1 ---------------------------------------------------------------------------REPORT OF THE MONTH, Volume X, Number 2 - 2006 - - - - from the North Carolina Statewide Program for Infection Control and Epidemiology ----------------------------------------------------------------------------CONTENTS: NEWS FEATURES Change of Practice - Check Your Practice: Two of four disinfectants recommended for cleaning eye exam equipment are ineffective according to UNC Health Care study QUESTION OF THE MONTH Microfiber Cleaning REGULATORY/LEGISLATIVE Amendments to North Carolina Reportable Diseases and Conditions Rule NEWS AND ANNOUNCEMENTS JCAHO Clarifies Position on Alcohol Hand Sanitizers Influenza Vaccination of Health-Care Personnel Recommendations Preventing Tetanus, Diphtheria and Pertussis Among Adolescents CDC’s Advisory Committee Recommends New Vaccine to Prevent Rotavirus Prevention of Hepatitis A Through Active or Passive Immunization FDA-Requested Recall - Cytosol Laboratories, Inc. FDA Recall of Some Lots of Cefazolin New OSHA Handbooks on Glutaraldehyde and Mold FDA Licenses New Vaccine to Reduce Older Americans’ Risk of Shingles New Antibiotic Active Against Resistant Hospital Pathogens Boca Medical Products, Inc. Issues Nationwide Recall of Insulin Syringe Product COURSES FOR THE INFECTION CONTROL PROFESSIONAL ______________________________________________________________________ NEWS FEATURES Change of Practice - Check Your Practice: Two of four disinfectants recommended for cleaning eye exam equipment are ineffective according to UNC Health Care study Applanation tonometers are standard equipment used to measure pressure in eyes in ophthalmology clinics, an important procedure. Tonometers lightly placed on the front surface of the eye can determine if glaucoma is present. Healthcare workers are required to disinfect the applanation tonometer after each use. A recently published study conducted by the University of North Carolina Health Care System found that two of the four disinfectants recommended for this purpose by the Centers for Disease Control and Prevention (CDC) and the Association for Professionals in Infection Control and Epidemiology (APIC) were ineffective. Both 70% isopropyl alcohol and 3% hydrogen peroxide were found to be ineffective for eliminating adenovirus type 8 from ophthalmic instruments. Adenovirus type 8 is a common cause of epidemic 2 keratoconjunctivitis, a self-limited infection known as pink eye. These documented outbreaks have occurred mostly in clinics and hospitals. Adnovirus is a hardy environmental survivor for up to 30 days on metal surfaces and is transmitted on contaminated eye equipment or hands. Based on their results, the authors concluded that only the two disinfectants that demonstrated effective killing of adenovirus, 70% ethyl alcohol and 5000 parts per million chlorine, should be used for eye exam equipment disinfection. The immersion time should be 5-10 minutes. This article was published in the Journal of Antimicrobial Agents and Chemotherapy, April 2006, vol 50, pages 1419-1424. QUESTION OF THE MONTH Microfiber Cleaning Q: Our healthcare facility is evaluating options for surface cleaning and floor mops. What are the advantages and disadvantages of microfiber products versus the standard cotton products? A: There are many advantages to the microfiber products currently available on the market for healthcare facilities. Microfiber pads contain a combination of polyester and polyamide that provide a cleaning surface 40 times greater than conventional string mops. A major advantage of the microfiber products is a reduction in the amount of chemical disinfectant used as well as disposal of it since a clean microfiber is used for each room. Microfiber products have a long washing lifetime of 500 to 1000 washings. Microfiber products are ergonomically superior since they are approximately five pounds lighter than a standard string mop and reduce cleaning times. Most importantly, microfiber has been found to provide the same or better removal of microorganisms on surfaces. REGULATORY/LEGISLATIVE Amendments to North Carolina Reportable Diseases and Conditions Rule Effective June 1, 2006, Novel Influenza Virus will become a reportable communicable disease in North Carolina (NC) under 10A NCAC 41A 0101. The addition is temporary and will become permanent by the end of the year. This will bring NC in line with the federal list of quarantinable diseases since President Bush added novel influenza virus on April 1, 2005. See the Executive Order at: http://www.whitehouse.gov/news/releases/2005/04/20050401-6.html which adds: "(c) Influenza caused by novel or reemergent influenza viruses that are causing, or have the potential to cause, a pandemic." Physicians who suspect a patient with this condition must report immediately to their local or state health department. In the coming months, the General Communicable Disease Control Branch will be adding an Appendix to the NC Pandemic Influenza Response Plan (http://www.epi.state.nc.us/epi/gcdc/pandemic.html) that will assist healthcare providers on evaluating and reporting suspect cases. 