Patient Safety Advisory Reprinted from the PA-PSRS Patient Safety Advisory—Vol. 2, No. 2 (June 2005) Produced by ECRI & ISMP under contract to the Pennsylvania Patient Safety Authority Risk of Fire from Alcohol-Based Solutions W hile flammable liquid germicides (alcohol and alcohol-based solutions) are good antimicrobial agents, their misuse can present a significant fire haz- used in anesthetizing locations for germicidal purposes…. ard. These solutions have been used for many years 13.4.1.2.2.2 Liquid germicides used in anes- in surgical preparation to prevent infections to pa- thetizing locations, whenever the use of cau- tients and are now being used throughout healthcare tery or electrosurgery is contemplated, shall facilities in the form of hand sanitizers or “hand rubs”. be nonflammable. Alcohol-Based Skin Prep Solutions 13.4.1.2.2.3 Whenever flammable aerosols A report submitted to PA-PSRS described a patient are employed, sufficient time shall be allowed receiving a second-degree burn and singed hair from to elapse between deposition and application the use of an alcohol prep solution during electrosur- of drapes to permit complete evaporation and gery. Another report described a patient’s hair catch- dissipation of any flammable vehicle remain- ing fire; though the report did not indicate that an al- ing. cohol or alcohol-based prep solution was used, hair catching fire can be indicative of the hair containing The controversy arises due to the inconsistencies alcohol. Although electrosurgery was the ignition between flammable aerosols and liquids among the source in the two reported events, surgical fires or three subsections. Literal interpretation of the sec- burns can occur with any ignition source (e.g., elec- tions suggests that the use of flammable aerosols is trosurgical unit, electrocautery unit, laser, fiberoptic permitted in anesthetizing locations and that the use light source). of flammable liquids is not. However, the contention is that, since it is the ignition of flammable vapors from A search of the U.S. Food and Drug Administration’s the aerosols or liquids that occurs, the interpretation Manufacturer and User Device Experience (MAUDE) should include the permitted use of both forms of ger- database, using the keywords “alcohol AND burn” micides, provided the germicide is properly used and and “alcohol AND fire” revealed 10 out of 41 reports applied to the patient’s skin. specifically associating the use of alcohol or alcohol- based solutions with surgical fires or patient burns. The American Society for Healthcare Engineering The remaining reports were unrelated to prep solu- (ASHE) of the American Hospital Association has tions and surgical fires or burns or lacked information proposed a tentative interim amendment (TIA)2 to to make an association. NFPA (NFPA 99) to amend and expand the language to section 13.4.1.2.2. The amendment would include Controversy currently exists over the use of flamma- permitting the use of flammable germicide solutions ble liquid germicides during electrosurgery or electro- during surgical procedures involving ignition sources cautery procedures. Several Authorities Having Juris- such as electrosurgery and electrocautery, with em- diction* (AHJ), such as the state of Nebraska (state phasis on the proper use and application of the germi- fire marshals, government health and human services cide solutions. We will continue to follow this issue as departments) and Centers for Medicare and Medicaid the controversy develops or the resolution to the con- Services (CMS), have interpreted National Fire Pro- troversy develops. tection Association Standards for Healthcare Facilities (2005) as permitting the use of only nonflammable This article is reprinted from the PA-PSRS Patient Safety Advisory, Vol. 2, No. germicides in anesthetizing locations. 2—June 2005. The Advisory is a publication of the Pennsylvania Patient Safety Authority, produced by ECRI & ISMP under contract to the Authority as part of the Pennsylvania Patient Safety Reporting System (PA-PSRS). The NFPA 99 standard section 13.4.1.2.21 states: Copyright 2005 by the Patient Safety Authority. This publication may be re- 13.4.1.2.2.1 Medicaments, including those printed and distributed without restriction, provided it is printed or distributed in its entirety and without alteration. Individual articles may be reprinted in their dispersed as aerosols, shall be permitted to be entirety and without alteration provided the source is clearly attributed. * Authority Having Jurisdiction is a term defined by NFPA to describe federal, To see other articles or issues of the Advisory, visit our web site at state, local, or regional agencies—typically government—concerned with public www.psa.state.pa.us. Click on “Advisories” in the left-hand menu bar. safety, such as the fire marshal or health department. ©2005 Pennsylvania Patient Safety Authority Page 1 Reprinted from the PA-PSRS Patient Safety Advisory—Vol. 2, No. 2 (June 2005) Risk of Fire from Alcohol-Based Solutions (Continued) A combination of two factors involving alcohol or alco- The concern with the hand rub sanitizers is the poten- hol-based prep solutions can lead to fire or burns:3-5 tial risk of fire from the released vapor from the alco- hol-based ingredient of the dispenser. However, on • If improperly applied, the solution may wick March 25, 2005, CMS amended this Final Rule6 to into the patient’s hair and linens or pool on allow placing hand rub dispensers in egress corridors. the patient’s skin, which can prolong the solu- Placing hand rub dispensers in egress corridors is tion’s drying time. based