REPORT OF THE MONTH, Volume IX, Number 3 – 2005
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from the North Carolina Statewide Program for Infection Control and Epidemiology
CONTENTS:
NEWS AND ANNOUNCEMENTS
NFPA Amends Ruling, Specifically Allows Alcohol-based Preps
Influenza
Prevention and Control of Influenza
Update: Influenza Vaccine Supply and Recommendations for Prioritization
During the 2005-06 Influenza Season
Influenza Vaccine Fluarix Approved
Adamantane-Resistant Influenza Viruses Increasing Worldwide
From the CDC and FDA
CDC Pneumonia Definitions
Updated Guidelines for the Management of Occupational Exposures to HIV and
Recommendations for Postexposure Prophylaxis (CDC)
FDA and CDC Issue Alert on Menactra Meningococcal Vaccine and Guillain
Barre Syndrome
FDA Approves VAQTA® (Hepatitis A Vaccine, Inactivated) for Children Aged
More Than One Year
FDA Approves a New Combination Vaccine against Whooping Cough
FDA Adds Laparoscopic and Endoscopic Electrosurgical Accessories to the List
of Reprocessed SUDs Subject to Premarket Notification Requirements
Nosocomial Burkholderia cepacia Pneumonia Associated with Contaminated
Alcohol-Free Mouthwash
Reduction in Central Line-Associated Bloodstream Infections Among
Patients in Intensive Care Units
Ralstonia Associated with Vapotherm Oxygen Delivery Device
Adult Immunization Schedule Updated
JCAHO 2006 National Patient Safety Goals
HIV Screening for Pregnant Women
Survey on Patient Safety Culture
Review of Clinical Avian Influenza A (H5N1) Infection in Humans
Hurricane-Related Infectious Disease Risk Slides
COURSES FOR THE INFECTION CONTROL PROFESSIONAL
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NEWS AND ANNOUNCEMENTS
NFPA Amends Ruling, Specifically Allows Alcohol-based Preps
The National Fire Protection Association’s (NFPA) Standards Council voted on July 29, 2005 to amend NFPA 99, Healthcare Facilities, to more explicitly allow alcohol-based surgical preps. The amendment recognizes the clinical advantages of using alcohol-based preps, but says that use must be balanced against fire safety concerns during electrosurgical and laser procedures. Precautions that staff must take include allowing preps to dry completely before a procedure and calling “time outs” to make sure conditions are safe before using heat-based surgical tools. The amendment became effective on August 18 for the 2005 edition of NFPA 99. The full amendment is online.
http://www.nfpa.org/assets/files/PDF/TIA99-05-2.pdf
Prevention and Control of Influenza
July 13, 2005, MMWR. Each year the Advisory Committee on Immunization Practices (ACIP) provides updated recommendations on influenza vaccination. This year the recommendations include information regarding vaccination of persons with conditions leading to compromise of the respiratory system; vaccination of health-care workers; clarification of the role of live, attenuated influenza vaccine in vaccine shortage situations; 2005-06 trivalent vaccine virus strains; and assessment of vaccine supply, timing of influenza vaccination, and prioritization of inactivated vaccine in shortage situations.
http://www.cdc.gov/mmwr/preview/mmwrhtml/rr54e713a1.htm
Also see the CDC’s web page on influenza.
Update: Influenza Vaccine Supply and Recommendations for Prioritization During the 2005-06 Influenza Season
September 2, 2005, MMWR. Influenza vaccine distribution delays or vaccine supply shortages have occurred in the United States in three of the last five influenza seasons. In response, prioritization has been implemented in previous years to ensure that enough vaccine is available for those at the highest risk for complications from influenza. The information in this report updates projections of influenza vaccine supply (TIV) during the 2005-06 influenza season.
http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5434a4.htm
Influenza Vaccine Fluarix Approved
August 31, 2005. The U.S. Food and Drug Administration approved GlaxoSmithKline's influenza vaccine Fluarix, just weeks before the start of the 2005-2006 U.S. flu season. U.S. health officials said the approval should ease supply problems after last season, when one of two flu vaccine makers lost its license to produce the drug.
