1.1 Scope. 1.1.1* This standard shall specify the minimum design, performance, testing, documentation, and certification requirements for new single-use and new multiple-use emergency medical operations protective clothing, including garments, helmets, gloves, footwear, and face protection devices, used by emergency medical responders prior to arrival at medical care facilities, and used by medical first receivers at medical care facilities during emergency medical operations. A.1.1.1 This standard addresses only emergency medical products and the design, performance, testing, and certification of specific products. For fire departments and fire department–based EMS services, the use criteria for emergency medical protective ensembles or protective clothing are covered in NFPA 1500, Standard on Fire Department Occupational Safety and Health Program, and NFPA 1581, Standard on Fire Department Infection Control Program. This document is intended to address the wide range of potential threats to emergency medical workers from the time of in-the-field incident intervention through the time of medical facility emergency room treatment. These threats range from mechanical to biological and can impact each emergency medical worker in a variety of ways. Each emergency medical worker should be trained to understand and respect the potential hazards inherent in the emergency medical field. It is essential that each worker evaluate the particular circumstances of each incident and appropriately evaluate the level of personal protection needed to protect themselves from the transmission of diseases and blood/body fluid-borne pathogens. The methods of transmission of currently known diseases are well known. Emergency medical workers are trained to understand these methodologies and protect themselves as well as the patient from incidental exposure. However, new diseases emerge every day, further necessitating the vigilance of emergency medical workers to protect themselves from unnecessary exposure. This document provides emergency medical workers with a wide array of personal protective clothing and equipment that can be chosen to significantly reduce the possibility of exposure to body fluid-borne pathogens. In addition, the document has been expanded to include limited protection from biological, nuclear, and radiological hazards. The hazards associated with emergency medical operations can be generally classified by the following groups: (1) Physical hazards. Protection is needed against cuts, punctures, abrasive surfaces, falling objects, incidental flame contact, environmental hazards such as rain and extreme ambient temperatures. (2) Body fluid-borne pathogen hazards. Protection is needed to reduce the potential for skin and particularly mucus membrane exposure to body fluid-borne pathogens. (3) Protection from chemical and biological agents. Protection is needed to reduce the cross contamination of exposed victims to emergency medical workers during rescue, triage, decontamination, pre-transport emergency medical treatment, transport, and treatment at the receiving medical facility. Specialized decontamination and/or isolation can be initiated at the emergency scene and continued at the receiving medical facility. This document is designed to offer a wide range of protective clothing and equipment options to meet the specific functional needs of emergency medical operations personnel performing a wide variety of tasks, working in a variety of environments, and with varying degrees of control over exposure and environmental threats. The frequency of exposure as well as the severity can also be addressed in the provision of protective clothing designed for single use as well as protective clothing designed for multiple use and certified as compliant with this standard. Research and testing for the development of criteria specific to single-use garments, cleaning/utility gloves, footwear covers, eye and face protection devices, and helmets was supported by NIOSH National Personal Protective Technology Laboratory as addressed in the report, “Improvement of Criteria for EMS Personal Protective Equipment.” 1.1.2* This standard shall also specify additional minimum design, performance, testing, documentation, and certification as requirements for multiple exposure use emergency medical protective ensembles that provide limited protection from specified [C]BRN terrorism agents. A.1.1.2 While separate requirements are specified for emergency medical protective elements, the [C]BRN requirements apply only to ensembles. Individual elements cannot be separately certified to the [C]BRN requirements of this standard. Only complete ensembles, in which all necessary elements are specified to achieve the stated performance requirements, can be certified to the [C]BRN criteria in this standard. Users are cautioned that exposure of emergency medical protective [C]BRN ensembles to biological and radiological terrorism agents should require disposal immediately after the [C]BRN ensemble is doffed. Criteria for single-exposure [C]BRN protective ensembles are addressed in the Class 4 ensemble requirements of NFPA 1994, Standard on Protective Ensembles for First Responders to CBRN Terrorism Incidents. 