What You Can’t See Can Hurt You
Allison M. DiMatteo, BA, MPS
Infection control in the dental office has come a long way in the past 25 years or more. In the 1980s, less than 30% of dentists wore gloves, masks, or gowns, according to the Academy of General Dentistry. Today, these infection-control tools are required in all dental practices (http://www.agd.org). The development and revision of precautions to protect against the transmission of blood-borne and other occupational microbial pathogens is based on updated scientific information, as well as documented and inferred clinical applications of new knowledge.1
Curt Hamann, MD, the CEO of SmartHealth, notes that the first Centers for Disease Control and Prevention (CDC) recommended infection control practices specific for dentistry were published in the MMWR (Morbidity and Mortality Weekly Report) in 1986. These recommendations were updated in 1993, after which the “Guidelines for Infection Control in Dental Health-Care Settings” was published in 2003.
“The CDC does not have a predetermined frequency for updating their recommendations and guidelines,” Hamann says. “If and when the peer-reviewed literature provides evidence-based information that materially conflicts with an existing recommendation or guideline, the CDC would initiate a review, which could result in an MMWR revision.”
Linda Basquill, DDS, immediate past chair of the Organization for Safety and Asepsis Procedures (OSAP) association board, does not expect a complete revision to the CDC Guidelines any time soon (there were 10 years between the first and second Guidelines). However, she cautions that this doesn’t mean there aren’t recommendations and updates coming out all the time.
“The updates and recommendations are always coming, and that information is disseminated in a variety of ways,” Basquill says. “It is critical that we stay abreast of the information so we are modifying what we do in our offices to comply with new recommendations and changes when necessary.”
To help dentists and their staff comply with infection control requirements, the American Dental Association (ADA) publishes the most recent recommendations from the CDC and other agencies in the Journal of the American Dental Association (JADA). Such publications also help acquaint clinicians with the most recent scientific and clinically based evidence that improves infection control in their practices, explains John A. Molinari, PhD, professor and chairman of the department of biomedical sciences at the University of Detroit Mercy School of Dentistry and infection control spokesperson for the ADA. In addition, the ADA has a variety of counsels comprised of member dentists, educators, and other clinical and scientific personnel who review these guidelines to determine where areas of emphasis need to be made to improve what is taking place in practice, Molinari says.
Since the 2003 “Guidelines for Infection Control in the Dental Healthcare Setting,” several hundred thousand copies have been distributed to dentists, dental hygienists, educators at dental, dental assisting, and dental hygiene schools, dental laboratories, and lecturers across the country.2 Unfortunately, despite the widespread and ongoing dissemination of information, compliance with the infection control guidelines remains an issue.
It is all too easy to become complacent and even “cut corners” with infection prevention activities, cautions Therese Long, MBA, CAE, executive director of OSAP. “Ignoring or overlooking key aspects of infection prevention can become habitual and, over time, hard for the dental team to recognize.”
Charles John Palenik, MS, PhD, MBA, director of Infection Control Research and Services at Indiana University School of Dentistry, notes that the number one problem with infection control or infection prevention is the individuals involved, adding that nobody likes having to comply. Compounding the problem is that very few areas in the United States have the onus of an inspector coming in to verify that infection control or prevention is being performed properly.
“When you talk to hospitals, they are accredited by several different agencies, the biggest being the Joint Commission, which now has started to certify ambulatory care, outpatient care, and some very large oral surgery groups,” Palenik says. “In these instances you say what you do, and you do what you say. But in most offices, there is tremendous variation in compliance, and we don’t have what’s called monitoring enforcement where, at any given time, the practice could be inspected.”
What dentists are expected and required to do to reduce cross-contamination risks includes implementing barriers, sterilizing instruments, and disinfecting surfaces. However, the standards are continually updated, added to, and further defined.
