Without a cure for infectious diseases like Ebola, measures to prevent their spread become the best line of defense for healthcare workers and the public at large. The use of optimal safety standards and protocols are critical, and technical standards from ASTM International guide the strength, integrity and potency of the key protective tools available to us today.
These are recent examples:
- National Nurses United, the largest union and professional association of registered nurses in the U.S., sent a letter to President Obama in October calling for the mandatory use of “full-body hazmat suits that meet the ASTM F1670standard for blood penetration, the ASTM F1671 standard for viral penetration, and that leave no skin exposed or unprotected.”
- The California Department of Public Health and Cal-OSHA updated its mandates for hospitals to include that workers at risk of exposure to the Ebola virus must be provided full-body personal protective suits that meet the ASTM F1670 and F1671 standards.
- The InterAgency Board for Equipment Standardization and Interoperability (IAB) released a new set of recommendations for hospitals that certain personal protective equipment (PPE) meet ASTM safety standards, including ASTM E96, F1671, F1868and for garments, ASTM D6319 for gloves and ASTM F1671 for footwear.
- The U.S. Occupational Safety and Health Administration (OSHA) suggests that coveralls should pass ASTM F1670 or F1671 in its fact sheet and PPE selection matrix intended to help employers select appropriate PPE for workers who may be exposed to Ebola.
Protective clothing safety
“Protective attire is designed to protect wearers from exposure to blood and other body fluids that can contain pathogens. Virtually every manufacturer of protective attire for exposure to blood or pathogens—and the two usually go together—has used the F1670 standard for the development of their products and also for use during production,” says Phillip Johnson, vice president, customer and technical services, Johnson Moen and Co. Inc., Rochester, Minn. Johnson is a member of ASTM Committee F23 on Personal Protective Clothing and Equipment.
Committee F23 develops the test methodology to help ensure that medical protective clothing materials serve their purpose in being a barrier to blood, body fluids and other potentially infectious materials. The companion standard is ASTM F1671, which is used to demonstrate the most protective level, Level 4, for surgical gowns, as described by the Association for the Advancement of Medical Instrumentation.
Germs live and thrive on surfaces and ASTM standard E1053 is a method that assesses disinfection of surfaces. E1053 most closely simulates a real-life situation of a contaminant drying on a surface before it is disinfected with a solution. This standard is cited by the U.S. Environmental Protection Agency (EPA) for disinfectant formulation acceptance.
Committee E55 on Manufacture of Pharmaceutical Products is now tackling potential new standards for single use systems (SUS), which are disposed of after use as opposed to being cleaned. SUS are an increasingly popular method of pharmaceutical production. Among the proposed ASTM standards are practices for testing single use system integrity and applying such systems in pharmaceutical and biopharmaceutical manufacturing, controlling the integrity of systems during the production process and characterizing particulates.