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A dental service man’s perspective R-Tech Dental of MN, LLC www.rtechdental.com Michael Wiltrout, owner 800-826-8704 CDC - For routine dental treatment, meet regulatory standards for drinking water. <500 CFU/mL of heterotrophic water bacteria. ADA – "Encourages industry and the research community to improve the design of dental equipment so that by the year 2000, water delivered to patients during nonsurgical dental procedures consistently contains no more than 200 CFU/ml at any point in the time in the unfiltered output of the dental unit." EPA - The number of bacteria in water used as a coolant/irrigant for nonsurgical dental procedures should be as low as reasonably achievable and, at a minimum, <500 CFU/mL OSAP - The regulatory standard for safe drinking water of <500 CFU/mL APHA (American Public Health Association) - the regulatory standard for safe drinking water of <500 CFU/mL AWWA (American Water Works Association) - the regulatory standard for safe drinking water of <500 CFU/mL European Union Drinking Water Standards specify a maximum of 100 CFU/mL Q. What are biofilms? Q. Will biofilms harm me? ◦ A. Biofilms are microscopic communities that consist primarily of naturally occurring water bacteria and fungi. They form thin layers on virtually all surfaces, including dental water delivery systems. These common microbes or germs accumulate inside things like showerheads, faucets and fountains, and in the thin tubes used to deliver water in dental treatment. ◦ A. Scientific reports have not linked illness to water passing through dental waterlines. In our environment, we are exposed to countless germs or bacteria. Yet, exposure to these common microbes does not mean that an individual will get an infection or a disease. However, when a person’s immune system is compromised because of age, smoking, heavy drinking, being a transplant or cancer patient or because of HIV infection, he or she may have more difficulty fighting off the invading germs. This is why the ADA encourages patients who may have weakened immune systems to inform their dentist at the beginning of any treatment. That way, the patient and dentist together can make the right treatment decisions. Q. What has been done to prevent me from being exposed to someone else’s saliva during dental treatment? ◦ A. The ADA recommends that dentists follow the infection control guidelines of the ADA and CDC. These recommendations include the sterilization of dental instruments and the flushing of waterlines between patients. Additionally, the recommendations call for the installation and maintenance of anti-retraction devices, where appropriate. All these measures should help prevent exposure to someone else’s saliva. Q. What is the ADA goal for dental unit water? ◦ A. In 1995, the ADA set a goal for water quality. It called for equipment to be available by the year 2000 that can provide unfiltered water with no more than 200 CFU/ml (colony forming units per milliliter). That's the same standard as for kidney dialysis machines, and it's a goal that manufacturers are working toward. The Food and Drug Administration has recently cleared a number of new products to improve water quality and time is needed to evaluate their effectiveness. The Association encourages manufacturers of new products to submit those products to the ADA Seal of Acceptance program for evaluation. Q. Is the water in my dentist’s office safe? Q. How soon will dentists have devices meeting this new (200 CFU/mL) goal in their offices? ◦ A. Scientific reports have not linked illness with water passing through dental waterlines. However, patients should feel free to ask their dentist about the quality of their dental treatment water or any other aspect of their practice. To help reduce the number of microorganisms in treatment water, the Association recommends that dentists follow the infection control guidelines of the CDC and ADA. This is in addition to other precautions that your dentist may have in place. ◦ A. The current trend is toward dental units with features to enhance water quality. The FDA has recently cleared a number of new products to improve water quality and time is needed to evaluate their effectiveness. That's why the ADA is continuing its leadership in education and research in this