Personal Protective Equipment (PPE): An Overview June 18, 2020 Susan DeRagon Senior Technical Consultant
Agenda Types of PPE Requirements & Recommendations 1 2 Face masks Medical grade Face shields/goggles Non-medical grade Gowns Labelling Gloves Proposition 65 Children’s products 2 2 info@qima.com info@qima.com
Face Masks 3 3 info@qima.com info@qima.com
Types of Masks Uses Cloth Surgical N95 Mask Mask Respirator CDC recommended for general public X Necessary for medical facilities & first responders X X Protects against droplets X X X Protects against aerosol X Custom fit X Loose fit X X 4 info@qima.com
Face Masks – N95 5 info@qima.com
Face Masks – Surgical 6 info@qima.com
Face Masks – Cloth 7 info@qima.com
Cloth Masks – Materials 8 info@qima.com
Cloth Masks – Construction Recommendations 9 info@qima.com
Cloth Masks – Testing (US) Labeling Testing (Safety) Quality/Performance Tests Country of Origin Flammability CF to Crocking Producer Markings/UPLR CPSIA/Prop 65 – Lead CF to Laundering Textile Fiber Identification Prop 65 – Phthalates CF to Perspiration Care Instructions Prop 65 – Cadmium Appearance after Laundering Emergency Use Authorization Fiber Content Analysis Dimensional Stability Tracking Label (if CP) Mechanical (if CP) Dimensions pH value Workmanship Formaldehyde Attachment Strength ASTM F2100-19-Surgical Face Mask- Abnormal Odor Differential Pressure (Delta P) CF = Colorfastness CP = Children’s Product 10 info@qima.com
Cloth Masks – Testing (EU) Labeling Testing (Safety) Quality/Performance Tests Country of Origin PAH – REACH CF to Crocking Producer Markings SVHC – REACH CF to Laundering Textile Fiber Identification Phthalates – REACH CF to Perspiration Care Instructions Cadmium – REACH Appearance after Laundering Fiber Content Analysis Dimensional Stability AZO Dyes – REACH Dimensions Formaldehyde Workmanship pH value Attachment Strength Organotin - REACH Abnormal Odor 11 info@qima.com
FDA’s Emergency Use Authorization (EUA) Allows FDA to help strengthen public health protections by facilitating availability of products Allows unapproved medical products or unapproved uses of approved medical products to be used in an emergency Waives certain pre-market FDA approvals – 501(k) submissions Terminated once emergency is over 12 info@qima.com
FDA’s Emergency Use Authorization – Face Masks A) Authorized face masks (including cloth B) Conditions related to advertising and face masks) labeling promotion Labeled accurately to describe the product All printed matter, including advertising and and include a list of the body contacting promotional materials, relating to the use of the materials; authorized face mask shall be consistent with the Not claim to be intended for use as a labeling elements listed in part A; surgical mask or to provide liquid barrier No printed matter, including advertising or protection; promotional materials, relating to the use of the Not recommend for use in clinical setting; authorized face mask may represent or suggest that Not labeled in a manner that would such product is safe or effective for the prevention or misrepresent the product's intended use treatment of patients during the COVID-19 pandemic. Not labeled as a respiratory protective All advertising/promotional descriptive printed device and not labeled to be used for matter relating to the use of the product shall clearly particulate filtration; and conspicuously state that Not labeled for use in high risk aerosol The product has not been FDA cleared or generating procedures approved The product has been authorized by FDA under an EUA for use as source control by the general public as well as by HCP in healthcare settings as to help prevent the spread of infection or illness during the COVID-19 pandemic 13 info@qima.com
Face Shields and Goggles 14 14 info@qima.com info@qima.com
Face Shields/Goggles Mandatory US Regulation: ANSI Z87.1:2015 American National Standard – Occupational and Educational Personal Eye and Face Protection Devices Scope of this standard: Requirements to address hazards such as impact, non-ionizing radiation and liquid splash exposures Certain hazardous exposures are not covered: bloodborne pathogens, X- rays, high-energy particulate radiation, microwaves, radio-frequency radiation, lasers, sports and recreation 15 info@qima.com
