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Make more ventilators

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April 6, 2020,07:10pmx
You have undoubtedly read or heard that we don’t have enough ventilators in this country to help Covid-19 victims breathe, especially in coronavirus hot spots like New York City, northern New Jersey, Detroit and New Orleans where hospitals need hundreds (if not thousands) of additional mechanized units.

In the face of this lopsided supply and demand dynamic, there is another more insidious problem lurking in that the prevailing design of manual ventilators (commonly known as Ambu bag resuscitators, which date from the 1950s) does not allow respiratory therapists or ambulatory technicians to precisely control the amount of oxygen that is pumped into the damaged lungs of those suffering from Covid-19. When you consider the incredible strain on first responders and medical staff in the throes of this pandemic, and the vulnerability of coronavirus patients, over-inflation of delicate lung tissues may well lead to routine violations of the Hippocratic oath: first do no harm.

As to the quantity conundrum, President Trump (finally) last week exercised his authority under the Defense Production Act (DPA) to supply components and compel manufacture of these critical devices. This will begin to address a severe shortage that may leave New York City hospitals without an adequate number of ventilators within days, even after California and Oregon have shipped ventilators east and the Federal government has distributed about half of the units stockpiled in the national reserve.

ResMed, one of the leading domestic manufacturers of ventilators, is “maximizing its production” of ventilators and bilevel non-invasive breathing machines, said CEO Mick Farrell.

Farrell emphasized that the rate-limiting issue that has slowed production acceleration has been their inability to gain “priority access to the [ventilator] components.” The DPA is intended to address this very issue, but the White House appeared reluctant to issue an executive order as the public health crisis intensified. For its part, ResMed said that it has been “actively engaging with key government officials” both here and abroad for weeks and that, notwithstanding any component supply limitations, it began ramping up production in early January as soon as the outbreak was detected in China. The company aims to double or even triple its annual production of ventilators and bilevels this year.

Another option to increase ventilator supply could be the conversion of Continuous Positive Airway Pressure (CPAP) or bilevel positive airway pressure (BiPAP or BPAP) machines typically used for treatment of sleep apnea.

A ResMed spokesperson suggested that this could be done but would require “significant rework to function as a ventilator.” A nascent effort to do just that is underway based upon work done by faculty at the University of California, Berkeley and the University of California, San Francisco. The effort appears to be consistent with new FDA guidelines that support “flexible . . . manufacturer modifications made to ventilators, anesthesia gas machines and other respiratory devices, and their accessories, in response to the COVID-19 public health emergency.”

Under a new schematic design co-developed by Berkeley mechanical engineering professor Grace O’Connell, the modified CPAP machine accepts oxygen where ambient air enters the device. The oxygenated air is then filtered and delivered to a patient through an FDA-approved endotracheal tube, and the exhaled air is re-filtered before being released. O’Connell emphasized that using an endotracheal tube bypasses the need for face masks, which could spread disease if aerosolized viruses escape.

A man wears a mask while walking past Sather Gate[+]
ASSOCIATED PRESS
The Berkeley innovation has morphed into a volunteer community effort, led by two students and centered in the San Francisco Bay Area. The group is appealing to sleep apnea sufferers to donate their CPAP or BIPAP machines to be converted, and is optimistic that they can make an impact on addressing the shortfall based upon estimates that there are 8-10 million such machines in American households that could be converted. Notably, both the devices and components necessary to convert them are readily available and therefore could be put into the market more quickly than newly manufactured units.

Converted CPAP machines would not take the place of a mechanical ventilator employed in hospital intensive care units, but could be used in the field to supplement existing Ambu bags. These manually controlled bag ventilators are used to administer short-term respiratory support in ambulances and emergency rooms until patients can be placed on mechanical ventilators that deliver controlled breath sizes.

Currently, respiratory therapists (or worse, harried ambulatory or emergency professionals) must manually squeeze a hard, plastic balloon-like sphere to deliver air into the lungs of patients who can no longer breath sufficiently on their own. Many intuit that the lungs are simply empty vessels and that the risk to patients lies in providing too little oxygen, given the patient circumstances. But the bigger challenge is to do this cautiously so as to avoid lung hyperinflation that damages the delicate alveoli air sacs. This damage often is not apparent at the time but becomes evident within days as the body triggers an inflammatory response with severe implications that can lead to organ failure and death.