area. The ADA strongly urges manufacturers to submit their devices for dental unit waterline use to the ADA Seal of Acceptance Program for scientific evaluation, which allows dentists to choose products with even greater confidence. Q. Does the ADA oppose government regulations on this issue-even if legislators adopt the ADA's own goal? ◦ A. Yes. The ADA favors a voluntary goal and strongly opposes any effort to turn a scientific goal into a legal dictate. The dental profession has an excellent, proactive record on this and other safety issues. In fact, the dental profession has led the way when it comes to improving water quality. Because of the ADA statement issued in 1995, the research and dental industries have responded very positively to this issue. The number of products (approximately 25) cleared by the FDA for improving water quality reflects this response. Q. What should patients know about waterlines? ◦ A. Patients should always feel free to ask their dentist about water quality or any other aspect of their practice. Patients also should inform their dentist of any health problems and medications they might be taking so the patient and dentist can make the right treatment decisions. Both dentists and patients should also feel free to visit the ADA website at www.ada.org for more information. CFU = Colony Forming Units of Bacteria ◦ ◦ ◦ ◦ ◦ ◦ ◦ Federal Water Quality Regulation is 500 CFU/mL Dentist with City Water Feed - 375,000 CFU/mL Dentist on CWS bottle - 1,200,00 CFU/mL Dentist on CWS bottle/w cleaner - <200 CFU/mL Highest# in a dental waterline - 41,000,00 CFU/mL Newly mfd. dental unit – 5,000,000 CFU/mL Toilet water – Anyone want to guess? Dental unit water line Tap water line Very small diameter 1/16”-1/8” ½” diameter Very slow flow rate drips/sec 5 L/min flowrate (>1000x dental) Plastic tubing is hydrophobic making biofilm attachment easy. The tubing is also a source of carbon for the bacteria. Copper as a metal and as a dissociated ion is Antimicrobial/Bacteriostatic Large surface area to volume ratio Small surface area to volume ratio Rough interior (extrusion molded) Smooth interior Left stagnant for long periods Fresh every time turned on Chlorine rapidly dissipates over 24 hours and can even be absorbed by the tubing. Chlorinated and replenished with every use. Distilled Water City Water No Chlorine Chlorinated No Minerals Calcium, Lime, Rust, etc. $0.50-$1/gal on average Free out of tap Must be delivered or made onsite Dispensed out of tap Not sterile Not sterile My syringe and/or handpiece leaks water. I can’t get water out of my handpiece. The patient says that the water tastes funny. Why does the city demand I get an RPZ valve? What are these colored stringy things? Why is the water foaming? ◦ How many offices represented here have all of their operatories operating off of a bottle? ◦ Did you know that it costs about $250 per operatory to convert a city fed unit into one that operates off of a bottle? ◦ The vast majority of new delivery systems come equipped with clean water systems because the cost to not have a clean water bottle is actually greater for the doctor and the manufacturer. CWS: The Disinfectant Delivery System DCI International 8145 Clean Water System $165.00 ◦ Clean water bottles were originally designed for mission work where water quality was questionable. They allowed a dental unit to be portable. ◦ Introduction of RPZ valve forced an expensive choice of city water vs. bottled water systems. ◦ Media & Patient concerns caused a major shift towards the bottle for its ability to allow the use of disinfectants. Series 009 Watts Reduced Pressure Zone Assemblies prevent the reverse flow of polluted water from entering into the potable water supply due to backsiphonage and or backpressure. Watts Series 009 is ideal for protection of health hazard cross-connections or for containment at the service line entrance. These expensive valves are required to be installed for any delivery unit not on a CWS. They are also required by law to be inspected by a plumber on a regular basis. Cost estimate > $500 + space requirements & inspections. Limited water volume – You have to change bottles frequently and filling and changing the bottle takes time. Cost and additional handling of distilled water if it is used. Disinfection procedures take time and if