Chapter 2.  Personal Protective Equipment

Background

Health care professionals are faced with an ever expanding list of possible contaminants and infectious diseases against which they must protect themselves and their patients.  As infection control professionals and scientists strive to remain on the cutting edge of identification, protection, and treatment of the latest emerging infections, they must also respond to the newer wrinkle of terrorism within the United States. A deliberate release of an infectious agent or contaminant, such as the 1995 Tokyo Sarin attack, 2001 U.S. Anthrax attacks, and 2004 Ricin attacks, in addition to rapidly emerging infectious diseases, such as Severe Acute Respiratory Syndrome (SARS), adds a dimension of the unknown when choosing or developing protocols for personal protective equipment (PPE).  PPE is protective clothing and equipment that serve as barriers and may range from gloves, gowns, masks, and protective eyewear (Centers for Disease Control and Prevention, 1997) to fully encapsulated vapor protective ensembles with self contained breathing apparatus.

Choosing the appropriate level of PPE to respond to a broad spectrum of threats from naturally occurring endemic events to a potentially virulent engineered weapon of mass destruction is a challenge.  An additional challenge is posed by the operational issues involved to effectively obtain, maintain, train for, and use personal protective equipment (PPE).  While one level, filter, garment, or device does not fit all circumstances, maintaining a broad spectrum of flexibility with PPE has a price tag.  The price includes material costs of obtaining and maintaining PPE; initial and ongoing training costs; and the cost of medical monitoring, fit testing, and regular drills and exercises in the context of an all-hazards, community integrated emergency response plan.  The price may be more than we have to spend, which may result in a lack of suitable, effective PPE for health care professionals.

Ideally, as with current infection control standards, the choice of appropriate PPE would be flexible and dependent on key symptoms or pathogen identification and the tasks to be performed.  Health care professionals could escalate levels of protection based on risks such as degree of pathogen contact and route of exposure. Logistical requirements for flexible PPE availabilities would be accommodated in routine operations, such as daily patient care in a hospital, where clinical staff has the opportunity to select from an array of PPE (gowns, masks, gloves, etc).  

However, the cost to maintain the large quantities necessary for care of mass casualties or chemical or contaminated patient events is prohibitive.  Stakeholders and subject matter experts are divided on this issue. Some believe various levels of PPE should be provided to be used at the discretion of the caregiver. Others suggest a prescriptive approach designed to provide a baseline level of protection against most hazards. This approach may promote a greater degree of safety if the caregiver is unable to determine the pathogen or contaminant or is not knowledgeable enough to make a safe PPE decision. (Marcus, 2002) Advocates for a prescriptive approach focus on safety as a primary factor. 

Not all health-care professionals should be expected to have a working knowledge of hazmat or weapons of mass destruction issues or to retain details about each emerging disease. They should not be expected to know how to rapidly determine what level of PPE is suitable for each presenting toxidrome.  Clinicians should be able to rely on evidence-based, best practice standards that provide guidelines for the safest, most effective PPE to wear in each circumstance.

Determining what baseline level of PPE to provide for staff should be based upon an ongoing hazards vulnerability analysis, which is currently required for health care facilities by the Joint Commission on Accreditation of Healthcare Organizations (JCAHO Standard EC 1.4). The hazards vulnerability assessment should reflect community hazards as well as facility specific hazards.  An example of a comprehensive hazards vulnerability assessment could include data already collected by the Local Emergency Planning Committee, which is mandated by the Occupational Safety and Health Administration (OSHA) Superfund Amendments and Reauthorization Act (SARA) Title III Hazardous Waste Operations Standard (HAZ-WOPER) (U.S. Department of Labor, Occupational Safety and Health Administration, 1991a) and reflects local industrial hazards.  Additional vulnerability and credible threat data can come from sources such as the information collected for the ODP State Homeland Security Assessment Strategy (SHSAS), which has evaluated top credible threats from a terrorist act, in addition to the already evaluated industrial hazards. 

After credible threats are assessed, health care facilities and agencies should evaluate their own capabilities and resources in addressing these threats.  Gaps should be addressed in relation to their impact rating.  An example of the PPE component of this hazards vulnerability assessment could be that the facility or agency is at risk for an industrial chemical event involving agent X, in which case it is reasonable to provide PPE appropriate to care for patients exposed to agent X.  Health care facilities already follow standard and transmission based precaution infection control guidelines (U.S. Department of Justice, National Institute of Justice, 2002), but also should have a logistics plan to respond to a mass casualty event.  PPE should be provided in numbers and sizes sufficient to address the predicted casualty numbers and staffing needs.  Staff should be trained in a competency based format to be able to operate safely in the ensemble(s) with regular follow-on training and exercises in addition to required medical monitoring and pertinent fit testing (U.S. Department of Labor, OSHA, 1996).

