Infection Control Today - 01/2004: ic community

Industry Responds to Alcohol-Based Handrub Controversy

Editors note: Representatives from various manufacturers of alcohol-basedhandrubs share their perspective on the current confusion and controversygenerated by the placement of hand-hygiene product dispensers in hospitalhallways and the flammability issues raised by fire safety officials. To readlast months update on this issue, log on to: www.infectioncontroltoday.com.

Reader Feedback

By Tina Brooks

Q: Should workers be allowed to launder uniforms and scrubs at home?

A: From the scientific evidence I have seen, as long asuniforms are laundered daily it really does not matter where they are cleaned.
Pam Higdem, RN, BSN, CIC Little Rock, Ark.

A: I say why not? We pay laundrys huge moneycontracts, and we get less than quality results.
Parie D. Reynolds, MSgt, USAF, CRST NCOIC, Operating Room Services FlightLackland AFB, Texas

A: We have been laundering our own scrubs for approximatelytwo years and have not noted an increase in surgical site infections. Our policy regarding soiled scrubs is that if they are grossly soiled theyare sent to the hospital laundry in a plastic bag for laundering and the laundryreturns to the department. This has worked well for the staff and anesthesia; the surgeons and othersare a different story, but theyve gotten used to it. We get an occasionalgrumble, but nothing too severe. We have decreased the number of lost andmissing scrubs. The staff are able to bring in their own scrubs to wear ratherthan the ones provided by the hospital. I have to say that it has worked verywell for us.
Linda Chase Clinical Director Holy Cross Hospital Taos, N.M.

Feedback Wanted
Send your opinions on anyinfection control related topic to: kpyrek@vpico.com

STERIS Corporation

By Elizabeth Park and Michael Ebers

According to the Centers for Disease Control and Prevention (CDC), more than2.4 million patients nationwide acquire nosocomial infections annually. Severalchanges in handhygiene recommendations have been made by the CDC in an attemptto change this trend, including the publication of the HICPAC Guideline for HandHygiene in Healthcare Settings in 2002.

The published literature reports several factors that affect hand hygiene,such as inadequate access to a sink, lack of soap and paper towels, and lack ofknowledge of guidelines/protocols.1 One approach to improving overall handhygiene has been to increase access to hand hygiene products by placingfast-acting alcohol products, including gels and foams, in convenient locationsthroughout hospital facilities. In particular, dispensers placed in hallwaysoutside of patient rooms have addressed the lack of access to sinks, soap, andwater.

Although the benefits of increased access to alcohol sanitizer products areapparent, questions about the risk of placement in egress hallways haverecently emerged. In order to address these questions, STERIS provided support to the American Society for Healthcare Engineering (ASHE) of the American Hospital Association for a risk-modeling study to determine the potential risk of placing and storing alcohol products in egresshallways. ASHE concluded in its recent study, Alcohol Based Hand Rub SolutionFire Modeling Analysis Report, that single containers installed in anegress corridor should not exceed a maximum capacity of 1.2 liters foralcohol-based handrub solutions in gel/liquid form. Single containers installed in a suite should not exceed a maximum capacityof 2 liters for alcohol-based handrub solutions in gel or liquid form.2 Themodeling scenario used by ASHE identified the maximum capacities allowable andclarified the potential risk with placement of alcohol-containing dispensers.

Recently, questions have also been asked about the safe use of foamed alcoholproducts. The National Fire Protection Association (NFPA) publishes consensuscodes intended to minimize the possibility of fire that are widely used as abasis for regulation at all levels of government. The NFPA 30B Code for the Manufacture and Storage of Aerosol Productsprovides guidance on aerosol products based upon a classification systemestablished through experimentation with aerosols under actual fire conditions.

NFPA 30B classifies Alcare and Alcare Plus as Level 1 aerosols. Level 1 isthe least hazardous classification for flammability. Provided that dispensersare mounted in hallways so that they do not pose an obstruction hazard, theregulations and standards set no specific limitations placed on the storage ordispensing of Level 1 aerosols in institutional facilities.

ASHE has also committed to amending the report to address pressurizedalcohols. History suggests that the incidence of fires in healthcare facilitiesis low and that the positive effect of increasing accessibility to hand hygieneproducts is significant in reducing the risk of nosocomial infections. Years ofpeer-reviewed, epidemiologic studies confirm the importance of a time-saving,easy-to-use means of decontaminating hands.

STERIS Corporation strongly supports the findings made by ASHE and activelyencourages research initiatives that provide guidance on the safest and mosteffective uses of alcohol handrinses and gels. Elizabeth Park is product manager and Michael Ebers isregulatory manager at STERIS Corporation.