they are not done properly, the water will either taste/smell bad or the unit may be damaged or have a higher contamination than if it were connected to city water. Bottles can explode although this problem has been basically eliminated due to HDPE bottles. Bottles get over-filled by staff causing water to get into the air lines of the unit. Fill the bottle to a point that is about 1” down from the neck of the bottle. This amount of air space will allow for the displacement that the feed tube will cause. It will also help protect the air delivery system of the clean water unit from water contamination. If you do not have a sink that has a long enough neck on it to fill the water bottle, the use of a funnel is recommended. DCI 8164 2 Liter Bottle $12 Larger capacity for longer run times between changes DCI 8941 Quick Switch Kit $70 Allows a quick change of the bottle. ◦ And his name is “biofilm”. ◦ Biofilm (a definition): A biofilm is a complex aggregation of micoorganisms marked by the excretion of a protective and adhesive matrix. They are often characterized by surface attachment, structural heterogeneity, genetic diversity, complex community interactions, and an extracellular matrix of polymeric substances. Biofilm lifecycle 5 stages of biofilm development. Stage 1, initial attachment Stage 2, irreversible attachment Stage 3, maturation I Stage 4, maturation II Stage 5, dispersion Each stage of development in the diagram is paired with a photomicrograph of a developing Pseudomonas aeruginosa biofilm. All photomicrographs are shown to same scale. Bacteria populations double every 20 minutes ◦ Example: 1 Bacteria 4096 Bacteria 134,217,728 Bacteria @8 AM @12 NOON @5PM This average assumes the untreated water is left stagnant at room temperature. Which is exactly what happens over night, or on weekends in delivery units. A clean water source that is attached to an infected unit becomes contaminated within 5 minutes of introduction to the unit. This contamination peaks at about 24 hours. Some of it comes from the original source water. Sterile water being the only exception to that rule. Most of it comes from retraction. This is why some units have higher contaminations than others. It depends on who was seen in the chair and how badly the unit is retracting. Pretty disgusting isn’t it? Bacteria in Patient #1 gets delivered to Healthy Patient #2 Some comes from the air used to pressurize the water bottles. What is it? ◦ Retraction is the action that occurs when a water relay within the dental unit shuts off and draws water back into the device. Is it bad? ◦ It is bad because if the level of retraction is great enough, it will draw bodily fluids back past the handpiece that is being sterilized and into the handpiece hose that is not. How do you test for retraction? ◦ We install a small 7” piece of clear tubing on the end of the handpiece hose. We step on the foot control and then let up. We measure how far the water gets drawn back. As the water valve stem moves to an off position, it retracts water. We install an anti-retraction valve. ◦ It is in-expensive. ◦ It only allows the water to flow in one direction. Why does the anti-retraction valve fail? ◦ As with most leakage problems within a delivery unit, check valves fail due to contamination from biofilm. ◦ Once this occurs, the check valve needs to be replaced. We provide a test kit. You use this test kit to take samples of your dental unit water in each operatory. The test kit is mailed into a laboratory. They test the water and contact you with the results. Testing for the problem ConFirm Monitoring Systems, Inc. 90401 Waterline test kit $95.00 Dental Unit Waterline Testing Service Instructions 1. Place refrigerant pack in the styrofoam lid and place in freezer overnight. 2. Flush waterlines for a minimum of 2 minutes before taking samples. Sampling should always be conducted just prior to any scheduled waterline maintenance or treatment. Samples must be shipped on Monday, Tuesday, and Wednesday only. Do not ship samples on any day preceding a holiday. 3. Collect DUWL samples using sterile collection vials. Fill vials to approximately ¾ full. Do not touch the outlet of the waterline or the interior of the collection vial. Note: The collection tubes contain a dehydrated chlorine neutralizer which is visible in the bottom of the vial. 4. Label each DUWL sample. Use a permanent marker or the labels provided. Indicate the sample location and the type. I.e. Operatory 3, air/water syringe (Op3, a/w). 