There are many differences between a response to a biological agent event and a response to a chemical or radiological event. PPE differs for infectious (caused by a pathogenic microorganism or agent) versus contaminated categories as well.  PPE worn for care of an infectious patient should follow standard infection control guidelines developed to manage the transmission of specific diseases, including airborne, droplet, and contact precautions (Association for Professionals in Infection Control and Epidemiology, Inc. Bioterrorism Task Force and Centers for Disease Control and Prevention [CDC] Hospital Infections Program Bioterrorism Working Group, 1999).

The charts on the following page are CDC Hospital Infection Control Practices Advisory Committee (HICPAC) recommendations related to standard and transmission-based infection control practices in the clinical setting.

Events predicted by the release of an engineered, weaponized biological agent resulting in infectious pathogens may defeat current standard precautions.  It is not impossible that such an event may occur  or a new strain of disease may emerge that would require a higher level of PPE than what is used routinely in standard precautions (Alibek, 2002).  During the SARS outbreak in China and Tokyo, medical personnel were shown providing care to infected patients in air purifying respirators.  The training and logistical infrastructure is not yet in place in the United States to provide safe, sustained patient care with this higher level of PPE.  Even so, planning discussions should include exploring options for supporting infectious mass casualty care involving higher levels of PPE, such as air purifying respirators or contained air atmospheres (SLAMMER unit model—United States Army Medical Research Institute of Infectious Disease.)  This effort would most certainly necessitate Federal support of personnel and equipment, as the cost to sustain such a capability at the health care facility or community level would be prohibitive.

Health-care professionals care for infectious patients in daily practice and should be adept at choosing and donning routine standard precaution PPE.  The Association for Professionals in Infection Control and Epidemiology (APIC) Bioterrorism Working Group identifies standard precautions routinely practiced by health care providers including hand washing, gloves, masks/eye protection or face shields, and gowns. Infection control professionals describe the lack of a sustained fit testing program (for N95 masks, etc.) and the frequent breaches of basic practice standards, such as changing PPE, hand washing, and early initiation of droplet precautions, as contributing to the spread of infection (APIC Bioterrorism Task Force and CDC Hospital Infections Program Bioterrorism Working Group, 1999).  Systems and procedures should be evaluated and improved to facilitate early recognition of a potentially infectious patient, such as the standard of care for identifying tuberculosis (TB) patients.

Select Table 1 for CDC Hospital Infection Control Practices Advisory Committee (HICPAC) recommendations related to standard and transmission-based infection control practices. Select Table 2 for a synopsis of types of precautions and patients requiring the precautions.

However, this should be on a broader scale and with quicker initiation of effective infection prevention and control, including donning PPE, initiating isolation, and potential quarantine.  An example would be a patient presenting to a medical triage area with a productive cough and fever being immediately placed in a barrier mask, the triage professional using protection against droplet transmission, and the need for isolation being considered quickly (Staiti, Katz, and Hoadley, 2003).  Increased indicators for isolation initiation will result in the demand for cost effective solutions to maximizing and increasing isolation ability in the United States, both with fixed and portable filtration systems.

The challenge of preventing transmission of infectious pathogens is exemplified in the current inability to prevent transmission of the common cold.  Infection control standards are proven to reduce transmission rates, but gaps in practices such as hand washing and use of appropriate PPE continue to contribute to the failure to contain infectious diseases.  While the answer to containment is most certainly more complicated than basic infection control practices, the inability to be consistent with them must be addressed.

Current guidelines for administering care to a potentially contaminated patient are based on traditional hazardous materials (HAZMAT) models (Bronstein and Currance 1994).  Organizations such as the OSHA, National Fire Protection Agency (NFPA), National Institute for Occupational Safety and Health (NIOSH), Soldier and Biological Chemical Command (SBCCOM), and ODP have descriptive categories for PPE that would be suitable for functioning in a hazardous materials environment.  PPE ensembles are traditionally geared towards industrial HAZMAT functions, but with the threat of WMD terrorist events, the need for availability and use of chemical protective PPE for health care professionals is apparent.

