virus), the California standard sets the default protection level at airborne precautions where use of respirators would be required (California Code of Regulations, 2010).
Recent efforts have also focused on voluntary consensus standards development and on third-party conformity assessment. ASTM International announced in April 2010 the establishment of a working group that will develop test methods to assess the effectiveness of antimicrobial gloves (ASTM International, 2010a). Additionally, a task group within the subcommittee on consumer rubber products has begun developing standards that focus on preventing the transfer of microorganisms through the use of antimicrobial agents (ASTM International, 2010c). Furthermore, an ASTM International subcommittee is focused on developing a product certification process for protective clothing and equipment that would include an option for third-party independent verification that the product met the relevant performance standards (ASTM International, 2010b).
Existing Standards, Guidelines, and Certification Processes
Food and Drug Administration (FDA)
Medical device legislation beginning in 1937 and amended in 1976 makes the FDA the principal agency for clearing personal protective equipment (PPE) for use by healthcare personnel. PPE devices used in healthcare environments are considered medical devices and are regulated as either Class I or Class II devices. Class I devices are considered low risk to the user, and the basic requirement is that the manufacturer meet general standards for good manufacturing processes. Some Class I devices require that the manufacturer provide a 510(k) submission and demonstrate that the device meets specific voluntary standards and is substantively equivalent to a similar “predicate” device currently on the market. Examples of Class I devices that require a 510(k) submission include surgeon and examination gloves. Class II devices are considered intermediate risk and must be cleared through the 510(k) process before they are allowed to be marketed. Surgical gowns, face masks, and respirators are also categorized as Class II devices.
The FDA does not conduct tests on medical devices; the agency reviews data submitted by manufacturers to demonstrate that the product has been tested (by the manufacturer or an independent testing organization) to meet specified consensus standards. Respirators are required to be certified by the National Institute for Occupational Safety and Health (NIOSH) and must meet additional requirements for flammability and fluid protection. The FDA does not have any specific PPE requirements for protection against infectious diseases such as influenza. Therefore, masks and respirators have requirements that are