“The ADA has individuals such as clinical dentists, scientists, and others, who are members of subcommittees and working groups that bring some of the direct concerns of practicing clinicians to the table when these guidelines are being reviewed and updated,” explains Molinari, who also serves on these ADA councils. “This allows the working groups to have a variety of opinions regarding what is being looked at in dental practice, dental education, manufacturing, and product development, so that the issues come to the forefront and can be addressed better.”
According to Palenik, despite the fact that the CDC has worked hard to develop its 2003 guidelines—which he considers to be the gold standard of infection prevention behavior that practices should emulate––there are still grey areas. What is still troublesome is the lack of a universal rule or regulation in some cases, he says. “Everything we do should be based on some evidence, some study, some collection of information that demonstrates it’s effective,” Palenik says. “When you do a lot of traditional things, and you have lots of rituals and this type of thing, you need to ask yourself if they really work. They must be evidence based.”
For example, the facts and evidence surrounding dental waterline contamination have been well documented in the scientific literature, explains Eve Cuny, MS, director of environmental health and safety at the University of the Pacific School of Dentistry. Up to a million or more colony-forming units per mL of water can be found in untreated lines, and these generally contain a variety of waterborne organisms that include bacteria, protozoa, and fungi.
According to Molinari, water contamination continues to be a major public health problem, and dental unit water is also contaminated and colonized by the very nature of the manufacturing of the units. While dentistry hasn’t seen any infectious disease outbreaks traced back to dental facilities, the fact remains that dentistry is being asked to be proactive in reducing the microbial colonization in the water that goes into patients’ mouths. There are many products and technologies available for this purpose that dentists can choose from, he says, some of which are less time-consuming than others.
The requirements for treating dental waterlines may vary from state to state, but waterline treatment is recommended by the CDC. They recommend that the water used in dental treatment contain no more than 500 colony-forming units per mL, which can be achieved easily with a variety of products and devices available on the market today, Cuny says. There isn’t a requirement or recommendation for testing waterlines to validate products, however.
This month’s cover feature provides a review of how the infection control guidelines for dental health care settings have changed the manner in which dental products, materials, and equipment are designed and manufactured in order to facilitate compliance with safety guidelines. Simultaneously, this feature will emphasize the need for dental professionals (dentists, assistants, and hygienists) to take a proactive approach to ensuring that routine infection control precautions are maintained in the dental office at all times.
Infection Control Challenges Continue to Trouble Dentistry
Historically speaking, Molinari says that one of the biggest challenges in terms of infection control was having clinicians recognize that they were routinely exposed to a number of occupational infectious pathogens, even though patients were not manifesting textbook symptomatologies. For example, with hepatitis B, the classic textbook symptom would be jaundice. In the absence of that, many clinicians felt that they weren’t seeing these types of patients when, in fact, they were, he says.
“The challenge was to get clinicians to routinely protect themselves for all patients and adopt a new way of practicing dentistry from what they learned in school,” Molinari recalls. “Probably the biggest challenge for many clinicians was the use of gloves, since they had not learned to use gloves in school, and they were now converting from wet-fingered to gloved dentistry. But that led the way for other precautions that would be very useful.”
According to Long, new infection control challenges facing dentistry include, but are not restricted to:
- more medically complex patients
- more complex invasive oral procedures
- more technologies to understand and, if appropriate, implement safely
- more products to evaluate and, if appropriate, incorporate safely
- more potential pharmacological and allergenic interactions
- more infectious diseases
- more regulations
- more access to care issues
- more environmental issues
Among the emerging infectious diseases that dentistry may face are those considered prion diseases (ie, proteinaceous diseases such as Creutzfeldt-Jakob disease or “mad cow disease”) that involve the degeneration of nervous tissue, explains Kurt Giles, PhD, an assistant adjunct professor in the Institute for Neurodegenerative Diseases at the University of California, San Francisco. Individuals infected with prion diseases may be asymptomatic for many years before they are clinically diagnosed, after which death invariably occurs within a year to 18 months, Giles says.
