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FDA Issues New Guidance for Face Masks and Respirators During the COVID-19 Public Health Emergency

Thursday, March 26th, 2020

As the nation’s industry mobilizes to fill the N95 protective mask shortage, the Food and Drug Administration has issued new non-binding guidance.

Below is information extracted from the document. Be sure to read it in full.

FDA is issuing this guidance to provide a policy to help expand the availability of general use face masks for the general public and particulate filtering facepiece respirators (including N95 respirators) for health care professionals during this pandemic. Additionally, this policy is intended to remain in effect only for the duration of the public health emergency related to COVID-19 declared by the Department of Health and Human Services.

They believe the policy set forth in this guidance may help address these urgent public health concerns by clarifying the regulatory landscape of face masks and respirators, helping to expand the availability of general use face masks for use by the general public, and of filtering facepiece respirators (including N95 respirators) for use by health care professionals in healthcare settings.

They recognize that there are multiple types of face masks, those intended for medical use (N95) as well as others. When alternatives, such as FDA-cleared masks or respirators, are unavailable, individuals, including healthcare professionals, might improvise PPE. FDA does not intend to object to individuals’ distribution and use of improvised PPE when no alternatives, such as FDA-cleared masks or respirators, are available.

Wherever possible, health care facilities should continue to use FDA-cleared face masks and NIOSH-approved and/or FDA-cleared N95 respirators or better. In response to the COVID-19 pandemic, FDA has also issued EUAs that authorize certain N95 Filtering Facepiece Respirators, including NIOSH-approved disposable FFRs9 and imported non-NIOSH-approved disposable FFRs10, for use in healthcare settings by healthcare personnel and are intended to help increase availability of these devices to front-line personnel during the public health emergency.

FDA requests that makers of alternative masks contact them to determine if they meet Emergency Use Authorization specifications.

The information on how to submit is in the guidance. Read it here.

Posted in Medical | Comments Off on FDA Issues New Guidance for Face Masks and Respirators During the COVID-19 Public Health Emergency

SOTech Builds Face Masks In Response To COVID-19 Announcement

Thursday, March 26th, 2020

SOTech converted part of their sewing floor this week to build face masks for local hospitals in Los Angeles that are terribly understocked in PPE. Now that they are up to speed producing 3000 masks a day, they want to support other organizations, companies and individuals in need during the COVID-19 pandemic.

They designed a ripstop cotton mask with a double ply forming a pocket to hold a non-medically rated disposable filter. The pocket

can also hold some models of N-95 or surgical masks made by other manufacturers. These washable covers are reusable. We are using materials common to SOTECH’s inventory – camouflage, olive and khaki tan ripstop and sheer cotton cloth. All masks include a metal nose contour piece sewn in and elastic ear loops that are one-size fits all. This elastic may or may not contain Laytex. Product is sold in mass quantities or three-packs encouraging users to wash and dry masks between uses rotating them and changing filter inserts each time.

Download pdf here.

Per FDA Guidelines: Face masks may be used when FDA cleared masks are unavailable. It is recommended against use in a surgical setting or where significant exposure to liquid bodily or other hazardous fluids may be expected. Body contacting materials include cotton cloth and elastic ear loops which may contain Laytex.

This is a one-time project only for community support until industry is able to provide adequate stocks of surgical masks and N-95 masks to first responders and the community. Available while supplies last. sotechtactical.com/collections/new/products/medical-protective-mask

Posted in Advertiser, COVID-19 Pandemic, Medical | Comments Off on SOTech Builds Face Masks In Response To COVID-19 Announcement

StatGear’s Hygiene Hand Antimicrobial Brass EDC Door Opener & Stylus Helps You Flatten The Curve

Thursday, March 26th, 2020

We received this note from StatGear founder Avi Goldstein and thought his idea was worth a share.

