Alcohol-based Handwashing Agents:

Alcohol-based Handwashing Agents:
A Clash With Regulators or Opportunity for Common-Sense Approach?

By Gina Pugliese, RN, MS; Judene Bartley, MS, MPH, CIC; TammyLundstrom, MD

The excitement about the news of alcohol-based hand rubs waspalpable following the Centers for Disease Control and Prevention (CDC)'srelease of guidelines outlining the efficacy of alcohol-based hand rubs, theirlow incidence of dermatitis and their key role in improving handwashingcompliance.¹ The most exciting part of the news was that theguidelines were based on scientific evidence, not just opinion. Now comes thehard part -- implementation. We knew that the century-old challenge remained --getting healthcare workers (HCWs) to wash their hands before and after everypatient-care interaction. Yet many of us did not anticipate the challenge ofimplementing these national guidelines that some suggest are inconsistent withexisting laws and regulations.

The evidence is clear; HCW compliance with hand hygiene can reduce the 2million healthcare-associated infections that occur in patients annually, aswell as reduce the risk of infections transmitted to workers. But the use ofthese waterless alcohol-based hand antiseptics, the centerpiece of the new CDCguideline, has been perceived to be in conflict with existing healthcare safetyregulations. These include, for example, handwashing requirements from theOccupational Safety and Health Administration (OSHA), flammability issues fromthe National Fire Protection Agency (NFPA), and corridor obstruction issues fromCenters for Medicare and Medicaid Services (CMS).

After waiting 17 years for the CDC Hand Hygiene guideline revision -- from1985 to 2002 -- we can hardly expect to get everyone to agree on how they shouldbe implemented in the first few months since the guidelines were released. Norcan we expect that the existing regulations will be consistent with theguidelines without additional scientific inquiry. What we can expect and shouldexpect -- and what is our responsibility -- is to take a common-sense approachto implementation based on current scientific evidence and not outdatedregulations or fear. (See the December issue of Infection Control Todayfor 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 notallow the use of alcohol-based hand products and that only soap and water may beused for handwashing. This is not true -- the CDC guidelines areconsistent with OSHA's Bloodborne Pathogen Standard.^2-3 Both the CDCGuidelines and OSHA's Standard call for 1) the provision of accessiblehandwashing facilities; 2) alternatives to handwashing (eg, hand antisepticcleaner) 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 infectiousmaterial (OPIM), and when either visibly dirty (per CDC) or grossly contaminated(per OSHA CPL). The only true differences are related to the goals of eachagency. CDC's goal is to reduce all infection risks in patients and stresses theneed 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 goalis to protect HCWs from bloodborne pathogen infections and requires handwashingwith soap and water after gross contamination or exposure to blood or OPIM thathave potential for transmission of bloodborne pathogens.

OSHA has shared the CDC guidelines with their field staff noting theguidelines discuss placement of sinks/gels to increase handwashing complianceand that the use of gel/alcohol hand cleansers are appropriate when there hasbeen no exposure to blood or other potentially infectious material.

OSHA's Bloodborne Pathogen Standard was, in part, based on guidance from theCDC on universal precautions and worker protection. As such, OSHA stressed theneed for handwashing with soap and water -- the common handwashing practice inthe late 1980s. Now we are in the 2000s and the evidence has changed --waterless alcohol-based products are, in fact, an acceptable method for handhygiene in the absence of visible dirt or exposure to blood or OPIM. One of thesuccesses of waterless, alcohol-based hand antiseptics is the reduction ofdermatitis that contributes to poor handwashing compliance and increased risk tothe worker by compromising the natural skin barrier. So, in the spirit ofprotecting workers and patients, let us focus on our common goal of promotinghandwashing compliance. Our facility-specific exposure control plans shouldoutline 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 alsoresulted in controversy. The NFPA's response on its Web site is: "NFPA 101,Life Safety Code, and NFPA 99, Health Care Facilities, do not specificallyaddress the use of alcohol-based hand sanitizers. Until such language isaddressed in the codes and standards, it becomes a judgment call by theauthority having jurisdiction (AHJ). When making the decision regardingsanitizers, 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 theissue has led to inconsistent interpretation and application by state and localauthorities. (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 intheir approach to alcohol use. In response to CDC's hand hygiene guidelines,many states such as Tennessee have determined that the medical benefits ofalcohol-based hand cleaners outweigh any potential fire risks, and advocate theuse of common-sense approaches to dispenser placement in corridors and patientrooms. Since alcohol-based hand antiseptics are available in a variety offormulations and dispensers including gel, foam and rinses, each facility mustaddress usage (e.g., product selection, dispenser type and location) based ontheir patient population, worker preferences, and consistency with theirfacility design -- e.g., adult and pediatric rooms, surgical suites andisolation room alcoves. Other states, like Michigan, have had a long-standingvariance to existing codes, permitting use of alcohol bottles in nursingstations, noting that these areas are continuously staffed and thus monitored.In terms of CDC's guideline, Michigan presently permits placement of thealcohol-based hand antiseptic dispensers in patient rooms but not corridors.

Risks and benefits must be balanced. Healthcare facilities have clearlyachieved an excellent safety status and the few fires that do occur areassociated with smoking and oxygen use. In the past few decades, there have beenrare reports of fire related to alcohol-based products. In the absence ofscientific data about the risk of fire associated with dispensers ofalcohol-based hand products, the benefits of prevention of infections inpatients and workers clearly outweighs the risk.

However, in our striving for evidence-based practices, there are studiesunderway to determine the true flammability of these products, in particular, asdispensed by the manufacturer. There is one alcohol foam product on the marketwith a dispenser that is designed to reduce flammability risks. This product isdispensed from an aluminum container that the manufacturer states has a ratedburst pressure of 170 pounds per square inch and ability to safely sustain atemperature of 130 degrees F (55 C).⁵ In the meantime, communicationwith local and state fire marshals should continue to ensure that patient careand worker protection are not compromised with overzealous interpretations ofcodes 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 intothe corridor, potentially obstructing traffic or contributing to a fire. Alcoholgel 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 healthfacility planning departments. It is highly unlikely that the intent of thisrule was to interfere with the quality of patient care or worker safety.

Until the existing laws or regulations or their interpretations andapplications catch up with current science and the standard of care, we must putour patients and workers first. We should continue to expect inconsistencies inlaws vs. science, especially with the rapid pace of evidence-based practices ascompared to the glacial pace of changes in laws and regulations. What we canhope for is those individuals that assist with interpretation and enforcement ofregulations will recognize these inconsistencies and use a rational andcommon-sense approach that focuses on quality of care and safety of patients andworkers.

Gina Pugliese, RN, MS, is vice president, Judene Bartley, MS, MPH, CIC isa clinical consultant and Tammy Lundstrom, MD, is a clinical consultant for thePremier Safety Institute of Oakbrook, Ill. Visit http://www.premierinc.com/safety