“Prion diseases represent a particularly difficult infection control problem, and the concern in dentistry surrounds where the infectivity of prion diseases lies (ie, peripheral nervous tissue),” Giles says. “In the United Kingdom, for example, given the human cases of ‘mad cow disease’ that were ultimately fatal (200 people died from the human form), endodontic files are now considered single use because there is no clear, proven way of disinfecting these instruments, which go right into the tooth and root and would be in contact with the nerve tissue.”
It is important to note that scientists are not sure that there is prion infectivity in, for example, the roots of teeth, let alone all tissues, even for people who have prion diseases, Giles emphasizes. However, based on the fact that there is a real limitation in the effectiveness of general infection control procedures against prions, dentistry should be willing to make things single-use as much as possible, or institute much more stringent cleaning and disinfection procedures, he says.
“With all emerging infectious diseases, the goal isn’t for people to change everything now, but to at least be aware of what’s happening so that if we do have more evidence that there is a transmissible disease, dental professionals can implement the necessary procedural changes,” Giles says.
The relevance of emerging diseases to dentistry and, therefore, to infection control can be seen in the efforts taken by infection control product manufacturers that are leading the way in developing surface disinfectant products and testing for efficacy against specific organisms (eg, against methicillin-resistant Staphylococcus aureus [MRSA]), explains Nancy Andrews, RDH, a dental consultant. Major companies are actually specifically testing for that, and consumers are learning to ask if a product they are using is effective against the latest emerging pathogens that they may be aware of, she says.
Long adds that ongoing challenges also include the economy and human nature. There is always a need to practice in a cost-efficient manner so that at the end of the day income exceeds expenses and the practice can keep its proverbial lights on, she says. With even greater emphasis on the recent upheaval in our economic system, it will be important for dental practices to balance efficiency, effectiveness, and safety, Long emphasizes.
Dental practices can best respond to all the challenges Long mentioned by staying informed, educated, and convinced of the relevancy of infection prevention practices. An excellent and easy way to do that is through OSAP, she says.
“While the full name is a mouthful (Organization for Safety and Asepsis Procedures), it is an excellent resource for all aspects of infection prevention in dentistry,” Long says. “No other organization concentrates solely on these issues to develop the tools to inform, educate, and persuade dental professionals to practice oral health care safely.”
Basquill concurs that the best way to respond to new and ongoing challenges is through education for dentists and their staff about what patients might present with and how to handle it. They need to understand necessary precautions and how they impact on the practice, themselves, and other patients.
“There are new issues moving to the forefront all the time (eg, MRSA),” Basquill says. “Education is one of the best things that we can do to help our office staff meet that challenge.”
Dental Offices Need Thier Own Infection Control Plan
The CDC’s Guidelines for Infection Control in Dental Healthcare Settings (2003) is analogous to the Constitution of the United States, which provides a basic design for how government should work, but doesn’t address every aspect of life, explains Long. Similarly, the authors of the CDC Guidelines outlined a minimum standard of care (ie, basic design) for dentistry. To do so, they consulted with a national advisory group of infection control experts, CDC consultants representing all the relevant branches of CDC and National Institute of Occupational Safety and Health (NIOSH), representatives from the Food and Drug Administration (FDA), Occupational Safety and Health Administration (OSHA), the Environmental Protection Agency (EPA), and other outside consultants representing associations, corporations, public health, and dental practitioners, Long says.
“Despite the breadth of their research (they quote 471 references) and representation, the CDC recognized that there is no way to address every situation, which is why they called these guidelines,” Long says. “Therefore, as dental clinicians try to abide by these guidelines, they need to break the general into the specifics of their practice. They can do this by developing their own practice-based infection control plan with Standardized Operating Procedures (SOPs).”
Long says that this means identifying who, what, when, and where products and devices should be used for a variety of procedures. These SOPs acknowledge the individuality of the procedures performed, physical plant/layout of the setting, and needs and duties of personnel. SOPs also reflect the relevant federal, state, and local regulations that impact the practice, she explains.