My company StatGear was started by myself, a NY City Paramedic 10 years ago and has been focused on designing ans manufacturing survival and rescue tools for many first responders and government agencies as well as some innovative edc (everyday carry) items for outdoor enthusiasts.

Our newly launched Kickstarter campaign is to raise funds for a keychain tool to help slow the spread of the coronavirus.

The Hygiene Hand is made from Brass. It won’t stop the COVID-19 virus from surviving on the surface but studies show it’s only there for hours rather than days associated with some other materials such as steel.

Here are a some of the uses for this device. It gives you some stand-off from those surface areas that might harbor the virus.

www.kickstarter.com/projects/34951038/hygiene-hand-antimicrobial-brass-edc-door-opener-and-stylus

Posted in COVID-19 Pandemic, EDC, Medical | Comments Off on StatGear’s Hygiene Hand Antimicrobial Brass EDC Door Opener & Stylus Helps You Flatten The Curve

USAF Basic Military Training Establishes Tactical Combat Casualty Care Course for All Airmen

Thursday, March 26th, 2020

Tactical Combat Casualty Care (TCCC) is an All Service Members Course (AMS) that teaches service members lifesaving skills to render basic medical aid to a trauma casualty. The five lifesaving skills learned are: rapid casualty assessment, tourniquet application, wound packing with a hemostatic dressing, application of a pressure bandage, and basic airway maneuvers to open the airway. The Secretary of Defense has directed that all military service members be trained and become proficient in basic lifesaving TCCC AMS skills, replacing the Combat Lifesaver course. (U.S. Air Force video by Sarayuth Pinthong)

Posted in Air Force, Medical, Training | Comments Off on USAF Basic Military Training Establishes Tactical Combat Casualty Care Course for All Airmen

Federal Resources Announces Disinfection Unit Leader Course

Wednesday, March 25th, 2020

The Disinfection Unit Leader (DUL) course prepares personnel to plan and manage disinfection of PPE, facilities, equipment, and vehicles. Includes application tactics and multiple disinfection solutions.

Course ends with a full scale disinfection of the training facility.

Their mobile training team is still providing on-site training.

E-mail training@federalresources.com for more info.

Posted in CBRNE, Medical, Training | Comments Off on Federal Resources Announces Disinfection Unit Leader Course

UCSD Medical Center Requesting MCSC’s Help to Support COVID-19 Crisis

Wednesday, March 25th, 2020

MARINE CORPS BASE QUANTICO, Va. —

The University of California San Diego Medical Center has requested Marine Corps Systems Command’s assistance to help medical professionals as they deal with the evolving crisis of COVID-19.

On March 16, Dr. Sidney Merritt, an anesthesiologist at UCSD Medical Center, contacted MCSC’s Advanced Manufacturing Operations Cell requesting assistance in coordinating 3D printer assets to design parts to enable the simultaneous ventilation of multiple patients.

AMOC initiated collaboration with the Naval Information Warfare Center Pacific Reverse Engineering, Science and Technology for Obsolescence, Restoration and Evaluation Lab to rapidly design, print, test and evaluate prototype ventilator splitters using various materials.

The AMOC team also worked with the Navy’s Bureau of Medicine and Surgery for support in evaluating, certifying and approving the parts prior to delivery to the medical center.

MCSC, NIWC Pacific and UCSD have established a Cooperative Research and Development Agreement to facilitate current and future support requests. A Memorandum of Understanding among MCSC, NIWC Pacific and the Navy’s Bureau of Medicine and Surgery is also being established to codify roles and responsibilities.

MCSC’s involvement

On March 18, Merritt provided design files for the ventilator splitter based upon a successful test print conducted by the UCSD engineering team. UCSD requested assistance in printing ventilator splitters in higher resolution and with diverse materials that could meet specific design requirements.

After receiving the design files, AMOC and the NIWC Pacific RESTORE lab printed several prototypes using different materials. In less than a day, AMOC used its industrial printer in Quantico, Virginia, and the RESTORE Lab employed its organic printers to produce initial prototypes.