Peer reviewed publications on the advantages of so-called low-tidal-volume ventilation (and the costs and risks associated with excess volume ventilation) suggest that about 75,000 Americans die each year from complications associated with acute lung injury, more than die from breast and prostate cancer combined. Moreover, treatment associated with lung damage resulting from hyperinflation costs an estimated $20 billion per year.

In fact, no currently available bag used in the field promotes compliance to metrics established by the American Heart Association and the European Resuscitation Council, according to Dr. Michael Peck. Peck is a board-certified anesthesiologist and chief medical officer of AirMid Critical Care Products, a startup venture company focused on developing and commercializing an innovative volume-controlled manual ventilator. [In full disclosure, my law firm is advising the company on regulatory matters.]

“We have been working on this technology to promote guideline-compliant breaths from resuscitators for some time, but the coronavirus has given us a heightened sense of urgency to move from prototype to finished product as quickly as possible,” Peck said. “With the exposure to potential lung injury from non-compliant ventilators, we are focused on making a product that addresses this safety issue.” The company believes that widespread use of its guideline-compliant manual ventilators will reduce lung injuries and save massive healthcare system costs.

One intriguing, though perhaps unanswerable, question is whether deaths caused by acute lung damage will be wrongly attributed to Covid-19?

“I have had discussions with a number of my colleagues around the country, and some of us suspect that a portion of the death toll attributed to the coronavirus actually is being caused by excess manual lung inflation – whether in an ambulance or in a crowded hospital hallway – so that the patient’s lungs are irreparably harmed,” Peck noted. “This is yet another aspect of the tragedy of this ongoing public health crisis, but if we can build enough of these ventilators we may not need to make painful decisions as to who gets one and who doesn’t. This certainly won’t be our last pandemic.”

John Osborn

I have been a senior executive with life sciences and healthcare companies, including a Merck joint venture, McKesson Specialty Health/US Oncology, and Cephalon. I now…Read More

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Eats Easy

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Tuesday, April 7, 2020 6:43:23 AM

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BREAKING NEWS: Pension cut looms

Eats Easy and its new mission
By Bea Cabrera | Posted on Apr 07 2020
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Eats Easy’s first food delivery service was done for Rachel by Eats Easy service representative Jun. (Contributed Photo)

Launched in February of this year, Eats Easy is CNMI’s first food delivery app that aims to deliver hot and fresh meals right straight at your doorstep.

The idea came about to cater to customers that have no means of transportation, busy professionals that don’t have time to cook or go out, man’amkos, and disabled persons.

Nowadays, Eats Easy’s new mission is to stay operational and deliver food to anyone who is hunkered down at home to prevent spread of COVID-19 in the community.

Eats Easy president Clint Albert said that Eats Easy aims to create a simple and seamless way of delivering food to clients.

“In almost every part of the world there is some sort of food delivery system from restaurants or apps like ours. We realized the most likely reason we don’t have it on island is due to the fact that houses are so hard to find here because there are no street signs, names, and even house numbers,” he said.

“But we didn’t want that to stop us with our vision to help people…Foodies that have no means to visit their favorite restaurants so we created a GPS-based app to address this… we currently deliver for The Shack, Oink, Sunny Side, Naked Fish, Poki Yaki… other restuarants include- Shirley’s, Oleai Beach Bar & Grill, Loco & Taco, Cristiano’s, Ajisen Ramen, Caravans, and 360 Revolving Restaurant but they are temporarily closed…we want to tell the community to stay home, stay safe because we got you,” he added.

The Eats Easy app is available at the Google Play Store and on their website atwww.conquerthehunger.com.

“We are currently developing the version 2 of the app and this should take about two weeks of work to finish it. Once it’s done iPhone users can download via apple store… a new web version will also be launched,” Albert said.

“For now, we are offering non-Android users to still reach out to us via our contact numbers, Watsapp, or FB messenger so we can still help them out with the delivery service,” Albert said.

