Alcohol-based Handwashing Agents:
A Clash With Regulators or Opportunity for Common-Sense Approach?
By Gina Pugliese, RN, MS; Judene Bartley, MS, MPH, CIC; Tammy Lundstrom, MD
The excitement about the news of alcohol-based hand rubs was palpable following the Centers for Disease Control and Prevention (CDC)'s release of guidelines outlining the efficacy of alcohol-based hand rubs, their low incidence of dermatitis and their key role in improving handwashing compliance.1 The most exciting part of the news was that the guidelines were based on scientific evidence, not just opinion. Now comes the hard part -- implementation. We knew that the century-old challenge remained -- getting healthcare workers (HCWs) to wash their hands before and after every patient-care interaction. Yet many of us did not anticipate the challenge of implementing these national guidelines that some suggest are inconsistent with existing laws and regulations.
The evidence is clear; HCW compliance with hand hygiene can reduce the 2 million healthcare-associated infections that occur in patients annually, as well as reduce the risk of infections transmitted to workers. But the use of these waterless alcohol-based hand antiseptics, the centerpiece of the new CDC guideline, has been perceived to be in conflict with existing healthcare safety regulations. These include, for example, handwashing requirements from the Occupational Safety and Health Administration (OSHA), flammability issues from the National Fire Protection Agency (NFPA), and corridor obstruction issues from Centers for Medicare and Medicaid Services (CMS).
After waiting 17 years for the CDC Hand Hygiene guideline revision -- from 1985 to 2002 -- we can hardly expect to get everyone to agree on how they should be implemented in the first few months since the guidelines were released. Nor can we expect that the existing regulations will be consistent with the guidelines without additional scientific inquiry. What we can expect and should expect -- and what is our responsibility -- is to take a common-sense approach to implementation based on current scientific evidence and not outdated regulations or fear. (See the December issue of Infection Control Today for more on the CDC guideline.)
Use of Alcohol-based Hand Agents is Consistent with OSHA
Concerns have been raised that OSHA's Bloodborne Pathogen Standard does not allow the use of alcohol-based hand products and that only soap and water may be used for handwashing. This is not true -- the CDC guidelines are consistent with OSHA's Bloodborne Pathogen Standard.2-3 Both the CDC Guidelines and OSHA's Standard call for 1) the provision of accessible handwashing facilities; 2) alternatives to handwashing (eg, hand antiseptic cleaner) when handwashing facilities are not feasible (or convenient); 3) handwashing after removal of gloves or other personal protective equipment; 4) handwashing following contact with blood or other potentially infectious material (OPIM), and when either visibly dirty (per CDC) or grossly contaminated (per OSHA CPL). The only true differences are related to the goals of each agency. CDC's goal is to reduce all infection risks in patients and stresses the need for handwashing with soap and water after any visible soiling of the hands, regardless of the type of body substance, eg, stool, urine or blood. OSHA's goal is to protect HCWs from bloodborne pathogen infections and requires handwashing with soap and water after gross contamination or exposure to blood or OPIM that have potential for transmission of bloodborne pathogens.
OSHA has shared the CDC guidelines with their field staff noting the guidelines discuss placement of sinks/gels to increase handwashing compliance and that the use of gel/alcohol hand cleansers are appropriate when there has been no exposure to blood or other potentially infectious material.
OSHA's Bloodborne Pathogen Standard was, in part, based on guidance from the CDC on universal precautions and worker protection. As such, OSHA stressed the need for handwashing with soap and water -- the common handwashing practice in the late 1980s. Now we are in the 2000s and the evidence has changed -- waterless alcohol-based products are, in fact, an acceptable method for hand hygiene in the absence of visible dirt or exposure to blood or OPIM. One of the successes of waterless, alcohol-based hand antiseptics is the reduction of dermatitis that contributes to poor handwashing compliance and increased risk to the worker by compromising the natural skin barrier. So, in the spirit of protecting workers and patients, let us focus on our common goal of promoting handwashing compliance. Our facility-specific exposure control plans should outline our strategies for achieving this goal.