The 3D-printed ventilator splitters were scanned to ensure accuracy with the design files and then brought to UCSD Medical Center for fit testing and further design analysis.

AMOC’s reputation in advanced manufacturing has grown since its establishment in 2019. The cell has demonstrated the ability to produce 3D-printed parts and provide other sustainment and manufacturing solutions in a timely fashion. When called upon, the AMOC can produce parts in a fraction of the time it takes traditional manufacturers.

“AMOC’s response to this situation demonstrates how additive manufacturing can respond quickly to supply chain disruptions and rapidly prototype, evaluate and test new solutions to meet emerging urgent requirements,” said Scott Adams, AMOC lead at MCSC.

The rapid response by AMOC and the NIWC Pacific RESTORE lab to UCSD Medical Center’s request for support is indicative of how the Department of the Navy is prepared to respond to the medical community during the COVID-19 crisis.

“I couldn’t be prouder of the Marine Corps and NIWC Pacific team,” said Carly Jackson, NAVWAR Chief Technology Officer. “We are demonstrating the power, agility and speed of response that our Naval research and development centers bring to bear in times of national need.”

By Matt Gonzales, MCSC Office of Public Affairs and Communication | Marine Corps Systems Command

Posted in Disruptive Tech, Guest Post, MARCORSYSCOM, Medical, USMC | Comments Off on UCSD Medical Center Requesting MCSC’s Help to Support COVID-19 Crisis

Darley Defense – Standing By to Help

Wednesday, March 25th, 2020

Darley Defense is procuring stocks of PPE and disinfecting products as fast as we can to be available to military and first responder customers at our cost.

We do not want to profit from this situation, only get the correct equipment to those working to protect us.

catalog.darleydefense.com

Posted in Advertiser, Medical, Press Release | Comments Off on Darley Defense – Standing By to Help

Regulus Global Prepared To Provide Field Hospitals To Deal With COVID-19 Pandemic

Wednesday, March 25th, 2020

Some months back I visited Regulus Global to discuss the fully equipped field hospitals they have been providing to the UN for Ebola response in Africa. Considering the current COVID-19 pandemic, I thought it was a good idea to share some of the information I learned.

Regulus Global has a history of providing fully functional, ready-to-deploy, scalable UN Level II Mobile Hospitals.

They provide Medical shelter modular systems which are mobile and rapidly-deployable featuring liners (with floor) to provide a clean environment for medical operations. Additionally, there is a pre-installed electrical system and air distribution plenum is standard.

They offer complete infrastructure/inventory for stabilization and treatment-in-place of patients during mass-gathering incidents. These include an Emergency Medical Treatment and Triage Solution Module (E-MTTS MOD). There are also three configurations for surge-capacity patients (12 bed, 25 bed hub and spoke and 25 bed square) which can be scaled by combining as needed. These freestanding units are designed for quick set-up and can be augmented with medical equipment and supply sets to provide a total turnkey solution for mobile medical needs.

Other options include alternate care sites used during a mass casualty event and/or drive-thru distribution systems for use during a pandemic all the way to hospital surge facilities.

Of particular interest during this current crisis, their Drive Thru Clinic System offers a versatile mode of providing services or conducting checkpoints.

Modular Mobile Hospital Configurations, including surgery, can provide complete stand-alone mobile hospitals customized for 12 to 100 beds or more.

Regulus will work with the customer to provide the right-sized mobile medical facility. Everything arrived kitted and ready-to-go. In many cases, transportation boxes are used for storage and as furniture in the medical facility.

Regulus Global can also provide full power generation and conditioning along with HVAC solutions as well as billeting and dining facilities for medical and support personnel.

To learn more, visit www.regulusglobal.com.

Posted in Advertiser, Medical | Comments Off on Regulus Global Prepared To Provide Field Hospitals To Deal With COVID-19 Pandemic