REFERENCES:

1. Guideline for Hand Hygiene in Healthcare Settings:Recommendations of the Healthcare Infection Control Practices Advisory Committeeand the HICPAC/SHEA/APIC/IDSA Hand Hygiene Task Force. Oct. 25, 2003; page 25.

2. Alcohol-based Hand Rub Solution fire Modeling AnalysisReport; American Society for Healthcare Engineering of the American HospitalAssociation, Aug. 22, 2003.

Ecolab, Inc.

By Kirsten M. Thompson

As a manufacturer of several alcohol handrub products and a sponsor of theAHA/ASHE study, we appreciate the attention given to the issue of flammabilityof alcohol-based handrubs and the placement of dispensers in the December 2003issue of ICT.

Based on the guidelines from the AHA/ASHE study, we recommend a proactiveapproach to the installation of alcohol-based handrubs by encouraging customersto utilize the following checklist:

• Determine that the alcohol-based handrub products to be routinely used andlocated in a patient hallway do not exceed the 1.2 liter capacity; likewise,products in patient rooms do not exceed 2 liters.

• Do not install dispensers over electrical outlets or near other sources of ignition. Document any dispensers in the facilitys fire plan that project more than 3.5 inches into the corridor.

• Identify that the proper storage equipment is in place to include flammable liquid storage cabinets on patient floors, and that quantities in these cabinets do not exceed that of the local fire code.

• Be aware of the proper handling, storage and disposition of thealcohol-based handrubs, and contact local fire authorities for specific disposalinstructions of product containers that may have product in them.

• Document that the local fire marshal or fire-code enforcement official has reviewed the use of the alcohol product in the area, such as outside a patient room, and has provided an approval letter both for the Joint Commission on the Accreditation of Healthcare Organizations (JCAHO) and the hospital records.

• When providing an in-service to healthcare workers, emphasize the need to allow the hands to dry completely after use to eliminate the potential for ignition. Instruct healthcare workers on the proper cleanup procedure for the product from a spill or misapplication.

In addition, we want to hear about enforcement situations as they develop tohelp avoid unnecessary removal of waterless alcohol handrubs after installation.

As a leading manufacturer of alcohol-based handrubs, we are working with thekey stakeholders to seek a reasonable solution for the use of these productsbased on good science, balancing fire safety concerns with infection controlinterests. The ASHE recommendations report is a good start for moving thediscussion forward but the varied interests involved with this issue will haveto work cooperatively while attempting to minimize the disruption of infectioncontrol procedures in the interim.

In terms of the next steps to be taken, AHA/ASHE is committed to working withthe NFPA to bring about changes in the national fire codes and will be draftinga tentative interim amendment that may get approved by the NFPA Fall EducationConference in Reno, Nev. as this article is submitted for publication in lateNovember. The AHA is planning to focus its resources on the code makers first,followed by the code enforcers (e.g., CMS, JCAHO, etc.).

From our perspective as a manufacturer, there are two points that deservefurther discussion and potential follow up as part of the AHA/ASHE study:

• While liquid/gel alcoholic solutions are most commonly used, the aerosolpressurized foam products have become increasingly popular in recent years. Wehave become aware of some specific enforcement problems relating to theseproducts and we expect objections to their use generally to be raised by fireservice enforcement. As a consequence, we believe that some level of analysisand testing should be included as part of this study, something we stronglyrecommended. As a legitimate component of the waterless handrub family, asimilar fire modeling for this product also needs to be addressed.

• The most prevalent use of alcohol-based handrub products has been inhospital and medical settings, but we see an increased use for them in othersettings including food service, food processing, schools and virtually anywheremicrobial contamination could be deemed a problem. Outbreaks relating tospecific organisms, such as the recent SARS threat, highlight the interest inthese products relating to high volume transportation nodes.

Being able to balance varying needs will allow us to do our part to providethe best product to our customers while satisfying the concerns of the fireprotection agencies.

Kirsten M. Thompson is a technical service expert in theHealthcare Professional Products Division of Ecolab, Inc.

Thatcher Pharmaceutical Company

By Clint Bodily

We appreciate ICTs willingness to help healthcare professionalsclarify some of the confusion and variation of opinion as to the potentialflammability risk of alcohol hand sanitizer products.

Thatcher Pharmaceutical Company manufactures a 64 percent ethyl alcohol-based hand sanitizer called GelSan, and as a result ofthe widespread concern over flammability risks, we have been helping to educateour customers about this issue for some time now.