3 The General Communicable Disease Control Branch is requesting the following additional amendments to 10 NCAC 41A .0101 Reportable Diseases and Conditions Rule: The category A bioterrorism diseases which include anthrax, botulism, plague, smallpox, tularemia, and viral hemorrhagic fever should be reported immediately rather than within 24 hours because mass casualties may result and law enforcement needs to be notified by public health authorities; Thrombotic thrombocytopenic purpura needs to be deleted since this condition is no longer considered communicable; Congenital toxoplasmosis should be deleted because it is no longer considered a public health threat with only 1 case reported in NC since 1991; and Novel influenza virus infection should be reported immediately since an influenza pandemic is overdue and initial cases need to be reported so that containment measures can be enforced to prevent further transmission, illness, and death. (from Dr. Jeffrey Engel, NC Department of Health) NEWS AND ANNOUNCEMENTS JCAHO Clarifies Position on Alcohol Hand Sanitizers March 15, 2006. Corridor location of alcohol-based hand rub (ABHR) dispensers has been viewed as a key strategy to improved access and adherence to hand hygiene. Following concerns expressed by multiple stakeholders, JCAHO clarified its December 2005 interpretation that restricted foam dispensers to patient rooms; the new guidance treats gels and foams the same and now permits foam dispensers in corridors. This clarification was published in the March 2006 issue of Joint Commission Perspectives. This new interpretation removes what is hoped to be one of the last barriers to hallway placement of dispensers with alcohol-based hand sanitizers because of fire safety concerns. Recent changes in national and international fire codes lifted previous restrictions for corridor placement of alcohol-based hand rub (AHBRs) dispensers, in part, because fire modeling studies on gel formulations showed a low risk for fire hazards if proper guidelines are followed (e.g., permissible placement and volumes). Key points of the JCAHO clarification include: * Foam dispensers are allowed in corridors if they meet the same conditions required for gel dispensers (Note: JCAHO states that this position may be modified if safety concerns arise in the future.) * There must be at least six inches from the center of a dispenser to an ignition source (e.g., electrical outlets). 4 * An equivalent level of safety may be achieved (if all specific requirements cannot be met) by performing a product-specific risk assessment and determining alternative methods for managing the risks. Download a FAQ on placement of dispensers near ignition sources: FAQ on placement of dispensers <http://lyris.premierinc.com/t/71671/79224/493/0/> (.doc) For background and more information, go to Premier's Safety Share article archives <http://lyris.premierinc.com/t/71671/79224/67/0/> and locate "Hand Hygiene" in the alphabetical index. This bulletin is a service of Premier Safety Share. Influenza Vaccination of Health-Care Personnel Recommendations February 24, 2006. Influenza Vaccination of Health-Care Personnel Recommendations of the Healthcare Infection Control Practices Advisory Committee (HICPAC) and the Advisory Committee on Immunization Practices (ACIP). This report summarizes recommendations of HICPAC and ACIP concerning influenza vaccination of health-care personnel (HCP) in the United States. These recommendations apply to HCP in acute care hospitals, nursing homes, skilled nursing facilities, physician's offices, urgent care centers, and outpatient clinics, and to persons who provide home health care and emergency medical services. The recommendations can assist health-care facility administrators, infection control professionals, and occupational health professionals in optimizing influenza vaccination programs and influenza infection control programs in their institutions. HICPAC and ACIP recommend that all HCP be vaccinated annually against influenza. MMWR Recommendations and Reports, Volume 55, No. RR-2, February 24, 2006 http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5502a1.htm Preventing Tetanus, Diphtheria and Pertussis Among Adolescents March 24, 2006. Preventing Tetanus, Diphtheria, and Pertussis Among Adolescents: Use of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccines Recommendations of the Advisory Committee on Immunization Practices (ACIP). In 2005, two tetanus toxoid, reduced diphtheria toxoid and acellular pertussis (Tdap) vaccine products were licensed for use in adolescents in the United States. Prelicensure studies documented the safety and efficacy of these products as a single booster dose. This report summarizes the Advisory Committee on Immunization Practices recommendations regarding the new vaccine; reviews tetanus, diphtheria, and pertussis vaccination policy in the United