Showing posts with label N95 face masks. Show all posts
Showing posts with label N95 face masks. Show all posts

Saturday, May 30, 2020

Terminology - Face shields (visières de protection) (2) Google Inc.

Copyright © Françoise Herrmann

In response to the shortage of Personal Protection Equipment (PPE), within the context of the COVID 19 pandemic, Google designed, manufactured and donated 49,000 face shields to medical personnel (Li, April 28, 2020). A prototyped design that was subsequently shared with manufacturers, converting their production pipelines to meet the demands for millions of PPE units.

In the R&D tradition, the project was authorized by the FDA, researched, prototyped and field-tested. Contrary to clearance for medical use, the FDA authorized the use of the Google-designed COVID19 face shields for medical personnel, under an Emergency Use Authorization. This means that use of the COVID 19 face shields is actually valid, only during those circumstances that justify the declared State of Emergency. Pursuant to the specification of the limitations of liability, the shields have not been tested or evaluated in any way for their capacity to filter, reduce or kill any viruses, bacteria or fungi. They are provided as a free service.

Following survey of existing face shields and feedback from clinicians, the Google COVID19 face shields were designed as disposable, single use, PPE in clinical settings, for the purposes of shielding eyes and face, from bodily fluids or liquid splashes. The design comprises three parts:

  • a 1" thick x .75" wide x 9" long polyurethane foam strip
  • PET film, cut to specification for the visor, that does not fog or become opaque when wiped with a sanitizer, and
  • a rubber band, girth hitched through the tab hole on one side of the visor, and stapled on the other. 

Assembly also requires double-sided tape to attach the foam strip, and a stapler to secure the rubber band with a staple, facing away from the user’s head.

The Google COVID 19 face shields were designed as single-use, and disposable, in clinical settings, per clinician request. Use of the 9" foam strip, flush with the full-width of the user’s forehead, was designed to prevent droplets from entering the face shield from above, whereas the 1" thickness of the foam strip was designed to provide distance between the shield and the user’s face. The distance is required, since the face shields are designed for use with an FDA-compliant Respiratory Protective Device (RPD) or mask, worn behind the shield. The visor extends from ear to ear, without covering ears, so that hearing is not obstructed. The visor also extends below the chin, measuring about 9 to 10 inches from top to bottom.

Specifications for fabricators are found in the Google Trestle Guide, referenced below. 

References
Google Trestle guide
file:///E:/Users/Administrator/Pictures/TrestleGuide.pdf
Li, A. (April 28, 2020) Google Assembles 49,000 face shields to help its local community. 9to5 Google
https://9to5google.com/2020/04/28/google-donates-face-shields/

Tuesday, March 31, 2020

Terminology - Price gouging (N95 face masks, ventilators, hazmat suits, US DPA)

Copyright@ Françoise Herrmann

Price gouging (i.e., extortion or making someone pay too much for something), in particular within the context of the current COVID19 pandemic, appears only slightly less gruesome than the original meaning of the term gouging. Indeed, the original meaning of the term gouging refers to a horrifying form of ocular torture, consisting in forcing an eyeball out of its socket using thumb pressure.[Merriam-Webster, gouging]

Perhaps then, that the current surge in the use of the term price gouging comes as no real surprise.  Use of the term price gouging has spiked recently in connection with logistics and procurement of medical equipment and safety supplies for the COVID19 Pandemic. Medical safety supplies such as N95 face masks and protective hazmat suits, and most recently medical equipment for COVID19 treatment, such as ventilators. N95 means that the masks are NIOSH (US National Institute of Occupational Safety and Health)-approved to reduce exposure to at least 95% of airborne particulate hazards.

In the highly contagious context of the COVID19 pandemic, where the survival of healthcare personnel depends on the use of protective wear such as N95 masks and hazmat suits, and admitted patients in critical condition depend on ventilators, nations worldwide are scrambling to stay ahead of the staggering number of cases and hospitalizations, replenishing stockpiles and creating them where there were none. However, such a scramble for procurement arises  in a bidding process, where states in the US, and beyond, are all competing against each other for critical medical supplies and equipment. As a result, prices are gouged. In other words, prices are driven up to unprecedented highs. 

