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Government paid $336 million for ventilators unsuitable for Covid-19 intensive care units treatment, experts say

The ventilators fail to meet HHS guidelines according to Columbia Journalism Investigations in collaboration with Univision Investiga. Lea esta historia en español.
Por: Sarena Snider,Jake KincaidyIan Hodgson,
28 May 2020 – 05:19 PM EDT
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Standing on the floor of a Ford factory in Michigan last week, President Donald Trump declared that 50,000 ventilators Ford will produce in partnership with GE Healthcare would add to "a great medical arsenal" amassed by the federal government in response to the coronavirus pandemic. However, experts and physicians say the ventilators, for which the Department of Health and Human Services paid $336 million, are inadequate to effectively treat COVID-19 patients.

Columbia Journalism Investigations found that the ventilators do not meet HHS' own internal minimum requirements. The pNeuton represents over one-quarter of the 180,000 ventilators purchased by HHS –more than any other model and the largest contract to fulfill the administration's promise to build 100,000 ventilators in 100 days. A total of 50,000 would be ready by July.

Dr. Matt Wynia, director of the Center for Bioethics and Humanities at the University of Colorado, said that unlike other intensive care ventilators, the pNeuton A-E lacks features to fine tune the support patients receive and could give "more ventilation that they really need, and that can be dangerous and can damage the lung."

The pNeuton ventilator, which was licensed by GE and produced by Ford, was originally designed by a Florida-based company, Airon, for short term use during emergency transport, not for intensive care units. No bigger than a toaster, t he pNeuton is ideal for cramped spaces like the back of an ambulance or helicopter, or for use with an MRI machine.


The FDA’s 2004 approval of the pNeuton notes that the suitable uses are for emergency vehicles, in-hospital transportation, or in aircraft.

On April 3 the FDA issued an Emergency Use Authorization, which approved the pNeuton’s use for COVID-19 patients. This authorization indicated that the pNeuton was suitable for "hospitals and alternate care units to meet the need for mechanical ventilation," a use not listed in the pNeuton’s 2004 FDA approval.

In response to questions regarding the pNeuton’s effectiveness, an HHS spokesperson said that the pNeuton "is not intended for continuous use in an intensive care unit (ICU) setting. Instead, it can be used for ICU transport between hospital departments".

This contradicts earlier statements from Ford and Airon, both of which indicated that the pNeuton was intended for ICU use. The pNeuton is "expected to meet the needs of most COVID-19 patients with respiratory failure or difficulty breathing," according to a March 30 statment from Ford, and "can be deployed in an emergency room setting, during special procedures or in an intensive care unit, wherever the patient may be located."

The pNeuton Model A-E produced by Ford is only approved for use on COVID-19 patients under the FDA’s Emergency Use Authorization. However, according to an HHS spokesperson, "at this point in time, there is no designated healthcare setting assigned to receive the pNeuton ventilator."

Lack of settings

Airon is a small company based in Melbourne, Florida. CEO Eric Gjerde is the first to acknowledge that the pNeuton is not designed for long-term use over a couple of hours.

"They are not ICU ventilators and don’t have the features of ICU ventilators," Gjerde said of the pNeuton. But when it comes to taking care of a critically ill patient, he said, "it will get the job done."

Experts and physicians interviewed for this story worry that the pNeuton lacks the necessary settings to make it a useful tool in treating COVID-19 patients, who generally require long-term intubation of more than a week. What may have seemed a smart buy from HHS could actually harm patients in desperate need of care, they say.

"I see it being an issue - our COVID patients are our sickest patients," said a respiratory therapist at Stanford Hospital who has used the pNeuton. "If I had to ventilate them on a pNeuton I wouldn’t feel comfortable not having other options that are on other ventilators."

The experts identified three problems with the pNeuton, two of which do not meet the minimum requirements initially posted by HHS in late March.


