodegradability of all materials in the system.

Evaluators stated the box needs: (1) to be more sturdy, (2) a built-in collection bowl to catch overflow, (3) a more positive seat for the faucet.

Surface Disinfection: BioSURF Outperforms All Current Competitors (Continued from page 2)

3. THE WIPE MATERIAL: LeCloth Dry WipesLeCloth Dry Wipes are a separate product sold by the same company selling BioSURF. They are dispensed from a cannister identical to those used for current generation pre-wet wipes, but they contain no liquid. Ideally, LeCloth Dry Wipes are wet just before each use and discarded after each operatory clean-up, to achieve maximum disinfectant kill. LeCloth Dry Wipes characteristics:

• Do not interfere with BioSURF kill.• Biodegradable.• Do not disintegrate during vigorous cleaning.• Can be re-wet frequently to keep

disinfectant delivery high during disinfection of an operatory.

• Discarded after each operatory clean-up as regular waste.

• 7"x 9" dimensions are convenient sizing.

LeCloth Dry Wipes = $5 per roll of 100 (5¢ per wipe)U.S.—order from PureLife Dental at www.purelifedental.comCanada—order from local dental dealers

4. CLINICAL TECHNIQUES for BioSURF use

Some types of rubber, plastic, paint, and naugahyde may not tolerate regular use of this high ethyl alcohol-chlorhexidine formulation. Clinicians should consider replacing items that will not tolerate effective disinfection after each patient, or use barriers for those items.

DISPENSING: Two possible methodsMETHOD 1: Dispense from Bag-in-a-Box directly onto wipe. (Preferred)

l Set up the system as pictured. (Note: the white bowl and glass pan are kitchenware and were purchased separately locally.) This placement positioning for the BioSURF box facilitates dispensing from the top of a counter.

l Loosely ball up 1 or several LeCloth Dry Wipes and open faucet holding wipes very close to orifice, allowing excess to drip into the bowl.

METHOD 2: Dispensing from Bag-in-a-Box into spray bottle.

l Position Bag-in-a-Box on counter edge and dispense into a pump spray bottle. Spray from pump bottle directly onto LeCloth Dry Wipes, wetting generously and allowing excess to drip onto counter to be wiped. (Do not spray directly onto surfaces. Fully fill bottle with fresh disinfectant daily.)

Application Steps:

1. Generously wet LeCloth per Method 1 (preferred) or Method 2 shown at left. Spread disinfectant evenly and generously and scrub to remove visible debris. Re-wet LeCloth generously as needed, as you proceed.

2. Allow disinfectant 3 minutes on surfaces to obtain penetration into soil and oral proteins and kill organisms within. Less than the 3 minute contact time can diminish kill since this disinfectant is killing organisms within soil and oral proteins.

3. OPTIONAL STEP. If streaking occurs on dark surfaces— damp-wet a paper towel with BioSURF and wipe surface quickly to produce even, shiny appearance as a last step, AFTER completing the 3 minute disinfection steps above.

ENVIRONMENTAL SURFACE DISINFECTANTS critical information (2-2015)

1. Do all disinfectants kill equally well? No – different formulations and chemical ingredients sold under different brand names kill very differently. This is particularly true when human proteins such as blood, saliva, etc. are present.

2. Should disinfectants be tested by an independent lab to confirm kill claims? Yes –because marketing and promotional claims can be very misleading.

In the U.S., environmental surface disinfectants must kill 99.9% of a specified test organism (3 log10 reduction of a 1 million organism challenge) to be registered as disinfectants by the Environmental Protection Agency (EPA). Unfortunately EPA does not test disinfectants to validate performance data submitted by companies.

EPA has suggested kill of the tuberculosis bacteria as the benchmark for disinfectants used in healthcare. However, our work has shown that disinfectants that can kill the tuberculosis bacteria often cannot kill some of the more difficult-to-kill viruses. Yet, virus kill is not required for EPA registration. However, it is viral infections that present the highest risk to dental clinicians in the U.S. today. Since 1985 we have accumulated a large database using the tuberculosis bacteria and the virus known as poliovirus I (Mahoney strain) in tests performed in triplicate on well over 150 different disinfectant formulations from around the world. We now know that only high ethyl alcohol formulations (≥70% ethyl alcohol) or chlorine based (≥2.5% sodium hypochlorite) can perform the kill needed in the presence of human proteins such as blood, saliva, crevicular fluid, suppuration (pus), etc, which are ALWAYS PRESENT ON SURFACES IN CLINICAL SETTINGS due to aerosols, spatter, spills, and body contact that occur during every treatment.