Basquill further clarifies the need for dental offices to have their own infection control plan, noting that while the CDC Guidelines are a great resource, they don’t include everything. For example, there are OSHA requirements as well as updates that cover areas not addressed by the 2003 Guidelines. And, as Long suggested, office infection control plans have to be more specific.
“For example, the CDC Guidelines talk about the importance of regulating medical waste, but they don’t provide specifics. In fact, they say you need to make sure that you are complying with your federal, state, and local guidelines. From state to state, the way we dispose of regulated medical wastes varies dramatically, and can even vary between counties, districts, etc, within a state,” Basquill says. “Your individual office infection control plan would outline the specifics of how that would be done in your office, down to the details about whose specific job it is. It takes the guidelines to a whole new level and details them for your specific office.”
Putting SOPs Into Practice for Proper Sterilization and Infection Control
According to the ADA and guidelines from the CDC, sterilization is best monitored using a combination of mechanical, chemical, and biological indicators. For sterilization, any item that enters the mouth and can be detached from devices (eg, dental handpieces, hand instruments, surgical instruments) should be heat sterilized between uses, explains Cuny. Heat sterilization is more reliable and enables validation of the sterilization processes, something that isn’t possible with chemical germicides, she says.
“With a chemical germicide, you can perhaps monitor the concentration of the formula, but you can’t really monitor whether or not sterilization has been achieved. With heat sterilization, through the use of either chemical or biological indicators, you have the benefit of being able to validate that sterilization actually was achieved,” Cuny elaborates. “The other benefit of heat sterilization over chemical germicides is being able to package the instruments for sterilization, which provides a nice way to store the instruments that will maintain their sterility.”
Once something is removed from a chemical germicide, it’s essentially an unpackaged instrument that now must be handled aseptically, which is a challenge. As soon as it’s put in a drawer or handled, it’s no longer sterile, Cuny explains.
Items that don’t enter the patient’s mouth and are considered noncritical can be disinfected with a low- to intermediate-level disinfectant. However, the most important thing about disinfecting is that surfaces or items be cleaned before they’re disinfected. It’s always a two-step process, Cuny says.
“There is always the need to clean surfaces first with a separate cleaning agent and then, after it’s been cleaned, apply the disinfectant,” Cuny points out. “The same concept applies to heat sterilization. The items must be free from debris in order for them to be effectively sterilized.”
Tim Lorencovitz, the infection control product manager for Sultan Healthcare, suggests that each dental office set up a central processing location—as well as a workflow—for handling instruments from contamination to cleaning, through to sterilization, and finally storage. Step one should be receiving the contaminated instruments in a specific area where they are cleaned. Step two is rinsing the instruments, Lorencovitz says. The third step is packaging the instruments in preparation for sterilization. The fourth and final step is the sterilization process, after which the instruments are stored and readied for the next patient. Of paramount importance to this process, he says, is precleaning or presoaking the instruments.
“Installing these procedures and having this type of set-up in place helps minimize cross-contamination,” Lorencovitz says. “In a larger institution, like a clinic or hospital, there are typically separate rooms for cleaning and sterilization, but when you’re dealing with a dental office, it’s a small place, so the process flow needs to be managed properly.”
Helpful Resources Are Available
There is a plethora of resources available through the government, associations, companies, and consultants. However, to do “one-stop shopping” for reliable, evidence-based updates and changes, Long recommends that dental professionals visit http://www.osap.org. The Organization for Safety and Asepsis Procedures concentrates solely on providing pertinent, practical, and proven information and education regarding infection prevention and safety, she says.
“The only organization solely dedicated to the safe delivery of dental care everywhere is OSAP,” emphasizes Hamann. “They are committed to advising interested clinicians, educators, researchers, manufacturers, distributors, and regulators of any breaking news or discoveries in the infection control space.”
As Molinari points out, we are all in an era where people want to be safe, where they look for what is risk-free, whatever it is. They don’t want infectious disease risks at all, but that’s impossible, and life is not risk free.
