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® ENGAGEMENT EVIDENCE EVIDENCE EDUCATION BIOTERRORISM AGENTS AND BARRIER PROTECTION EDUCATION EVIDENCE ENGAGEMENT EDUCATION A SELF STUDY GUIDE Registered Nurses Overview Ansell Healthcare Products LLC has an ongoing commitment to the development of quality hand barrier products and services for the healthcare industry. This self-study, Clinical Reference Manual: Bioterrorism Agents and Barrier Protection is one in a series of continuing educational services provided by Ansell. This educational module examines the history and evolution of bioterrorism, including an extensive review of the six primary biological agents and their respective clinical presentations, as well as prevention strategies and infection control measures and appropriate barrier protection for each of the agents. Program Objectives Bioterrorism Agents and Barrier Protection Upon completion of this educational activity, the learner should be able to: 1. Discuss the history of bioterrorism. 2. Discuss the disease caused by Bacillus anthracis, Anthrax. 3. Discuss the disease caused by Variola virus, Smallpox. 4. Discuss the disease caused by Clostridium botulinum, Botulism. 5. Discuss the disease caused by Francisella. 6. Discuss the diseases referred to as Hemorrhagic Fever Viruses. 7. Discuss the disease caused by Yersinia pestis, Plague. 8: Describe the characteristics of good barrier protection for the different gloving materials available. Intended Audience The information contained in this self-study guidebook is intended for use by healthcare professionals who are responsible for or involved in the following activities related to this topic: • Educating healthcare workers • Establishing institutional or departmental policies and procedures • Decision-making responsibilities for hand-barrier products • Maintaining regulatory compliance with agencies such as OSHA, ADA and CDC • Managing employee health and infection control services Instructions Ansell Healthcare is a provider approved by the California Board of Registered Nursing, Provider # CEP 15538 for 3 contact hour(s). Obtaining full credit for this offering depends on completion of the self-study materials online as directed below. This continuing education activity is approved for 3.75 CE credits by the Association of Surgical Technologists, Inc., for continuing education for the Certified Surgical Technologist and Certified Surgical First Assistant. This recognition does not imply that AST approves or endorses any product or products that are included in the presentation. Approval refers to recognition of educational activities only and does not imply endorsement of any product or company displayed in any form during the educational activity. To receive contact hours for this program, please go to the “Program Tests” area and complete the post-test. You will receive your certificate via email. AN 85% PASSING SCORE IS REQUIRED FOR SUCCESSFUL COMPLETION Allow 4 to 6 weeks for processing and issuance of a certificate. Any learner who does not successfully Any learner who does not successfully complete the post-test will be notified and given an opportunity to resubmit for certification. For more information about our educational programs or hand-barrier-related topics, please contact Ansell Healthcare Educational Services at 1-732-3452162 or e-mail us at [email protected]. Planning Committee Members: Lori Jensen, RN Pamela Werner, RN, BSN, CNOR, MBA The planning committee members declare that they have an affiliation and financial relationship as employees of Ansell Healthcare, which could be perceived as posing a potential conflict of interest with development of this self-study module. This module will include discussion of commercial products referenced in generic terms only. i Contents What is Bioterrorism?...............................................................................................1 History and Evolution of Bioterrorism.......................................................................1 Bacillus anthracis, Anthrax.......................................................................................3 Variola virus, Smallpox.............................................................................................5 Clostridium botulinum, Botulism..............................................................................8 Hemorrhagic Fever Viruses....................................................................................10 Francisella tularensis, Tularemia............................................................................13 Yersinia pestis, Plague ..........................................................................................15 Personal Protective Equipment...............................................................................17 Post-Test................................................................................................................20 Bibliography...........................................................................................................21 Notes................................................................................................................22–23 ii WHAT IS BIOTERRORISM? Bioterrorism is defined as the deliberate or threatened use of bacteria, viruses, or toxins to cause disease, death, disruption, or fear. The most likely large-scale attack of bioterrorism is expected to be an aerosolized agent. Any of the Category A diseases have the potential to be aerosolized: anthrax, smallpox, botulism, viral hemorrhagic fevers, tularemia, and plague. HISTORY AND EVOLUTION OF BIOTERRORISM Key bioterrorist events • Geneva Protocol signed to prohibit research and development of biological weapons. • United States offensive biological weapons program dismantled. • Biological and Toxin Weapons Convention signed. Bioterrorism is not a new phenomenon and has been used as a weapon for centuries. In 700 BC, the Assyrians poisoned the water wells of their enemies with the poison rye ergot. In the 1300s, during the siege of Kaffa (now in Ukraine), the Tartars catapulted plague-infected corpses over the walls of the city, which probably led to the Black Death plague epidemic that followed. It has been said that during Pizarro’s conquest of South America in the 1600s, he ensured his victory by giving the natives “gifts” of clothing that had been tainted with the smallpox virus. In 1763, during the French and Indian War and under the guise of friendship, Native Americans were given gifts of blankets that had been previously used by patients that died of the smallpox virus. In 1797, Napoleon attempted to force the surrender of Mantua by infecting the citizens with swamp fever. During the Civil War, Confederate troops left carcasses of dead animals, usually horses, in the Union soldiers’ source of drinking water. During World War II, allegations were made against the Germans for attempting to spread cholera in Italy and plague in Leningrad, and use biological bombs over Britain. Also, it was alleged that the Germans deployed anthrax against their enemies in both World Wars I and II. Other significant events in the history of bioterrorism include: 1925: The Geneva Protocol was signed. This document prohibited research and development of biological weapons, although history has proven that offensive biological programs continued despite the treaty. 