States; and describes the clinical features and epidemiology of pertussis. MMWR Recommendations and Reports, Volume 55, No RR-3, March 24, 2006. http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5503a1.htm http://www.cdc.gov/mmwr/pdf/rr/rr55e223.pdf 5 CDC’s Advisory Committee Recommends New Vaccine to Prevent Rotavirus February 21, 2006. Rotavirus is the leading cause of gastroenteritis in infants and young children in the United States and worldwide. The Advisory Committee on Immunization Practices (ACIP) to the Centers for Disease Control and Prevention (CDC) recommend a newly licensed vaccine to protect against rotavirus, a viral infection that can cause severe diarrhea, vomiting, fever and dehydration (gastroenteritis) in infants and young children. The ACIP recommendation is for infants to receive three doses of the oral vaccine at two, four, and six months of age. Children should receive the first dose of the vaccine by 12 weeks of age and should receive all doses of the vaccine by 32 weeks of age. There is insufficient data on safety and efficacy outside of these age ranges. The new vaccine, RotaTeq™ (marketed by Merck and Company), is the only vaccine approved in the United States for prevention of rotavirus gastroenteritis (vomiting and diarrhea). Recommendations of the ACIP become recommendations of CDC once they are accepted by the director of CDC and the Secretary of Health and Human Services and are published in the Morbidity and Mortality Weekly Report. For more information on rotavirus and the rotavirus vaccine, visit www.cdc.gov. http://www.cdc.gov/nip/pr/pr_rotavirus_feb2006.pdf Prevention of Hepatitis A Through Active or Passive Immunization May 19, 2006. Prevention of Hepatitis A Through Active or Passive Immunization Recommendations of the Advisory Committee on Immunization Practices (ACIP). Routine vaccination of children is an effective way to reduce hepatitis A incidence in the United States. Since licensure of hepatitis A vaccine during 1995-1996, the hepatitis A childhood immunization strategy has been implemented incrementally, starting with the recommendation of the ACIP in 1996 to vaccinate children living in communities with the highest disease rates and continuing in 1999 with ACIP's recommendations for vaccination of children living in states, counties, and communities with consistently elevated hepatitis A rates. These updated recommendations represent the final step in the childhood hepatitis A immunization strategy, routine hepatitis A vaccination of children nationwide. This report updates ACIP's 1999 recommendations concerning the prevention of hepatitis A through immunization (CDC. Prevention of hepatitis A through active or passive immunization: recommendations of the Advisory Committee on Immunization Practices [ACIP]. MMWR 1999:48[No. RR-12]:1-37) and includes 1) new data on the epidemiology of hepatitis A in the era of hepatitis A vaccination of children in selected U.S. areas, 2) results of analyses of the economics of nationwide routine vaccination of children, and 3) recommendations for the routine vaccination of children in the United States. Previous recommendations for vaccination of persons in groups at increased risk for hepatitis A or its adverse consequences and recommendations regarding the use of immune globulin for protection against hepatitis A are unchanged from the 1999 6 recommendations. MMWR Reports and Recommendations Vol 55, No RR-7, May 19, 2006. http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5507a1.htm FDA-Requested Recall - Cytosol Laboratories, Inc. February 13, 2006. The U.S. Food and Drug Administration (FDA) delivered a letter to Cytosol Laboratories, Inc., of Braintree, MA, to request a recall of all brands and sizes of Balanced Salt Solution (BSS) that the firm manufactures. BSS is a solution used by health professionals to irrigate a patient's eyes, ears, nose and/or throat during a variety of surgical procedures including cataract surgery. FDA requested the recall because product lots were found to have elevated levels of endotoxin. The BSS products subject to the recall order were manufactured by Cytosol Laboratories, Inc. for distribution under 3 labels: "AMO Endosol" distributed by Advanced Medical Optics, Inc. (AMO), Santa Ana, Calif.; "Cytosol Ophthalmics" distributed by Cytosol Ophthalmics, Lenoir, NC; and "Akorn" distributed by Akorn, Inc., Buffalo Grove, Ill. http://www.fda.gov/bbs/topics/news/2006/NEW01315.html FDA Recall of Some Lots of Cefazolin March 2, 2006. Hanford Pharmaceuticals and the Food and Drug Administration (FDA) notified healthcare professionals about the recall of four lots (379,975 vials) of Cefazolin for Injection, USP, 1 g/10 mL vials, an antibiotic used in a hospital environment to treat skin and skin structure, respiratory and other infections. The product was distributed by Sandoz, Inc. of Broomfield, CO and Watson Pharmaceuticals, Inc. of Corona, CA. Certain lots of the active ingredient used to manufacture the product have been shown to