1.1.3* This standard shall not be interpreted as specifying requirements for protection from all CBRN terrorism agents, from all radiological agents, from hazardous chemicals, from flammable or explosive atmospheres, or from thermal hazards. A.1.1.3 Organizations responsible for CBRN first responders, chemical response functions, and other hazard protection, including radiological, cryogenic, or hazardous chemicals, should use protective ensembles and protective clothing specifically designed for those activities. Criteria for protection from hazardous materials are provided in the following standards: (1) NFPA 1991, Standard on Vapor-Protective Ensembles for Hazardous Materials Emergencies (2) NFPA 1992, Standard on Liquid Splash-Protective Ensembles and Clothing for Hazardous Materials Emergencies (3) NFPA1994, Standard on Protective Ensembles for First Responders to CBRN Terrorism Incidents. 1.1.4* Other than for emergency medical protective ensembles that are certified as compliant with the [C]BRN requirements of this standard, this standard shall not be interpreted as specifying requirements for respiratory protection, and protection from airborne pathogens. A.1.1.4 Specific criteria addressing respiratory protection are not covered in this standard. However, responders and receivers that are engaged in emergency medical operations involving airborne pathogens or other respiratory hazards should wear appropriate respiratory protection. At a minimum, appropriate respiratory protection should include filtering facepieces that are certified by the National Institute for Occupational Safety and Health (NIOSH). P-100 air-purifying respirators will provide the highest level of particulate protection. In addition, responders and receivers engaged in operations involving [C]BRN hazards should, as a minimum, wear air-purifying respirators that are certified by NIOSH as CBRN air-purifying respirators (CBRNAPRs) or certified by NIOSH as CBRN powered air-purifying respirators (CBRN PAPRs). Biological agents can also be transmitted via aerosols, which are a hazard by inhalation, and in some cases, by dermal exposure. Organizations responsible for biological hazard protection should use protective clothing and respiratory protection specifically designed for those activities, including protective ensembles that are designed for [C]BRN protection covered under this standard. Criteria for protection from chemical agents, airborne and liquid-borne biological hazards, and particulate hazards are also provided in NFPA 1994, Standard on Protective Ensembles for First Responders to CBRN Terrorism Incidents. 1.1.5 Certification of all emergency medical ensemble elements and protective clothing items, and medical care facility ensemble elements and protective clothing items as compliant with the requirements of this standard shall not preclude certification to additional appropriate standards where the ensemble elements or protective clothing items meet all applicable requirements of each standard. 1.1.6* This standard shall not be construed as addressing all of the safety concerns associated with the use of compliant emergency medical operations protective clothing for the protection of their personnel. It shall be the responsibility of the persons and organizations that use this standard to conduct testing of protective clothing to establish safety and health practices and determine the applicability of regulatory limitations prior to using this standard for any designing, manufacturing, and testing. A.1.1.6 This standard provides a range of different types of protective clothing and equipment that can be used in the provision of emergency patient care and transportation prior to arrival at a medical care facility by emergency medical responders, emergency patient care by medical first receivers at a medical care facility, and body recovery by emergency medical responders. The selection of protective clothing and equipment for emergency medical operations should account for a hazard assessment undertaken by the department or organization that is responsible for employees that are involved in emergency medical operations. The hazard assessment should be performed in accordance with Title 29, Code of Federal Regulations, Part 1910.132, “General Requirements of Subpart I, Personal Protective Equipment,” to ensure compliance with Title 29, Code of Federal Regulations, Part 1910.1030, “Protecting Health Care Workers from Occupational Exposure to Blood- Borne Pathogens,” or the applicable local, state, regional, or national regulations. The hazard assessment should identify the specific risks of emergency medical responders or medical first receivers to hazards that include, but are not limited to, those listed in Table A.1.1.6(a). Table A.1.1.6(a) List of Potential Emergency Medical and Related Hazards Biological Hazards Thermal Hazards Blood-borne pathogens High convective heat Airborne pathogens Low radiant heat Biological toxins High radiant heat Biological allergens Flame impingement Chemical Hazards Steam Inhalation Hot liquids Skin absorption or contact Molten metals Chemical ingestion or injection Hot solids Hot surfaces Liquefied gas contact Electrical Hazards Chemical flashover High voltage Chemical explosions Electrical arc flashover Physical Hazards Static charge buildup Falling objects Person-Position Hazards Flying debris Projectiles or ballistic objects Daytime and nighttime visibility Abrasive or rough surfaces Pointed objects Falling from elevated surfaces Slippery surfaces Drowning Excessive vibration Person-Equipment Hazards Environmental Hazards Material biocompatibility High heat and humidity Ease