Hello, I'm looking for the following: Complete PPE Screening Guidance N95 respirators (hospitals) NIOSH- approved (if doubling as mask – FDA) • There are two types of respirators that are appropriate for healthcare workers with close contact with COVID-19 patients: 1) N95 Respirators; and 2) Surgical N95 Respirators. - Surgical N95 Respirato Show More...
Hello, I'm looking for the following: Complete PPE Screening Guidance N95 respirators (hospitals) NIOSH- approved (if doubling as mask – FDA) • There are two types of respirators that are appropriate for healthcare workers with close with COVID-19 patients: 1) N95 Respirators; and 2) Surgical N95 Respirators. - Surgical N95 Respirators are the appropriate device in the healthcare setting when both aerosol and barrier protection (i.e., splash or sterile field) are needed and must be approved by both NIOSH as a FFR (42 CFR Part 84) and FDA as Class II Medical Device (21 CFR 878.4040). - FDA tests: Fluid resistance (ASTM F1862), flammability, and biocompatibility. - GMP requirements, including quality system requirements under 21 CFR Part 820 are waived for N95 respirators listed in Appendix B (authorized for HCP) under FDAs EUA. NIOSH requirements are not waived. - N95 Respirators (approved by NIOSH under 42 CFR Part 84) are appropriate for healthcare settings where only protection from patient generated aerosols is required. Medical (Surgical) masks FDA • Surgical masks must be FDA approved under 21 CFR 878.4040 as Class II Medical Devices. • Tested for fluid resistance (ASTM F1862), flammability, and biocompatibility. • Are made in different thicknesses and with different ability to protect you from with liquids. Exam gloves No certification, but standards • Non-sterile, disposable patient examination gloves are appropriate for care of COVID-19 patients. • The American Society for Testing and Materials (ASTM) has standards for patient examination gloves: - ASTM D6319 – Standard specification for nitrile examination gloves for medical applications. Gowns (medical), disposable with elastic wrists • Non-sterile, disposable patient isolation gowns are appropriate for care of COVID-19 patients. • Four defined levels of protection tested to meet ANSI AAMI PB70: - Level 1: Minimal risk, to be used, for example, during basic care, standard isolation, cover gown for visitors, or in a standard medical unit; - Level 2: Low risk, to be used, for example, during blood draw, suturing, in the Intensive Care Unit (ICU), or a pathology lab; - Level 3: Moderate risk, to be used, for example, during arterial blood draw, inserting an Intravenous (IV) the Emergency Room, or for trauma cases; - Level 4: High risk, to be used, for example, during long, fluid intense procedures, surgery, when pathogen resistance is needed or infectious diseases are suspected (non-airborne) • Regardless of how the product is named (that is, isolation gown, procedure gown, or cover gown), when choosing gowns, look for product labeling that describes an intended use with the desired level of protection based on the above risk levels. Product names are not standardized. • A surgical gown is regulated by the FDA as a Class II medical device that requires a 510(k) premarket notification. Surgical gowns can be used for any risk level (Levels 1-4). Eye face shields • Must meet ANSI Z87.1 for splash protection Goggles • Must meet ANSI Z87.1 for splash protection Boot covers • Not recommended by CDC – We use Tyvek. Hair cover (bouffant) • Not recommended by CDC. Drugs and Consumables • Biohazard bag (Regulated Waste) PLASTIC BAG MAKERS COULD DO THIS SHOWING TEAR AND IMPACT TESTS • Must meet DOH requirements for the collection of Regulated Medical Waste (RMW) under Title 10 part 70-2.2 o Red plastic bag, of sufficient strength • Must meet DOT requirements for the transportation of RMW under 49 CFR 173.197 (e) o Can not exceed a volume of 46 gallons, must pass tests prescribed for tear and impact resistance under ASTM D 1922 and ASTM D 1709 respectively. Must meet a tear resistance of 480grams in both parallel and perpendicular planes with respect to length of the bag and an impact resistance of 165 grams. • Must meet OSHA requirements under 29 CFR 1910.1030(g)(1) (i) o Marked with a biohazard symbol Biohazard bag (Specimen transport) • Must meet DOT requirements for the transport of Category B infectious substances under 49 CFR 173.199(b) o Must be leak-proof for liquids or sift-proof for solids and for liquids transported by air must withstand without leaking an internal pressure of 95 kPa or 14 psi • Must meet OSHA requirements under 29 CFR 1910.1030(g)(1) (i) o Marked with a biohazard symbol Soap, liquid (1L size) • Safety box needle (Sharps) disposal • OSHA’s minimum requirements for sharps containers include: - Closable; - Puncture-resistant; - Leakproof on side and bottom; and - Labeled (Biohazard) or color-coded (red) in accordance with standard. • Production of a sharps container is regulated by the FDA as a Class II medical device that requires a 510(k) premarket notification. - While not regulatory, FDA has published a detailed list of questions product evaluators at healthcare facilities or waste disposal companies should ask when selection a sharps container, that manufacturers should consider in the design process (e.g., puncture resistance, safety features, autoclaving capability, container color and warning labels, and overfill protection. • Sharps containers must meet DOH requirements for the collection of RMW under Title 10 part 70-2.2 o Marked with a biohazard symbol, rigid, leakproof, puncture-resistant, and closable (Same as OSHA). • Must meet DOT requirements for the transportation of sharps under 49 CFR 173.134(c)(2)(x) o Securely closed to prevent leaks or punctures, less than 18-gallon capacity if transported in a wheeled rack, and made of puncture resistant plastic that meets ASTM standard F2132-01. COVID swab test kits • Wadsworth has changed our guidance to require an NP swab only because the NP swab has shown high accuracy, and there is no need to swab a patient twice. There are three criteria that must be followed to meet the need for NP swabs or NP swab alternatives: - The Flocked swab tip must be synthetic (dacron or rayon) fiber and appropriately small sized for a nasal cavity (OP is too large) - Shaft must be narrow and made of flexible plastic - Shaft must have a break point adequately distal from the swab tip to avoid breaking in the nasal cavity
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