5. Complete sample submission form and return with samples. 6. Place the frozen refrigerant pack with the water samples in the styrofoam shipper. Place the styrofoam shipper in mailer box. 7. Complete US Express Mail shipping label and affix to box. 8. US Express Mail can be picked up by your US Post Office mail carrier or delivered to a Post Office. It must be picked up or delivered the same day the samples are taken, and sent overnight. 9. If you have any questions, please call customer service at 800-819-3336. Results will be faxed or e-mailed after 7 days of incubation. Dental Unit Waterline Testing Instructions We recommend initial testing and subsequent testing as you see fit. Manufacturer recommends monthly testing of waterlines to ensure you are meeting established guidelines. There are so many different methods and chemicals available it is mind boggling. ◦ ◦ ◦ ◦ ◦ ◦ ◦ Dry flushing Bleaching (5.25% sodium hypochlorite 1:10 ratio) Filtration (iodine inline filters, clearline) Sterilization (UV lights) Shock treatments (Mint-A-Kleen, Sterilex) Tablet in bottle treatments (BluTab, ICX) Sterilizable water delivery tubings Use city water in your bottle. (It is free and readily available. Distilled is better if the office wants to pay for it. Distilled water is only better if a disinfectant is being used otherwise it is worse.) Use the BluTab product in each and every bottle. (The water does not have to be dumped out and is good for 28 days.) Shock your waterlines using Mint-A-Kleen - this removes the biofilm buildup. (I recommend that this be done at least monthly and whenever the unit will not be used for a few days.) Test your waterlines yearly or as frequently as you want to afford. Daily Treatment of waterlines ConFirm Monitoring Systems, Inc. BT50 750mL BluTab Tablets 50/box $27.95 BluTab® BT50 Waterline Maintenance Tablets BluTab® Waterline Maintenance Tablets are formulated specifically for dental unit waterlines. BluTab® is designed to be continuously present in your waterlines and helps keep lines clean. Directions for Use: 1) Place tablet or tablets (see table below) in empty dental unit water bottle every time you refill the water. BluTab® is intended for use with potable water (including tap or distilled). 2) Fill bottle with desired volume of water and connect to dental unit. Tablet dissolves in a few minutes. 3) BluTab® may be left in the waterlines overnight and for extended periods of nonuse. BluTab® has been shown to be effective for up to 28 days. Use water solution until it is expended; or up to 28 days. It is not necessary to purge lines at the end of each day. 4) BluTab® is not intended for use as a biofilm removal agent. Before starting a treatment program with BluTab®, flush lines with an antimicrobial product registered with the U.S. EPA which is appropriate for use in dental unit water lines. Repeat flushing protocol every two months. Consult with the manufacturer of your dental unit or water delivery system to determine the best method to flush your water system. For a list of recommended products, call 1-800-819-3336. Clinical monitoring of water quality can ensure that procedures are performed correctly. Test water quality monthly to establish effectiveness of your maintenance program. If water quality results approach or exceed the CDC recommended bacteria counts, repeat flushing protocol. BluTab Use Directions Note: Used daily, per bottle to keep water clean. Product does not remove biofilm. Mint-A-Kleen product Anodia Systems 2000-500 Box of 10 500mL bottles $115.00 Mint-A-Kleen® is a light blue, mint flavored solution for use in operative, scaling procedures and cleaning dental unit’s waterlines. Mint-A-Kleen® is bottled in 16 oz. bottles. Use Mint-A-Kleen® to cleanse dental unit water lines and dental units heavy-duty water bottle. Waterline Cleaning Procedure: After the last patient leaves; Purge waterlines with air. Inject Mint-A-Kleen® into all waterlines and allow to remain overnight. Next morning purge the waterlines with water for 30 seconds. Operative/ Hygiene Procedures: Solution used in place of water during operative/scaling procedures Mint flavoring helps to mask