of contamination Ambient cold Thermal comfort Wetness Range of motion High wind Hand function Insufficient or bright light Ankle and back support Excessive noise Vision clarity Radiation Hazards Communications ease Ionizing radiation Fit (poor) Nonionizing radiation Ease of donning and doffing It is important to recognize that the protective clothing specified in this standard does not protect against all of the hazards listed in Table A.1.1.6(a). In identifying the potential hazards, the department or organization should determine the likelihood of exposure and the consequence of exposure. The combination of these two factors should establish the risk of exposure and should permit the prioritization of protection needs. As the requirements in this standard were designed to provide individuals with some protection against hazards associated with blood-borne pathogen exposure, it is important that the selected clothing and equipment enable the department or organization to comply with Title 29, Code of Federal Regulations, Part 1910.1030, “Protecting Health Care Workers from Occupational Exposure to Blood-Borne Pathogens.” These regulations require that employers (departments and organizations) provide appropriate protective clothing and equipment to their workers. Appropriate protective clothing and equipment are defined as those items that prevent blood and other infectious liquids from passing through the clothing or equipment item to the wearer’s skin or underclothing. For this reason, a principal component of most clothing and equipment requirements in this standard is a test that demonstrates the barrier performance of the item and the material in preventing liquid penetration. Additional requirements are added to demonstrate that the respective clothing or equipment item provides some degree of protection against other hazards that are relevant to the use of that item that might commonly be anticipated as part of emergency medical operations. As part of the hazard and risk assessment conducted by the department or organization, it is important that the department or organization consider which portions of the body might become exposed. Exposures might occur to the arms and legs, as well as to the head, eyes and face, hands, feet, respiratory system, and hearing. Protective clothing and equipment should be specified for anybody area that is at risk of exposure. Table A.1.1.6(b) provides some factors for consideration of each of the protective clothing items addressed in this standard. 1.1.7 This standard shall not be construed as addressing all of the safety concerns, if any, associated with the use of this standard by testing facilities. It shall be the responsibility of the persons and organizations that use this standard to conduct testing of protective clothing and ensembles to establish safety and health practices and determine the applicability of regulatory limitations prior to using this standard for any designing, manufacturing, and testing. 1.1.8* This standard shall not specify requirements for any accessories that could be attached to the certified product but are not necessary for the certified product to meet the requirements of this standard. A.1.1.8 Fire and emergency response organizations are cautioned that accessories are not a part of the certified product but could be attached to the certified product by a means not engineered, manufactured, or authorized by the manufacturer. Fire and emergency response organizations are cautioned that if the accessory or its means of attachment causes the structural integrity of the certified product to be compromised, the certified product might not comply with the standard for which it was designed, manufactured, and marketed. Additionally, if the accessory or its attachment means are not designed and manufactured from materials suitable for the hazardous environments of emergency incidents, the failure of the accessory or its attachment means could cause injury to the emergency responder. Because the aftermarket for certified product accessories is so broad, fire and emergency response organizations are advised to contact both the manufacturer of the accessory and the manufacturer of the certified product and verify that the accessory and its means of attachment are suitable for use in the intended emergency response environment. Fire and emergency response organizations should seek and receive written documentation from both the accessory manufacturer and the manufacturer of the certified product to validate the following information: (1) The accessory for a certified product, and its attachment method, will not degrade the designed protection or performance of the certified product below the requirements of the product standard to which it was designed, manufactured, tested, and certified. (2) The accessory, when properly attached to the certified product, shall not interfere with the operation or function of the certified product, or with the operation or function of any of the certified product’s component parts. Users are also cautioned that the means of attachment of the accessory that fail to safely and securely attach the accessory to the certified product can cause the accessory to be inadvertently dislodged from the certified product and create a risk to the wearer or other personnel in the vicinity. 1.1.9 Nothing herein shall restrict any jurisdiction or manufacturer from exceeding these minimum requirements.