If you are an Oregon manufacturer who currently produces one or more of the products below, please send your company contact information and relevant details to firstname.lastname@example.org and we will pass this on to the appropriate contacts.
CURRENT STATE PROCESS
The Governor’s Office is currently prioritizing surgical masks and N95 masks as well as testing kits and cotton swabs. They will be purchased by DAS (department of administrative services)
The Regional Solutions Team across Oregon is reaching out to hospitals and ER entities get an idea of the demand for these products. They will soon be feeding this information into a statewide portal to match supply and demand. We will announce this portal when it is complete. If you would like to speak with the regional solutions team, county area contacts can be found here. When you send us your information we will share with appropriate state contacts and submit via this form
In the meantime, please register on the Oregon Procurement Information Network (ORPIN) This will allow you be found by DAS and allow you to be considered by other State agencies as well.
Legacy Health has shared their needs and includes a clear purchasing process for those wishing to sell or donate to them. Learn more here.
CURRENT FEDERAL PROCESS
The National Institute of Standards and Technology (NIST) MEP National Network is providing Opportunity Synopses that will contain specific product specifications for critically needed supplies (right now they are asking for bottles for hand sanitizer). Once the Opportunity Specifications have been provided we will reach out to you if there is a match.
To sell medical supplies or equipment to the federal government, please submit a price quote under the COVID-19 PPE and Medical Supplies Request for Quotation. Full details can be found in the solicitation (Notice ID 70FA2020R00000011). This solicitation requires registration with the System for Award Management (SAM) in order to be considered for award, pursuant to applicable regulations and guidelines. Registration information can be found at www.sam.gov. Registration must be “ACTIVE” at the time of award.
The dashboard offers a place for buyers and sellers in the private sector to connect. FEMA emphasizes they do not endorse any vendors.
Instructions are: If you need to purchase PPE for your critical workers, then put in your contact information and need in the ‘Need PPE’ chat box. If you are selling PPE to critical workers, then put in your contact information and product availability in the ‘Selling PPE’ chat box.
- FEMA just posted their list of critically needed supplies here:
N95 Filtering Facepiece Respirators
Other Filtering Facepiece Respirators (e.g., those designated as N99, N100, R95, R99 R100, or P95, P99, P100)
PPE surgical masks, including masks that cover the user’s nose and mouth and provide a physical barrier to fluids and particulate materials
PPE gloves or surgical gloves, including those defined at 21 CFR 880.6250 (exam gloves) and 878.4460 (surgical gloves) and such gloves intended for the same purposes.
- FEMA COVID-19 Supply Chain Task Force: Supply Chain Stabilization HERE
- FEMA Supply list and active request here
Critical Supply List
- Gowns, Disposable, All Sizes -ISO rated, surgical gowns, impermeable, polypropylene, 3-layer, looking for at least 500,000 of each size or 2,000,000 of one size fits all
- N95 Masks (current Oregon priority)
- Surgical Procedure Masks (current Oregon priority)
- Surgical Procedure Masks w/Shield Attached
- Face shields – with band, disposable
- Goggles -antifog, splash/impact-resistant, Condor, similar to Grainger #1VT70
- Gloves, Exam, All Sizes – long cuff 11-12″, nitrile
- Powered Air Purifying Respirators (PAPR) – MaxAir CAPR Systems
- PAPR Hoods, All Sizes – 3M or alternative brands
- PAPR Filters
- Comfort Strips (Max Ari 2000-201)
- Li-Ion Batteries, Small (Max Ari 200-36T)
- Impermeable Barriers
- Sanitizing/Disinfectant Wipes
- Hand Sanitizer Bottles – 4, 8, 12, 24 oz. bottles
- Hand Sanitizer Refills – 1200 ml or 2000 ml
- Hand Soap – any sizing, foaming or not, sanitizing, Go Joe, looking for about 500 individual 20 oz packages
- Cleaning Solution Spray – Vionex, Cavicide or similar
- Biohazard Waste Bags – red, 10 gal, 24″ or similar in size
- Digital thermometers (forehead)
- Disposable Thermometers
- Disposable stethoscopes
Due to the influx of requests, we may not be able to reply personally to every message, but we will get your information to the appropriate contacts for further coordination. If you have already reached out to us, we have your information and will call on you when we have more specific details to share.
At the state level, we will share data here and here to avoid you having to enter duplicate information. At the federal level, we will coordinate with NIST National Network and the Foundation for Manufacturing Excellence.
Thank you for your support!
FDA & ISO STANDARDS
Guidance on Production of PPE from the FDA Approval (RRF2591-110526)
Specific to the manufacturing of PPE in response to the COVID-19 outbreak, the FDA is interested in hearing from manufacturers who may be able to help mitigate potential shortages of the below items by increasing U.S. availability of them. The FDA is collaborating with manufacturers of personal protective equipment (PPE) to help facilitate mitigation strategies related to the COVID-19 outbreak.
To help alleviate supply pressures, the FDA may consider an expedited review of manufacturing site changes or premarket submissions. Please note that the FDA is not waiving requirements; they are fast-tracking on a case by case basis.
All manufactures must comply with all CFR Title 21.
At a high level, the steps to achieve FDA approval generally are:
- Ensure you have a compliant Quality Management System
- Develop the product you would like to submit while maintaining required records
- Submit the product to an independent FDA certified lab for testing to ASTM Standards
- Submit product to FDA for approval
Manufacturers may email FDA. This email is carefully monitored and has proven to be a valuable resource thus far in helping FDA mitigate potential supply chain disruptions. To facilitate a rapid response to such inquiries, please go to this link to get additional information and to see an example of information that FDA would find helpful to have initially.
To support rapid response efforts to the COVID-19 pandemic, the American National Standards Institute (ANSI) is providing access to key international standards supporting biological evaluation of medical devices; protective clothing used in health care settings; and business continuity management, security, and resilience. The coordinator of the U.S. voluntary consensus standardization system, ANSI is also the U.S. member body to the International Organization for Standardization (ISO).
Through the ANSI portal, Freely Available ISO Standards to Help Address COVID-19 Crisis, the following ISO standards are accessible in read-only format at no cost during the crisis; additional standards may be added in the near future. ACCESS STANDARDS
Association for the Advancement of Medical Instrumentation (AAMI)
As the COVID-19 crisis unfolds in the U.S., AAMI is providing this curated collection of resources to assist the health technology field as they respond. While AAMI finds these sources to be credible and has compiled this collection as a service to the field, these references are not endorsed by AAMI and the inclusion of any reference or resource should not be construed as endorsement, promotion, or support of any organization.