Preparing for an Influenza Pandemic Personal Protective Equipment for Healthcare Workers (2008) / Chapter Skim
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3 Designing and Engineering Effective PPE
3 Designing and Engineering Effective PPE
Pages 77-112
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From page 77... ...
Further, the equipment needs to be effective in a work environment that involves interaction with and examination of patients and long working hours in a crisis pandemic situation. As discussed in Chapter 1, PPE is one component of an overall systems approach to infection prevention and control, which during an influenza pandemic will also require environmental and policy measures including vaccination of healthcare workers, use of antiviral medications, isolation precautions, and ventilation and air exchange controls.
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From page 78... ...
, the equipment is not available or they have not received training, the equipment is uncomfortable or difficult to use, the equipment interferes with their interaction with the patient and affects dexterity or the ability to perform a medical procedure, or they do not see the situation as a high risk. Better guidance is required on the unique needs of healthcare workers so that appropriate performance requirements can be developed and Degree of Protection Cost Comfort Regulations Regulati ons FIGURE 3-1 The design drivers for PPE.
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From page 79... ...
space is fairly large, it is possible to produce a large number of variations of the same item of PPE, thereby driving up its cost. By developing PPE based on a prescribed set of evidence-based performance requirements or standards, manufacturers will be able to create products that will be less expensive and more effective; such standards will also enhance compliance in the use of PPE since they will minimize, if not eliminate, the errors typically associated either with the selection of PPE by personnel responsible for PPE procurement in healthcare settings or with its use by healthcare workers themselves.
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From page 80... ...
According to the 2006 interim guidelines for an influenza pandemic, N95 respirators are recommended for healthcare workers in caring for patients with confirmed or suspected influenza or in situations, such as bronchoscopy or resuscitation, that are likely to generate infectious respiratory aerosols (CDC, 2006)
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From page 81... ...
Cost Maintenance and Aesthetics • Product cost Reuse • Total life-cycle • Variety of styles cost • Easy to and colors • Minimal environ decontaminate and • Customizable mental impact discard disposable elements • Easy to clean and replace parts in reusable PPE FIGURE 3-2 A structured approach to evidence-based performance requirements. For example, protection against the influenza virus and guarding against splashes and contact with bodily fluids are the major functional requirements of PPE.
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From page 82... ...
Careful consideration should be given to the trade-offs between disposable and reusable PPE, particularly given the extreme demands that would be placed on a disposable PPE supply in an influenza pandemic. Maintenance and reuse are key factors for consideration in developing performance requirements (IOM, 2006)
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From page 83... ...
The potential modes of failure of the PPE component in the field should be anticipated and the product suitably designed to guard against such failures. A formal failure modes and effects analysis process should be adopted to ensure the robustness of the resulting design.
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From page 84... ...
Respiratory protection will be necessary in an influenza pandemic if there is a likelihood of aerosol transmission. If properly selected and used, respiratory protection has been demonstrated to significantly reduce hazardous exposures.
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From page 85... ...
Teleman and colleagues (2004) found that the consistent use of N95 filtering facepiece respirators by healthcare workers for contact with severe acute respiratory syndrome (SARS)
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From page 86... ...
. Further research is needed to clarify the role of medical masks in providing barrier protection during an influenza pandemic as these masks are widely available and will be accessible to healthcare workers and to the general public.
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From page 87... ...
Other studies have shown that fit testing increases simulated workplace protection factors for elastomeric and filtering facepiece respirators (Coffey et al., 1999, 2004; Lawrence et al., 2006)
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From page 88... ...
There were also significant differences among the models of filtering facepiece N95 respirators and medical masks. The results of these studies indicate that filtering facepiece TABLE 3-1 OSHA APF Valuesa Type of Respiratory Inlet Covering Helmet Loose Quarter Half Full or Fitting Class of Respirator b,c Mask Mask Face Hood Facepiece Air purifying 5 10d 50 -- -- Powered air purifying -- 50 1,000 25/1,000e 25 Supplied air (airline)
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From page 89... ...
Filtering facepiece N95 respirators can lose their original shape or structural integrity after they are worn for extended periods or are repeatedly donned and doffed, and it is possible that the effect of these conditions could compromise the level of protection provided by the respirator. Research is needed on innovative approaches (including shape memory polymers discussed later in this chapter)
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From page 90... ...
Research is needed that can provide data with which to more accurately select respirators based on the protection provided in different healthcare exposure situations. Improving the Efficacy of Filtration NIOSH classifies respirator filters by the type of aerosol for which they can be used and their filtration efficiency (NIOSH, 2004a)
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From page 91... ...
To overcome this problem, modern respirator filters are constructed with electrically charged (electret) fibers that enhance collection efficiency by electrostatic attraction without increasing breathing resistance.
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From page 92... ...
Current problems associated with using PAPRs in the healthcare setting include high noise levels inside the respiratory inlet covering, facepiece flow rates, and limited battery life.
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From page 93... ...
. These requirements include maximum noise levels inside the respiratory inlet covering of 80 dBA, flow rates of 115 liters per minute (L/min)
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From page 94... ...
