Organizations or Agencies

Pre-Marketing Testing and Approval or Certification

Does the product meet the designated standards and criteria?

NIOSH, FDA

Marketing and Use in the Workplace

What PPE is required or recommended and under what circumstances?

OSHA, CDC, Joint Commission

Post-Marketing Evaluation and Product Investigation or 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.

STANDARDS DEVELOPMENT

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-

1

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.



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