contain microbial contamination (Bacillus pumilus, Staphylococcus hominis, Propionibacterium acnes, or Micrococcus luteus) which may pose a serious or lifethreatening risk for some patients. Hospitals, clinics, and users should stop using the affected lots immediately. http://www.fda.gov/medwatch/safety/2006/safety06.htm#Cefazolin New OSHA Handbooks on Glutaraldehyde and Mold OSHA recently posted to its Web site two new handbooks. Best Practices for the Safe Use of Glutaraldehyde in Health Care helps employers and employees understand and control exposures to glutaraldehyde, a toxic chemical used to disinfect and clean heatsensitive medical, surgical and dental equipment. Preventing Mold-Related Problems in the Indoor Workplace offers recommendations to owners, managers, and occupants on how to fix mold problems in buildings. http://www.osha.gov/Publications/glutaraldehyde.pdf http://www.osha.gov/Publications/preventing_mold.pdf 7 FDA Licenses New Vaccine to Reduce Older Americans’ Risk of Shingles May 25, 2006. The Food and Drug Administration (FDA) licensed Zostavax, a new vaccine to reduce the risk of shingles (herpes zoster) for use in people 60 years of age and older. Shingles is a disease caused by the varicella-zoster virus, the same virus that causes chickenpox. After an attack of chickenpox, the virus lies dormant in certain nerve tissue. As people age, it is possible for the virus to reappear in the form of shingles, which is estimated to affect 2 in every 10 people in their lifetime. Shingles is characterized by clusters of blisters, which develop on one side of the body and can cause severe pain that may last for weeks, months or years after the virus reappears. Zostavax is manufactured by Merck & Co., Inc., of Whitehouse Station, New Jersey. http://www.fda.gov/bbs/topics/NEWS/2006/NEW01378.html New Antibiotic Active Against Resistant Hospital Pathogens May 2006. Researchers have discovered a new antibiotic with a unique mechanism of action that allows it to eradicate several hospital pathogens for which other agents are often ineffective, such as methicillin-resistant Staphylococcus aureus (MRSA) and vancomycin-resistant enterococcus (VRE). The antibiotic, named platensimycin, is a member of a formerly unknown class of antimicrobials produced by Streptomyces platensis. Nature 2006;441:358-361 (from Reuters Health) Boca Medical Products, Inc. Issues Nationwide Recall of Insulin Syringe Product May 19, 2006. Boca Medical Products, Inc., of Coral Springs, Florida initiated a recall of 41 boxes of Closercare Insulin Syringe 29g 1cc product lot number 5JCZ1 as displayed on the inner case and 2320 boxes of Ultilet Insulin Syringe 30g 1/2cc product lot number 5KEO1 as displayed on the inner case. The products are being recalled because of bacterial contamination with Paenibacillus. This presents a risk of local infection due to soft tissue injection with a contaminated syringe as well as a risk of introduction of contaminating organisms into a previously sterile vial. The introduced contamination may degrade the insulin, which could lead to problems maintaining insulin levels. Previous recalled lot was 5GEX1. Consumers who have product lots 5JCZ1 and 5KEO1, should stop usage and return the specific products. Wholesalers should stop retail and return the product lots. For any question related to the case; consumers should call 1-800-354-8460. http://www.fda.gov/medwatch/safety/2006/closercare_recall.htm 8 COURSES FOR THE INFECTION CONTROL PROFESSIONAL “Infection Control Part II: The ICP as an Environmentalist” will be held in Chapel Hill September 18-22, 2006. Registration and course information are available online. http://fridaycenter.unc.edu/pdep/icii/ "Infection Control in Long-Term Care Facilities” will be held October 23-25, 2006 in Chapel Hill. Information about the March 2006 course is available online. http://fridaycenter.unc.edu/pdep/iclong/ “Infection Control Part I: Clinical Surveillance of Healthcare-Associated Infections” will be held in the spring of 2007. Information about the May 2006 course is online. http://fridaycenter.unc.edu/pdep/ici/ -----------------------------------------------------------------------------------Contributors to Report of the Month: Karen K. Hoffmann, RN, MS, CIC; William A. Rutala, PhD, MPH; David J. Weber, MD, MPH; Jennifer MacFarquhar, RN, BSN, CIC; Eva P. Clontz, MEd. -----------------------------------------------------------------------------------To subscribe to the Report of the Month, send email to spice@unc.edu Report of the Month is also available on the home page of the Statewide Program for Infection Control and Epidemiology at http://www.unc.edu/depts/spice/ The Statewide Program for Infection Control and Epidemiology (SPICE) is funded by the General Assembly of North Carolina to serve the State. SPICE is not a regulatory agency but provides education and consultation to North Carolina healthcare facilities. Sent July 2006 Copyright 2006 Statewide Program for Infection Control and Epidemiology