Development of this standard should be expedited so it can go into effect at the earliest possible date. GOWNS, EYE PROTECTION, GLOVES, AND OTHER PPE Preventing large-droplet and contact transmission requires the appropriate use of barrier garments including gowns, protective eyewear, and gloves combined with proper hand hygiene practices (respiratory protection is addressed above)
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From page 95... ...
Available gowns vary in their design features, which should reflect the expected distribution of healthcare workers' exposures to the body fluids of patients. Because body fluid exposures are most often to frontal surfaces and often occur at gaps between protective garments (such as the wrist area at the junction between gowns and gloves)
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From page 96... ...
Such prescriptive standards could potentially permit manufacturers to consolidate some product lines. The increased efficiency could reduce manufacturers' production costs and potentially provide a cost benefit for healthcare institutions when purchasing gowns to meet the increased demand for barrier garments during an influenza pandemic.
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From page 97... ...
Eyeglasses do not constitute protective eyewear, and there is no evidence that side shields placed on eyeglasses provide any added protection. The specific circumstances under which protective eyewear should be worn during an influenza pandemic need to be explored and may include the performance of procedures that can produce splashing or spraying such as intubation, extubation, suctioning, bronchoscopy, nebulizer treatment, irrigation, and the manipulation of equipment that pumps blood or body fluids under pressure (DHHS, 2005)
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From page 98... ...
Innovations focused on integrating eye protection and respirators will be particularly important to the next generation of PPE products for healthcare workers. Gloves and Hand Hygiene Little is known about the potential for transmission of influenza virus by direct contact with intact or nonintact skin of the hands.
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From page 99... ...
Current guidelines for healthcare workers' glove use during an influenza pandemic are as follows (DHHS, 2005) : • A single pair of patient care gloves should be worn for contact with blood and body fluids, including during hand contact with respiratory secretions (e.g., providing oral care, handling soiled tissues)
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From page 100... ...
As outlined above, a number of other design elements that are critical to enhancing the wearability and use of the respirator would have to be factored in to either adapt current respirators or design and manufacture new approaches to respiratory protection. Design and Development of Intelligent PPE The role of PPE is to protect the healthcare worker.
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From page 101... ...
. Application of Shape Memory Polymers to Enhance Comfort and Fit of PPE Since the healthcare worker's temperature will change during the workday, research should be directed to investigate the use of shape memory polymers to develop respirators that conform to the wearer's facial profile and maintain a tight faceseal with changing temperature.
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From page 102... ...
Moreover, current methods preclude the fit testing of individuals with facial hair, and respirators are not designed specifically for young children. Therefore, the use of shape memory polymers in the design of respirators should be investigated to enhance ease of fit and comfort and potentially to minimize fit testing.
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From page 103... ...
that could be employed on PPE in a healthcare setting. Questions of interest include the following: • For what period of time does PPE remain contaminated with infectious influenza viruses, and what improvements can be made in doffing and decontamination procedures given that information?
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From page 104... ...
Long-Term Key Research Needs • What protective roles do gloves, gowns, and face shields or other eye protection play in preventing influenza transmission? What protection would medical masks provide to the wearer during an influenza pandemic?
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From page 105... ...
Based on an in-depth analysis of the design and engineering of effective PPE for healthcare workers, the committee has developed the following set of recommendations: Recommendation 2 Define Evidence-Based Performance Re quirements (Prescriptive Standards) for PPE NIOSH, through the National Personal Protective Technology Laboratory (NPPTL)
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From page 106... ...
; • designing respirator facepieces to integrate medical devices such as a stethoscope and to improve commu nication between the user and others; • establishing a new set of performance requirements for PAPRs and for reusable filtering facepiece respi rators that meet the needs of healthcare workers; and • incorporating sensors into PPE to detect breaches and notify users of end of service life and other pro tection information.
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From page 107... ...
Particu lar attention should be paid to disseminating information to healthcare workers on PPE effectiveness relevant to influenza. These efforts require: • expedited efforts to finalize a standardized method for measuring the total inward leakage of respirators as part of the NIOSH respirator approval protocols; • clear measures of filter efficiency; and • clear measures for comparing the effectiveness of respirators, gowns, gloves, eye protection, and other types of PPE based on evidence-based performance requirements.
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From page 108... ...
2006. Interim guidance on planning for the use of surgical masks and respirators in health care settings during an influenza pandemic.
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From page 109... ...
Presentation at the Institute of Medicine Workshop on Personal Protective Equipment for Healthcare Workers in the Event of Pandemic Influenza: Next Steps and Research Direc tions, February 22, 2007. Washington, DC.
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From page 110... ...
2004. Respiratory protection against Myco bacterium tuberculosis: Quantitative fit test outcomes for five type N95 filter ing-facepiece respirators.
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From page 111... ...
Presentation at the Institute of Medicine Workshop on Personal Protective Equipment for Healthcare Workers in the Event of Pandemic Influenza: Next Steps and Re search Directions, February 22, 2007. Washington, DC.
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From page 112... ...
American Journal of Infection Control 31(6)
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