bad tastes and smells. Decrease wear on handpiece and burs. Less smear layer on tooth’s preparation. Increase cutting efficiency with improved cutting on tooth structure. Increase patient cooperation. Less exposure to aerosols due to the viscosity of Mint-A-Kleen® . Lubricates tissue during scaling or operative procedures. Use with designated pressurized system for high speed handpiece. SAFE: Contains no toxic products, palatable. Mint-A-Kleen® is recommended to clean the biofilm when using such systems as ultraviolet lights, iodine filters, and filtering systems that treats the water. * The pressurized system is activated by the foot control and is for designated handpiece. Mint-A-Kleen Use Directions Can be used alone, or as a shock product when using tabs. Timeline 1990 – “CBS 60 minutes/Street Scenes” Florida AIDS Dentist – Bring on handpiece sterilization. 1993 – CDC recommends that dental waterlines be flushed at the beginning of the clinic day to reduce the microbial load. 1995 – ADA asks dental manufacturers to provide equipment with the ability to deliver treatment water with < 200 CFU/mL. 1995 – JADA September Vol. 126 “Contribution of Biofilm Bacteria to the Contamination of the Dental Unit Water Supply” 1995 – We begin retrofitting units with Clean Water Systems. 1996 – We offer free anti-retraction testing to our clients – The ADA recommends that handpiece waterlines be checked every six months to ensure they are not retracting saliva. 1996 – A-dec publishes 85-0983-00/12-96 “A-dec’s Detailed Steps to Weekly Waterline Asepsis” – This guide details the use of 1:10 bleach (5.25% sodium hypochlorite) solution. 1999 – In our newsletter, we introduced Sterilex Ultra-Kleen as a replacement for the 1:10 sodium hypochlorite (bleach) procedure. Ultra-Kleen uses a combination of oxidation, hydrolysis and solubilization to destroy and break up biofilm. The bleach solution was eating all of the metal fittings within the units. 1999 – A-dec endorses the use of Ultra-Kleen – “A better alternative (less damaging) to bleach is the use of commercially available product called Ultra-Kleen.” 1999 – M.R.L.B. International markets their Denta-Pure Iodinated cartridges for use on the end of the handpiece hose. They stop the retraction problem and bring CFU counts to zero. 2000 - ABC’s 20/20 February 18th show airs “The Dentist’s Dirty Little Secret” where they tell the general public that toilet water is several times cleaner than dental delivery system water. Brought to light the problem of “suck back” 2000 – Massive numbers of dentists sparked by the PR nightmare that 20/20 brought to light, order clean water systems. 2000 – June R-Tech begins marketing Bio 2000 (Mint-A-Kleen) a chlorhexidine product in place of Sterilex due to the fact that we had been experiencing problems with crystalline build up at the points of use from Sterilex use. 2004 – A-dec comes out with ICX tablets that uses three primary active ingredients: sodium percarbonate, silver nitrate, and cationic surfactants. The tablet eliminates the need to purge waterlines at night. 2005 – R-Tech offers ConFirm Monitoring Systems, Inc. BluTab product as a less-expensive alternative to A-dec ICX. 2008 – Present recommendation: Use a tablet product such as BlueTab or ICX in all of your bottles of water Use a biofilm shock product such as Mint-A-Kleen or Sterilex once a month or more frequently if waterline testing shows a higher than normal CFU/mL. Test your waterlines yearly or as frequently as you want to afford. ConFirm recommends monthly testing. ADA Statement on Dental Unit Waterlines Adec’s Self-contained Water System Owner’s Guide, Publication No. 85-0675-00 Adec’s Systems Guide, Publication No. 85-0801-00 Anodia Systems product literature Clearline Microfiltration advertisement Compendium, Vol. 17, No. 7, July 1996 Starting pg. 691 Confirm Monitoring Systems product literature DCI International product literature “Dental Unite Waterlines – Taking the High Road… Now” Dentistry Today August 1997 by Dr. Gary Kono, D.D.S. “If we had only Known… Reactions to Dental Waterline contamination” Dean Swift B.Sc. B.Ed. FADM JADA, Vol. 126, September 1995 starting pg. 1255 JADA, Vol. 128, September 1997 starting pg. 1235 Sterilex product literature Wikipedia.org/wiki/biofilm www.bioeng.washington.edu (Dr. James Bryers video speech)