“I think what dentistry has accomplished has made dentistry the safest it’s ever been,” Molinari says. “Dental professionals should let their patients know what is going on in the practice to make that environment as safe as possible, whether it’s talking about new sterilizers, new barriers that you’re using, changes that you’ve made in the gloves you purchase for their comfort and their protection, etc.”
As a product manager, what worries Lorencovitz is that some dental offices believe infection control is a necessary evil, an added expense, and something they have to do without truly realizing what the risks are if they don’t clean and disinfect properly or follow the correct procedures. Their thoughts may be that there’s never been a need for infection control, so it’s not a big deal, but he emphasizes that you don’t know who’s walking in your door, what your patients may have, or what you can give to your patients.
“The greatest threat to optimal infection control is complacency. Compliance with consistent hand hygiene remains a holy grail throughout our health care delivery system,” explains Hamann. “Hospital-acquired infections with high morbidity, mortality, and associated costs are a great institutional and individual motivator. Dental office-acquired infections, however, do not benefit from any epidemiologic tools readily available to us today which assist us in quantifying the risk.”
“We must be vigilant to prevent complacency and perform the same SOPs the same way, every day, to prevent the possibility of microbial transmission,” Long says. “Many people don’t look at it this way, but infection prevention really does ‘touch’ every procedure, every patient, and every clinician in dentistry.”
Palenik raises the overall ethic question that’s involved with infection control, noting that the true mark of a professional dedicated to infection prevention is what he or she does when nobody is looking.
“It’s never what you do when someone is watching,” Palenik says. “If you take it upon yourself that this is your ethical responsibility, not only to your patients but to the people that work in the office, it’s a commitment.”
The Latex Allergy Issue
According to Nancy Andrews, RDH, a dental consultant, the CDC Guidelines laid the foundation for turning dental professionals’ attention to the issue of latex and rubber allergies, as has science. As a result, she says that some of the manufacturers, particularly SmartPractice, have really made an effort to identify all the elements that can trigger latex allergies or chemical allergies in products.
“I think that the product manufacturers have been more attentive to this issue because it has emerged as an increasingly important challenge in the lives of everybody in health care,” Andrews says. “One of the most recent developments has been a new product that’s nonlatex. We used to have vinyl, and nitrile, and polychloroprene, and other similar products, so the range of products that are nonlatex is larger, with different characteristics, price points, and features for people to select from to meet their needs.”
However, when it comes to handling latex and rubber allergies in the context of infection control requirements, Curt Hamann, MD, the CEO of SmartPractice, notes that regrettably, most dental clinicians “self diagnose” their alleged latex or powder allergies and simply select rubber products that are latex and/or powder free, with persistent symptoms being palliated with over-the-counter emollients and topical steroids. Most clinicians who believe they are allergic to latex or cornstarch powder when tested are found to be allergic to something completely different or are suffering from irritant contact dermatitis (ICD), he says.
“Intact healthy skin is our best infection control barrier. Anything which compromises our natural barrier should be taken very seriously, whether it is irritation, eczema, or sharps injuries,” Hamann emphasizes. “Because there are several common allergenic chemicals used in dentistry that easily permeate through examination gloves (eg, acrylate monomers and glutaraldehyde), as well as residual allergenic processing chemicals in most gloves (eg, carbamate, thiuram, mercaptobenzothiazole), it is impossible to know definitively what is the offending chemical without testing. A diagnosis requires either a blood or prick test for latex allergy and patch testing for dental allergens known to cause allergic contact dermatitis.”
Overall, however, Andrews notes that dentistry’s choices are greatly expanding as education about related issues like powdered gloves increases. For example, if there is powder in your glove, it aerosolizes whatever material is in the glove that may be allergenic, whether it’s latex, or a chemical, or anything else. That increases the individual’s exposure, and it’s not just from direct contact, but by inhalation and secondary contact with aerosolized powder that may have blown through the air onto another surface.
