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By Deborah Davis, MS, MBA and Barbara Bor, RN, ICP, CIC
As the first places ill people usually go for medical attention, hospitals and clinics may have the earliest opportunity to recognize and initiate a response to a bioterrorism outbreak. Such biological event management interfaces with an institution's disaster plan. In the aftermath of Sept. 11, most healthcare facilities are designing their bioterrorism readiness plans based on the Emergency Incident Command model that first responder community agencies have had in place for natural and physical disasters. These plans are being expanded to encompass a bioterrorism response, which includes consultation with infectious disease physician experts and infection control practitioners (ICPs) who provide the immediate containment and precautionary activity required for a suspected biological agent. Each state's department of health serves as the agency in charge for a bioterrorism event and provides the link to federal agency supports. ICPs, however, play a key role in the detection and investigation of infectious diseases in their facilities.
The Role of ICPs
By means of various surveillance processes, ICPs assist with the detection and investigation of trends and clusters of disease symptoms and unexplained deaths that could be associated with a biological agent. In addition, infection control provides ongoing monitoring for possible biological outbreak indicators. Through communication pathways with admissions, nursing supervisors, pathology, microbiology, the emergency center and ambulatory care, infection control practitioners review:
Case definition, case finding and review and interviews confirm an infectious outbreak within patient and community populations. During data collection and the analysis of information, the ICP implements transmission-based isolation practices to prevent the spread of potential infectious agents to other patients and staff. All suspected or confirmed cases of bioterrorism are reported to the state department of health to assure public health intervention measures are initiated.
The ICP, in collaboration with other healthcare personnel, will be asked to ascertain what potentially has happened in relation to a biological event. Questions the ICP might address include:
Policies and Plans
Bioterrorism policies should give guidance to healthcare staff on the containment and exposure prevention of the infectious agent. Education is a critical component when preparing for such an event. With the aid of simple grids, transmission routes as well as isolation and personal protective equipment (PPE) requirements can be communicated. A pre-event plan would require an understanding of biological cases and the immediate availability of PPE to manage the initial suspected or confirmed infectious cases in the hours soon after identification.
Containment is one of the first infection control practices to be implemented when a communicable disease is suspected. During the early phase of ascertaining if a bioterrorism case has occurred, the ICP would institute the minimal movement concept for managing potentially infectious patients.1 Minimizing movement of the patient through the building and implementing appropriate transmission-based isolation would be important until a biological cause is ruled out and a specific agent is identified through laboratory supports and the evolving symptoms of the suspected patient. If a communicable disease is suspected:
Furthermore, biological disaster management requires that a facility understand its air handling systems in order to protect occupants and buildings from airborne hazards. The ICP assists with implementing a protective action plan should an airborne illness be experienced or an airborne-transmitted agent be released in the building. The ICP may recommend a mechanical engineering analysis, if necessary, to determine how the facility's air handling systems could affect the health of the building occupants. If airborne transmission of the agent were possible, the plan would include determining if secondary aerosolization of the suspected agent were also possible. In addition, the plan would give direction for recognizing the need for physical decontamination of any casualties.
Agents of Concern
While anthrax recently has been foremost in the news, other diseases with recognized bioterrorism potential include botulism, plague and smallpox.
According to the Centers for Disease Control and Prevention (CDC), direct person-to-person spread of anthrax is extremely unlikely. Communicability is not a concern when treating patients with anthrax. That being said, all patients in healthcare facilities, including patients with symptoms of anthrax infection, should be managed in accordance with universal precautions. These precautions are designed to reduce transmission from recognized and unrecognized sources of infection and to prevent direct contact with all body fluids, secretions, excretions, nonintact skin and mucous membranes. In addition, in its Bloodborne Pathogen Standard, the Occupational Health and Safety Administration (OSHA) states that gloves must be worn when there is reasonable likelihood of hand contact with blood or other potentially infectious material and when handling contaminated items or surfaces. 2 For more information, visit www.osha.gov.
The gram-positive anaerobic bacillus Clostridium botulinum causes botulism. Foodborne botulism is the most common form, but an inhalation form could be used during an act of bioterrorism. This organism produces a potent neurotoxin, which inhibits the release of acetylcholine, resulting in characteristic flaccid paralysis that can create respiratory failure and upper airway obstruction. Person-to-person transmission does not occur.
People usually contract plague from being bitten by a rodent flea that is carrying the gram-negative bacillus Yersinia pestis, resulting in lymphatic and blood infections (bubonic and septicemia plague). The pulmonary variant, pneumonic plague, can be transmitted person-to-person through respiratory droplets (i.e., coughing, sneezing), infecting those who have direct and close (within 6 feet) exposure to an ill patient.
For pneumonic plague, droplet precautions should be used in addition to standard precautions. Droplet precautions require healthcare providers and others to wear a surgical-type mask when within three feet of the infected patient. Based on local policy, some healthcare facilities require a mask to be worn when simply entering the room of a patient on droplet precautions.2
The last cases of naturally occurring smallpox disease were seen in Somalia in 1977, and in 1980, the World Health Organization (WHO) declared smallpox eradicated from the earth. The United States stopped vaccinating children in 1972. Immunity to the disease has waned, however, adults who were vaccinated for smallpox before 1972 would require a booster to accelerate their immune response to the disease if it were reintroduced through a bioterrorist action.