Adamantane-Resistant Influenza Viruses Increasing Worldwide
September 22, 2005. A study in Lancet reported that new research indicates the proportion of influenza A viruses that are resistant to adamantane derivatives has increased markedly worldwide in the last decade-- a trend researchers believe is "a cause for concern." Another study in the same issue showed that flu vaccines are only modestly effective in elderly persons.
CDC Pneumonia Definitions
Centers for Disease Control and Prevention (CDC) new definitions for pneumonia, Criteria for Defining Nosocomial Pneumonia, can be found online at
http://www.cdc.gov/ncidod/hip/NNIS/members/pneumonia/Final/PneumoCriteriaV1.pdf
CDC web page for links to criteria, instructions and flow charts are online at
http://www.cdc.gov/ncidod/hip/NNIS/members/pneumonia/pneumonia_final.htm
There are new definitions from formerly NNIS (National Nosocomial Infections Surveillance) for Pneumonia 1, Pneumonia 2 and Pneumonia 3. Information can be found in this document:
http://www.cdc.gov/ncidod/hip/NNIS/NosInfDefinitions.pdf
Updated Guidelines for the Management of Occupational Exposures to HIV and Recommendations for Postexposure Prophylaxis (CDC)
September 30, 2005. This report updates U.S. Public Health Service recommendations for the management of health-care personnel (HCP) who have occupational exposure to blood and other body fluids that might contain human immunodeficiency virus (HIV). Although the principles of exposure management remain unchanged, recommended HIV postexposure prophylaxis (PEP) regimens have been changed. This report emphasizes adherence to HIV PEP when it is indicated for an exposure, expert consultation in management of exposures, follow-up of exposed workers to improve adherence to PEP, and monitoring for adverse events, including seroconversion. To ensure timely postexposure management and administration of HIV PEP, clinicians should consider occupational exposures as urgent medical concerns.
(Summary from the MMWR)
http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5409a1.htm
FDA and CDC Issue Alert on Menactra Meningococcal Vaccine and Guillain Barre Syndrome
October 1, 2005. The Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) are alerting consumers and health care providers to 5 reports of Guillain Barre Syndrome (GBS) following administration of Meningococcal Conjugate Vaccine A, C, Y, and W135 (trade name Menactra), manufactured by Sanofi Pasteur. It is not known yet whether these cases were caused by the vaccine or are coincidental. FDA and CDC are sharing this information with the public now and actively investigating the situation because of its potentially serious nature.
Because of the potentially serious nature of this matter, FDA and CDC are asking any persons with knowledge of any possible cases of GBS occurring after Menactra administration to report them to the Vaccine Adverse Event Reporting System (VAERS) to help the agencies further evaluate the matter. Individuals can report to VAERS by phone at 1-800-822-7967or on the web at
For more information see the MMWR online at
http://www.cdc.gov/mmwr/preview/mmwrhtml/mm54d1006a1.htm
FDA Approves VAQTA® (Hepatitis A Vaccine, Inactivated) for Children Aged More Than One Year
August 11, 2005. The Food and Drug Administration (FDA) approved an application of a pediatric/adolescent formulation of VAQTA® (hepatitis A vaccine, inactivated) (Merck & Co., Whitehouse Station, New Jersey) for use among persons aged 12 months-18 years. Previously, the pediatric/adolescent formulation of VAQTA was approved for use in persons aged 2-18 years. The approved labeling change applies only to VAQTA and not to other licensed hepatitis A vaccines. VAQTA is now indicated for active immunization of persons aged >12 months to protect against disease caused by hepatitis A virus.
http://www.fda.gov/cber/products/havamer081105.htm
FDA Approves a New Combination Vaccine against Whooping Cough
June 10, 2005. The Food and Drug Administration (FDA) approved a new vaccine for a single booster immunization against pertussis (whooping cough), in combination with tetanus and diphtheria, for adolescents and adults 11-64 years of age. The vaccine will be marketed as Adacel by Aventis Pasteur Limited located in Toronto, Canada. Adacel is the first vaccine approved as a pertussis booster for adults. Vaccines for prevention of tetanus and diphtheria (Td vaccine) in adolescents and adults have been available for many years. Recently, FDA approved a similar vaccine called Boostrix, manufactured by GlaxoSmithKline, for use in adolescents 10-18 years of age.