1940: Japanese dropped plague, by planes, at Ninpo. 1969: President Nixon dismantled the United States offensive biological weapons program, although research related to defense against biological weapons continues to this day. Protection against Bioterrorism 1972: The Biological and Toxin Weapons Convention was signed and ratified by 140 nations. This agreement required termination of all offensive weapons research and destruction of existing stockpiles of agents. 1 1978: In London, an alleged KGB agent assassinated a Bulgarian exile using ricin toxin. 1984: To alter the outcome of a local election, Rajneesh cult members sprayed salmonella on salad bars in Oregon, causing more than 700 people to become ill. 1995: A sarin nerve agent attack aimed at subway passengers in Tokyo. 2001: Letters laden with anthrax were mailed to media, news organizations, and politicians. Bioterrorism Agents and Barrier Protection The threat of biologic weapons (BW) has increased over the last two decades with a number of countries working on offensive weapons (USAMRIID). Biological weapons have distinct advantages over traditional weapons. First, they can attack a very large area in a very short period of time using aerosolized biological agents. The detection of the biological release would most likely be delayed since these agents are odorless, colorless, and tasteless. Unless the terrorists call and announce the agent they released, the public will not be aware until victims become ill, which is usually days or weeks later. Using biological agents as weapons also has the advantage of a delayed recognition in the medical community. The diseases produced by biological agents all present with very similar symptoms in the beginning, usually non-specific flu-like symptoms that make early diagnosis difficult. Further, many physicians have not seen these diseases in their medical practice and have only read about them in medical textbooks. Another reason that the threat of using biological agents as weapons has increased is that biological weapons are very inexpensive to create. 2 At a cost of $2000 or more for conventional weapons, a $1 in biological weapons could produce similar results. (AORN 2004) While nuclear weapons production requires specific facilities, anthrax can be germinated in a basement laboratory. Also, the knowledge to produce and disseminate these agents is easily accessible through current technology, such as the Internet. Furthermore, at the end of the Cold War, many Russian scientists working in offensive biological programs lost their jobs. The whereabouts of these Soviet scientists is an unknown factor and the whereabouts of their products is unclear. Biological agents can be delivered in several different ways, including orally in food, and through water or air. Today, most experts predict the most likely method of biological attack would be a large-scale attack using an aerosolized agent that may or may not be contagious. Which biological agents would pose the greatest threat when used as a weapon? Potentially, thousands of agents could be used in a bioterrorism attack. However, the Centers for Disease Control (CDC) and the US Army Medical Research Institute of Infectious Diseases (USAMRIID) narrowed the list based on a number of criteria, including how easy it is to obtain and produce the agent, the agent’s stability in the environment, and whether the agent is contagious and/or lethal. Next, the CDC grouped the agents into three categories based on the likelihood of their use as a biological weapon. The categories are A, B, and C. The CDC identified the Category A agents as high priority agents that pose a risk to national security. Category A consists of six diseases: anthrax, smallpox, botulism, viral hemorrhagic fevers, tularemia, and plague. This study guide will review the six Category A diseases, providing a description, clinical manifestations, diagnosis, treatment, post-exposure prophylaxis, and infection control, including appropriate barrier protection. Bacillus anthracis, Anthrax DEFINITION Anthrax is caused by Bacillus anthracis, a gram-positive spore-forming bacterium, and is found in soil worldwide. Humans contract the disease from close contact with animals or animal products infected with the bacteria. Of the three routes of exposure – inhalation, cutaneous, and gastrointestinal – inhalational anthrax is the one that is of greatest concern as a bioweapon. (USAMRIID 2005) Inhaled spores typically germinate 1-6 days but there have been reports of illness up to 6 weeks after exposure in the mediastinal lymph nodes; therefore, the time period between exposure and onset of symptoms may be as long as several weeks. Scanning electron micrograph (SEM) of bacillus anthracis in lung tissue There are three forms of anthrax: Cutaneous Most common natural form. Mortality of 10% to 20% if untreated; less than 1% when treated. Inhalation Most lethal form, with mortality of 45% to 87% following inhalation of spores. Inhalation anthrax may be complicated by hemorrhagic meningitis in 50% of cases and GI hemorrhage in 80% of cases. Most likely form of the disease to occur in a bioterrorist event. Gastrointestinal Results from the ingestion of large numbers of vegetative bacilli from poorly cooked infected meat. Due to difficulty in early diagnosis, mortality is high. Clinical manifestations of the three forms of Anthrax INCUBATION PERIOD EARLY SIGNS/SYMPTOMS Inhalational (primary involvement is the mediastinum) 1-6 up to 40 days. Non-specific febrile syndrome including fever, malaise, headache, fatigue and drenching sweats. Abrupt development of severe respiratory distress with dyspnea, stridor, cyanosis, septicemia, shock and death. Cutaneous 1-2 days. Small papular or vesicular rash that may be pruritic. Same as above. Gastrointestinal 1-6 days. Fever, focal abdominal pain, vomiting. Hematemisis. ANTHRAX LATER SIGNS/SYMPTOMS 3 TREATMENT Treatment consists of hospitalization, intravenous antibiotics, and intensive supportive care. Antibiotic treatment should be administered as soon as the diagnosis is suspected. Early initiation can reduce mortality, which approaches 100% when treatment is delayed. POST-EXPOSURE PROPHYLAXIS Anthrax lesion on the skin caused by the bacterium Bacillus anthracis DIAGNOSIS Bioterrorism Agents and Barrier Protection Rapid field tests results have uncertain sensitivity and specificity for inhalation anthrax, but a widened mediastinum with or without infiltrates on chest x-ray is highly suggestive in a young or otherwise healthy person with the typical presentation. Bloody pleural effusions are also common. Basic diagnostic testing should include gram stain and culture of blood, which can be obtained following your facility’s standard routine. Confirmatory tests must be performed by special reference laboratory in the Laboratory Response Network (LRN) (JAMA 2002). The state laboratory needs to be notified ahead of time that anthrax is a possibility. The local health department will investigate and give directions on how to obtain and send the cultures. B. anthracis can be cultured from the lesion for laboratory confirmation in the cutaneous form. The local health department will need to be notified and provide directions to obtain and send these cultures. 