Making Sense of Disinfectant Labels: A Step-By-Step Approach

By J. Hudson Garrett, PhD

Every day, infection preventionists (IPs) and other healthcare personnel face significant challenges due to evolving technology, healthcare reform and, of course, time constraints. Choosing the right disinfectant products must be a carefully made decision but it shouldnt be burdensome. Yet, because healthcare products are continually being released, updated and retired from the marketplace, IPs would be challenged to monitor the status of every single item within their facilities. This article will provide a methodical approach to evaluate and effectively use healthcare disinfectants including:
Understanding product labels
Evaluating broad-spectrum efficacy claims
Adhering to overall contact time
Educating staff to improve compliance

 
Components of Healthcare Disinfectant Labels
In the United States, all surface disinfectants must be registered with the United States Environmental Protection Agency (EPA), the federal government agency responsible for approval of all products containing ingredients with the potential to enter the environment.  Once a product is approved by the EPA, the manufacturer will receive an EPA registration number for that specific product. In addition, the EPA assigns an establishment number to the manufacturer and specific locations.

The EPA dictates what information must be included on EPA-registered product labels. For healthcare disinfectant labels, these include the product name, ingredient statement, Keep Out of Reach of Children statement, signal words, first aid instructions, net contents/net weight, EPA Registration number, EPA Establishment number, precautionary statements, directions for use information, storage and disposal statement, and any product specific marketing claims and graphics. As you can see, proper interpretation of these labels can sometimes be overwhelming.
 

Criticality of Broad-Spectrum Efficacy Claims
When evaluating a new or existing healthcare disinfectant, you should review the full listing of efficacy claims available from the products manufacturer. It is also important to review other ancillary materials such as the Material Safety Data Sheet (MSDS) and instructions for use documents. Product labels typically list efficacy claims by class of microorganism, including bacteria, viruses, mycobacterium (TB) and fungi. 

When evaluating microorganism efficacy claims, review your facilitys infection prevention risk assessment and infection prevention and control plan, as well as the pharmacy antibiogram to ensure proper selection of a product with relevant pathogenic efficacy claims. The broader spectrum a products efficacy, the more effective the product will be against a wide variety of gram positive and gram negative bacteria. In addition, with the continual emergence of new and mutations of existing multidrug-resistant organisms (MDROs), IPs should seek products with broad general bactericidal efficacy, but also products that have demonstrated effectiveness against organisms such as multidrug-resistant Acinetobacter baumannii, ESBL-producing organisms such as Escherichia coli, and carbapenem-resistant organisms such as Klebsiella pneumonia. Products with efficacy against these more resistant pathogens will assist the IP in combating the daily threats of these microorganisms.

Viruses, particularly the bloodborne pathogens and those with the potential for causing outbreaks (i.e., norovirus, Influenza and rotavirus) are also of concern to the users of healthcare disinfectants. You should expect (and require) claims against bloodborne pathogens such as HIV, hepatitis B and hepatitis C for any product that will be used in the healthcare environment. Also, seek products with other efficacy claims including enveloped and non-enveloped viruses where appropriate. Note: Products may have different contact times for viruses than for bacteria.
Products effective against mycobacterium are minimally considered intermediate-level disinfectants. (Many clinicians inquire as to why TB is not specifically tested in the laboratory setting for initial product approval. This is due to the high pathogenicity and potential transmission of this organism to the laboratory worker. Rather than put the laboratory workers at risk, a surrogate organism, typically Mycobacterium bovis, is utilized for testing procedures.)
Increasingly more prevalent are fungal organisms being recovered in the healthcare environment such as Candida albicans and Aspergillus. When evaluating fungal efficacy claims, seek products with efficacy against pathogenic fungal organisms that are clinically relevant based on the facilitys risk assessment.
 

Its All About the Time: Importance of Overall Contact Time
Manufacturers of disinfectants are required to list detailed information regarding efficacy claims and contact time for each class of microorganism for which the product is effective. This typically includes the classes of bacteria (both Gram-positive and Gram-negative), viruses, mycobacterium and fungi. In accordance with the current requirements from the EPA, labels must also provide detailed information on the products effectiveness against bloodborne pathogens including HIV, hepatitis B virus and hepatitis C virus.

Special instructions for cleaning and disinfecting surfaces or other objects potentially contaminated with bloodborne pathogens are simple and easy to interpret. Many manufacturers provide several contact times, most often one for bacteria, one for viruses, another for mycobacterium and possibly one for fungi, as well. These contact times may vary greatly from anywhere from one minute to 10 minutes. Because it is impossible for the user of the product to determine the type of potential contamination that exists on the surface to be treated, the user should disinfect the surface according to the longest contact time found on the product label to ensure full efficacy of the solution is maximized. For example, a healthcare disinfectant that you are reviewing has a contact time for bacteria of one minute, a contact time of two minutes for viruses including HIV, a five-minute contact time for Tuberculosis, and a 10-minute contact time for Fungi, then the total contact time for the product when used correctly is 10 minutes. It is impossible for the user of the disinfectant product to know what microorganisms are present on the environmental surface without using advanced laboratory methods. Hence, the surface should be assumed to be contaminated. Utilizing the longest contact time will ensure that all microorganisms included on the products label are successfully inactivated.
 

The Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) provides for federal control of pesticide distribution, sale and use in the United States. Because healthcare disinfectants are registered with the EPA, consumers can be assured that the products are properly labeled and when used in accordance with the manufacturers instructions, the products will not cause unreasonable harm to the environment. The use of the product, however, must be consistent with the directions for use and also any labeling instructions. This is typically found on the products label with the following verbiage: It is a violation of Federal Law to use this product in a manner inconsistent with its labeling.

Importance of Staff Education
To meet the Joint Commission and other accreditation/regulatory agency requirements, the users of any healthcare disinfectant must be properly trained on the use of the products in accordance with the facilitys policy, as well as the manufacturers label and instructions for use.  This training should include all relevant indications for use, instructions for use and any relevant safety information. Healthcare facilities should take full advantage of any educational services, including product in-service training, from the products manufacturer to ensure that all potential users of the products receive full training to meet regulatory and accreditation requirements and, more importantly, to ensure safe use of the product.

Regulatory and accreditation agencies such as the Centers for Medicare and Medicaid Services (CMS), state departments of public health, and the Joint Commission all assess compliance and proper usage of healthcare disinfectants in healthcare facilities, including hospitals and long-term care facilities. Specifically, surveyors from these agencies solicit feedback from users of healthcare disinfectants regarding proper contact time, efficacy claims and MSDS information.
For more information on the approval process and federal regulations for healthcare disinfectants, visit the Environmental Protection Agencys website at http://www.epa.gov/oppad001/ad_info.htm/.

When used correctly, healthcare disinfectants assist in maintaining a clean environment in all healthcare settings, both inpatient and outpatient. Regular cleaning and disinfection protocols are critically important in reducing the presence of these pathogens on the high-touch surfaces such as bedrails, over-bed tables, glucose meters, blood pressure cuffs and stethoscopes and prevent cross-transmission. Always be sure to formally evaluate efficacy, safety, labeling instructions, and potential impact on the users of healthcare disinfectants prior to making a decision regarding a potential product.

 For specific information disinfection guidelines in healthcare settings, visit the CDC website at www.cdc.gov/hai/.

J. Hudson Garrett Jr., PhD, is director of clinical affairs for PDI Healthcare. He can be reached at hgarrett@pdipdi.com/.