However, 70% ethyl alcohol is NOT the whole story. To kill in the presence of fresh human whole blood, the formulation requires a specific grade of ethyl alcohol plus surfactants and other trace ingredients to retard evaporation, facilitate even spreading, and aid protein wetting. Our data indicate that only two commercial formulations (Lysol III and GermXtra*) are able to kill in the presence of the human proteins enumerated above, and penetrate to kill the organisms trapped within.

3. Should I clean before I disinfect? Yes, clean – but use a generous coating of a disinfectant that kills in the presence of clinically relevant proteins as the cleaner (Lysol III or GermXtra*). Then after removal of the visible debris, re-apply the Lysol III or GermXtra* for the disinfection step. In other words, spread Lysol III or GermXtra* twice – once to clean and once to disinfect.

Because most disinfectants are NOT able to kill in the presence of human proteins, clinicians have been directed to clean before they disinfect. Unfortunately, clinicians have chosen to clean with products that do not kill in the presence of human proteins. This forces the cleaning person into direct contact with contaminated surfaces at a time when the organisms are most likely to be still viable. INSTEAD, surfaces should be spread generously with a broad spectrum disinfectant that kills in the presence of proteins.

rella@tracresearch.org 801-368-5727

OVER

*GermXtra is not sold currently in the U.S.

4. Why is it a bad idea to spray disinfectants directly onto surfaces? There are three answers to this question: (1) Spraying leaves many areas uncovered with liquid between the spray droplets in which organism kill does not occur; (2) All disinfectants are strong chemicals that should not be aerosolized; and (3) Hand pump spray containers used by most for direct application draw in air that is used to expel the liquid. Exposure of the disinfectant chemicals to air degrades their kill potency.

INSTEAD OF SPRAYING DIRECTLY ONTO THE SURFACE – spray liberally into an applicator, such as a 4x4" gauze sponge, and then use it to spread the disinfectant evenly over the surface to be disinfected. The surface should be left generously wet for a period of time to allow the disinfectant to penetrate and kill the microorganisms. This wait period is called “contact time”. All disinfectants require a contact time that varies according to the formulation of the disinfectant. Directions on many disinfectant containers specify 10 minutes. Most clinicians make the mistake of wiping sprayed surfaces too quickly after application.

5. Are pre-wet wipes, such as the popular CaviWipes, a good solution for surface disinfection?

No—for two reasons: (1) The quaternary ammonium compound chemical used in this product (and most other wipes) is neutralized by human proteins which exposes the user to any pathogens present; and (2) The pull-out dispensing exposes the chemicals on the wipes to air degradation and the wipes to drying. We have tested many different brands of pre-wet wipes, and NONE achieve a broad spectrum kill, either in the absence or presence of human proteins. For this reason we consider pull-out-dispensed pre-wet wipes to be dangerous to both patients and clinicians in clinical settings.

This official reprint may not be duplicated. This reprint is prepared by CR for the purpose of providing dental clinicians with objective information about dental products.

©2015 CR Foundation®

Reprinted September 2015, with permission, from Volume 8 Issue 7, July 2015, Pages 1–3

Course Handout

Surface Disinfection: Can it be effective, safe, and easy?

Each patient expects the treatment area to be clean and free of microbes from previous patients. Each member of the dentalteam expects the workplace to be safe and free of pathogens. No one wants to be sick, even if the illness is not life threatening.Today, critical points in surface disinfection are:

• Dental treatment scatters saliva, blood, crevicular fluid, biofilm, and hard and soft tissue on everything and everyone.• The contamination comes mostly from aerosols that travel everywhere, but also from smears, splatters, and spills. • Oral microbes are contained within the various fluids and tissues, and are rarely found free on clinical surfaces. • When microbes are mixed with oral complex proteins, all disinfectants do NOT kill equally well.• Marketing has misled clinicians, and they continue to choose products that cannot deliver the kill they expect. • Current industry guidelines direct to clean BEFORE disinfecting which seriously compromises exposure prevention.