4 Antibiotics should be administered to all persons that have been exposed or potentially exposed to the release of anthrax before symptoms have occurred. Patient contacts (family, friends, and healthcare workers) who were not originally exposed to the release do not require prophylaxis. VACCINATION The Department of Defense (DoD) and the Department of Health and Human Services have purchased a stockpile of vaccine doses. Vaccination is currently required for most military deployed to Iraq, Afghanistan and S. Korea. It is not currently being used on the general public. Researchers continue to develop and test new Anthrax vaccine(s) (USAMRIID 2005). INFECTION CONTROL All precautions are utilized to decrease the spread of recognized and unrecognized infection and to prevent exposure to all bodily fluids. Standard Precautions – Is recommended for all forms of B. Anthrax 1.Handwashing Wash hands immediately after gloves are removed, between patient contacts, and when otherwise indicated to avoid transfer of microorganisms to other patients or environments. Hand wash with soap and water or 2% CHG after spore contact. (Weber 2003) • Gowns should be worn when entering the room if it is anticipated that clothing will have contact with the patient, environmental surfaces, or items in the room. The gown should be removed before leaving the patient’s room. • Patient transport should be limited to essential purposes only. • Noncritical patient-care equipment should be dedicated whenever possible. Variola Virus, Smallpox DEFINITION Gloves should be worn as standard procedure when handling contaminated items 2.Gloves Wear gloves when touching blood, bodily fluids, secretions, excretions, and contaminated items; put on clean gloves just before touching mucous membranes and nonintact skin. Change gloves between tasks and procedures on the same patient after contact with material that may contain a high concentration of microorganisms. Remove gloves promptly after use, before touching noncontaminated items and environmental surfaces, and before going to another patient. Wash hands immediately to avoid transfer of microorganisms to other patients or environments. 3.Masks, Eye Protection, Face Shields Wear a standard surgical mask and eye protection or a face shield to protect mucous membranes of the eyes, nose, and mouth during procedures and activities that are likely to generate splashes or sprays. Transmission Based Precautions Several sources recommend contact precautions for cutaneous anthrax for persons with draining lesions. Contact Precautions • Place patient in a private room. • Gloves should be worn when entering the room and removed before leaving the room. Hands should be washed with an antimicrobial agent or soap and water with spore contact. Smallpox is the most devastating infectious disease in the history of mankind. This “ancient scourge” threatened 60% of the world population even in 1967 when World Health Organization (WHO) launched an intensified plan to eradicate smallpox. (AORN 2004) The variola virus that emerged in human populations dates back to the 12th Century BC. Literature dating from approximately 3700 BC in Egypt and 1100 BC in China suggests that the original sources of smallpox were in Asia and Africa. There is evidence that a major smallpox epidemic occurred at the end of the eighteenth Egyptian dynasty. Research from the mummy of Pharaoh Ramses V, who died in 1157 BC, indicates that he most likely died of smallpox. From ancient Egypt, traders spread the disease to India, and then to Europe during the Middle Ages. Spanish colonists brought smallpox to the United States in the fifteenth and sixteenth centuries. After an extensive and successful eradication program, WHO declared Endemic smallpox eradicated in 1980. There was a suspected report of smallpox in NYC in 2002, (cnn.com) Successful efforts to prevent the spread of smallpox through vaccination changed the course of history of Western medicine. Most people think that since smallpox was eradicated, it is no longer a threat. 5 Variola Minor This is a much less severe and less common form of smallpox, with death rates of 1% or less. CLINICAL MANIFESTATIONS OF SMALLPOX Bioterrorism Agents and Barrier Protection Transmission electron micrograph (TEM) of the smallpox virus However, when smallpox was eradicated, two samples were maintained for research purposes. These samples were kept at the CDC and in a research facility in Russia. The potential for secret stockpiles to exist outside these facilities continues to be an unknown factor. In the aftermath of the events of September and October 2001, there is heightened concern that the variola virus might be used as a bioterrorism agent. (USAMRIID) Variola Major Is a severe and more common form of smallpox, with a more extensive rash and higher fever. The fatality rate is around 30%. There are four types of variola major smallpox: 1. Ordinary: the most frequent form, accounting for 90% of all cases. 2. Modified: a mild form occurring in persons previously vaccinated for smallpox. 3. Malignant/ Flat: Characterized by lesions that do not develop to the pustular stage. 4. Hemorrhagic: a very rare and very fatal form. 6 Exposure to the virus is followed by an incubation period during which people do not have any symptoms, may feel fine and do not shed the virus. The incubation period averages about 12 to 14 days, with a range from 7 to 17 days. During this time people are not contagious and cannot spread the virus to others. Typically, a two-stage illness will follow. First is the Prodrome stage, lasting from 2 to 4 days. During this stage, the person will present with “flu-like” symptoms including fever, malaise, head and body aches, and sometimes vomiting. The fever is usually high, in the range of 101° to 104° Fahrenheit. During this stage the person may be contagious. Two to three days later the affected person moves to the eruptive stage. The smallpox rash is very characteristic. The rash emerges first as small red spots on the tongue and in the mouth. These spots develop into sores that break open and spread large amounts of the virus into the mouth and throat. At this time, a rash will also appear on the skin starting on the face hands and forearms. The rash will usually spread to all parts of the body within 24 hours. The fever usually breaks as the skin rash appears and the patient may feel better. Around the third day of the skin rash, the rash becomes raised bumps. By the fourth day, the bumps fill with thick, opaque fluid and have a depression in the center that looks like a belly button (this is a major distinguishing characteristic of smallpox). DIAGNOSIS Smallpox is most frequently misdiagnosed as varicella, or chickenpox, which is caused by the herpes virus. The most effective criteria for distinguishing the two infections is an examination of the following characteristics of the lesions: The eruptive stage of smallpox Fever will rise again and stay high until scabs form over the bumps. The bumps will become pustules that are raised, round, and firm to the touch. The pustules then begin to form a crust and then scab over. The pustules and scab portion takes approximately 5 days, and the person remains very contagious during this time. At this