Under Review
Confused about conflicting product "information"? The ADA offers additional input.
By Nancy Andrews, RDH, BS
The American Dental Association (ADA), in response to member requests for clarification of the overwhelming amount of confusing and sometimes conflicting "information" regarding dental products, created the ADA Professional Product Review™. The ADA performs laboratory tests on products along with clinical evaluations collected from a volunteer group of dentists, yielding product evaluation reports published in their newsletter. This year a panel of experts presented results of past Review evaluations of a variety of products. Dr. John A Molinari discussed some aspects of the Review Surface Disinfectant review published in 2007. This article gives some background, generally explains the goals of the ADA Professional Product Review™, and focuses on how to reconcile different (possibly conflicting) information sources, specifically related to surface disinfectants.
What is the ADA Review?
The ADA Professional Product Review is a quarterly publication of the ADA Council on Scientific Affairs and is sent to ADA member dentists. The ADA has a scientific laboratory to perform laboratory studies and utilizes survey responses collected from members of the ADA Clinical Evaluator (ACE) Panel made up of ADA dentists to provide clinical feedback. The goals of the Review include:
- To provide unbiased information and guidance to members intended to supplement available information from professional and regulatory guidelines, manufacturers, sales and marketingcampaigns and other independent product review entities.
- To help clinicians identify reliable science and important practical considerations of product selection and use.
- To resolve unanswered questions that may exist related to safety, efficacy, ease-of-use, practical realities of products.
- To improve communication of science, clinical and laboratory product information to the dental community.
Accordingly, the Review:
- Is not a regulatory body (has no legal control over the production, sale or use of products).
- Is not a substitute for regulatory certification or approval of a product such as given by the EPA or Food and Drug Administration (FDA).
- Is not a product rating service. The ADA Review refrains from recommending particular products over others: instead providing information to assist personal judgment and product selection, recognizing that different people have varying preferences and requirements for products.
Regulation and Classification of Germicides
In the United States, liquid chemical germicides (surface disinfectants for use on hard, nonporous environmental surfaces) are regulated and registered by the EPA, and classified by their germicidal action. The EPA uses different terms to classify germicides than the CDC and FDA, sometimes causing confusion. Those that inactivate Mycobacterium tuberculosis var. bovis (TB) are termed "intermediate-level disinfectants" by the CDC and FDA, and "hospital disinfectants with tuberculocidal claims" by the EPA. All intermediate-level disinfectants must be approved for sale and distribution by the EPA. Germicides that do not inactivate TB, but destroy most vegetative bacteria, some fungi and some viruses are termed "low-level disinfectants" by the CDC and FDA, and "hospital disinfectants" by the EPA. Low-level disinfectants may be used on housekeeping surfaces and clinical surfaces without blood present, but intermediate-level disinfectants with broad spectrum activity offer the margin of safety most clinicians prefer to disinfect clinical surfaces.
The EPA requires manufacturers to have formulations tested using accepted methods for antimicrobial activity, stability and toxicity to animals and humans. These specific tests must be performed by outside, independent approved laboratories and submitted to the EPA. Ultimately, EPA approval carries full regulatory power, and is the validation healthcare workers and industry members rely on to insure a product’s safety and efficacy. It is a violation of federal law to use these surface disinfectants in a manner inconsistent with its labeling. Workers must follow safety precautions and use directions on labeling of all registered products. This includes specific dilution, contact time, method of application, or any other condition of use specified. EPA requires tests that show products are safe and effective when used as directed, so products must be tested according to label directions.
The role of pre-cleaning
According to the CDC, the presence of organic soil may compromise the germicidal efficacy of disinfectants. Also, the removal of all visible blood, organic and inorganic matter can be as critical as the germicidal activity of the disinfecting agent: for maximum effectiveness, surfaces should be pre-cleaned before disinfectants are applied. Many surface disinfectants have "for use on hard, non-porous pre-cleaned surfaces" printed on the label, with instructions to perform two steps: clean then apply the disinfectant for the specified contact time. Some products are excellent cleaners and may be used for both cleaning and disinfection steps. Some disinfectants, however, are poor cleaners, and should be applied following the use of a separate, chemically compatible, cleaner, or soap and water.
Independent product reviews may be conducted using laboratory testing protocol or data that differs from that submitted by manufacturers and accepted by the EPA. For example, tests may be conducted for specific features of a disinfectant such as potency, corrosion, toxicity, use-life or contact time in a variety of ways. These tests, while revealing specific information, are not substitutes for regulatory testing and approval of products. Any questions regarding safety, efficacy and performance should be directed to manufacturers
Optimal features of disinfectants
The ideal surface disinfectant would have the
following features:
- Be able to penetrate and show activity in the presence of bioburden
- Broad spectrum antimicrobial activity
- Residual activity that becomes reactivated when surfaces are moistened
- Minimal toxicity
- Compatibility with disinfected surfaces
- Be tuberculocidal and virucidal.
None of the available products fulfills all of these criteria. While some products may be more potent, or fast-acting, they may have other characteristics such as odor, corrosiveness, irritation to skin, toxicity, tendency to evaporate rapidly, or ease-of-use issues such as mixing, storage or shelf-life features that should be considered when selecting them. Product reviews such as the ADA Review provide helpful information when evaluating specific features of products.
The bottom line
Product selection is a matter of judgment, after considering many different information sources, and making trade-offs between different features and benefits. Tests do not stand alone, and products do not stand alone: technique and protocol are inherently vital to their success. The results of any review process should be considered along with manufacturers’ information, and products should always be used according to manufacturers’ directions, regulatory standards and professional best practices.
Sidebar:
The importance of "TB kill time"
A disinfectant’s potency against Mycobacterium tuberculosis is recognized as an important benchmark (or threshold organism) because TB is considered the hardest organism to inactivate besides spores (Sterilization is required to kill spores). TB is a benchmark organism used to determine potency of a germicide. Any germicide with a tuberculocidal claim on the label is considered capable of inactivating a broad spectrum of pathogens, including less hardy vegetative bacteria, viruses, and fungi after being in contact for a specified time. The contact time is critical to achieve inactivation of the organisms. In addition to TB, manufacturers specifically test products against clinically important species and indicate the exposure time needed to inactivate them, such as MRSA, Hepatitis B and C, Herpes and HIV. Some organisms may survive exposure to a tuberculocidal disinfectant; label instructions must be carefully read and followed.
Nancy Andrews is a nationally recognized speaker, educational consultant, and author; focusing on disease risks, infection prevention, and ergonomics. She is on the California Dental Association, American Dental Association and Organization of Safety and Asepsis Procedures (OSAP) speakers’ bureaus. Contact her at http://nancyandrewsrdh.net
|
|
|