Face Shield/Goggle Requirements Optical Requirements Other Requirements Optical quality Googles ventilation Luminous transmittance Haze Chemical/Prop 65 Refractive powers Lead Cadmium Physical Requirements Phthalates Drop ball BPA Ignition (flammability) Corrosion of metal parts Minimum coverage area 16 info@qima.com
Face Shield/Goggle Claims and Optional Tests Impact-Rated Marking – Z87+ Other Optional Tests Lateral protection Droplet and Splash protection – High mass impact D3 High velocity impact Dust protection – D4 or D5 17 info@qima.com
FDA’s Emergency Use Authorization – Face Shields A) Authorized face shields labeling B) Conditions related to advertising and promotion Labeled accurately to describe the product as a face shield for medical All printed matter, including advertising and purposes and include a list of the body promotional materials, relating to the use of the contacting materials; authorized face shield shall be consistent with Not integrated with any other article of the labeling elements listed in part A above; PPE such as face mask but rather is for No printed matter, including advertising or use as a standalone face shield; promotional materials, relating to the use of the Intended for either a single user, single authorized face shield may represent or suggest use, or for multiple uses by the same that such product is safe or effective for the user; prevention or treatment of patients during the Includes instructions for recommended COVID-19 pandemic. cleaning and/or disinfection materials All advertising/promotional descriptive printed and processes, if applicable; matter relating to the use of the product shall Must not contain any materials that will clearly and conspicuously state that cause flammability; The product has not been FDA cleared or Not intended for any use that would approved create an undue risk in light of the public The product has been authorized by FDA health emergency under an EUA for use by healthcare providers as personal protective equipment 18 info@qima.com
Gowns 19 19 info@qima.com info@qima.com
Types of Gowns Surgical gowns Surgical isolation gowns Non-surgical gowns 20 info@qima.com
Gowns – ASTM F2407 Tests Tensile Strength: ASTM D5034, ASTM D1682 Tear Resistance: ASTM D5587 (woven), ASTM D5587 (nonwoven), ASTM D1424 Seam Strength: ASTM D751 (stretch woven or knit) Lint Generation: ISO 9073 Part 10 Water Vapor Transmission (breathability): ASTM F1868 Part B, ASTM D6701 (nonwoven), ASTM D737- 75 21 info@qima.com
Gowns – Additional Testing (US) Labeling Testing (Safety) Quality/Performance Tests Country of Origin Flammability CF to Crocking Producer Markings/UPLR Prop 65 – Lead CF to Laundering Textile Fiber Identification Prop 65 – Phthalates CF to Perspiration Care Instructions Prop 65 – Cadmium Appearance after Laundering Fiber Content Analysis Dimensional Stability Sharp Points/Sharp Edges Dimensions Formaldehyde Workmanship Attachment Strength CF to Water CF = Colorfastness 22 info@qima.com
Gowns – Additional Labeling Requirements Includes labeling that accurately describes the product Includes recommendation against use in surgical setting or where significant exposure to liquid bodily or other hazardous fluids may be expected Includes a recommendation against use in a clinical setting where the infection risk level is high Makes no claims regarding flammability Makes no claims of antimicrobial or antiviral protection Makes no claims of infection prevention or reduction 23 info@qima.com
Gloves 24 24 info@qima.com info@qima.com
Gloves – ASTM Standards ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application ASTM D3578-19 Standard Specification for Rubber Examination Gloves ASTM D5250-19 Standard Specification for Poly(vinyl chloride) Gloves for Medical Application ASTM D6977-19 Standard Specification for Polychloroprene Examination Gloves for Medical Application 25 info@qima.com
Gloves – Materials Used Gloves Definition Advantage Protection Level Latex Gloves Made of natural Highest comfort, Bacteria, viruses rubber flexibility, fit and tactile sensitivity Nitrile Gloves Made of synthetic Stretchy, durable Chemicals, viruses material Vinyl Gloves Made of synthetic Cost-efficient synthetic Chemical material, sometimes option, comfortable referred to as synthetic 26 info@qima.com
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