COVID-19 MEDICAL SUPPLIES GUIDELINES

 

VENTILATORS

• The FDA released new guidance that allows more manufacturers to make ventilators at this time.
• The agency is allowing for device modification, and the utilization of ventilators intended for other environments.
• High acuity, invasive, portable, battery operated ventilators
• Example models: Puritan Bennet 840, Viasys Avea, Drager Evita, GEinvent, Maquet Servo-I, Hamilton G5, GE Carescape

COVID-19 TEST KITS

• The FDA provides emergency use authorizations for the production of COVID-19 test kits. Click here to learn more.
• Nasal swab guidance for COVID-19 test kits can be found here.
• 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

PERSONAL PROTECTIVE EQUIPMENT

N95 Respirators (hospitals)

• 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 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.
  • N95 Respirators (approved by NIOSH under 42 CFR Part 84) are appropriate for healthcare settings where only protection from patient generated aerosols is required.
  • KN-95 must meet NIOSH and/or EU standards and be CE certified.

Medical (surgical) masks

• Surgical masks must be FDA approved under 21 CFR 878.4040 as Class II Medical Devices.
• Manufacturing standard: ASTM F2100 – 19 standard
  • ASTM F2100 Level 1 standards for material quality apply in hospital/ICU settings
    • Fluid Resistance with synthetic blood: 80mmHg
    • Differential pressure: <4.0mmH2O
    • Bacterial Filtration Efficiency (BFE) %: ≥95%
    • Submicron Particle Fitration (PFE) @ 0.1u, %: ≥95%
    • Flammability: Class 1

Exam gloves

• Non-sterile, disposable patient examination gloves are appropriate for care of COVID-19 patients.
• Regulated by FDA: FDA21 CFR 880.6250 (non-powdered patient examination glove)
• Manufacturing standard:  ASTM D6319 for powder-free nitrile gloves, ASTM D3578 for powder-free latex gloves

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) line, in 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).
• 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

DRUGS AND CONSUMABLES

Biohazard bag (Regulated Waste)

• Must meet DOH requirements for the collection of Regulated Medical Waste (RMW)  under Title 10 part 70-2.2
  • Red plastic bag, of sufficient strength
• Must meet DOT requirements for the transportation of RMW under 49 CFR 173.197 (e)
  • 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)
  • 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.
• Sharps containers must meet DOH requirements for the collection of RMW under Title 10 part 70-2.2
  • 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)
  • 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.

ADDITIONAL RESOURCES

The CDC has also listed crisis/alternate strategies on its site, including acceptable product classifications.

The FDA has posted a notice addressing Frequently Asked Questions on PPE supplies, including expedited review of manufacturing site changes.