The first problem involves the fraction of inspired oxygen, or FIO2, which is the amount of oxygen mixed in with air, which flows into the patient’s lungs. Room air has an FIO2 of 21 percent, and physicians like to keep the oxygen mix as close to that level as possible, increasing the amount of oxygen if the patient needs more help. Most ventilators will allow the physician to precisely adjust the FIO2 anywhere from 21% up to 100%. However, the pNeuton only has two FIO2 settings –65% or 100%.

According to Dr. Marc Cohen, an anesthesiologist who treated covid patients at the New York Community Hospital in Brooklyn, "the limit on the FIO2 settings is a major issue in my opinion, because you can’t tell if someone can come off the ventilator as well if you can only select two options. Running the machine on the higher setting of 100 percent for too long could also lead to lung damage."

Dr. Ricky Feltman, another doctor on the COVID-19 team at New York Community Hospital in Brooklyn, added that not being able to take the FIO2 below 65% is "terrible."

"When we are getting someone off a ventilator, we like to get people down to 45% or 55% oxygen," Dr Feltman continued. "With 65%, good luck. That’s really bizarre."

Gjerde responded that the pNeuton can be used with an oxygen blender to reduce the level of O2, but that this use had not been approved by the FDA.

The second issue has to do with the amount of air that flows in and out of the lung with each breath, called the tidal volume. Tidal volume is usually set based on the size of a patient ‒ the smaller the patient, the less air flows in and out with each breath.

Other ventilators like the Ventec V+ Pro, manufactured by GM, can go down to just 50 mL of air with each breath. The pNeuton, however, can only go down to 360 mL, which is the recommended starting volume for a woman over 5'6" or a man over 5'4". This could be a problem for smaller patients or patients who need lower volumes because of lung damage.

"You start with a recommended tidal volume but that often gets adjusted," said Wynia. "The idea is you want to use the lowest tidal volume to avoid lung injury, and not being able to adjust those parameters is problematic because it means you're going to have people getting more ventilation than they really need, and that can be dangerous and can damage the lung."

According to the user manual, achieving the correct tidal volume may not be possible on the pNeuton machine because the amount of air that flows through the machine is fixed at 36 L/min. Due to the fixed flow rate, another important setting –the inspiration expiration ratio– cannot be controlled separately from the tidal volume. Dr. Kenneth Candido, at Illinois Masonic hospital, said it is important to control these settings independently to achieve certain combinations needed by patients with damaged lungs.

"There should be independence of these two functions," added anesthesiologist Dr. Candido. "If you have bad lung disease you want to spend less time breathing in that oxygen and more time resting."

Gjerde acknowledged that the fixed flow means that the tidal volume and breath rate are interdependent, and that the lower bound on the tidal volume was the lowest level determined safe by the FDA.

Finally, the pNeuton delivers air in what physicians call a square wave pattern. The ideal wave pattern looks more like a wave, slowly increasing air pressure before peaking and then falling off sharply. The square pattern that the pNeuton delivers has a constant pressure that stops and starts.

This setting, says Dr. Jeff Dichter, a physician who contributed to the national ventilator stockpile guidelines, can be uncomfortable and distressing to patients. If the patient tries to breathe against this pattern, the pressure can also damage the lung and lead to a build up of pressure in the chest cavity –which can be fatal if untreated.

Dr. Jeff Hersh, Chief Medical Officer of GE Healthcare, wrote in a statement that not all patients need advanced ICU ventilators and that the pNeuton could fill in the gaps should shorages of ICU ventilators arise. "Not all patients will need high acuity ventilators that you would commonly find today in an ICU setting—some may need less intricate ventilatory support to give their bodies time to fight the virus," Hersh wrote. "That’s the role a less complex ventilator would play during the current COVID-19 pandemic."

Yet this response is an oversimplification, physicians and experts say. "Having an airplane that doesn’t fly isn’t better than not having an airplane," said Dichter. "If a ventilator can’t do what it needs to do for a patient - chances are the patient isn’t going to survive."

As the COVID crisis shocked the country in March of 2020, hospitals feared shortages of ventilators and other critical medical equipment. The Center for Public Integrity reported there were just 16,600 ventilators in the national strategic stockpile and some that were sent to New York hadn’t been properly maintained and were no longer functional.

