Resources for Manufacturers Wanting to Help with COVID-19 Response

By: Editorial Staff Posted: 04/14/2020

Learn how to help provide much needed PPE and other supplies to King County, Washington State, and hospitals

Are you a manufacturer or do you know a manufacturer who would like to support for the COVID-19 response? Here are different ways you can help:

WHAT DO GOVERNMENTS AND HOSPITALS NEED?

Here is a list of personal protection equipment (PPE) and other supplies are needed:
  •  Disposable gowns
  • Coveralls
  • N95 masks
  • Surgical Procedure Masks
  • Face shields
  • Gloves
  • Powered Air Purifying
  • Respirators (PAPR)
  • PAPR hoods and filters
  • Comfort Strips (Max Ari 2000-201)
  •  Li-Ion Battery
  • Small (Max Ari 200-36T)
  • Impermeable Barriers
  • Sanitizing/Disinfectant Wipes
  • Hand Sanitizer Bottles and Refills
  • Cleaning Solution Spray
  • Digital thermometers (forehead)
  • Disposable Thermometers
  • Disposable Stethoscopes 

WHAT CAN YOUR MANUFACTURING COMPANY DO?

King County

  • If you have a product or service you would like to offer to King County Emergency Operations, register online.
State of Washington
  • If you or your company or organization have PPE in stock to sell or donate, record what you have on this website form.
  • If you or your company or organization are actively making PPE for purchase or donation, record what you have on this website form.
  • If you are willing to re-purpose your manufacturing operations for the production of PPE supplies, click here to offer your capabilities.
  • If you want to offer other items/services (not PPE), direct inquiries and information to this email.
Partnering with Hospitals - American Hospital Association (AHA)
  • If you are already manufacturing PPE or you are a supplier offering PPE and other critical supplies during this time, please contact AHA using this form.
  • If you are a manufacturer who is able to help, but you are not already connected with your local hospital or health system, please contact AHA using this form and provide an in-depth explanation of your needs and capabilities.
  • If you are an innovator or engineer who has technical or manufacturing experience and are looking to help during this time of crisis, please fill out this form.

SUMMARY OF AGENCY PROCESSES
Here is a summary of agency processes, where to find guidelines, and further information:

King County Process
Given the high-level of interest, King County has set up a register businesses to register their information and what they can do (making sanitizer, masks etc.). Register online.

Washington State Process
At the state level, there are three levels of possibilities to help provide PPE:

  1. You have PPE products in stock to purchase or donate.
  2. You are actively making PPE for purchase or donation. You have the design, supplies, etc. and are already in production.
  3. Your manufacturing company wants to help, but needs designs and information to get started.
The Department of Enterprise Services (DES) works through the following process to purchase/receive donations of PPE:
  1. The state exhausts their current stock. First they look a what companies or organizations have PPE in stock. They will order that PPE based on availability and cost as per State purchasing guidelines.
  2. If existing stock is exhausted, they will look at companies who are actively producing PPE. They will order that PPE based on availability and cost as per State purchasing guidelines.
  3. If this stock gets behind or is exhausted, they will start helping new companies to shift their manufacturing to making PPE.
If you have inquiries regarding other items, including the following list, direct information to this email.
  • Offers of PPE that are not on the list specified above
  • Suggestions for other equipment or technology
  • Ideas for involving community organizations in gathering or making items
  • Views from non-manufacturers on how to produce additional items
Learn more from Impact Washington

Partnering with Hospitals
General Information about how to partner

American Hospital Association (AHA), through The Association for Health Care Resource & Materials Management (AHRMM), is vetting non-traditional suppliers that are offering PPE supplies throughout the COVID-19 pandemic. If you are a supplier offering PPE and other critical supplies or if you are a manufacturer able to help, please contact us using this form and provide an in-depth explanation of your needs and capabilities.

RESOURCES ON HOW TO MAKE PPE PRODUCTS

Request access for free American Society for Testing and Materials (ASTM) standards used in the production and testing of personal protective equipment - including face masks, medical gowns, gloves, and hand sanitizers.


INFORMATION FROM THE U.S. FOOD AND DRUG ADMINISTRATION (FDA)
The FDA recognizes that the need by healthcare providers and personnel for personal protective equipment (PPE) such as surgical masks and surgical and isolation gowns, may outpace the supply during the COVID-19 outbreak and they are open to collaborating with manufacturers to help facilitate mitigation strategies.

To help alleviate supply pressures, the FDA may consider expedited review of manufacturing site changes or pre-market submissions—manufacturers of PPE (particularly surgical masks and surgical or isolation gowns) may contact FDA regarding plans to increase availability of these products to the U.S. market.

For reference, the applicable product codes discussed in these FAQs are:
  • Surgical masks (FXX)
  • Surgical mask with antimicrobial/antiviral agent (OUK)
  • Pediatric/child facemask (OXZ)
  • Surgical gowns (FYA)
  • Isolation gowns and surgical apparel accessories (FYC, LYU, OEA)
  • Surgical suits (FXO)
If you would like help mitigate potential shortages of the above product codes     manufacturers, email FDA at deviceshortages@fda.hhs.gov. To facilitate a rapid response to your email, please see use this format for your email:

Subject of the email: “Product Codes XXX, Shortage Mitigation Options for FDA Engagement,” where XXX represents the product code(s).

Body of the email:
  • Describe the affected product or products which may include the brand name, model number, 510(k) number, etc.
  • Describe the proposed mitigation approach.
  • Identify what you are interested in discussing with FDA, such as:
    • Expedited review of a pre-market submission, or
    • Expedited review of a manufacturing site change if you are a class III device manufacturer, or
    • Information about importing certain products.

EXAMPLES OF COMPANIES IN AND AROUND SEATTLE WHO ARE MAKING PPE