Over the past several years, our company has worked closely with healthcarefacilities who use our product, and we have found that there is a huge variationof opinion as to where alcohol gel dispensers should or should not be allowedand how much volume those dispensers should contain. We have spoken with manydifferent organizations and contacts, ranging from the NFPA to the OccupationalSafety and Health Administration (OSHA), to localized fire marshals, and foundthat regulations vary from state to state, and sometimes even from county tocounty and facility to facility.

Since there is no universal specification regarding the flammability issue,our company has encouraged healthcare facilities to base their decisions on theinformation that has been documented from reliable studies and statistics, andcommunicated to the public from sources such as the CDC, the Society forHealthcare Epidemiology of America, Inc. (SHEA) and the Association forProfessionals in Infection Control and Epidemiology (APIC). These organizationshave posted articles and reliable information on this subject. While it is ourpersonal opinion that dispensers would be most effective in hallways, we do notwant to conflict with any state or local fire regulations so our companyroutinely recommends that hospitals place our GelSan dispensers inside ofpatient rooms as a general rule.

It has been our policy to encourage each facility to work closely with itslocal fire marshal. Because of the fact that some fire marshals have alloweddispensers in corridors, and others have not, we feel it is important for eachindividual hospital to state its position to the local fire marshal andvice-versa. If a particular fire marshal will allow dispensers in hallways; thatis a plus. If a fire marshal will not allow dispensers in hallways, thena facility should respect and comply with that regulation. Either way, it is beneficial for hospitals and fire marshals to be talking toone another. We feel that this process will greatly help to clarifymisconceptions about the potential flammability risk of alcohol-based handrubsand lead to future specifications that will be more universal for everyone.

As a manufacturer, we provide constructive feedback to our customers on theexact placement of dispensers inside of the patient rooms, and help facilitiesto avoid common mistakes such as hanging dispensers above power outlets or lightswitches, etc. We also encourage infection control nurses to create a protocolfor their facility that is based on CDC guidelines and instructs hospital staffon when to use our product, when to wash with soap and water, and teaches theimportance of performing proper hand hygiene. Such protocols should includespecific safety instructions for dispenser mounting and proper storage ofreplacement gel packets, and instruct workers to let alcohol gel dry on theirhands before touching metal doors or any hospital equipment that couldpotentially cause a spark. If a hospital creates a protocol that instructshealthcare workers how to correctly use and store alcohol handrub products, manyof the concerns with flammability risk will be safely addressed.

As a matter of opinion only, we feel that the benefits of using alcoholhandrubs in hospitals far outweigh the potential flammability risks. If alcohol-based products are stored away from open flames, sparks, orextreme temperatures, they are generally very safe and stable substances. Our company provides safe handling and storage instructions on our MaterialSafety Data Sheet (MSDS), which tells our customers how to properly handle and use our product. The number of hospital acquired infections our nation faces today seems to be a much greater threatto patient safety than the remote risk of a fire resulting from the use ofalcohol-based handrubs.

We commend the ongoing efforts of the CDC, APIC, JCAHO, the NFPA, and allstate and local fire marshals who are addressing this issue. We look forward tothe day when clarified specifications are agreed upon so that alcohol handrubproducts can be effectively used to help reduce the spread of infections inmedical facilities everywhere.

Clint Bodily is with Thatcher Pharmaceutical Company.

3M Health Care Services

By Gayle D. Peters

The benefits offered by alcohol-based hand antiseptics are significant tohealthcare professionals and patients. It is widely recognized that improvedhand hygiene is a key factor in reducing the risk of healthcare associatedinfections which directly cause or contribute to an estimated 80,000 deathsannually and cost the U.S. healthcare system $4.5 billion.

3M was pleased to support the American Society for Healthcare Engineering(ASHE) fire-modeling study to acquire information that facilitates agreementconcerning placement of dispensers to promote proper hand hygiene. Educationabout proper use of products is important in all areas of the healthcarecontinuum.

Gayle D. Peters is with 3M Health Care Services.

Coloplast Corp.

By Randy Barranger

The article titled, Flammability of Alcohol Hand Hygiene Products:Extinguishing the Flames of Controversy was a well-done piece summarizing theissues surrounding alcohol-based hand hygiene products. As one of themanufacturers that co-sponsored the fire modeling study, Coloplast applauds thecooperation that has been shown between the manufacturers, AHA, ASHE, CDC, NFPA,APIC and other organizations, to address an unresolved controversy on theplacement of the alcohol-based hand rub dispensers.