The federal government sprang into action, and HHS posted a request for information (RFI) for manufacturers who could produce ventilators that met specific requirements for the national stockpile. The requirements, which include technical functions that experts describe as essential, were established by physicians and experts during the agency’s 2014 working group.

HHS abandoned the requirements posted in its initial RFI and deferred to the FDA's "umbrella" emergency use authorization, which passed just days before the contract was announced in late March. The action approved the off-label use of medical devices for Covid-19 patients during the pandemic. Devices approved under such emergency authorization must be accompanied by fact sheets for patients and health care providers, which warn that the devices have not received the same type of review as FDA-approved devices and may carry more risk.

When asked why HHS bought ventilators that did not meet the minimum requirements posted internally, an agency spokesperson said that the contract was not in response to the RFI, and deferred to the FDA’s decision to grant emergency use authorization.

Since it is a pneumatic ventilator, the pNeuton functions only using compressed oxygen that flows through the machine without external electricity or batteries.

This streamlined design also helps keep costs down. Eric Gjerde, the CEO of Airon and inventor of the pNeuton, said that his ventilators typically retail for around $6,000 compared to standard units –which can cost in the tens of thousands.

Gjerde said that his ventilator is perfect for the national stockpile because it will still operate in an emergency when there is no electricity –like an earthquake– and that it can sit in a box for ten years and still work, unlike the national stockpile ventilators that failed.

"Having a variety of ventilators is important because there are lots of different types of ventilators," Gjerde said. "Every hurricane season we get calls from hospitals who are trying to get pneumatic ventilators. I think that’s really critical."

The specifications of the CARESCAPE R860, the other ventilator being produced by GE, do meet the minimum requirements. So do the ventilators being produced by General Motors and Phillips.

"Some patients may need less intricate ventilatory support to give their bodies time to fight the virus," said Amy Sarosiek, a spokesperson for GE Heath.

According to a press release, Ford is in charge of manufacturing capabilities while GE is providing clinical expertise and the ventilator design licensed from Airon.

Doubts

As the medical community learns more about how to treat COVID-19, some have doubts about the effectiveness of ventilators.

"Now, we’re thinking ventilators are bad. Once patients go on a ventilator, they’re done. I really don’t even know why yet, and I’m reading and chatting with other doctors constantly about this," says Feltman. "Right now I can only think of two people who got off of a vent," he says.

Feltman found that even just "proning" patients, or putting them on their bellies for hours or even days, has worked for 60% to 70% of patients. He believes this is due to blood flow or anatomy, such as the placement of the heart in the sternum –or the fact that a belly compresses the alveoli (the air sacs at the end of the respiratory tree of the lungs and are vital to respiration). Proning is now being used by doctors around the world.

Feltman's frontline observations match the conclusions taken from the largest dataset of hospitalized patients to-date in the U.S. A study published on April 22 following 5,700 patients at Northwell Health –New York’s largest hospital system– showed that 88% of patients placed on ventilators died.

Feltman references a Lancet study that found that up to 97% of patients died on ventilators –31 of the 32 patients– at Wuhan Pulmonary Hospital.

Candido said that higher than necessary FIO2 and tidal volume can cause trauma to patients' lungs and that many doctors are now finding that patients do well on high flow nasal cannula tubes with an FIO2 of just 35 percent - about half of the pNeuton’s minimum setting.

"If this was in early March or end of February I might be more enthusiastic about the possibility or the utility of these devices. As this has gone on and on the likelihood of needing them, or requiring them or them being useful is probably null and avoid," Candido said.

*Columbia Journalism Investigations is an investigative-reporting unit at the Columbia Journalism School. Additional reporting was provided by Alexander Lemonides, Zak Cassel, Robert Grimmer, Momina Khan, Ciara Long, and McCaffrey Blauner from the Using Data to Investigate Across Borders class at the Columbia School of Journalism.


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