In the matter of procurement price gouging, connected to the COVID19 pandemic, figures do the talking. For example, according to New York State Governor Andrew Cuomo, N95 masks that used to cost 85 cents/piece are now selling for 7$ a piece (Cuomo Press Conference, March 22, 2020). Likewise, according to Cuomo, ventilators that used to cost $20,000 now cost $50,000 (Cuomo Press Conference March 30, 2020). Thus, price gouging is occurring in a catastrophic situation that is recording exponential increases in the number of confirmed cases and death toll. For example, in New York City alone, between March 22 and March 31 (today), confirmed cases increased from approx. 10,764 and 76 deaths, to approx. 40,900 confirmed cases (at 9:30 EST) and 932 deaths (NYCity DOH, March 31, 2020). Likewise, confirmed cases for the State of New York have climbed to close to 80,000 cases to date, with no predicted leveling in sight (NY DOH, March 31, 2020)

To prevent further price gouging of medical equipment and safety supplies, ahead of the epidemiological catastrophe now unfolding, New York Governor Andrew Cuomo was even driven, on March 22, to call for the nationalization of medical supply procurement in the US, and use of the Defense Production Act (DPA). In other words, a plea for the Federal Government to take over the procurement of medical supplies, in an attempt to prevent uncontrolled bidding, and the inevitable spike in prices of critical medical equipment and supplies. In Cuomo’s own words:
“I’m calling on the Federal Government to nationalize the medical supply chain.The Federal Government should immediately use the Defense Production Act to order companies to make gowns, masks and gloves. Currently, states are competing against other states for supplies.” [Coleman,J., March 22, 2020]

Short of nationalizing the production of medical supplies and equipment in the US, which would mean that the Federal Government would take over and own the production facilities of US companies, the Defense Production Act (DPA) offers a close alternative form of executive intervention in private business and industry. Voted in 1950, during the Korean War, the DPA allows the Federal Government variously to regulate prices (prevent price gouging), to requisition property, to allocate resources, and/or to commission production (or request prioritization of production) for the procurement of vital defense equipment, whether the equipment consists of medical supplies, materials such as titanium and aluminum, the development of new technologies or the disclosure of information. Since voted in 1950, the DPA has been used on several low-key occasions (Kanno-Youngs, Z and A. Sawnson, March 31,2020). In fact, most recently, the DPA has been used, precisely in connection with the procurement of ventilators for the COVID 19 pandemic.  

Indeed, on March 27, 2020, President Trump signed a Memorandum on Order Under the Defense Production Act Regarding General Motors Company, according to which General Motors, in collaboration with Ventec Life Systems, a small ventilator manufacturer, have risen to the occasion, stepping-in to volunteer, and subsequently agreeing  to set up crash production of ventilators at a General Motors factory in Kokomo, Indiana (Boudette & Jacobs, 2020). Ventilators that might be delivered, before the end of the month of April 2020, to places like New York City, dubbed the canary in the coal mine (1). In other words, the hardest-hit US city, where it is anticipated that there will be a desperate need for ventilators in the coming weeks, as well as many additional critical shortages, in the stressed-out healthcare system.


Note
(!) The canary in the coal mine: Expression used by Cuomo during the March 30, 2020 Press Conference. The term refers to the caged canaries that coal miners would carry into the coal mines to alert them to the presence of hazardous gases such as carbon monoxide.

References
Boudette, N. E. and A. Jacobs (March 30, 2020) Inside G.M.’s Race to Build Ventilators, Before Trump’s Attack. NYTimes
https://www.nytimes.com/2020/03/30/business/gm-ventilators-coronavirus-trump.html
CDC - COVID19 – Cases in the USA
h
ttps://www.cdc.gov/coronavirus/2019-ncov/cases-updates/cases-in-us.html
CDC- NIOSH-approved N95 Particulate filtering facepiece respirators
Coleman, J. (March 22, 2020) Cuomo calls on the federal government to order companies to manufacture medical supplies.The Hill.com
https://thehill.com/policy/healthcare/public-global-health/488882-cuomo-requests-federal-
government-order-companies-to
DOH- D
epartment of Health – New York City - Daily Data Summary – COVID19 NYC – March 31, 2020
DOH- Department of Health – NY State - NY county by county breakdown of positive Novel CV cases – NY State
John Hopkins University Coronavirus Resource Center – World data on Coronavirus pandemic
h
ttps://coronavirus.jhu.edu/map.html
Kanno-Youngs, Z and A. Sawnson (March 31,2020) Wartime Production Law Has Been Used Routinely, but Not With Coronavirus,  NYTimes
NY Governor A. Cuomo Press Conference – March 22, 2020
NY Governor Cuomo Press Conference requesting Fed. Government to nationalize medical supply chain – Albany briefing – March 22, 2020
NY Governor A. Cuomo Press conference – March 30, 2020
Rascoe, A. (March 25,2020) Trump Resists Using Wartime Law To Get, Distribute Coronavirus Supplies--  NPR (National Public Radio)
Trump, D.J. (March 27, 2020) Memorandum on Order Under the Defense Production Act Regarding General Motors Company