Following a traditional HAZMAT model, if an event occurs that results in contaminated victims,  it is widely taught that field health care providers should wait for arriving HAZMAT technicians to determine the contaminant and level and to separate and decontaminate victims before emergency medical services professionals can treat them.  Several factors complicate this scenario.

Emergency Medical Services

The first arriving Emergency Medical Services (EMS) units may not be aware of potential contamination until they are already engaged in care.  Portable detection technology small enough to be worn on a service uniform to vehicle mounted systems do exist; however, this technology has a large price tag, not only in the cost of the technology, but also in the training, planning, and maintenance to assure system reliability.  Naturally, this is a capability that would enhance the EMS professional's ability to recognize the warning signs of a possible contaminated scene prior to scene entry. This capability is being taught in emergency medical technician curricula (O'Keefe et al., 2001), though the depth of coverage and time allotted is limited.

Additionally, should EMS professionals suddenly find themselves in a contaminated environment, most do not have escape masks or other PPE that would enable them to minimize further contamination while they self-evacuate from the scene.  This does not take into consideration that once health care professionals have initiated care and seen patients in need, they may stay on the scene to help (National Personal Protective Technology Laboratory, 2003). Currently, escape masks are not widely provided and, while small enough to be clipped to a utility belt, are not small enough to be a minimal burden yet have some length of effectiveness.  Longer effectiveness generally requires a larger size, with potential non-compliance issues in light of all the other items carried on a typical EMS utility belt.  To be effective, the EMS professional or other first responder would need to have the mask available at the time of discovery of a possible contaminated area.  Some EMS agencies are budgeting for and providing escape masks to EMS professionals as an additional layer of PP. Additionally, some agencies are overpressuring and filtering their vehicle airflow to provide a sheltered environment for personnel and patients while the doors and windows are closed (personal communication with Steve Cantrill, M.D., December 8, 2003).

In the event of an incident resulting in potentially contaminated patients, such as an industrial accident, a deliberate release, a "white powder" incident, or detonation of a radioactive dispersal device (RDD or "dirty bomb"), ambulatory victims are likely to self refer to the nearest medical facility, as occurred after the 1995 Tokyo subway Sarin attacks.  Non-ambulatory and deceased casualties may be left at the scene to be cared for by arriving EMS professionals and other first responders.  If EMS is on scene early in the event, ambulatory victims may gravitate towards the visible presence of help, the emergency vehicle and professionals in uniform.  Plans, processes, equipment, and training designed to protect EMS professionals and other responders are needed, preferably without increasing the mortality rate of the victims. Rapid access to appropriate PPE and the ability to provide a clean shelter, such as by overpressurizing the emergency response vehicle and providing filters around air intake and output, would be ideal.  Rapid access to detection equipment to determine presence, type, and level of contaminant is also needed.  Technologies such as hand held devices and mounted sensors, supported by training and funding, may one day be the rule rather than the exception.

Currently, most EMS plans focus on traditional response elements in these scenarios, such as identifying a contaminant potential, removing the responder from immediate danger, and calling in trained responders, such as fire department HAZMAT teams.  The plan to preserve the critical medical capacity is sound, but may occur at the expense of the victim. 

Increasingly, EMS professionals are being called on to provide medical care, triage, and treatment in a hot or warm zone.  They are donning PPE, with a range from standard precautions to barrier suits such as Tyvek; standard or powered air purifying respirators with concurrent chemical resistant suits, boots, and gloves; and even self-contained breathing apparatus and related suits, including bunker gear.

Debate continues as the price of equipment, maintenance, training, and exercising necessary to sustain this response capability is high.  Whether EMS should be engaging in warm or hot zone entry at all, whether to triage, treat or decontaminate (Lindsay, 1999) are some of the issues.  Some agency plans state that this is a role not for EMS, but for fire department HAZMAT.  Others argue that fire department HAZMAT personnel are limited in number, and should focus on agent identification, not victim rescue.  Properly outfitted and trained EMS professionals may be able to enter some contaminated areas safely and begin to save lives.  If trained personnel can determine contaminant type and level and immediate dangers, such as flammable or oxygen deficient atmospheres, specially equipped and trained EMS personnel may enter an area and commence operations. Life saving measures can be instituted with simple airway establishment, effective triage and administration of antidotes. 

