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By Shannon E. Mills, DDS n Guidelines, regulations and stand- ards related to dental water quality all influence the design and mar- keting of dental equipment, clinical practice and occupational safety. The Centers for Disease Control and Pre- vention (CDC) “Guidelines for Infec- tion Control in Dental Health-Care Settings, 2003, provide the standard of care for clinical practice relative to dental water quality that inform regulations and enforcement by state dental boards1 . CDCguidelinesmayalsobeusedto establish the standard of care in the course of malpractice litigation. A recent case report describing fatal legionnaire’s disease linked to contaminated dental water2 , along with studies demonstrating high lev- els of bacterial lipopolysaccharide in dental treatment water3,4 , have raised new questions about the health con- sequences of biofilm colonization of dental waterlines. When selecting a device or mate- rial to control or eliminate biofilm in dental water, the end user should have knowledge of the regulatory processes and standards and be pre- pared to ask the manufacturer about relevant approvals and clearances. The US Food and Drug Administra- tion (FDA) is responsible for protect- ing the public health by assuring the safety, efficacy and security of medical devices, including dental equipment, instruments and materi- als. Dental units and handpieces are Class I Medical Devices, ultrasonic scalersareClassIIdevicesanddental lasers are currently unclassified. All require 510k clearance to market and mustconformtoGoodManufacturing Practice (GMP). Thereiscurrentlynospecificdocu- mentation required for water deliv- ery systems. FDA currently uses national and international standards in their pre-market review process. After-market dental water treat- mentdevicesmustbeclearedasClass I or II medical devices and are subject to general controls under the Food Drug and Cosmetics Act. Waterline treatmentsystemsintegratedintothe dental unit are included in the 510(k) approval for the unit. Anti-biofilm and other germicidal agentsmustberegisteredwiththeUS Environmental Protection Agency or state environmental regulators. The general controls provisions of the Food Drug and Cosmetics Act include requirementsforannualregistration, listing of devices, good manufactur- ing practice, labeling and prohibi- tions against misbranding and adul- teration. Waterline products that claim dis- infectant efficacy must be registered with the Environmental Protection Agency (EPA). If not EPA-registered, they can be labeled as waterline cleaners only. Waterline treatment devices that are sold separately and require connection to dental units must be registered with the FDA as medical devices. Some states may also require registration with their environmental regulatory agency. Biofilm is considered to be a “pest” bytheEPA,andtherefore,labelclaims to prevent, destroy, repel or mitigate biofilm on an inanimate environ- mental surface are pesticidal claims that require registration under the Federal Insecticide Fungicide and Rodenticide Act (FIFRA) — including product efficacy data. Biofilm expresses unique char- acteristics and requires unique and relevant test methods for measur- ing product efficacy. The choice of method will dictate the type of label claim. EPA has proposed interim guid- ance for efficacy evaluation of anti- microbial pesticides for treating hard non-porous surfaces contaminated with bacterial biofilm. Registrants and applicants may propose and submit alternative practices to the agencyforassessmentandevaluation on a case-by-case basis, and this guid- ance may be updated in the future. Dental unit design characteristics contribute to biofilm growth and resistance to remediation because of long lengths of narrow bore tubing, dead legs, gauges, control blocks and valves5 . The complex geometry of dentalwaterdeliverysystemscreates unique challenges for inactivation and removal of biofilm. For this reason, the International Organization for Standards (ISO) under ISO Technical Committee 106 —Dentistryhasundertakenthedevel- opment of international standards specific to dental equipment that describe test methods to demonstrate the ability of waterline treatment products to remove or prevent devel- opment of biofilm in dental equip- ment. These standards describe use of a standardized microbial consortium and test conditions needed for labora- tory evaluation of treatment methods to improve or maintain the microbio- logical quality of water from dental equipment but do not set standards for microbial levels in dental unit water. These standards may be used in the future by FDA, EPA and state environmental regulators as part of approval and registration processes. Summary: The manufacturers of dental waterline treatment devices and agents must have appropriate approvals and clearances from fed- eral or state regulatory agencies to make anti-biofilm claims. Knowing the basic regulatory framework can help dentists make better informed purchasing decisions in order to ensure the health and safety of patients and health-care workers. For more information on FDA regu- lation of medical devices, go to www. fda.gov/MedicalDevices/default.htm. To learn more about EPA registration of products with anti-biofilm claims, go to www.fda.gov/MedicalDevices/ default.htm.ANSI/ADAandISOstand- ardsareavailableatwww.ada.org/en/ science-research/dental-standards. References 1. Kohn WG, Collins AS, Cleveland JL, et al. Guidelines for infection control in dental health-care set- tings--2003. MMWR Recomm Rep 2003;52(RR-17):1-61. 2. Ricci ML, Fontana S, Pinci F, et al. Pneumonia associated with a dental unit waterline. Lancet 2012;379(9816):684. 3. Huntington MK, Williams JF, Mac- kenzie CD. Endotoxin contamina- tion in the dental surgery. J Med Microbiol 2007;56(Pt 9):1230-1234. 4. Szymanska J. Exposure to bacte- rial endotoxin during conserva- tive dental treatment. Ann Agric Environ Med 2005;12(1):137-139. 5. Mills SE. The dental unit waterline controversy: defusing the myths, defining the solutions. J Am Dent Assoc 2000;131(10):1427-1441. exhibitors16 ADA 2015 — November 7, 2015 Dental unit waterlines: Update on guidelines, regulations, standards Here at the ADA To learn more about DentaPure, which canhelpwithallyourwaterlineneeds, stop by the booth, No. 3231 in the Tech Expo Arena. 5 Installing DentaPure is a simple process. (Photo/Provided by Crosstex International)