BIOSPRAYTM TECHNICAL DEVELOPMENT DEPARTMENT
TECHNICAL BULLETIN Bulletin No.: Subject:
TB1621 CDC Guidelines Relevant to BioSprayTM Systems
CDC GUIDES & REFERENCES This BioSprayTM Technical Bulletin (“Bulletin”) is based on data from the Centers for Disease Control and Prevention (“CDC”), the American Industrial Hygiene Association (“AIHA”) and various other reference documents cited by the CDC and AIHA, specifically, -
Guideline for Disinfection and Sterilation in Healthcare Facilities, 2008 (“2008 CDC Guide”), William A. Rutala, Ph.D., M.P.H., David J. Weber, M.D., M.P.H., and the Healthcare Infection Control Practices Advisory Committee (HICPAC);
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Guidelines for Environmental Infection Control in Health-Care Facilities, 2003 (“2003 CDC Guide”), Recommendations of CDC and the Healthcare Infection Control Practices Advisory Committee (HICPAC);
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American Industrial Hygiene Association Position Statement Chemical Fumigation in Healthcare Settings (“2009 AIHA PS”), AIHA Board of Directors, 12/14/09;
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Guideline for Handwashing and Hospital Environmental Control, 1985 (“1985 CDC Guideline”), Julia S. Garner; Martin S. Favero, Hospital Infections Program Center for Infectious Diseases, Centers for Disease Control and Prevention; and
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Disinfection Sterilization & Preservation (“2001 Favero/Bond Book”), Favero MS, Bond WW. Chemical disinfection of medical and surgical materials. In: Block SS, ed. Disinfection, sterilization, and preservation, 5th ed. Philadelphia, PA: Lippincott Williams & Wilkins, 2001;881–917,
(collectively, “Guide” or “Guides”) and is believed to be reliable and credible, however, 1 Priority Biocidal, LLC accepts no liability for the accuracy of the data referenced from any third-party sources. BACKGROUND The CDC mission, by collaborating with other institutions, public agencies and private companies, is to create expertise, information and tools to the people and communities through health promotion, prevention of disease, injury and disability, and preparedness for new health threats. CDC does not approve, endorse or confirm any products or services for the health and/or well being of the general public including products or services for the prevention of infectious diseases. CDC provides recommendations and guidelines only and encourages the use of such guidelines for institutions, public agencies and private companies to prepare quality programs and solutions for the control and prevention of infectious diseases in the work place and public environments. Incorporated in the data made available by the CDC are guidelines for disinfecting health care environments that include, among other items, recommendations on the uses of alcohol as a disinfectant and the methods of application for cleaning and disinfecting products. As BioSpray™ Sanitizing and Disinfecting Systems (“BioSpray™ Systems” and “BioSpray™”) are new and use an alcohol-based formula this Bulletin includes the following Guide references and how BioSpray™ meets or exceeds CDC guidelines: Alcohol: 70% Concentration……………………...…………………… Page 2 Alcohol: Large Surface-Area Disinfectant…………………………….. Page 3 Misting / Aerosolizing (Spraying) Cleaners...……................................ Page 4 Disinfectant Fogging…………………………………...……….……… Page 5 Other Relevant References in Guides…………………….………......... Page 6 Modification and Expansion of the Guides to Include BioSpray™….... Page 6 Copyright 2010. BioSpray™ is a trademark of and manufactured by 1 Priority Biocidal, LLC, 2410 Gravel Drive, Fort Worth, Texas 76118 USA (1.3) Page 1 of 6
ALCOHOL: 70% CONCENTRATION
Relevant CDC Reference The 2008 CDC Guide has multiple references to a concentration of 70% Isopropyl Alcohol as effective disinfectant, and is specifically cited on page 105 in Table 1. Methods of sterilization and disinfection; K. Ethyl or isopropyl alcohol (70-90%).
Why BioSpray D2™ Meets or Exceeds CDC Guidelines The reference to 70% Isopropyl Alcohol assumes a disinfecting solution of only Isopropyl Alcohol with no other active ingredients, and in this case the Isopropyl Alcohol concentration is recommended to be between 70-90%. BioSpray D2™ is not an Isopropyl Alcohol only disinfectant, but rather contains 58.6% Isopropyl Alcohol combined with 150ppm Quaternary Ammonium compounds (“Quats”), specifically: Isopropyl Alcohol…………………………………… 58.6000% Octyl Decyl Dimethyl Ammonium Chloride……….. 0.0075% Didecyl Dimethyl Ammonium Chloride……………. 0.0045% Dioctyl Dimethyl Ammonium Chloride…………….. 0.0030% Because of its unique, proprietary alcohol-quat blend, BioSpray D2™ has an efficacy that exceeds the cidal action of both Isopropyl Alcohol and Quats individually, is EPA registered1 as Tuberculocidal and Virucidal, and eliminates 99.999% of all detectible pathogens2, making it a superior disinfectant to a concentration of 70-90% Isopropyl Alcohol as recommended in the Guides. 1
For more information on BioSpray’s™ government registrations and certifications, see BioSpray™ Technical Bulletin TB6714 “Government Registration Compliance”. 2
For more information on BioSpray D2™ formula validations and microbiology efficacy tests, see BioSpray™ Technical Bulletin TB9821 “Microbiology Efficacy Lab Tests”.