The disease is created by the orthopox virus variola, which is unique to humans and highly contagious after an incubation period. The virus is transmitted through an infected person's saliva droplets that are aerosolized by coughing or speaking or through direct contact with the infected individual's skin when skin pustules or scabs are present. With modern air handling systems in healthcare buildings, it is possible for airborne transmission of the virus to occur indirectly through the circulating air and heating systems. Airborne and contact precautions should be used in addition to standard precautions when treating patients with suspected or confirmed smallpox.
Airborne precautions require healthcare providers and others to wear respiratory protection when entering the patient's room. Appropriate respiratory protection is based on facility selection policy and must meet the minimal National Institute for Occupational Safety and Health (NIOSH) standard for particulate respirators, N95.2 Contact precautions require healthcare providers and others to wear clean gloves for entry into the patient's room and a gown for contact with the patient and the patient's environment. Based on local policy, some healthcare facilities require a gown to be worn when merely entering the room of a patient on contact precautions. The gown must be removed before leaving the patient's room and hands must be washed with an antimicrobial agent.
Key Considerations for PPE Selection
Informed use of PPE is a critical component of a facility's infection control and bioterrorism response program. Appropriate PPE includes gloves, gowns, laboratory coats, face shields, masks, eye protection and ventilation devices when there is reasonable likelihood of contact with potentially infectious material.
When choosing a glove, the first consideration should be the barrier requirement related to the procedure or task. In other words, what is the level of exposure risk? Patient-care activities that involve exposure to blood, body fluids and other potentially infectious material and activities that may stress the glove material, such as the handling of instruments and sharps and the management of vascular lines, are examples of high-risk situations. Patient-care activities that require glove use for short periods of time and minimal exposure to blood or body fluids are considered low risk for exposure. Examples of low-risk situations are administering an intramuscular injection, routine suctioning, caring for a newborn, emptying a urinal and handling food. Individual usage patterns and the length of time a glove is worn may also affect glove barrier effectiveness. Double-gloving may be indicated for more rigorous procedures.
While price is certainly an important factor, and comfortable fit, ease of donning and grip need to be considered, barrier protection is the reason gloves are worn in the first place. So, what should you look for when selecting medical gloves? Medical gloves are regulated by the Food and Drug Administration (FDA) and must meet certain performance criteria. Many other optional tests can give additional information about how the gloves will perform.
See Table 1 for information to discuss with your supplier when selecting medical gloves. Additionally, gloves labeled as "powder-free" are required by the FDA to have 2 milligrams or less of total particulate per glove, and the lowest allowed protein level claim is "less than or equal to 50 micrograms per gram."
Deborah Davis, MS, MBA, is technical director for Allegiance Healthcare Corporation's gloves business. Davis is currently a doctoral student at the University of Wisconsin-Milwaukee.
Barbara Bor, RN, CIC is part of Regions Hospital Bioterrorism Readiness Task Force in St. Paul, Minnesota. She participates with other metropolitan Minnesota APIC infection control professionals and the Minnesota Department of Health work group on bioterrorism planning, sharing and standardizing practice recommendations for managing a bioterrorism event.
Additional Considerations Related to Policy Development and Education
Following bioterrorism procedures, outlined by the Disaster Plan Command Center, the ICP assists with policies that address:
|Attribute||Required by FDA?||Explanation|
|Process average AQL (pinhole rate)||Yes||Acceptable Quality Level refers to confidence in barrier protection, or infers the number of pinholes. All medical gloves must be statistically sampled to meet certain AQLs.|
|Tensile Strength||Yes||The number reflects how much force is required to stretch a sample of a glove until it breaks.|
|Elongation||Yes||This relates to material stretchiness; a sample with a higher elongation will stretch more before breaking.|
|Thickness||Yes||The FDA requires a minimum of 0.10 mm for surgical gloves and 0.08 mm for exam gloves.|
|Length||Yes||The FDA requires a minimum length ranging from 245 to 265 mm (depending on size) for surgical gloves and from 220 to 230 mm (depending on size) for exam gloves.|
|Manufacturer Complies with Quality System Regulations (QSR)||Yes||QSR requires a system of rigorous design control, documentation and process control.|
|ISO 9001/9002 Certified||No||The certification required for marketing product internationally. Specifies a quality systems model for quality assurance in design/development, production, installation and servicing.|
|Puncture Resistance||No||This test measures the force required to rupture a sample of material with a steel pin. A higher number reflects greater puncture resistance.|
|Bacteriophage Penetration Resistance||No||This test measures the effectiveness of materials used in protective clothing by using a surrogate microbe under conditions of continuous contact. The test method requires only three samples. The outcome is either "pass" or "fail."|
|Tear Resistance||No||There are standard methods to measure the force required to start a tear in a material as well as the force necessary to continue tearing once an initial tear is made.|
|Chemical Resistance||No||There are standard methods to measure the resistance of protective clothing to permeation by various chemical agents. Ask what chemicals were tested and what the average normalized breakthrough time was.|
|Residual Levels of Accelerators||No||Various methods can detect small amounts of chemicals left on glove surfaces. Ask if testing has been done to detect residual levels of chemicals such as thiurams, thiasols and carbamates as well as various antioxidants and antiozonants.|
|Details on Program for Glove Usage Analysis||No||Some manufacturers offer programs to help assure appropriate glove usage and standardization, including safety and cost savings considerations.|