time the scabs begin to fall off, leaving pitted scars. This takes another 6 to 7 days, and the person remains contagious. About 3 weeks after the rash first appeared, the scabs fall off and the person is no longer contagious. TRANSMISSION Person-to-person transmission of smallpox occurs through aerosol droplets expelled from the oropharynx of infected persons, or by direct contact with an infected person. It is the highest after face-to-face contact with a patient after developing fever and during the first week of the rash. The virus can also be spread through contaminated bedding and clothing, and through direct contact with infected bodily fluids. It is not known to be transmitted by insects or animals. Time and Pattern of Appearance The most obvious distinction between smallpox and chickenpox is the manner in which the skin lesions appear. In chickenpox, the lesions occur in successive “crops.” It is possible to determine several different stages of lesion maturation and development at the same time. In smallpox, the lesions appear simultaneously. All lesions have the same maturation. Density and Location Chickenpox lesions tend to be denser over the trunk, while smallpox lesions are denser on the face and extremities. Smallpox is almost always seen on the palms and soles of the feet, which is unusual for chickenpox. Smallpox can be confirmed in the laboratory by electron microscopic examination of vesicular or pustule liquid or scabs. Definitive laboratory identification and characterization involves growth of the virus in the cell culture, and characterization of strains by use of biologic assays, including polymerase chain reaction, restriction fragment-length polymorphism analysis, and EnzymeLinked Immunoabsorbent Assay (ELISA). Culture for smallpox is available only at the LRN National Labs, at the CDC and USAMRIID and are performed under BLS-4 conditions. Notification of the local and state health departments is necessary. 7 TREATMENT Currently, there are no known effective antivirals. Provide the patient supportive care and antibiotics for secondary infections. The discovery of a single suspected case of smallpox must be treated as an international health emergency and immediately brought to the attention of national officials through local and state health authorities. POST-EXPOSURE PROPHYLAXIS Bioterrorism Agents and Barrier Protection All contacts must be vaccinated within 3 to 5 days. Contacts include all household members, patients, staff, and visitors to the hospital at the same time as the smallpox case.7 Monitor all patient contacts for 17 days, and if one of the contacts starts showing signs of a fever, they should be isolated as soon as possible. Patients become infectious the day before the rash, so conduct a thorough history of all contacts the day before they broke out, and monitor all of those contacts. INFECTION CONTROL Patient(s) should be isolated and all precautions used until all scabs separate. Standard Precautions 1.Handwashing Wash hands immediately after gloves are removed, between patient contacts, and when otherwise indicated to avoid transfer of microorganisms to other patients or environments. 2.Gloves Wear gloves when touching blood, bodily fluids, secretions, excretions, and contaminated items. Put on clean gloves just before touching mucous membranes and nonintact skin. Change gloves between tasks and procedures on the same patient after contact with material that may contain a high concentration of microorganisms. Remove gloves promptly after use, before touching 8 noncontaminated items and environmental surfaces, and before going to another patient, and wash hands immediately to avoid transfer of microorganisms to other patients or environments. 3.Masks, Eye Protection, Face Shields Wear a standard surgical mask and eye protection or a face shield to protect mucous membranes of the eyes, nose, and mouth during procedures and activities that are likely to generate splashes or sprays. Transmission Based Precautions Airborne Precautions • Place patient in a single occupancy, Airborne Infection Isolation Room (AIIR) (formally – Negative Pressure Isolation Room) • For mass exposure contain those exposed in a designated area and utilize barrier precautions. • Use external air exhaust or high efficiency particulate air filters if the air is recirculated. (CDC 2007) Contact Precautions • Place patient in a private room. • Gloves should be worn when entering the room and removed before leaving the room. Hands should be washed with an antimicrobial agent or a waterless handwashing agent immediately after removing gloves. • Gowns should be worn when entering the room if it is anticipated that clothing will have contact with the patient, environmental surfaces, or items in the room. The gown should be removed before leaving the patient’s room. • Patient transport should be limited to essential purposes only. • Noncritical patient-care equipment should be dedicated whenever possible. Clostridium botulinum, Botulism DEFINITION Botulism is a rare but serious paralytic illness caused by a nerve toxin produced by the bacterium Clostridium botulinum, the most potent neuro toxin known to humans. There are seven (7) neurotoxins produced by this spore-forming bacillus. The toxins, A through G, are the most potent neurotoxins known. There are three (3) main types of botulism that effect humans: foodborne, infant and wound. In the US an average of 145 cases a year are reported: • Foodborne - 15% • Infant botulism - 65% • Wound - 20% (CDC posted 2009) It is possible that the aerosolized form of botulism could be used as a biological weapon. The paralytic symptoms would appear after inhalation or the contamination of food or water supplies. (USAMRIID) The clinical manifestations are similar for each of the botulism routes and are dependent on the route of exposure and dose received. DIAGNOSIS The patient’s clinical history and physical examination can be an indicator of botulism, patient(s) seeking medical services that exhibit progressive symmetrical descending flaccid paralysis strongly suggests botulism. The most sensitive testing for botulism is mouse neutralization (bioassay) of the patient serum. Botulism bacteria, 80x on 35mm film TREATMENT Treatment consists of mechanical ventilation support if necessary and supportive care. Respiratory failure due to paralysis is the most serious concern and is usually the cause of death. Antitoxin is available, and is particularly effective in foodborne cases. Early administration of antitoxin can neutralize the circulating toxins in the body. This can prevent patients from worsening, but recovery still takes many weeks. PROPHYLAXIS A toxiod of C. Botulism for types A, B, C, D & E is available under Investigational New Drug (IND) therapy only. The vaccine has several contraindications due to hypersensitivities inherent in its production. Clinical manifestationS of BOTULISM BOTULISM Botulism (all forms) INCUBATION PERIOD 12-36 hours, longer if exposed to low doses of toxin EARLY SIGNS/SYMPTOMS Generally no fever. Symmetric cranial neuropathies, such as drooping eyelids, difficulty swallowing or speaking. Mental status generally alert. LATER SIGNS/SYMPTOMS Symmetric descending weakness — generalized weakness and progressive to respiratory failure Sensory exam generally normal. Blurred vision. 