on certain conditions specified in the amend- • If the patient is draped before the solution is ment. The amendment to the Final Rule became ef- completely dry, the alcohol vapors can be- fective on May 24, 2005. Factors influencing the deci- come trapped under the surgical drapes and sion to amend the Final Rule are that the dispensers channeled to the surgical site. contain a relatively small amount of alcohol-based gel (alcohol-based gel is the most common form of hand If these conditions occur, a heat source used at the rub sanitizers), the dispensers do not release alcohol surgical site could ignite the alcohol vapors, resulting vapors, and the risk of fire is low when the dispensers in a fire and/or burn. Many clinicians are unaware of are properly installed and used. the risk of surgical fires or burns associated with the use, or misuse, of alcohol and alcohol-based prep Notes solutions. Practices that may help to reduce this risk 1. National Fire Protection Association (NFPA) Standard for Health- include: care Facilities. NFPA 99. Quincy (MA):2005. 2. ASHE Proposes Amendment to NFPA 99 For Safe Usage Of • Purchasing skin prep solutions that provide Alcohol Based Surgical Prep Solutions, suggests hospitals cited by CMS consider requesting a waiver. American Society for Health- clear and explicit instructions and warnings. care Engineering of the American Hospital Association (ASHE) • Ensuring that the prep solution does not soak [online] [cited 2005 May 17]. Available from Internet: http:// into hair or linens. Sterile towels can be www.ashe.org/ashe/codes/nfpa/ nfpa099_proposeamend_absp.html. placed to absorb drips and runs during appli- cation, and can then be removed prior to 3. ECRI. A Clinician’s Guide to Surgical Fires: How They Occur, How to Prevent Them, and How to Put Them Out [Guidance Arti- draping the patient. cle]. Health Devices 2003;32(1):5-24. • Prior to draping, ensuring that the prep solu- 4. ECRI. Improper Use of Alcohol-Based Skin Preps Can Cause tion is completely dry. This may take a few Surgical Fires. [Hazard Report]. Health Devices 2003;32(11):441-3. minutes or more depending on the amount 5. ECRI. Fire Hazard Created by the Misuse of DuraPrep Solution and location of the solution. Inspecting the [Hazard Report]. Health Devices 1998;27(11):400-2. prepped area before draping. Some solutions 6. CMS Issues Interim Final Rule Allowing Alcohol-based Hand change appearance when dry (e.g., change Rub Dispensers in Egress Corridors. ASHE Regulatory Advisory. from shiny to matte). American Society for Healthcare Engineering of the American Hos- • During surgery, being aware of any sudden pital Association [online] [cited 2005 May 17]. Available from Inter- net: http://www.ashe.org/ashe/codes/handrub/pdfs/ flash of heat. Such a flash is indicative of an regadv_abhr_interimfinalrule_rev2_050325.pdf. alcohol fire. If a fire is suspected, immediately 7. 42 CFR Parts 403, 416, 418, 460, 482, 483, 485 Medicare and search for any flaming or smoldering materi- Medicaid Programs; Fire Safety Requirements for Certain Health als, and remove and extinguish them. Care Facilities; Amendment [online]. Fed Reg 2005 Mar;70 • Following prep solutions suppliers’ recom- (57):15229-39. [cited 2005 May 17]. Available from Internet:http:// a257.g.akamaitech.net/7/257/2422/01jan20051800/ mended instructions for use. edocket.access.gpo.gov/2005/pdf/05-5919.pdf. • In-service about the proper use and risks of using alcohol and alcohol-based prep solu- tions could be provided to all surgical staff including nurses, surgeons, and anesthesia providers. Alcohol-Based Hand Rub Sanitizing Solutions In January 2003, CMS published a Final Rule in the Federal Register, Fire Safety Requirements for Cer- tain Health Care Facilities (68 FR 1374),7 which in- cluded requirements for prohibiting “the placement of accelerants, including alcohol-based hand rub dis- pensers (ABHR), in egress corridors,” but allowing their placement in patient rooms and other areas. Page 2 ©2005 Pennsylvania Patient Safety Authority Reprinted from the PA-PSRS Patient Safety Advisory—Vol. 2, No. 2 (June 2005) An Independent Agency of the Commonwealth of Pennsylvania The Patient Safety Authority is an independent state agency created by Act 13 of 2002, the Medical Care Availability and Reduction of Error (“Mcare”) Act. Consistent with Act 13, ECRI, as contractor for the PA-PSRS program, is issuing this newsletter to advise medical facilities of immediate changes that can be instituted to reduce serious events and incidents. For more information about the PA- PSRS program or the Patient Safety Authority, see the Authority’s website at www.psa.state.pa.us. ECRI is an independent, nonprofit health services research agency dedicated to improving the safety, efficacy and cost-effectiveness of healthcare. ECRI’s focus is healthcare technology, healthcare risk and quality management and healthcare environmental management. ECRI provides information services and technical assistance to more than 5,000 hospitals, healthcare organizations, ministries of health, government and planning agencies, and other organizations worldwide. The Institute for Safe Medication Practices (ISMP) is an independent, nonprofit organization dedicated solely to medication error prevention and safe medication use. ISMP provides recommendations for the safe use of medications to the healthcare community including healthcare professionals, government agencies, accrediting organizations, and consumers. ISMP's efforts are built on a non-punitive approach and systems-based solutions. ©2005 Pennsylvania Patient Safety Authority Page 3