This report shows the science, the products, and the procedures necessary for effective, safe, easy surface disinfection in 2015.

Gordon’s Clinical Bottom Line: Infection control is probably not your favorite topic, but it is of utmost importance since most surface disinfectantsare clinically inadequate. For this report, TRAC Research recently tested 5 ethyl alcohol based and 3 other popular products and makes suggestions for youto upgrade handling of contaminated surfaces.

We need disinfectants that kill andclean at the same time

1. How can clinicians tell which surface disinfectants kill well?Chemical formulation is the key. In the U.S., all disinfectants must list ACTIVE and OTHER ingredientson the label using the exact form shown to the right for the example Lysol Spray III. Clinicians shouldalways look for this listing on their surface disinfectant.

Many years ago researchers characterized the kill potential of chemicals used worldwide for disinfection (see published works by Block, S.S. and by Morton, H.E.). TRAC Research has re-confirmed this work repeatedly since 1989 (see JADA, Oct. 1989, and many CRA Newslettersand Clinicians Reports), testing over 170 products sold in 6 countries. The chart below summarizes results using two pathogens known as difficultto kill with chemicals (tuberculosis bacteria and polio virus 1 Mahoney Strain) in the absence and presence of fresh human whole blood:

Chart Summary:• Certain formulations based on high ethyl alcohol kill well both in the absence and presence of fresh human whole blood IF a

specific grade of ethyl alcohol is used along with OTHER INGREDIENTS that allow even spreading, retard evaporation, and aid protein wetting.

• Products whose formulations rely primarily on the other 5 chemicals generally fail to kill under the above test conditions. • Clinicians can generally predict a disinfectant’s kill by comparing active ingredients on the label to Table 1 above.

NOTE: A clinician’s technique and diligence CANNOT overcome a disinfectant’s chemical inadequacy.

TABLE 1: General kill potential of commonly used surface disinfectant active ingredients

= Inactivated 3 log10 of a 1 million organism challenge (99.9% kill). = Failed to inactivate 3 log10 of 1 million organism challenge (99.9% kill).

ACTIVE INGREDIENTS:Alkyl (50%C14, 40%C12, 10%C16)

dimethyl benzyl ammonium saccharinate ......0.10%Ethanol .........................................................58.00%

OTHER INGREDIENTS: .....................................41.90%TOTAL: ...........................................................100.00%

6 Major Active Ingredients used alone or incombination in commercially available environmental

surface disinfectants used in dentistry

NO Blood in test system Fresh Human Whole Blood in test system

Tuberculosis bacteria Poliovirus 1 (Mahoney) Tuberculosis bacteria(+50% blood)

Poliovirus 1 (Mahoney)(+10% blood)

CHLORINE 2.6% by volume killed killed not killed killed

ETHYL ALCOHOL >70% by volume/58% by weight killed killed killed killed

IODOPHOR not killed killed not killed not killed

ISOPROPYL ALCOHOL >70% by volume killed not killed killed not killed

PHENOLIC killed not killed not killed not killed

QUATERNARY AMMONIUM COMPOUND not killed not killed not killed not killed

Example Label

Clinicians Report Page 2 July 2015

Graph Summary:• All 8 disinfectants tested achieved the necessary 3 log10 kill of poliovirus within 3 minutes, if blood was NOT present (white bars).• With 10% blood, GermXtra passed after 3 and 10 minutes (red and pink bars), and Lysol Spray III passed after 10 minutes (pink bar).• The data illustrate clearly that disinfectant kill is: 1) highly formulation dependent; 2) seriously challenged by oral proteins.

2. Do all surface disinfectants kill pathogens equally well?NO. Generally, if a chemical kills 3 log10 (99.9%) of a million organism challenge, it can claim disinfection. Green line below indicates kill limit.

FIGURE 1: Kill profile at 3 & 10 min of 8 environmental surface disinfectants on poliovirus 1 in absence and presence of 10% fresh whole human blood (WHB)

� = >70% ethyl alcohol present in formulation † Quaternary ammonium compound

Disinfectant companies know their products fail to kill if complex body fluids are present. For years they have put clinicians at high risk bydirecting to clean before disinfecting. This dangerously puts “the cart before the horse” and places the cleaning personnel in harm’s way. We need disinfectants that kill and clean at the same time. TRAC tests show GermXtra and Lysol Spray III accomplish this goal.