http://www.fda.gov/bbs/topics/ANSWERS/2005/ANS01361.html
FDA Adds Laparoscopic and Endoscopic Electrosurgical Accessories to the List of Reprocessed SUDs Subject to Premarket Notification Requirements
September 29, 2005. The Food and Drug Administration (FDA) added laparoscopic and endoscopic electrosurgical accessories to the list of reprocessed SUDs currently subject to premarket notification requirements that will now require submission of supplemental validation data View the federal register announcement online.
a257.g.akamaitech.net/7/257/2422/01jan20051800/edocket.access.gpo.gov/2005/05-19510.htm
Nosocomial Burkholderia Cepacia Pneumonia Associated with Contaminated
Alcohol-Free Mouthwash
The Centers for Disease Control and Prevention (CDC) has been notified by several states of clusters of pneumonia and other infections caused by Burkholderia cepacia. These cases had exposure to alcohol-free mouthwash manufactured by Carrington Labs (Irving, TX) for Medline Industries (Mundelein, IL).
CDC is working with state health departments and the Food and Drug Administration to determine the magnitude of this outbreak. Carrington Labs analysis of in-house retained samples has confirmed contamination in multiple lots of the product in both 4 oz. and 2 oz. bottles leading to a recall of all alcohol-free mouthwash manufactured by Carrington Labs for Medline.
The suspect product bears a 7 or 8 digit lot number on the bottom of the bottle; suspect lot numbers include numbers 0503*** through 0508*** and 0503**** through 0508**** (asterisks represent any digit). The product is available in 2 oz. bottles as well as 4 oz. bottles and was distributed only to hospitals and long term care facilities. The product is not distributed for direct retail sale to the consumer. However, the 2 oz. bottles are packaged with other items, such as toothbrushes, toothpaste, etc. by Medline into a “personal hygiene hospital admission kit” so some mouthwash may be in the possession of the consumer within a residential setting. Medline alcohol-free mouthwash with the above lot numbers should not be used. Individuals who are aware of cases of B. cepacia colonization or infection occurring during or shortly after exposure to these products should contact their health department and CDC at 1-800-893-0485.
Reduction in Central Line-Associated Bloodstream Infections Among
In participating hospitals in southwestern Pennsylvania, during a 4-year period (April 2001-March 2005), bloodstream infection rates among ICU patients declined 68%, from 4.31 to 1.36 per 1,000 central line days. The results suggest that a coordinated, multi-institutional infection-control initiative might be an effective approach to reducing health-care--associated infections. MMWR October 14, 2005.
www.cdc.gov/mmwr/preview/mmwrhtml/mm5440a2.htm
Ralstonia Associated with Vapotherm Oxygen Delivery Device
In August 2005, a health-care facility in Pennsylvania reported the occurrence of Ralstonia spp. in six patients aged 21 days to 8 years to the Philadelphia Department of Health and CDC. Preliminary laboratory and epidemiologic investigation identified the Vapotherm 2000i oxygen delivery device (Vapotherm Inc., Stevensville, Maryland) as an associated risk factor for recovery of the organism from blood and respiratory tract samples. Although the source of Ralstonia has not yet been identified, Vapotherm has created new infection-control procedures to reduce the risk for infectious disease transmission among patients using their machines. This report summarizes the initial results of this ongoing investigation and provides recommendations to prevent further spread of Ralstonia species in hospitals. MMWR October 21, 2005. http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5441a5.htm
Adult Immunization Schedule Updated
October 14, 2005. The Advisory Committee on Immunization Practices (ACIP) annually reviews the recommended Adult Immunization Schedule to ensure that the schedule reflects current recommendations for the use of licensed vaccines. In June 2005, ACIP approved the Adult Immunization Schedule for October 2005-September 2006. This schedule has also been approved by the American Academy of Family Physicians and the American College of Obstetricians and Gynecologists. The Adult Immunization Schedule was published in the MMWR and is available online
www.cdc.gov/mmwr/preview/mmwrhtml/mm5440-Immunizationa1.htm
JCAHO 2006 National Patient Safety Goals
May 31, 2005. The Joint Commission on Accreditation of Healthcare Organizations (JCAHO) announced the 2006 National Patient Safety Goals and related Requirements that will apply specifically to accredited hospitals and critical access hospitals. Major additions to this fourth annual issuance of National Patient Safety Goals, which were approved by the Joint Commission's Board of Commissioners, include a new Requirement that "hand-offs" of patients between caregivers be standardized, with particular attention to assuring the opportunity for asking and responding to questions. This Requirement is part of the Goal: "Improve the effectiveness of communication among caregivers." In addition, a new Requirement applicable to all types of accredited organizations which provide surgical or other invasive services, specifies that all medications, medication containers and other solutions used in perioperative settings are to be labeled. This Requirement is part of the Goal: "Improve the safety of using medications."
