Personal Protective Equipment
The equipment worn to minimize exposure to hazards that cause serious workplace injuries and illnesses. These injuries and illnesses may result from contact with chemical, radiological, physical, electrical, mechanical, or other workplace hazards.(1) PPE can be either single-use disposable or reusable.
The COVID-19 pandemic has demonstrated the importance of Personal Protective Equipment (PPE) for both those in the medical field and the general public. According to the FDA, PPE for infection control can include “protective clothing, helmets, gloves, face shields, goggles, facemasks and/or respirators”.(2) PPE helps minimize the spread of infectious diseases from person to person in combination with other means of infection control, such as washing hands, using hand sanitizers, and covering coughs and sneezes.(2) Along with the protections it provides in the medical field, PPE is used to ensure workplace safety against dust, chemicals, and other potential hazards in other fields.(3)
Gloves have been utilized as PPE in the medical field as early as the 1760s, and surgical masks have been utilized as PPE since the early 1900s. PPE use by healthcare workers provides protection for both the healthcare worker and the patient.(4) Additionally, PPE provides protection for lab workers, distribution employees, and engineers, among others. Currently in the U.S., surgical gowns and medical gloves are regulated by the FDA. N95 respirators, surgical masks, and face masks are regulated by the FDA, CDC NIOSH, and OSHA.5 Globally, different regulatory agencies regulate PPE efficacy. MicroBio Consulting is staying up to date with the regulations surrounding the various forms of PPE both in the U.S. and across the globe.
The COVID-19 pandemic has increased the manufacturing of PPE both in the U.S. and around the world. As stated above, PPE use is concentrated in hospitals, warehouses, test labs, and other workplaces where exposure to hazards is common. PPE for warehouse use encompasses everything from head protection in the form of helmets to leg protection in the form of protective footwear.(3) In the medical and lab industries, PPE use is most common in the form of masks, respirators, gowns, and gloves.(5)
Testing required for PPE validation processes differs significantly by PPE type (i.e. N95 respirator, medical gown, medical gloves). Testing required for medical gowns includes tensile strength, tear resistance, seam strength, lint generation, and water vapor transmission. Testing required for medical gloves includes leak resistance, tear resistance, and biocompatibility.(5) Respirators are required to pass either NaCl or DOP filtration testing to ensure adequate filtration, along with biocompatibility testing.(6) This is just scratching the surface for PPE testing requirements. Our team helps coordinate required testing with various test labs to ensure products are meeting the necessary requirements and regulations. Along with general testing requirements for PPE use, reusable PPE must meet additional requirements to ensure it can adequately be reprocessed for future use. For more information on reprocessing, click here: (insert link to reprocessing page).