9 INFECTION CONTROL Standard precautions are adequate for HCW as B. Toxin is not dermally active and secondary aerosols are not a hazard (USADRIIM). Standard Precautions 1. Handwashing Wash hands immediately after gloves are removed, between patient contacts, and when otherwise indicated to avoid transfer of microorganisms to other patients or environments. Bioterrorism Agents and Barrier Protection 2. Gloves Wear gloves when touching blood, bodily fluids, secretions, excretions, and contaminated items; put on clean gloves just before touching mucous membranes and nonintact skin. Change gloves between tasks and procedures on the same patient after contact with material that may contain a high concentration of microorganisms. Remove gloves promptly after use, before touching noncontaminated items and environmental surfaces, and before going to another patient, and wash hands immediately to avoid transfer of microorganisms to other patients or environments. 3. Masks, Eye Protection, Face Shields Wear a standard surgical mask and eye protection or a face shield to protect mucous membranes of the eyes, nose, and mouth during procedures and activities that are likely to generate splashes or sprays. hemorrhagic fever viruses DEFINITION Viral hemorrhagic fevers (VHFs) refer to a group of illnesses that are caused by several distinct families of viruses. These viruses occur in different endemic locations. Their transmission if from 10 rodent reservoir, dust contaminated excreta, ticks, body fluid or contaminated meats of infected animals and mosquito borne. Each disease causes a febrile syndrome characterized by hemorrhagic complications, but mortality rates, incubation periods, and susceptibility to antiviral therapy vary depending on the etiologic agent. While some types of hemorrhagic fever can cause relatively mild illnesses, many of these viruses cause severe, life-threatening disease. These organisms pose a biological threat due to their potential to cause severe morbidity. Except for dengue virus, all the VHFs are laboratory infectious by aerosol. The four (4) viral family of viruses considered dangerous due to their potential for weaponization by aerosol are: Arenaviridae • Lassa Fever • Argentine, Bolovian, Venezuelan VHF Caused by Tuninvirus, Machupo, Guanarito and Sabia viruses Bunyaviridae • Hanta virus genus • Congo Crimean VHF (Nairovirus genus) • Rift Valley Fever virus (Phlebovirus genus) Filoviridae • Ebola • Marburg Flaviviridae • Dengue • Yellow DIAGNOSIS Definitive diagnosis requires the resources found at reference laboratories that have biocontainment capability. Patients presenting with an acute febrile illness and indications of vascular involvement, especially if a detailed history includes travel to an endemic area should have VHF as a presumptive diagnosis. Notification of the local health department POST-EXPOSURE PROPHYLAXIS is necessary. For decisions regarding There is no post-exposure prophylaxis obtaining and processing diagnostic currently available for VHFs. There is specimens, contact local, state, and a licensed live attenuated yellow fever regional laboratory authorities or the CDC. vaccine and presently no other VHF agents available for use in USA. (USAMRIID) TREATMENT Patients receive supportive therapy INFECTION PREVENTION because there is no established cure for Patients with VHF have large quantities VHFs. Ribavirin, an antiviral drug, has been of infectious viruses in their blood and effective in treating some individuals with body fluids and secretions. Extreme care Lassa fever. Treatment with convalescent- should be taken to avoid sharps injuries. phase plasma has been used with success Strict adherence to all infection control for some VHFs. precautions, in addition to increased barrier Comparison of VHF agents & diseases (USAMRIID) Characteristic features Countermeasures No Often biphasic, severe second phase with bleeding, very high bilirubin and transaminases, jaundice, renal failure 17-D live attenuated vaccine very effective in prevention, no postexposure countermeasure available 3-5% No Flu-like syndrome with addition of cough, GI symptoms, hemorrhage, bradycardia Formalin - inactivated vaccine available in India Siberia 0.2-3% No Frequent sequelae of hearing loss, neuropsych complaints, alopecia TBE vaccines (not avail. in US) may offer some cross-protection Ebola hemorrhagic fever Africa, Phillipines (Ebola Reston) 50-90% for Sudan/Zaire Common Severe illness, maculopapular rash, profuse bleeding and DIC Anecdotal success with immune serum transfusion Marburg virus Marburg hemorrhagic fever Africa 23-70% Yes CCHF CrimeanCongo hemorrhagic fever Africa, SE Europe, Central Asia, India 30% Yes Often prominent petechial/ecchymotic rash Anectotal success with Ribavirin No Hemorrhagic disease rare, classically associated with retinitis and encephalitis. Significant threat to livestock - epidemics of abortion and death of young Human killed vaccine DOD IND, live attenuated vaccine in clinical trials Effective locally produced vaccines in Asia (not avail in U.S.). Experimental vaccine at USAMRIID. Ribavirin effective in randomized, controlled clinical trial Disease Endemic Area Mortality Yellow fever virus Yellow fever Africa, South America Overall 3-12%, 20-50% if severe second phase develops KFD virus Kyasanur Forest Disease Southern India OHF virus OMSK hemorrhagic fever Ebola virus Virus Flavivirus Filoviruses RVF Rift Valley fever Africa <0.5% Hantavirus (Hantaan, Dobrava, Seoul, Puumala) Hemorrhagic fever with renal syndrome (HFRS) Europe, Asia, South America (rare) 5% for Asian HFRS No Prominent renal disease, marked polyuric phase during recovery, usually elevated WBC Lassa virus Lassa fever West Africa 1-2% Yes Frequent inapparent/ mild infection, hearing loss in convalescence common Ribavirin effective in clinical trial with nonrandomized controls Junin Argentine hemorrhagic fever Argentinean pampas 30% Rare Prominent GI complaints, late neurologic syndrome Immune plasma, Ribavirin effective Candid 1 vaccine Machupo Bolivian hemorrhagic Bolivia 25-35% Rare Similar to AHF Protective but not avail. in U.S. Immune plasma effective, Ribavirin probably effective, Candid 1 vaccine protects monkeys Bunyaviruses Arenaviruses Nosocomial transmission 11 precautions as suggested by USAMRIID, should be taken when VHFs are suspected. Additional measures may include: • AIIR with 6-12 air exchanges • All entering room should wear: – Double gloves – Impermeable gowns – Leg and shoe coverings – Eye protection – N-95 (HEPA) mask or positive pressure air-purifying respirators (PAPR’s) • Access restricted to necessary caregivers Bioterrorism Agents and Barrier Protection Person-to-person spread of VHF is via direct contact with body fluids, cadavers, and symptomatic patients. Inadequate use of infection precaution methods also can be the cause of spread. All precautions should be employed INFECTION CONTROL Appropriate isolation precautions for patients with suspected or confirmed VHF include a combination of airborne, contact, droplet, and standard precautions. Although airborne transmission of these agents appears to be rare, airborne transmission theoretically may occur; therefore, airborne precautions should be instituted for all patients with suspected