According to Albert, even before the COVID-19 pandemic, their team has been trained to uphold a strict standard in food handling and hygiene.

“We follow such quality standards such as washing our hands before leaving the office to go for a delivery, cleaning, and sanitizing our insulated bags twice a day, making sure we do not touch the food at any time. We pack the bagged orders in the insulated bags in front of our restaurant partners’ reps. The only time we open the bags again is in front of the customers who ordered them,” he said.

“Especially during this time, we added more steps to ensure safety from the virus. We use alcohol to sanitize our hands every time we get in the car, touch money, before touching insulated bags and making a delivery, we added alcohol in the cleaning process of the bags, we clean and wipe down the inside of the cars with alcohol every day and we require our service reps to wear a a mask when picking up and delivering food,” he added.

Albert works alongside longtime friends Marco Santiago, East Eats vice president; Lovely Macaranas, treasurer; Jeric Despi, tech head; and their team of service reps.

“Our goal is to hopefully partner with most of the restaurants on island and we would like to create a special item with each one of them that’s only available to order in the app. For example a Shirley’s Eats Easy Burger or The Shack’s Eats Easy Smoothie,” he said.

“We are also looking into different innovations and ideas to help our partner restaurants and customers. One of the things we will be doing is the Annual Eats Easy Foodie Awards where we give out awards like Best Chicken on Island, Most Delivered, and the like,” he added.

For more information, call (670) 286-0520 and (670) 286-0432 and email: conquerthehunger.

Bea Cabrera
Bea Cabrera, who holds a law degree, also has a bachelor’s degree in mass communications. She has been exposed to multiple aspects of mass media, doing sales, marketing, copywriting, and photography.
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Report: Pentagon Knew Of Possible Coronavirus Threat For Years
April 5, 20204:58 PM ET
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The Pentagon was aware of the likelihood of a pandemic brought on by a novel coronavirus years ago, according to a 2017 internal document reported by The Nation.
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The Pentagon was aware of the likelihood of a pandemic brought on by a novel coronavirus years ago, predicting with startling accuracy shortages of masks, hospital beds and ventilators that could occur in an outbreak, according to a 2017 internal document reported by The Nation.

The 103-page document — which the magazine describes as an update to an earlier Defense Department pandemic influenza response plan — cites a novel respiratory illness as the "most likely and significant threat" in a pandemic situation.

The documents also warns that shortages of masks and ventilators would have a "significant impact on the availability of the global workforce."

"The intelligence community and the military were well aware of what could, and unfortunately, did happen" said Nation reporter Ken Klippenstein in an interview with NPR’s All Things Considered.

Klippenstein reports that he obtained the document from a Pentagon official who requested anonymity. Klippenstein says the Pentagon has not responded to his requests for comment on the story.

Klippenstein told All Things Considered that within intelligence circles, a coronavirus has been viewed as a likely threat going back at least five years. And while President Trump has said the current COVID-19 pandemic "came out of nowhere," Klippenstein says it is "inconceivable that the White House did not receive this," referencing information contained in the 2017 Pentagon report.

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Klippenstein adds," The threat of a highly transmissible pathogenic virus that targets the respiratory system, this was appreciated for at least the last 10 years."

The "USNORTHCOM Branch Plan 3560: Pandemic Influenza and Infectious Disease Response," as the document is titled, mentions past coronavirus outbreaks, including the MERS outbreak. The document notes that coronvavirus infections are also quite common worldwide.

Though unclassified, the Pentagon plan is an internal document intended to foresee the causes of and potentials hurdles to arise in a pandemic situation. It outlines scenarios that may arise during a global outbreak and options for how the military might respond. Within the document are also references to classified materials that could provide additional support to its conclusions.

The report’s conclusions have foreshadowed many of the concerns currently being voiced by both elected officials and medical professionals over hospitals beds and medical equipment.

One section reads: "even the most industrialized countries will have insufficient hospital beds, specialized equipment such as mechanical ventilators, and pharmaceuticals readily available to adequately treat their populations during clinically severe pandemic."

This story was produced and edited for broadcast by Janaya Williams, Gemma Watters and Tinbete Ermyas.

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