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ALCOHOL: LARGE SURFACE-AREA DISINFECTANT
Relevant CDC Reference The 2003 CDC Guide, Section E. Environmental Services, #2. General Cleaning Strategies for Patient-Care Areas, a. Cleaning of Medical Equipment, page 74 states, “However, alcohol evaporates rapidly, which makes extended contact times difficult to achieve…a factor that precludes its practical use as a large-surface disinfectant”; and this recommendation was taken from the 2001 Favero/Bond Book, Chapter 43, Chemical Disinfection of Medical and Surgical Materials, that cites on page 904, “Alcohols”, “Because [of] alcohol’s…rapid evaporation [it] makes adequate contact time impossible on open surfaces; therefore they are inappropriate for use on environmental surfaces”.
Why BioSpray D2™ Meets or Exceeds CDC Guidelines As referenced previously in the section “ALCOHOL: 70% CONCENTRATION”, BioSpray D2™ has a reduced total alcohol concentration at 58.6% which helps to reduce the evaporation rate. The other significant factor in the reduction of the evaporation rate is the addition of a vegetablebased glycerol compound which bonds to the alcohol molecules allowing the Isopropyl Alcohol to remain on the environmental surfaces for the required contact times. Another important factor is that BioSpray D2™ contains a quat-compound (as also referenced in the section “ALCOHOL: 70% CONCENTRATION”) that remains on the surface after the alcohol does finally evaporate, extending the cidal action and providing the necessary contact times for all EPA registered disinfectant efficacy claims. Because BioSpray D2™ is a proprietary alcohol-quat blend combined with a vegetable-based glycerol compound and the alcohol concentration is lower, it does remain on open environmental surfaces for the necessary contact times. In addition, the cidal action of BioSpray D2™ continues after the alcohol finally evaporates as a result of the 150ppm Quats remaining on the surface. The necessary disinfection contact time of 5 minutes has been validated by an independent laboratory, MicroBioTest, Inc., Sterling, VA, and registered with EPA, which certifies BioSpray D2™ ability to be used as a large-surface disinfectant1, meeting the Guides recommendation for ensuring appropriate dwell times. 1
For more information on BioSpray D2™ formula validations and microbiology efficacy tests, see BioSpray™ Technical Bulletin TB9821 “Microbiology Efficacy Lab Tests”.
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MISTING / AEROSOLIZING (SPRAYING) CLEANERS
Relevant CDC Reference The 2003 CDC Guide, Section E. Environmental Services, #2. General Cleaning Strategies for Patient-Care Areas, b. Cleaning Housekeeping Surfaces, page 76 states, “The basic strategies for areas housing immunosuppressed patients include…c) avoiding the use of cleaning equipment that produces mists or aerosols”.
Why BioSpray D2™ Meets or Exceeds CDC Guidelines BioSpray D2™ is an EPA registered disinfectant. The Guides all clearly differentiate between the cleaning step and the disinfection step, and specifically the 2003 CDC Guide, Section E. Environmental Services, #1. Principles of Cleaning and Disinfecting Environmental Surfaces, page 72 states, “Cleaning is the necessary first step of any sterilization or disinfection process.”, and “If the surface is not cleaned before the…procedures are started, the success of the sterilization or disinfection process is compromised .”. The cleaning and disinfecting steps are more completely differentiated in the 2008 CDC Guide, Definition Of Terms, pages 8-9 which states, (i) Disinfection describes a process that eliminates many or all pathogenic microorganisms, except bacterial spores, on inanimate objects…Factors that affect the efficacy of both disinfection and sterilization include prior cleaning of the object…; and (ii) Cleaning is the removal of visible soil (e.g., organic and inorganic material) from objects and surfaces and normally is accomplished manually or mechanically using water with detergents or enzymatic products. Thorough cleaning is essential before…disinfection…”. The Guides state disinfectants are not to be fogged (as referenced in “DISINFECTANT FOGGING”, page 5) and state that cleaners are not to be sprayed. Because BioSpray D2™ is to be applied with a microfiber towel, sponge or cloth in the cleaning phase to comply with the Guides and per BioSpray D2’s™ registration with the EPA, it can be used to completely pre-clean surfaces to be disinfected1 as such, it meets the Guides recommendation of not using compressed air and/or water under pressure for cleaning to ensure infectious material is not re-aerosolized. 1
For more information on using BioSpray D2™ as a cleaner, see BioSpray™ Technical Bulletin TB6412 "Disinfecting Protocol Health Care Facilities". See “DISINFECTANT FOGGING”, page 5 for information on why BioSpray™ Systems meet CDC Guidelines for spray disinfecting.