VHF. TRANSMISSION BASED PRECAUTIONS Airborne Precautions • Place the patient in a private room with AIIR. • Use external air exhaust or high-efficiency particulate air filters if the air is recirculated. • Keep the door to the room closed. • N-95 respirator. Contact Precautions • Place patient in a private room. • Gloves should be worn when entering the room and removed before leaving 12 the room. Hands should be washed with an antimicrobial agent or a waterless handwashing agent immediately after removing gloves. • Gowns should be worn when entering the room if it is anticipated that clothing will have contact with the patient, environmental surfaces, or items in the room. The gown should be removed before leaving the patient’s room. • Patient transport should be limited to essential purposes only. • Noncritical patient-care equipment should be dedicated whenever possible. Droplet Precautions • Place the patient in a private room or in a room with other patients who have the same infection. • When a private room and like infection patients are unavailable, spatial separation of a least three feet should be maintained. • Healthcare workers should wear a standard surgical mask when working within three feet of the patient. Standard Precautions 1. Handwashing Wash hands immediately after gloves are removed, between patient contacts, and when otherwise indicated to avoid transfer of microorganisms to other patients or environments. 2. Gloves Wear gloves when touching blood, bodily fluids, secretions, excretions, and contaminated items; put on clean gloves just before touching mucous membranes and nonintact skin. Change gloves between tasks and procedures on the same patient after contact with material that may contain a high concentration of microorganisms. Remove gloves promptly after use, before touching noncontaminated items and environmental surfaces, and before going to another patient, and wash hands immediately to avoid transfer of microorganisms to other patients or environments. 3. Masks, Eye Protection, Face Shields Wear a standard surgical mask and eye protection or a face shield to protect mucous membranes of the eyes, nose, and mouth during procedures and activities that are likely to generate splashes or sprays. Place all persons who have had close or high-risk contact with a patient suspected of having VHF during the 21 days following onset of symptoms under medical surveillance. If multiple patients with suspected VHF are admitted to one healthcare facility, group them in the same part of the hospital to minimize exposure to other patients and healthcare workers. Francisella tularensis, Tularemia DEFINITION Tularemia is an acute onset infectious disease caused by Francisella tularensis. There are several forms of the disease; Typhoidal tularemia with pneumonia, and rarely ulceroglandular or oculoglandular forms of the disease, as well as others. The natural occurring form of the disease may present in infected animals and is transmitted by bites of infected ticks, deerflies or mosquitos. Inhaling or ingesting, as may be delivered by dry aerosol or sprayed over food and water sources as a potential BW may cause the disease. The potential use of this Category A agent is of grave concern because it Tularemia is commonly transmitted through tick bites can be extremely virulent at low doses. Inhalation of, as low as 10 colony-forming units can cause disease. Tularemia occurs throughout much of North America, Europe, and Asia. It is resistant for months in cold temperatures below freezing. Clinical manifestations of Tularemia Tularemia is mostly a disease of rural exposure due to its animal hosts. Persons that hunt and farm are more likely to be exposed to naturally occurring disease. Most cases occur June to September. Winter cases occur among hunters and trappers when they handle infected animal hides and carcasses. Cases occurring in urban areas or in those with no risk factors should alert Clinical manifestationS of TULAREMIA TULAREMIA Pneumonic tularemia INCUBATION PERIOD 3-5 days; can range from 1-14 days. EARLY SIGNS/SYMPTOMS Abrupt onset, fever, headache, chills, rigors, body aches, sore throat, dry cough, dyspnea, tachypnea, pleuritic pain, or hemoptysis. LATER SIGNS/SYMPTOMS Illness may be rapidly progressive and severe or may be indolent with progressive weakness and weight loss over several weeks to months. The progression of pneumonia tends to be slower than that of pneumonic plague. If untreated, can progress to respiratory failure, meningitis, sepsis, shock, and death. 13 TREATMENT The disease can be fatal if not treated with the right antibiotics. Administration of parenteral antibiotics. POST-EXPOSURE PROPHYLAXIS Bioterrorism Agents and Barrier Protection Post-exposure prophylaxis with antibiotics should be initiated following confirmed or suspected bioterrorism exposure, and for post-exposure management of healthcare workers and others who had unprotected face-to-face contact with symptomatic patients. There is an investigational live attenuated vaccine. Research to find and evaluate new and better vaccine is on going. INFECTION CONTROL Wearing gloves is an effective precaution against infection healthcare personnel to the possibility of a biological attack. Treatment of tularemia is critical to avoid progression to respiratory failure; meningitis; kidney, spleen, or liver involvement; sepsis; shock; and death. DIAGNOSIS There is no rapid diagnostic testing available for tularemia. F. tularensis may be diagnosed through recovery of organisms in culture from blood, ulcers, conjunctival exudates, sputum, gastric washings and throat swabs. It requires the use the use of special diagnostic and safety procedures. Results can be read out in several hours if the designated reference laboratory in the National PH Laboratory Network is notified and receives the appropriate collected specimens. Notify local health department. Person-to-person transmission of tularemia has not been documented; therefore, standard precautions would be appropriate for patients with tularemia. Standard Precautions 1. Handwashing Wash hands immediately after gloves are removed, between patient contacts, and when otherwise indicated to avoid transfer of microorganisms to other patients or environments. 2. Gloves Wear gloves when touching blood, bodily fluids, secretions, excretions, and contaminated items; put on clean gloves just before touching mucous membranes and nonintact skin. Change gloves between tasks and procedures on the same patient after contact with material that may contain a high concentration of microorganisms. Remove gloves promptly after use, before touching noncontaminated items and environmental surfaces, and before going to another patient, and wash hands immediately to avoid transfer of microorganisms to other patients or environments. 