Underscoring the important role that standards play in supporting safety in the health care context, the Centers for Disease Control and Prevention (CDC) has referenced standards for personal protective equipment (PPE) used in healthcare. The guidance outlines scientific evidence and information on national and international standards, test methods, and specifications for fluid-resistant and impermeable gowns and coveralls used in healthcare.
Among the referenced standards is the American National Standard (ANS) developed by the Association of the Advancement of Medical Instrumentation's (AAMI) Protective Barriers Committee, ANSI/AAMI PB70:2012. The standard establishes a classification system and the associated minimum requirements for the liquid barrier performance of protective apparel, including surgical and isolation gowns for use in health care facilities. The standard is based on industry-accepted test methods. AAMI is an ANSI member and accredited standards developer.
Another ANS noted by CDC in its consideration for selecting protective clothing used in healthcare for protection against microorganisms, is developed by ANSI member and audited designator the National Fire Protection Association (NFPA). NFPA 1999, Standard on Protective Clothing for Emergency Medical Operations, specifies minimum documentation, design, performance, testing, and certification requirements for new single-use and new multiple-use emergency medical operations protective clothing used by emergency responders, both prior to approval at medical care facilities, and at these facilities during emergency operations. These requirements help guard against highly infectious liquid-borne pathogens.
The CDC also references standards from ANSI member and audited designator ASTM International, which has developed a number of standards for patient examination gloves. These standards include:
ASTM D6319, Standard Specification for Nitrile Examination Gloves for Medical Applications
ASTM D3578, Standard Specification for Rubber Examination Gloves
ASTM D5250, Standard Specification for Poly(vinyl chloride) Gloves for Medical Application
ASTM D6977, Standard Specification for Polychloroprene Examination Gloves for Medical Application
And in an update to its guidance for the care of patients with known or suspected COVID-19, and based on local and regional situational analysis of PPE supplies, the CDC on March 10, 2020, announced that facemasks are an acceptable alternative when the supply chain of respirators cannot meet the demand, and that respirators should be prioritized for procedures that are likely to generate respiratory aerosols. ANSI member NIOSH has made available an approved N95 list for healthcare professionals.
As ANSI previously reported, amid the coronavirus outbreak, several ANSI members have published recommendations, including IAPMO, the American Chemistry Council (ACC) and the National Institutes of Health (NIH). In addition, BOMA International, an ANSI member and accredited standards developer, recently published a two-page guidance document for building owners.
ASHRAE, an ANSI member and audited designator, has also published proactive guidance to help address concerns with respect to the operation and maintenance of heating, ventilating, and air-conditioning systems.
ANSI will continually monitor and update member news on ansi.org. Ideas and suggestions for ANSI Online news items may be submitted to [email protected]. All submissions are published at ANSI's discretion.
See related news:
Frequently Asked Questions about Personal Protective Equipment (CDC)