National Academies Press: OpenBook

Preparing for an Influenza Pandemic: Personal Protective Equipment for Healthcare Workers (2008)

Chapter: Appendix C: PPE-Related Standards and Regulations

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Suggested Citation:"Appendix C: PPE-Related Standards and Regulations." Institute of Medicine. 2008. Preparing for an Influenza Pandemic: Personal Protective Equipment for Healthcare Workers. Washington, DC: The National Academies Press. doi: 10.17226/11980.
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Page 181
Suggested Citation:"Appendix C: PPE-Related Standards and Regulations." Institute of Medicine. 2008. Preparing for an Influenza Pandemic: Personal Protective Equipment for Healthcare Workers. Washington, DC: The National Academies Press. doi: 10.17226/11980.
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Page 182

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C PPE-Related Standards and Regulations TABLE C-1 Overview of PPE-Related Standards and Regulations Surgical FDA guidance:a respirators • NIOSH certification—tested to meet criteria outlined in 42 CFR 84 • Fluid resistance: ASTM F1862:2000a • Material performance: ASTM F2100-04 • Bacterial filtration efficiency: ASTM F2101-01 • Flammability: 16 CFR 1610, UL 2154 OSHA compliance: • NIOSH certification—tested to meet criteria outlined in 42 CFR 84 • Comprehensive respirator program that includes annual fit testing Other OSHA compliance: respirators • NIOSH certification—tested to meet criteria outlined in 42 CFR 84 • Comprehensive respirator program that includes annual fit testing Surgical FDA guidance: masks • Particulate filtration: ASTM F1215:1989 • Bacterial filtration: ASTM F2101:2001 • Fluid resistance: ASTM F1862:2000a • Material performance: ASTM F2100-04 • Differential pressure: MilM36945C • Flammability: 16 CFR 1610, UL2154 Continued 181

182 PREPARING FOR AN INFLUENZA PANDEMIC Surgical FDA guidance: gowns • Barrier performance: ANSI-AAMI PB70:2003 o 4 levels of performance based on AATCC 42:2000 and ASTM F1671:2003 o Fluid resistance: ASTM F1670-03 o Bloodborne pathogens resistance: ASTM F1671-03 • Non-barrier properties o Snag resistance: ASTM D5587:1996 and ASTM D2582:2000 o Grab tensile strength: ASTM D5034:1995 o Linting: IST 160.1:1995 o Heat loss: ASTM F1868:1998, Part C o Water vapor transmission: ASTM E96:2000 • Flammability: 16 CFR 10, UL 2154 • Sterilization method and validation • Biocompatibility testing: ISO 10993 Part 10 (skin irritation and sensitization) Medical FDA guidance: gloves • Latex gloves: ASTM D3578:2005 • Vinyl gloves: ASTM D5250:2000e4 • Surgeons’ gloves: ASTM D3577:2001ae2 • Biocompatibility testing: ISO 10993 Part 10 • Powder-free: ASTM D6124:2001 • Reduced protein level: ASTM D5712:2005e1; ASTM D6499: 2003; ASTM D 3578:2005 Eye OSHA compliance (29 CFR 1910.133): protection • ANSI standard Z87.1-1989 (for devices purchased after 7/5/94) NOTE: AAMI = Association for the Advancement of Medical Instrumentation; AATCC = American Association of Textile Chemists and Colorists; ANSI = American National Standards Institute; ASTM = ASTM International; FDA = Food and Drug Administration; ISO = International Organization for Standardization; NIOSH = National Institute for Occupational Safety and Health; OSHA = Occupational Safety and Health Administration; PPE = personal protective equipment. a For all PPE subject to FDA regulations, requirements include establishment registration and adherence to manufacturing quality and labeling regulations.

Next: Appendix D: Standing Committee on Personal Protective Equipment in the Workplace and Board on Health Sciences Policy »
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During an influenza pandemic, healthcare workers will be on the front lines delivering care to patients and preventing further spread of the disease. As the nation prepares for pandemic influenza, multiple avenues for protecting the health of the public are being carefully considered, ranging from rapid development of appropriate vaccines to quarantine plans should the need arise for their implementation. One vital aspect of pandemic influenza planning is the use of personal protective equipment (PPE)—the respirators, gowns, gloves, face shields, eye protection, and other equipment that will be used by healthcare workers and others in their day-to-day patient care responsibilities.

However, efforts to appropriately protect healthcare workers from illness or from infecting their families and their patients are greatly hindered by the paucity of data on the transmission of influenza and the challenges associated with training and equipping healthcare workers with effective personal protective equipment. Due to this lack of knowledge on influenza transmission, it is not possible at the present time to definitively inform healthcare workers about what PPE is critical and what level of protection this equipment will provide in a pandemic. The outbreaks of severe acute respiratory syndrome (SARS) in 2003 have underscored the importance of protecting healthcare workers from infectious agents. The surge capacity that will be required to reduce mortality from a pandemic cannot be met if healthcare workers are themselves ill or are absent due to concerns about PPE efficacy.
The IOM committee determined that there is an urgent need to address the lack of preparedness regarding effective PPE for use in an influenza pandemic. Preparing for an Influenza Pandemic : Personal Protective Equipment for Healthcare Workers identifies that require expeditious research and policy action: (1) Influenza transmission research should become an immediate and short-term research priority so that effective prevention and control strategies can be developed and refined. The current paucity of knowledge significantly hinders prevention efforts. (2) Employer and employee commitment to worker safety and appropriate use of PPE should be strengthened. Healthcare facilities should establish and promote a culture of safety. (3) An integrated effort is needed to understand the PPE requirements of the worker and to develop and utilize innovative materials and technologies to create the next generation of PPE capable of meeting these needs.
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