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DISINFECTANT FOGGING
Relevant CDC Reference The 2008 CDC Guide, Air Disinfection, page 31 states, “Disinfectant fogging is rarely, if ever, used in U.S. healthcare facilities for air and surface disinfection in patient-care areas”, and also at Recommendations For Disinfection and Sterilization In Healthcare Facilities; C. Recommendations; #6 Disinfectant Fogging, page 86 states, “Do not perform disinfectant fogging for routine purposes in patient-care areas”, and these recommendations were taken from the 2003 CDC Guide, Section E. Environmental Services, #2. General Cleaning Strategies for Patient-Care Areas, b. Cleaning Housekeeping Surfaces, page 75 states, “Disinfectant fogging is not recommended for general infection control in routine patient-care areas”; the 1985 CDC Guideline, Section 5: Housekeeping; Control Measures, “Disinfectant fogging is an unsatisfactory method of decontaminating air and surfaces and is not recommended”, and from the 2009 AIHA PS; Background, page 2 states “The Centers for Disease Control and Prevention (CDC) in their Guidelines for Environmental Infection Control in Health-Care Facilities (CDC, 2003) does not recommend chemical fogging for general infection control in routine patientcare areas”.
Why BioSpray D2™ Meets or Exceeds CDC Guidelines As covered in preceding section, “MISTING / AEROSOLIZING (SPRAYING) CLEANERS”, page 4, the Guides state disinfectants are not to be fogged. Further, the Guides (i) all clearly differentiate between fog and spray applications; (ii) terms of “fog” and “spray” are not used interchangeably in any of the Guides; and (iii) provide specific descriptions that “fog” and “spray” are two separate and distinct methods of application. The American Industrial Hygiene Association Position Statement: Chemical Fumigation in Healthcare Settings, which is a reference for the 2008 CDC Guide, clearly considers fogging to be fumigating and the Guide uses “fog” and “fumigate” terms synonymously, with medical dictionaries and reference guides defining them as, “applying smoke, vapor, or gas to, especially for the purpose of disinfecting or of destroying pests”. BioSpray™ Systems are not fog or fumigation applicators and do not apply smoke, vapor or gas but rather are patent-pending spray disinfectant application systems using maximum efficiency, environmentally responsible and high volume, low pressure spray guns1. Because the BioSpray™ Systems are not fogging applicators and as they are to be used after the cleaning phase in the disinfectant step as recommended in the Guides, and as the Guides contain no restrictions relating to spray disinfectants, BioSpray™ Systems meet the Guides recommendations of not using foggers or fumigators. 1
For more information on using BioSpray D2™ as a spray disinfectant, see BioSpray™ Technical Bulletin TB6412 "Disinfecting Protocol Health Care Facilities".
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OTHER RELEVANT REFERENCES IN GUIDES There are also relevant references in the Guides where the BioSpray™ Systems can help solve environmental disinfection challenges, specifically: The 2008 CDC Guide; Surface Disinfection, Is Surface Disinfection Necessary?, page 30 states (i) “Studies also have shown that, situations where the…procedure failed to eliminate contamination from the surface and the cloth is used to wipe another surface, the contamination is transferred to that surface and the hands of the person holding the cloth.” The BioSpray™ Systems can be utilized to help eliminate the potential for cross-contamination because it is a no rinse, no rub, no touch spray application; and, The 2008 CDC Guide; Definition Of Terms, page 9 states, “Factors that affect the efficacy of…disinfection…include…physical nature of the object (e.g., crevices, hinges, and lumens);…”. The BioSpray™ Systems can be utilized to help ensure the BioSpray D2™ disinfecting solution gets into hard-to-reach crevices, hinges, etc., by the atomizing spray produced from the maximum efficiency, environmentally responsible and high volume, low pressure spray guns.
MODIFICATION AND EXPANSION OF THE GUIDES TO INCLUDE BIOSPRAY™ As covered in the “BACKGROUND” section on page 1 of this Bulletin, the CDC does not name, endorse or reference specific products or services. BioSpray™ is a unique product with patent-pending proprietary technology that has certifying laboratory documents which are registered with and accepted by the applicable governmental regulatory bodies in the United States of America and Australia verifying its efficacy and effectiveness and validating that BioSpray™ meets or exceeds CDC Guidelines relevant to BioSpray™ Systems as outlined in this Bulletin.
For questions regarding the information contained in this Technical Bulletin, please email
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