3. Masks, Eye Protection, Face Shields Wear a standard surgical mask and eye 14 Yersinia pestis bubonic plague x250 protection or a face shield to protect mucous membranes of the eyes, nose, and mouth during procedures and activities that are likely to generate splashes or sprays YersiniA pestis, Plague DEFINITION Plague is a disease caused by Yersinia pestis, a bacterium found in rodents and their fleas in many areas around the world. Under natural conditions, plague is transmitted to humans via rodent fleas infected with the bacterium, although humans can also contract it by direct contact with infected animal body tissues or by inhaling infected droplets. There are three (3) forms of plague that may affect humans: • Bubonic • Septicemic • Primary pneumonic (USAMRIID 2005) Y. Pestis is contagious in the pneumonic form of the disease which makes it an ideal form for use as a biological weapon. The mortality for untreated pneumonic plague approaches 100%. The organism incubates for up to six (6) days and is dose dependent. Onset of primary pneumonic plague is acute and fulminent. See chart below for specifics. Pneumonic plague can be readily spread person-to-person. Most of the secondary cases are to home caregivers (80%), medical professionals (14%), and persons in close contact up to six (6) feet. Clinical manifestations of PLAGUE Pneumonic plague will infect the lungs as a result of inhalation of the organisms (primary pneumonic) or spread there due to septicemic (secondary pneumonic) plague. DIAGNOSIS From an epidemiological perspective the arrival of an increasing number of patients with rapidly progressing pneumonia accompanied by bloody sputum should create a high degree of suspicion. This would be the manifestation of the intentional release of pneumonic plague. A delay in diagnosis and treatment is associated with high fatality rates. There are no readily available rapid tests to detect plague. Definitive diagnosis is made by culture from clinical specimen. Clinical manifestationS of PLAGUE PLAGUE INCUBATION PERIOD EARLY SIGNS/SYMPTOMS LATER SIGNS/SYMPTOMS Pneumonic plague 1-6 days, dose dependent. High fever, chills, HA, malaise, myalgias. Increasing dyspnea, stridor, cyanosis, rapidly progressive respiratory failure, circulatory collapse. Bubonic 2-8 days. Acute and fulminant onset of non-specific symptoms. Characteristic Bubo. 15 Bioterrorism Agents and Barrier Protection Select a strong, comfortable medical glove related to the procedure or task at hand Report the possibility of plague to the local health department. Other tests need to be coordinated through the local health department. TREATMENT Although early treatment is important, plague is not believed to be as contagious as once thought. Persons transmit the plague infection most at the end stage of the disease. Parenteral antibiotics, given early, in the first 20-24 hours, clears the sputum of the plague bacillus. (CDC) POST-EXPOSURE PROPHYLAXIS Those individuals with face-to-face contact (within 6 ft) to person or persons with pneumonic plague or exposed to the aerosol of a potential BW attack should receive antibiotic prophylaxis for 7 days. No vaccine is currently available for plague. Research is ongoing to develop new and improved plague vaccines, particularly in light of the current bioterrorist threat and concerns about intentional dissemination of aerosolized plague organisms. INFECTION CONTROL Droplet precautions, a transmission based technique, in addition to Standard Precautions should be implemented until affected patients have been on the appropriate antibiotic of 48 hours. A biohazard clean suit is an example of personal protective equipment 16 Droplet Precautions •Place the patient in a private room or in a room with other patients who have the same infection. Special air handling capabilities is not required. •When a private room and like infection patients are unavailable, spatial separation of a least three feet should be maintained. •Healthcare workers should wear a standard surgical mask when working within three feet of the patient. A mask is to be donned prior to entering the patient room. Standard Precautions 1. Handwashing Wash hands immediately after gloves are removed, between patient contacts, and when otherwise indicated to avoid transfer of microorganisms to other patients or environments. 2. Gloves Wear gloves when touching blood, bodily fluids, secretions, excretions, and contaminated items. Put on clean gloves just before touching mucous membranes and nonintact skin. Change gloves between tasks and procedures on the same patient after contact with material that may contain a high concentration of microorganisms. Remove gloves promptly after use, before touching noncontaminated items and environmental surfaces, and before going to another patient. Wash hands immediately to avoid transfer of microorganisms to other patients or environments. 3. Masks, Eye Protection, Face Shields Wear a standard surgical mask and eye protection or a face shield to protect mucous membranes of the eyes, nose, and mouth during procedures and activities that are likely to generate splashes or sprays. In all forms of plague, avoid surgery, autopsy, or any other procedure that could cause aerosolization. If it is absolutely necessary to perform these procedures, wear an N-95 mask and perform the procedure in a negative pressure room. Personal Protective Equipment (PPE) DEFINITION Informed use of PPE is a critical component of a hospital’s infection prevention and bioterrorism response program. Where there is likelihood of contact with potentially infectious material, appropriate PPE includes gloves, gowns, laboratory coats, face shields, masks, eye protection, and ventilation devices. PPE refers to a variety of barriers and/or respirators to protect mucus membranes, airways, skin , and clothing from contact with infectious agents. Medical Gloves When selecting a medical glove, an important consideration should be the barrier requirement related to the procedure or task at hand. Be aware of the level of exposure risk that the patientcare activities will require. Procedures that involve exposure to blood, bodily fluids, and other potentially infectious material require a glove that provides appropriate barrier protection. Latex MEDICAL GLOVES Natural rubber latex (NRL), commonly referred to as “latex”, remains the gold standard for hand barrier protection due to its strength, proven barrier protection, elasticity, fit, feel, comfort, and relatively low cost. With the availability of lowprotein, powder-free gloves, many clinicians are confidently continuing to wear gloves made of latex. Latex gloves 17 are recommended as the first choice for barrier protection in the healthcare environment, except for wearers who are allergic to latex proteins. In the event of bioterrorist activity, clinical personnel can have confidence in the barrier properties of the latex glove to protect them. Doublegloving in a bioterrorist event is also recommended. Latex is available in both surgical and examination gloves. Latex-Free Medical Gloves Bioterrorism Agents and Barrier Protection For healthcare workers allergic to latex, the preferred recommendation as an alternative for medical examination gloves would be a latex-free material of nitrile or neoprene, and a latex-free material of neoprene or polyisoprene for surgical gloves. In independent testing for barrier properties, studies showed that nitrile, neoprene, and latex gloves are comparable in barrier properties during in-use performance testing. Nitrile Nitrile is a petroleum-based, cross-linked film. It is extremely strong with puncture resistance superior to all glove films. Nitrile’s elasticity is very good and the gloves tend to conform to the shape of the wearer’s hands, providing