The alcohol-based handrub products have been shown to be a highly effectivetool for health care professionals to use in the challenge of nosocomialinfections. We hope that fire marshals throughout the U.S. will adopt theguidelines developed from the ASHE firemodeling study and modify local firecodes to allow healthcare facilities to place the alcohol handwash dispensers inlocations that will encourage their use. Whether in the hallways or insidepatient rooms, the easy access to alcohol handwash products is one of the keysto increasing adherence to hand-hygiene protocols. Considering the eight to 20 opportunities for hand hygiene per patient hour,there are many opportunities for hand hygiene during patient care, so ifdispensers are outside patient rooms, personal carriage of the product is alsoimportant as a complement to the dispenser usage.

The collaboration and conclusion on these flammability issues is quitetimely, as JCAHO has announced the 2004 National Patient Safety Goals and mostrecently their revised Infection Control Standards for 2005. ... Reducing therisk of nosocomial infections must become a top priority for hospitals and otherhealthcare organizations, to quote Richard Croteau, MD, JCAHOs executive director of strategicinitiatives.

Randy Barranger is vice president of commercial developmentfor Coloplast Corp.

REFERENCE:

1. Centers for Disease Control and Prevention. Guideline forHand Hygiene in Health Care Setting: Recommendations of the Healthcare InfectionControl Practices Advisory Committee and the HICPAC/SHEA/APIC/IDSA Hand HygieneTask Force. MMWR 2002:51 (No. RR-16, 20,24).

Executive Summary: Alcohol-Based Handrub SolutionFire-Modeling Analysis Report
(Released Aug. 22, 2003 by the American Society for Healthcare Engineering)

Note: Because of the flammable nature of alcohol-based hand rubs, theinstallation of dispensers and the storage of products should be discussed withthe local fire marshal and/or local building officials to address compliancewith prevailing building and fire codes. Organizations are encouraged to utilizethis fire modeling study to inform the discussion and arrive at a solution thatmeets the dual goals of effective hand hygiene and fire safety.

Alcohol-based products are more effective for standard hand hygiene or handantisepsis by healthcare personnel than soap or antimicrobial-containing soapproducts. For optimal effectiveness, both the type and concentration of alcoholin the handrub are important variables. Two of the more common formulations ofalcohol-based handrubs used in the U.S. are equal to or greater than 60 percent of ethyl alcohol or isopropyl alcoholby volume. Alcohol is a flammable liquid. Local building and fire codes regulatethe storage and use of flammable liquids. The use of alcoholbased handrubstherefore may present a fire hazard within healthcare facilities. This, combinedwith the increasing prevalence in use of alcoholbased handrubs as part ofoverall hand hygiene programs in U.S. health care facilities, necessitatescareful analysis to assure the spectrum of safe care of patients mitigates bothhealthcare-associated infections (HAI) and facility-associated fires.

The American Society for Healthcare Engineering (ASHE) of the AmericanHospital Association commissioned a study of how these handrubs will react to afire in a typical patient care environment. The report documents a computerizedfire-modeling study conducted for typical installations of dispensers containingalcohol-based handrubs. This study includes modeling fire scenarios to capture areasonable range of potential fire scenarios to analyze the overall level ofhazard presented by the hand-hygiene solution.

The study results indicate that installing handrub dispensers is acceptablein both corridor and suite location. The results also showed the spacing ofdispensers at or near each patient room entrance not to be a significant riskfor additional ignition and involvement of more than one dispenser. Based on these results, ASHE recommends the following for the use and storageof the alcohol-based hand rub solutions:

• Single containers installed in an egress corridor shouldnot exceed a maximum capacity of 1.2 liters for alcohol-based handrub solutionsin gel/liquid form. Single containers installed in a suite should not exceed amaximum capacity of 2 liters for alcohol-base hand-rub solutions in gel/liquidform.
• Dispensers should not be installed over electrical receptacles or near other potential sources of ignition.
• Dispensers that project more than 3.5 inches (4.5 inches if the 2003 Edition of the Life Safety Code is adopted) into the corridors should be noted in the facilitys Fire Plan and Training Program.
• All storage of replacement alcohol-based handrubcontainers on patient floors, regardless of the quantity, should be within anapproved flammable liquid storage cabinet.
• The quantity of replacement alcohol-based handrubcontainers stored and used on any floor, including bulk storage in centralsupply rooms, should not exceed the maximum quantity permitted by the localprevailing building and fire codes.

For more details, visit http://www.cdc.gov/handhygiene/firesafety