www.jcaho.org/accredited+organizations/patient+safety/06_npsg/06_npsg_cah_hap.htm
JCAHO 2006 National Patient Safety Goals and related Requirements that will apply specifically to accredited long term care facilities were also announced. Major additions include a new Requirement that "hand-offs" of residents between caregivers be standardized, with particular attention to assuring the opportunity for asking and responding to questions. This Requirement is part of the Goal: "Improve the effectiveness of communication among caregivers." In addition, a new Goal to "Prevent health care-associated pressure ulcers (decubitus ulcers)" has been adopted, and includes a specific Requirement that the long term care facility assess and periodically reassess each resident's risk for developing a pressure ulcer (decubitus ulcer) and take action to address any identified risks.
www.jcaho.org/accredited+organizations/patient+safety/06_npsg/06_npsg_ltc.htm
JCAHO 2006 National Patient Safety Goals and related Requirements that will apply specifically to accredited home care organizations can be found at
www.jcaho.org/accredited+organizations/patient+safety/06_npsg/06_npsg_ome.htm
(from JCAHO)
HIV Screening for Pregnant Women
The U.S. Preventive Services Task Force released new recommendations on HIV screening. The Task Force recommends that all pregnant women, not just those considered at high risk, be screened for the virus that causes AIDS because testing has proven so successful at helping prevent the spread of the disease to babies. In 1996, the Task Force found insufficient evidence that screening all pregnant women had any benefit. Scientific advances in treating HIV have changed that. In addition to its recommendations about pregnant women, the Task Force also reaffirmed its recommendation that adolescents and adults at increased risk for HIV be tested. The Task Force broadened its definition of high risk to include those getting care at homeless shelters or clinics specializing in the care of sexually transmitted diseases. The recommendations were published in the July 5, 2005 Annals of Internal Medicine. The recommendations are online at
http://www.ahrq.gov/clinic/uspstf/uspshivi.htm
Survey on Patient Safety Culture
The Agency for Healthcare Research and Quality (AHRQ) has sponsored the development of this survey on patient safety culture as part of its goal is to support a culture of safety and quality improvement in the Nation's health care system. This survey tool can be used to assess the safety culture of a hospital as a whole, or for specific units within hospitals, as well as to track changes in patient safety over time and evaluate the impact of patient safety interventions. The survey forms, User's Guide, and Feedback Report Template are available online.
http://www.ahrq.gov/qual/hospculture/
Review of Clinical Avian Influenza A (H5N1) Infection in Humans
On September 29, 2005, the New England Journal of Medicine published a review article on avian influenza A(H5N1) infection in humans by The Writing Committee of the World Health Organization (WHO) Consultation on Human Influenza A/H5. The article includes clinical features, management, and hospital infection control of human infection with influenza A (H5N1). It is important to note that many questions remain and, as more information about this disease is gathered, modifications to current recommendations will likely follow. (Avian Influenza A (H5N1) Infection in Humans, New England Journal of Medicine, September 19, 2005, Volume 353, Number 13, pages 1374-1385.)
Hurricane-Related Infectious Disease Risk Slides
David Weber has provided a new set of slides, Hurricane Related Infectious Disease Risks, posted on the SPICE web page.
http://www.unc.edu/depts/spice/Hurricane.ppt
COURSES FOR THE INFECTION CONTROL PROFESSIONAL
"Infection Control in Long-Term Care Facilities” will be held March 6-8, 2006 in Chapel Hill.
“Infection Control Part II: The ICP as an Environmentalist” will be held in Chapel Hill October 31-November 4, 2005.
“Infection Control Part I: Clinical Surveillance of Healthcare-Associated Infections” will be held in Chapel Hill May 8-12, 2006.
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 October 2005
Copyright 2005 Statewide Program for Infection Control and Epidemiology