The Hygienic Benefits of Antimicrobial Copper Alloy Surfaces in Healthcare Settings
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The Hygienic Benefits of Antimicrobial Copper Alloy Surfaces In Healthcare Settings A compilation of information and data for International Copper Association Inc. Written by: Al Lewis Environmental Marketing & Communications Inc. With editorial contributions by Ken Geremia and Ruth Danzeisen WITHIN THE U.S., THIS DOCUMENT IS FOR INTERNAL USE ONLY BY THE ICA, ITS MEMBERS, AFFILIATES AND THEIR MEMBERS, AND MANUFACTURERS OF PRODUCTS MADE WITH ANTIMICROBIAL COPPER ALLOYS International Copper Association Inc. 260 Madison Avenue New York, NY 10016 212-251-7240 Copperinfo.org © 2009, International Copper Association Inc. A1335-XX/09 Printed in the USA ii Notice Regarding the Use of This Document in the U.S. ONLY U.S. ENVIRONMENTAL PROTECTION AGENCY (EPA) REGISTERED ALLOY PRODUCERS AND END-USE PRODUCT MANUFACTURERS THAT PURCHASE EPA REGISTERED ANTIMICROBIAL COPPER ALLOYS FROM A REGISTERED ALLOY PRODUCER ARE PERMITTED TO PROMOTE THEIR COPPER PRODUCTS AS ANTIMICROBIAL. This document is for scientific and academic purposes only and is not intended nor should it be used in conjunction with the sale, marketing, or distribution of Antimicrobial Copper Alloys within the United States. This document is intended for internal use only by the ICA, its members, affiliates and their members, and manufacturers of antimicrobial copper alloy products. This document is meant to be used as background for the development of promotional materials. Portions of the document can be used as long as the language on any resultant marketing collateral developed is consistent with EPA product registration approvals. THE DOCUMENT CAN BE SHARED WITH END-USE PRODUCT MANUFACTURERS ONLY AFTER THEY’VE AGREED TO MANUFACTURE ANTIMICROBIAL COPPER PRODUCTS. They too can use it to develop their own marketing collateral, but they are subject to the same rules and regulations as fabricators of copper and copper alloys. This document includes conclusions about copper alloys that do not reflect EPA antimicrobial public health product registration approvals. They are the opinions of the researchers and authors and are based on their review of an extensive body of peer- reviewed research, including preliminary studies not reviewed or approved by EPA. EPA- approved testing to demonstrate the antimicrobial activity of copper alloys has only been performed against the following organisms: Staphylococcus aureus, Enterobacter aerogenes, Escherichia coli O157:H7, Pseudomonas aeruginosa and Methicillin-resistant Staphylococcus aureus (MRSA). Any reference to effectiveness against other organisms has not been substantiated by EPA-approved testing. Further, any references that state or imply effectiveness in controlling disease or the transmission of bacteria that can cause disease in humans have not been approved by either the EPA or FDA (U.S. Food and Drug Administration). It is imperative that all marketing and promotion of antimicrobial copper alloy surfaces in the U.S. adhere to EPA guidelines. For locations outside of the U.S., local regulatory guidelines should be consulted and followed. All promotional messaging developed for use in the U.S. must clearly and prominently state that registered copper alloys kill 99.9% within two hours, and that these claims are based on laboratory testing when the product is cleaned regularly (to be free of dirt or grime that can interfere with contacting the copper surface). This document includes discussion of studies and test results showing, in some cases, effective kill rates in time periods less than two hours. This information is provided for background iii purposes, but the shorter time periods should not be cited in relation to the marketing of antimicrobial copper alloys in the U.S. Antimicrobial claims for copper alloys are restricted, at this time, to claims of 99.9% bacterial kill within two hours. In addition, marketing materials must contain the following language in the same font size and prominence as any antimicrobial claims: The use of a copper alloy surface is a supplement to and not a substitute for standard infection control practices; users must continue to follow all current infection control practices, including those practices related to the cleaning and disinfection of environmental surfaces. Copper alloy surface materials have been shown to reduce microbial contamination, but they do not necessarily prevent cross-contamination. The Copper Development Association must review and approve all promotional materials developed to support the sale of these products in the U.S. The CDA is committed to the proper stewardship of antimicrobial copper alloy products and has an obligation with the EPA to ensure that all promotional materials developed adhere to the registration and approved label language. Please see Chapter XVI for additional information. It is a violation of U.S. federal law to make public health claims that are inconsistent with the approved product registration. iv Table of Contents Notice Regarding the Use of This Document in the U.S. ........................................... iii Index of Tables and Figures ...........................................................................................x I. Introduction .....................................................................................................................1 Definitions of Copper‘s Antimicrobial Action .................................................................2 II. Antimicrobial Mechanisms of Copper ..........................................................................3 Copper‘s Electrochemical Properties ................................................................................3 Molecular Mechanisms of Copper‘s Antimicrobial Action ..............................................4 III. Existing Applications for Hygienic Copper ..................................................................7 Agricultural Applications .................................................................................................7 Antifouling Surfaces and Paints........................................................................................8 Hygienic Formulations for Medical Devices ....................................................................8 Consumer Products ...........................................................................................................9 IV. Hospital-acquired Infections: Prevalence, Costs and Pressures to Reduce Infections ...................................................................................................................11 U.S. Centers for Disease Control and Prevention (CDC) Sounds the Alarm .................11 Hospital-Acquired Infections Threaten Patient Safety ...................................................12 The Financial Burden of Hospital-acquired Infections ...................................................13 Medicare Is Changing How Hospitals Will Do Business ...............................................16 Chapter Summary ...........................................................................................................17 V. Toxic Microbes of Concern to the Healthcare Industry ............................................19 Bacteria of Concern to the Healthcare Industry: ............................................................19 MRSA: A Dangerous Threat Becomes Prevalent in Hospitals Today .......................20 Hospital-acquired MRSA Infections Have Increased Dramatically ......................20 Hand Washing, Necessary but Insufficient to Control MRSA in Neonatal Intensive Care Units ...............................................................................21 MRSA Viable for Months on Many Touch Surfaces ............................................21 Probable Reservoirs for MRSA Infection ..............................................................22 Precautionary Measures Needed to Control MRSA in Long-term Care Facilities ............................................................................................................22 Community-acquired MRSA on the Rise ..............................................................23 Treating MRSA Is Difficult ...................................................................................23 New Antibiotics Are Not Being Developed to Combat MRSA ............................23 Vancomycin-resistant Enterococcus (VRE) ..............................................................24 E. coli O157:H7 ..........................................................................................................24 Clostridium difficile ....................................................................................................24 Acinetobacter sp. ........................................................................................................25 Klebsiella sp. and Escherichia sp. .............................................................................25 Serratia sp. .................................................................................................................26 v Pseudomonas sp. ........................................................................................................26 Enterobacter sp. .........................................................................................................26 Viruses of Concern to the Healthcare Industry: ..............................................................26 Influenza .....................................................................................................................26 Rotavirus