Since there is a credible threat in the United States of an act of terrorism involving a weapon of mass destruction, should not the treatment paradigm shift to provide EMS professionals the tools and PPE to effectively and rapidly save lives in the face of contamination?  The Department of Homeland Security (DHS) National Medical Response Teams: Weapons of Mass Destruction, (NMRT: WMD) have long supported the model of hot or warm zone medical entry, with the express purpose of initiating time weighted life saving measures, such as effective triage, airway establishment, and antidote administration (personal communication with RADM Robert Knouss, Director, Office of Emergency Preparedness, National Disaster Medical System, United States Public Health Service, April 2002).

Ultimately, the PPE choice for field health care personnel will vary by circumstances and agent.  In the broader categories of infectious agent versus contaminant, infection control standards guide the choice with standard precautions for the infectious pathogen.  For treatment of contaminated patients, the choice of PPE must co-exist with an effective all-hazards response plan that clearly describes the expected roles and responsibilities of EMS personnel.  If EMS personnel are expected to provide medical treatment or triage during the decontamination process, then a prescriptive approach to PPE would suggest a minimum of "Level C" for the warm zone, consisting of powered air purifying respirators with a protection factor of at least 1000, hooded to eliminate the need for fit testing, and appropriate filters such as the combination organic vapor/acid gas/HEPA or "WMD" cartridges, or the filter appropriate in response to the identified agent such as radioactive particles, chemicals not filtered by the "WMD" cartridges,  as well as chemical resistant gloves, boots, and suits to match or exceed the level of respiratory protection chosen.   This level ensemble or higher would require a medical monitoring program, potential fit testing, ongoing competency based training and exercises, a scene safety process, and equipment availability and ongoing maintenance.

In 2005, OSHA published an interpretation of their industrial PPE standards specifically geared towards healthcare professionals engaged in care of potentially contaminated patients.  This standard of care outlines the use of Level C PPE, to include a hooded, powered air purifying respirator with an APF of 1000, appropriate filters chosen as the result of a hazards vulnerability analysis, level C chemical resistant suit, gloves, and boots. The original OSHA regulations for medical monitoring, presence of a safety officer, and training standards still apply.  With a minimum standard of PPE for contaminated casualty response, agencies must focus on standards compliance, many having chosen to purchase partial face shield APRs instead of the PAPRs required.  Agencies must still engage in a hazards vulnerability analysis to determine their operational needs for PPE; some agencies may need to provide a higher level of PPE as a result.  Agencies should be aware of the limitations and requirements for functioning in the level(s) of PPE chosen, and include maintenance, training, exercises, safety, and medical monitoring as part of their overall response plan, as it pertains to PPE.  (OSHA Best Practices for Hospital-based First Receivers of Victims from Mass Casualty Incidents Involving the Release of Hazardous Substances, 2005.).

Health Care Facilities

Since the expectation following an event involving contamination is that many victims will self-refer to known or closest medical facilities, health-care facilities must be prepared to deal with contaminated casualties without the benefit of prior decontamination.  While health care facilities that are JCAHO-compliant have decontamination capabilities, often rudimentary, for one or two patients, they may not have the ability to address a surge of self-referred, contaminated patients, including non-ambulatory patients.  Many health care facilities have increased their decontamination ability with such items as portable decontamination tents and/or expanded fixed facility plumbing, but the larger numbers of patients predicted by such credible threat scenarios as those identified in assessments such as ODP SHSAS process cannot be handled by the majority of health care facilities (U.S. Department of Justice, National Institute of Justice, 2002).  The health care facilities are slowly acquiring the PPE necessary to support sustained and robust mass casualty decontamination with the concurrent resource price tag of operations level or functional competency based training necessary to function safely in PPE. Other costs include equipment maintenance, resupply, fit testing, and medical monitoring prior to and during PPE operations, and effective emergency plan development. 

The remaining issue to be addressed is sustainability funding once these levels have been achieved.  Will health care facilities and health care professionals continue to develop a robust PPE program without another large scale terrorist attack, or will motivation diminish as other health-care system challenges arise?