Fire Safety Risks -- A Local Authority Issue
Concerns that alcohol-based products may pose a serious fire hazard have also resulted in controversy. The NFPA's response on its Web site is: "NFPA 101, Life Safety Code, and NFPA 99, Health Care Facilities, do not specifically address the use of alcohol-based hand sanitizers. Until such language is addressed in the codes and standards, it becomes a judgment call by the authority having jurisdiction (AHJ). When making the decision regarding sanitizers, the AHJ should consider the location, amount, use (storage vs. usage) and the medical benefits of such a product."4
Unfortunately, the lack of specific NFPA codes and standards to address the issue has led to inconsistent interpretation and application by state and local authorities. (See FAQ www.nfpa.org/MemberSections/Health_Care/CodeRed/CodeRed.asp#faq)
The state AHJ is often the office of fire safety, and states vary widely in their approach to alcohol use. In response to CDC's hand hygiene guidelines, many states such as Tennessee have determined that the medical benefits of alcohol-based hand cleaners outweigh any potential fire risks, and advocate the use of common-sense approaches to dispenser placement in corridors and patient rooms. Since alcohol-based hand antiseptics are available in a variety of formulations and dispensers including gel, foam and rinses, each facility must address usage (e.g., product selection, dispenser type and location) based on their patient population, worker preferences, and consistency with their facility design -- e.g., adult and pediatric rooms, surgical suites and isolation room alcoves. Other states, like Michigan, have had a long-standing variance to existing codes, permitting use of alcohol bottles in nursing stations, noting that these areas are continuously staffed and thus monitored. In terms of CDC's guideline, Michigan presently permits placement of the alcohol-based hand antiseptic dispensers in patient rooms but not corridors.
Risks and benefits must be balanced. Healthcare facilities have clearly achieved an excellent safety status and the few fires that do occur are associated with smoking and oxygen use. In the past few decades, there have been rare reports of fire related to alcohol-based products. In the absence of scientific data about the risk of fire associated with dispensers of alcohol-based hand products, the benefits of prevention of infections in patients and workers clearly outweighs the risk.
However, in our striving for evidence-based practices, there are studies underway to determine the true flammability of these products, in particular, as dispensed by the manufacturer. There is one alcohol foam product on the market with a dispenser that is designed to reduce flammability risks. This product is dispensed from an aluminum container that the manufacturer states has a rated burst pressure of 170 pounds per square inch and ability to safely sustain a temperature of 130 degrees F (55 C).5 In the meantime, communication with local and state fire marshals should continue to ensure that patient care and worker protection are not compromised with overzealous interpretations of codes that may not necessarily apply.
Do Dispensers Really Obstruct Corridors?
CMS also has weighed in its concerns with corridor obstruction, citing its "4 inch" rule that does not permit wall attachments to project into the corridor, potentially obstructing traffic or contributing to a fire. Alcohol gel dispensers may not be an issue with dispensers that meet the standard. However, this is an issue that will need to be discussed with state health facility planning departments. It is highly unlikely that the intent of this rule was to interfere with the quality of patient care or worker safety.
Until the existing laws or regulations or their interpretations and applications catch up with current science and the standard of care, we must put our patients and workers first. We should continue to expect inconsistencies in laws vs. science, especially with the rapid pace of evidence-based practices as compared to the glacial pace of changes in laws and regulations. What we can hope for is those individuals that assist with interpretation and enforcement of regulations will recognize these inconsistencies and use a rational and common-sense approach that focuses on quality of care and safety of patients and workers.
Gina Pugliese, RN, MS, is vice president, Judene Bartley, MS, MPH, CIC is a clinical consultant and Tammy Lundstrom, MD, is a clinical consultant for the Premier Safety Institute of Oakbrook, Ill. Visit http://www.premierinc.com/safety