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Business Structure Evaluation Process Updates

We're currently conducting an evaluation of Lee Health's business structure.  Explore all available documents and dive deeper into the process by learning more here. 

PPE Supply Needs

Lee Health is accepting PPE (Personal Protective Equipment) donations

The CDC is now recommending the use of cloth face covers/masks to help slow the spread of COVID-19 when in public places. With the increased demand of PPE (Personal Protective Equipment) we are currently accepting donations through the Lee Health Foundation to keep our staff and patients safe. Below are specifics for supply needs and resources for patterns and material to use when crafting personal protective equipment for healthcare professionals.

Supply donations to support Lee Health can be delivered to:

Lee Health Foundation
9800 S Healthpark Drive, Suite 405
Fort Myers, Florida 33908

We ask that donors please call (239) 343-6950 to arrange a time to drop off the supplies and with any questions.

Supply Needs

DIY/Homemade Items

FDA Regulated Items for Manufacturing

Improvising Personal Protective Equipment during COVID-19

Supply Needs

  • To view a complete list, click here
  • Non-Medical N95 Respirators: The FDA has issued several Emergency Use Authorizations (EUA) to allow hospital use of non-medical NIOSH-approved masks and some imported non-NIOSH-approved N95 masks (that satisfy one of the listed foreign quality standards).  If a community partner has non-medical N95 masks – we could accept these for use under the FDA EUA.

The following information relates to the DIY items that are not regulated by the FDA.

  • Connect with the local Sewing Network - Southwest Florida Face Mask Crew Group 

         Non-Surgical Masks: Non-surgical face masks not intended for the prevention of disease are NOT regulated by the FDA (FDA Product Code QKR).  The FDA has issued guidance that allows enforcement discretion (e.g. not explicitly regulated) for non-surgical face masks intended to be worn by the general public or healthcare personnel.  In an ideal world, we would test samples from batches of non-surgical masks – BUT, something is better than nothing and the public/staff can wear homemade non-surgical masks outside of isolation areas if permitted by hospital policy.

         Gowns, Aprons, Caps:  Garments that are not intended for use in the prevention of disease are not ‘devices’ within the meaning of the Federal Food, Drug, and Cosmetic Act (21 USC § 321) and are not subject to FDA rules.  The FDA does not regulate gowns or aprons unless they make a therapeutic claim. We can accept gowns/aprons from anyone.

         UF Anesthesiology Masks: University of Florida Department of Anesthesiology has provided instructions and guidelines for making masks with surgical drape. Lee Memorial Hospital has 54” x 54” surgical drape fabric available to the community to make masks for our healthcare providers. Each sheet of surgical drape will make 30-40 masks each. Floral wire, or any other flexible wire can be used for the nose piece. If you are interested, please contact [email protected] for more information.

FDA Regulated Items for Manufacturing:

  • Class 1 devices:
         Isolation Gowns:  Non-surgical isolation gowns (FDA Product Code OEA) are Class 1 devices and are exempt from pre-market approval.  Isolation gowns can be manufactured and distributed by any entity as long as it is registered and listed with the FDA (a quick and easy process).  The regulatory hurdles to make and distribute isolation gowns are low: registration, listing, and a quality management system (good manufacturing practices or GMP).  I can help set up the requisite paperwork in less than a day to register with the FDA as a manufacturer of FDA-compliant isolation gowns. 

         Surgical Apparel:  Surgical apparel (FDA Product Code LYU) and surgical caps (FDA Product Code FYF) are regulated under 21 CFR 878.4040 and are Class 1 devices exempt from pre-market approval (requiring only: registration, listing, and record keeping/GMP).  However, surgical gowns (FDA Product Code FYA) are Class 2 devices requiring 510(k) approval (pre-market approval).
  • Class 2 devices:
         Surgical Masks:  Surgical masks (FDA Product Code FXX) and N95 respirators are Class 2 devices and require pre-market approval.  However, both the FDA and an institutional review board have the authority to grant authorization for emergency use of unapproved devices (see attached articles).  Non-approved surgical masks or public health emergency masks intended to prevent transmission of COVID-19 may be utilized if either the FDA authorizes emergency use or the Lee Health IRB determines that it is a ‘non-significant risk device’ (see attached: Nonsignficant Risk Medical Device Investigations).

         Public Health Emergency Mask: A filtering face piece respirator for use by the general public in public health medical emergencies is intended for use to cover the nose and mouth of the wearer to help reduce wearer exposure to pathogenic biological airborne particulates during a public health medical emergency, (see, 21 CFR 880.6260).  A public health emergency mask is a Class 2 device requiring pre-market approval.
  • Medical N95 Respirators:  Crisis alternatives for N95 Respirators are the most challenging to quickly ramp up alternative sources of supply.  However, like surgical masks, either the FDA or the Lee Health IRB may authorize alternative sources of non-approved experimental N95 respirators (however, quality controls will need to be implemented to mitigate risks of injury).  The FDA has issued an Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency.