. "5 Certifying and Regulating Healthcare PPE: Defining an Integrated System." Preparing for an Influenza Pandemic: Personal Protective Equipment for Healthcare Workers. Washington, DC: The National Academies Press, 2008.
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Preparing for an Influenza Pandemic: Personal Protective Equipment for Healthcare Workers
Organizations or Agencies
Pre-Marketing Testing and Approval or Certification
Does the product meet the designated standards andcriteria?
Marketing and Use in the Workplace
What PPE is required or recommended and under whatcircumstances?
OSHA, CDC, Joint Commission
Post-Marketing Evaluation and Product Investigationor Recall
Are products effective in the workplace?
NIOSH, FDA, CPSC
NOTE: AAMI = Association for the Advancement of Medical Instrumentation; CDC = Centers for Disease Control and Prevention; CPSC = Consumer Product Safety Commission; FDA = Food and Drug Administration; ISO = International Organization for Standardization; NIOSH = National Institute for Occupational Safety and Health; OSHA = Occupational Safety and Health Administration.
Before marketing, most healthcare PPE products, including gowns, gloves, and respirators, are tested to meet specific performance standards (e.g., flammability, fluid resistance) (Appendix C). In addition, healthcare PPE manufacturers need to meet quality of manufacturing standards as determined by the Food and Drug Administration (FDA). The standards are detailed in FDA guidance documents and in Occupational Safety and Health Administration (OSHA) regulations. As will be discussed later in the chapter, the National Institute for Occupational Safety and Health (NIOSH) certification process is available for testing and certifying respirators.1 A similar certification process is not available at the present time for other healthcare PPE (e.g., gowns, gloves, eye protection).
Manufacturing, performance, and testing standards are developed by voluntary standards-setting organizations including the International Organization for Standardization, ASTM International, and the Associa-
N95 respirators that are approved by FDA for use in healthcare facilities (termed surgical respirators by FDA) must also meet a set of standards identified in the FDA guidance documents.