GermXtra�

3 min No blood3 min with 10% WHB

10 min with 10% WHB

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5

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Lysol Spray III�

tbMinuteman�

BioSurf�

Wipe Out�

Cetylcide II†

Cavicide†

Pure‡

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1.9

4.6 4.7

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2.5

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3. There are many products named Lysol, so how do I know which one to buy and the best place to buy it?• Best way to KNOW you have the correct product is to check the label ingredients (see #1 above). Look for 58% ethanol (by weight). • Schein, Patterson, Benco, and Burkhart sell the 58% ethanol formulation under the name Lysol I.C. Disinfectant Spray. • Local discount and groceries sell the 58% ethanol formulation under the name Lysol Spray III (NOTE: Crisp Linen scent has least “flowery” scent).

TRAC Conclusions:Environmental surfaces can be disinfected effectively, safely, and easily if efficacious disinfectants are chosen and used correctly. However, both thedisinfectant industry and clinicians are urgently in need of change to make this happen routinely. Why change? When a serious pathogen hitsunexpectedly, you are ready and all benefit—patients, staff, and doctors. Currently of 170+ products tested by TRAC Research, only Lysol Spray IIIin the U.S. and GermXtra in Canada show consistent kill in the presence of human protein debris when used as directed in section 5 above.

4. Why do speakers and/or authors tell me not to use ethyl alcohol (also called ethanol) for surface disinfection?Reasons may include:

• They do not perform disinfectant testing themselves, so they may be easily misled by people with vested interests.• They do not know that it is the formulation, not just ethyl alcohol alone, that is needed. • They may not have tested using difficult to kill viruses and clinically relevant types and amounts of human proteins.• They may have other reasons or biases to promote certain products.• They may not realize the health and safety of you and your patients are jeopardized by products that fail to kill in the presence of oral proteins.

6. Can Lysol Spray III and GermXtra be used to disinfect all types of surfaces?NO. High ethyl alcohol products need trial before liberal and regular use. Some rubbers, plastics, paints, and naugahydes require plastic barriers ratherthan routine treatment with chemicals. Today, healthcare equipment needs to be upgraded to allow effective disinfection after each patient.

5. Steps for effective, safe, easy surface disinfection.

Step 1. Pre-clean by holding a 4x4 inchcotton filled gauze pad over disinfectantorifice and spray dripping wet to create“custom wipe” just before use. Currently,no commercial pre-wet wipes providekill in the presence of oral proteins.

Step 2. Generously spread disinfectantevenly and scrub to remove visibledebris. Re-wet the gauze padfrequently during wiping. Do not spraydirectly onto surfaces to avoid unevenwetting and excessive aerosols.

Step 3. Leave surfaces generously wetat least 3 minutes for GermXtra and 10minutes for Lysol Spray III to allowdisinfectant penetration of oral proteinsand effective kill.

Step 4. Disinfect pre-cleaned surfacesusing a second generously wet 4x4pad, and leave surfaces damp,allowing to air dry or paper towel wipe to smooth streaks or puddles.

CDC – Age 19 & Over Recommended Vaccines

Tetanus, Diptheria , PertussisChickenpox

Papilloma Female

Papilloma Male

Shingles

Measles-Mumps-Rubella

Pneumonia 13

Meningitis 4-valent conj

Influenza

Pneumonia 23

Hepatitis A

Hepatitis B

Meningitis B

Haemophilus influenza B

all adults certain risks no rec

19-21 yrs 22-26 yrs 27-49 yrs 50-59 yrs 60-64 yrs 65+ yrs

3 doses

1 dose

1 dose

2 or 3 doses depending on vaccine

1 or 3 doses depending on indication

1 or 2 doses depending on indication

1 or 2 doses depending on indication

2 or 3 doses depending on vaccine

3 doses

1 or more doses depending on indication

1 dose annually

Substitute Tdap for TD once, then Td booster every 10 yrs

2 doses

3 doses

1 dose