good comfort and fit. There are no latex proteins in nitrile; therefore, there is no chance of latex allergy with use. Nitrile exhibits excellent chemical resistance and is recommended as a preferred alternative to latex for a bioterrorist event. Nitrile is available in examination gloves. Neoprene (Polychloroprene) Neoprene is a petroleum-based crosslinked film that provides a similar fit, feel, and barrier protection to latex. Neoprene contains no latex proteins, and is available without chemical accelerators, making it a great choice for those with Type IV chemical allergy. It is a strong material, with good resistance to many chemicals, and provides great comfort. Neoprene’s elasticity is close to that of latex with very high memory. The film is able to retain its 18 original shape and is somewhat puncture resistant. Neoprene is available in both surgical and examination gloves. Polyisoprene Polyisoprene is a petroleum-based, crosslinked film. Polyisoprene provides high strength, elasticity, and comfort. It contains no latex proteins, but contains some curing agents that can cause allergic reactions. Polyisoprene is durable and is somewhat puncture resistant. Polyisoprene provides good barrier protection but is more permeable than latex, and is recommended as a preferred alternative to latex in a bioterrorist event if nitrile or neoprene are not available. Polyisoprene is available in surgical gloves. Polyvinyl Chloride (PVC) Many hospitals provide a latex-free material called Polyvinyl chloride (PVC), commonly known as “vinyl”, as a choice for exam gloves. PVC is a petroleumbased film, but it is not molecularly crosslinked. Because it lacks cross-linking, the individual molecules of vinyl tend to separate when the film is stretched or flexed. This causes small holes and breaches to form during glove donning and normal use. Repeated studies have demonstrated that vinyl gloves have higher failure rates when tested in simulated and actual conditions. (CDC 2007) Vinyl is the weakest of the glove films, with poor elasticity, memory and fit. In 2007 the CDC released the Guideline for Isolation Precautions: Preventing Transmission of Infectious Agents in Healthcare Settings. This document also emphasized the poor barrier properties of vinyl gloves. It reads, “While there is little difference in the barrier properties of unused intact gloves, studies have shown repeatedly that vinyl gloves have higher failure rates than latex or nitrile gloves when tested under simulated and actual clinical conditions.” For this reason either latex or nitrile gloves are preferable for clinical procedures that require manual dexterity and/or will involve more than brief patient contact. Because of these poor physical properties, vinyl would not be an acceptable choice to use when handling the diseases caused by biological agents. Polyvinyl chloride is only available in examination gloves. Selecting a Glove That is Right For You Glove selection is serious business. The two primary considerations should be barrier protection and allergen content. If a glove does not provide an intact barrier, it is not doing its job. To maximize barrier effectiveness, you may wish to choose a glove manufacturer that is reliable and experienced, to ensure that your gloves will be of consistent quality and regularly available. Conclusion “Biological weapons are widely available,” states former FL Governor and US Senator Bob Graham, and “The number of people who can manipulate pathogens has increased.” The healthcare community is on the forefront of access, preparedness and recognition. We need to keep our skills and knowledge current to be able to service our communities. Local Law Enforcement Authorities * Local or County Health Department * State Health Department * CDC Emergency Response Hotline: CDC Bioterrorism Preparedness & Response Program: CDC Emergency Preparedness Resources: Strategic National Stockpile: FBI (general point of contact): FBI (suspicious package info): USAMRIID General Information: USAMRICD Training Materials: U.S. Army Medical NBC Defense Information: Johns Hopkins Center for Civilian Biodefense: Infectious Diseases Society of America: Epidemiologic Clues of a BW or terrorist attack • The presence of a large epidemic with a similar disease or syndrome, especially in a discrete population • Many cases of unexplained diseases or deaths • More severe disease than is usually expected for a specific pathogen or failure to respond to therapy • Unusual routes of exposure for a pathogen, such as the inhalational route for diseases that normally occur through other exposures • A disease that is unusual for a given geographic area or transmission season • Disease normally transmitted by a vector that is not present in the local area • Multiple simultaneous or serial epidemics of different diseases in the same population • A single case of disease be an uncommon agent (smallpox, some viral hemorrhagic fevers, inhalational anthrax, pneumonic plague) • A disease that is unusual for an age group • Unusual strains or variants of organisms or antimicroboal resistance patterns different from those known to be circulating • A similar or exact genetic type among agents isolated from distinct sources at different times or locations • Higher attack rates among those exposed in certain areas, such as inside a building if released indoors, or lower rates in those inside a sealed building if released outside • Disease outbreaks of the same illness occurring in noncontiguous areas • A disease outbreak with zoonotic impact • Intelligence of a potential attack, claims by a terrorist or aggressor of a release, and discovery of munitions, tampering, or other potential vehicle of spread (spray device, contaminated letter) (USAMRIID 2005) 770-488-7100 404-639-0385 http:www.bt.cdc.gov Access through State Health Dept 202-324-3000 http://www.fbi.gov/pressrel/pressrel01/mail3.pdf http://www.usamriid.army.mil http://ccc.apgea.army.mil http://www.nbc-med.org http://www.hopkins-biodefense.org www.idsociety.org/bt/toc.htm Table 3. Points of Contact and Training Resources. * Clinicians & Response Planners are encouraged to post this list in a an accessible location. Specific local and state points of contact should be included. 19 Bibliography Davis D, Bor B. Biological Contamination and Bioterrorism Preparedness: Key Considerations for Infection Control Practitioners. Inf Control Today. July 2002: 40-44. Sinclair R, Boone S, Greenberg D, Keim P, Gerba G. Persistence of Category A Select Agents in the Environment. App Environ Micro. 2008: pg 555-563. Pattillo M. Bioterrorism. Advance for Nurses. Oct 2005: 17-22. Cosgrove S, Perl T, Song X, Sisson S. Ability of Physicians to Diagnose and Manage Illness Due to Category A Bioterrorism Agents. Arch Int Med. 2005;165: 2002-2006 Beasley A, Kenenally S, Mickel N, Korowicki K, McCann S, Arundell J, Simmons W, Williams H. Treating Patients with Smallpos in the Operatign Room. AORN Journal. 2004;80: 681-689. Chronological History of Bioterrorism- History of Bioterrorism. 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BUMC Proceedings. 2004;17:400-4006. ® Ansell Healthcare Products LLC. 111 Wood Avenue South, Suite 210 Iselin, NJ 08830 USA Toll-free: (800) 952-9916 www.ansell.com ©2011 Ansell Limited. All Rights Reserved. 23