Choosing appropriate PPE for health care facility personnel is subject to debate with positions  from, "We don't provide that capability; we lock the door and call the fire department" to a variety of Level A, B, or C, as defined later in this document.  Available research on specific residual levels of contamination that will result in secondary contamination of health care professionals and facilities is scant.  However, existing research and theory suggest that self-referring ambulatory patients will have lower levels of contamination than non-ambulatory patients and that contamination will primarily be present in clothing and exposed areas such as the face, hair, and hands.  Non-ambulatory patients presumably will have a greater chance of field decontamination intervention prior to transport to a health-care facility.  Additional research needs to be conducted on these theories, starting with designated, credible, high threat agents. 

Assuming that these theories are correct, PPE choices for health-care professionals can best be described as providing protection against the most credible threats with the least restrictive impact on providing patient care, and the least operational impact with fit testing, medical screening, lengthy training, onerous equipment maintenance, and high costs.  Based on the community integrated hazards vulnerability assessment, a baseline example of prescriptive PPE could be a hooded, powered, air purifying respirator, appropriate filter cartridges, and chemical resistant suits, gloves, and boots providing splash and vapor protection.  Possibly the hazards vulnerability assessment will reveal the need for a greater level of protection, such as Level B with supplied air or self-contained breathing apparatus (SCBA).  Processes must surround the PPE choices, to include methods for identifying potential contamination as soon as possible, initial and sustained competency based training, medical screening and monitoring suitable for the PPE level chosen, an ongoing safety program that allows changes in personnel in PPE during an incident, and the ability to recognize the need for rehabilitation and rehydration. 

Providing and maintaining these levels of PPE are the new reality for U.S. health care professionals.  Advances must strive to allow the most flexible and cost effective, safest, least restrictive ensembles that will allow ease of operations and achieve the bottom line—life saving patient care without sacrificing the caregiver.  Ultimately, a best practice for health care professionals to choose appropriate PPE will hinge on an agency's or facility's detection capability, which should be a combination of passive, fixed sensors, and portable monitors.

Currently a plethora of anecdotal theories give recommendations and suggestions for personal protection during a WMD incident, although the health care industry lacks not only an absolute standard of pertinent PPE but also best practices for utilizing PPE in the context of a chemical or radiological event.  Much of this problem stems from the premise that health care facilities lack the financing or personnel necessary to meet or exceed recommendations.  A solid best practice guideline would give health-care facilities the opportunity to strive toward meeting a nationally identified standard and would bring health-care facilities into compliance with the best practice methods supported by quantitative research.  2005 OSHA standards address a baseline of Level C PPE consisting of a hooded PAPR with an APF of 1000, chemical resistant gloves, boots and suits, in the context of the current OSHA training and safety standards.

In addition to the need for best practice PPE guidelines, an increase in public education regarding infection control standards and hazardous materials response expectations is needed in the context of an all-hazards response plan.  Educating the public, such as with the current CDC public messages for SARS and West Nile Virus, will assist health care professionals in managing public expectations of how treatment would be provided in a WMD event.  A barrier to quickly taking respiratory precautions such as placing a mask on a symptomatic patient when the patient enters  the medical system has been the perception that such action is customer unfriendly,  Certainly, a robust public education and risk communication program would help diminish the spread of disease and contamination.

Several elements need to be considered by health-care professionals when it comes to choices of PPE.  PPE is widely thought of in ensembles and rated in levels that reflect its ability to protect from biohazards or industrial hazards.  NFPA and OSHA have descriptions of the widely used fire/ HAZMAT/industrial protective ensembles, (Levels A, B, C, and D), and DHS has an adapted description that attempts to make the descriptions applicable to first responders/health care professionals (Levels 1, 2, 3, and 4).

Understanding the various levels of PPE and what they will protect against is important in assessing the needs of health-care facility preparedness.  Most health-care facilities lack sufficient PPE for health care providers.  This situation drastically reduces the facilities' capabilities in handling a mass casualty incident involving a biological agent, offers an increased risk of secondary exposure, and creates the potential of rendering a facility useless if contaminated. 

Although PPE preparedness and planning levels are increasing due to community and Federal planning efforts, according to several U.S. General Accounting Office (GAO) reports, most U.S. hospitals are not prepared for biological or WMD incidents. Hospitals lack planning, training, and PPE.  In fact, most hospitals surveyed by the GAO had no more than 3 PPE suits per 100 staffed beds. Often, they had only one PPE suit per 100 staffed beds.  As a benchmark, the GAO recommends that each hospital have a 3-day supply of PPE, including gloves, gowns, and shoe coverings (U.S. General Accounting Office, April 2003, and U.S.  General Accounting Office, August 2003.)

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