An ad hoc committee will plan and conduct a two-day public workshop that will focus on current processes and next steps toward the integration of federal processes for respiratory protective devices for use in health care settings.The Food and Drug Administration (FDA) and the National Institute for Occupational Safety and Health (NIOSH) have responsibilities for evaluating and regulating respiratory protective devices for health care workers.

The workshop, through invited speakers and participant discussion, will explore current conformity assessment processes and potential options for a) determining when a product is safe for its intended use; b) test methods and evaluation processes for pre- and post-market evaluation; and c) approaches to determine how a conformity attestation should be made.

This workshop will examine the following issues regarding the current processes and next steps toward the integration of federal processes for respiratory protective devices for use in health care settings:

--Test methods-- The workshop will discuss tests and testing requirements to be considered in a unified national conformity assessment process for testing and evaluating N95 respiratory protective devices for use in health care settings. The performance, design, quality, and reliability testing and evaluation requirements will be discussed. Specifically, the following test methods and associated requirements will be discussed:

• Filtration performance-- The workshop will provide an overview of current test methods and identify any issues that need to be resolved.
• Fluid resistance (Splash and spray)-- Currently, FDA requires ASTM F1862: Standard Test Method for Resistance of Surgical Mask to Penetration by Synthetic Blood for validation of fluid resistance on surgical N95 respirators. The workshop will discuss the strengths and limitations of this test method and ongoing research and/or alternative test methods that could be considered.
• Flammability-- The workshop will discuss flammability testing and its applicability regarding all health care settings and in surgical settings as well as explore the current test method and ongoing research and/or alternative test methods that could be considered.
• Biocompatibility and usability-- The workshop will discuss the strengths and limitations of test methods that evaluate biocompatibility and usability including issues of cytotoxicity, sensitization, and irritation.

-- Pre-market and post-market evaluation and testing requirements-- The workshop will examine the issues regarding the labeling and approval of products including those that exceed evaluation standards. Approaches to post market evaluation will also be discussed.
-- Third party evaluations-- Workshop participants will discuss the advantages and disadvantages of using qualified third parties to perform some of the required testing in the context of a unified process.
-- Liability issues-- Workshop participants will discuss the pros and cons for supporting various options from a liability point of view.
-- Other types of respiratory protective devices-- Workshop participants will discuss the issues and specific approaches that could be used to determine how other types of RPDs could be evaluated in the context of a unified process.

The committee will plan and organize the workshop, select and invite workshop speakers and discussants, and moderate the discussions. A summary of the presentations and discussions at the workshop will be prepared by a designated rapporteur in accordance with institutional guidelines.