“As we’re becoming more aware of patients who are sensitive to these chemicals and elements, we’re realizing that every office must be prepared to have a nonlatex setup for allergic patients,” Andrews says. “It’s not just a conversation about workers being allergic but anticipating patients that are potentially allergic and how you very rapidly transition from a standard operatory that may contain latex to one that’s completely devoid of it.”
Judging What Will Work for Infection Control and Sterilization
In terms of how clinicians can be sure that the specific infection control products and equipment in which they’re investing actually do what they’re supposed to, Eve Cuny, MS, says that the dental devices and products on the market intended for use in infection control are regulated by the Food and Drug Administration. The respective manufacturers therefore must submit their marketing materials to the FDA for validation before they’re allowed to make certain claims.
“So, in terms of performance of a sterilizer, for example, that must be cleared by the FDA before the manufacturer can be allowed to market claims about it to the profession,” Cuny says. “The only exception to that would be disinfectants, which are regulated by the Environmental Protection Agency (EPA) rather than the FDA.”
Disinfectants require EPA approval in order to make specific kill claims, says Tim Lorencovitz. If a product is introduced that doesn’t have an EPA approval but says that it kills microorganisms on a surface, then it probably shouldn’t be on the market, he adds.
“Continuing education has been successful in educating consumers to ask the right questions of manufacturers, and manufacturers are compelled more and more by competition to provide that information as a selling point for their products,” says Nancy Andrews, RDH. “Manufacturers have become more sophisticated about qualifying their products and, honestly, wanting to get credit for the required hurdles they have to jump over, which are expensive. It’s expensive to get FDA clearance or EPA clearance for your product, and that gives you an advantage over your competition when you communicate that.”
According to Curt Hamann, MD, it’s very difficult for dentists to know definitively if new infection control products do what they claim to in terms of improving or ensuring infection control. The majority of infection control devices are regulated by the FDA with a 510(k), he explains.
“This is true, for example, with examination and surgical gloves, but the FDA does not require any clinical studies which substantiate efficacy in use. A glove formulation which meets the American Society for Testing and Materials (ASTM) stretch and strength requirements before and after aging could receive FDA marketing clearance despite the fact that it melts with exposure to an acrylate dental monomer,” Hamann points out. “Similarly, the majority of dental examination gloves have 50% less rubber in them today than they did five years ago.”
Hamann explains that cost pressure has led to the substitution of rubber with calcium carbonate, without any in-use clinical validation of the impact on safety and efficacy in use. Meeting ASTM standards and clearance by the appropriate regulatory bodies (FDA and EPA, in particular) is important, despite the limitations, he says.
Lorencovitz suggests that dental professionals will likely see more companies proving their claims through technical studies and data. He also points out that there are other resources for product evaluations, such as the Clinician’s Report and the Dental Evaluation and Consultation Service (DECS), a part of the United States Air Force. Both provide objective and unbiased product evaluations. For infection control in particular, Lorencovitz notes that OSAP provides comparison charts of disinfectants that review available disinfectants and their claims.
“We live in the age of evidence-based dentistry. Wherever scientific evidence exists—whether in the form of peer-reviewed articles, reviews of the literature, or systematic reviews—that’s the strongest and most reliable basis to determine the safety and efficacy of products,” emphasizes Shannon E. Mills, DDS. “Unfortunately, oftentimes that information is lacking.”
Regardless of the sources consulted—and Mills advises dental professionals to check more than one source for information about a product—a healthy degree of skepticism is necessary when reviewing product evaluations and reviews. Consider whether the format is peer-reviewed and scientific in nature, he says, and don’t be afraid to ask questions of sales representatives.
1. Molinari JA. Infection control. Its evolution to the current standard precautions. J Am Dent Assoc. 2003;134(5): 569-574.
2. Newton A. Infection control. Are you adhering to the guidelines? AGD Impact. March 2007:22.
About the Author
Allison M. DiMatteo, BA, MPS