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FDA approves Q-tip-like swabs to allow patient self-testing for COVID-19

The FDA announced today that spun synthetic swabs — with a design similar to Q-tips — could be used to collect samples from patients suspected of having COVID-19. Patients could even take the samples themselves from the front of the nose, the agency said.

The solution could help solve multiple problems:

  • The nationwide shortage of  long nasal swabs typically by healthcare workers used for COVID-19 sample collection.
  • Danger to healthcare workers from exposure to COVID-19 patients.
  • Calls from several governors, business leaders and members of Congress to vastly increase testing before businesses can reopen and social distancing can be reduced.
  • The level of discomfort that patients who have been tested using those traditional swabs have reported, including President Donald Trump. “Not something I’d want to do every day,” Trump said after being tested March 13 for the first time. (He was tested again April 2.) “Nothing pleasant about it.”

The FDA said it collaborated with UnitedHealth Group, the Gates Foundation and diagnostics company Quantigen on a clinical investigation to determine whether spun synthetic swabs could be used for COVID-19 testing.

U.S. Cotton (Gastonia, N.C.) developed a polyester-based, Q-tip-type swab that is fully synthetic for compatibility with COVID-19 testing, according to the agency. Harnessing its large-scale, U.S.-based manufacturing capabilities, U.S. Cotton plans to produce these new polyester swabs in large quantities to help meet the needs for coronavirus diagnostic testing, the agency said.

“This action today demonstrates the ingenuity that results from the FDA working in partnership with the private sector,” said FDA commissioner Stephen Hahn in a news release. “We appreciate the work of these collaborators to consider how these test supplies could be broadly distributed to meet not only the testing needs of the United States but also global needs around the pandemic. All of these actions by these American organizations will help continue to expand our testing capability.”

 

Source: https://www.massdevice.com/fda-approves-q-tip-like-swabs-to-allow-patient-self-testing-for-covid-19/

Covid-19 pandemic: a wake-up call for domestic production of medical devices

According to GlobalData analysis, approximately 75,000 more ventilators and 5.6 billion N95 respirator masks are in demand due to the Covid-19 outbreak in the US. The crucial reality is that demand is much higher than domestic manufacturers’ ability to deliver. Supply chains have moved abroad for many years and are highly dependent on imports.

To secure medical supplies, many countries have ceased export of the essential medical devices to other countries. On 2 April, the US invoked the Defense Production Act to resolve supply chain issues related to the manufacturing of ventilators and to ensure the production of additional N95 face masks, requesting 3M to cease exporting respirators that are manufactured in the US to the Canadian and Latin American markets. In late March, the European Union announced it was restricting the export of personal protection equipment to all third-party countries. The Indian government has banned the export of ventilators and sanitizers since 24 March. As the pandemic continues to worsen, more countries are likely to introduce new export curbs.

Domestic manufacturing of essential medical devices can not only overcome trade barriers but also ensure product quality and market stability. During the pandemic, counterfeiting and price gouging of imported goods happen frequently with surging demand. The Netherlands has recalled nearly half of the shipment of 1.3 million masks imported from China, which do not meet quality standards. The price of masks made in Indonesia increased four times after the outbreak. Some ventilator distributors tripled the pricing for the same model and still sold out immediately, leading to inflation in the ventilators market.

China lies at the heart of many medical supply chains. According to the International Trade Centre, China exported approximately $73M of medical or surgical related instruments in 2019 with an increase of 8% since 2016. This does not include the raw materials that are required for medical devices manufacture, such as the rubber bands that hang masks on ears. China is the largest manufacturer and exporter of masks, with 50% of the global supplies. Many multinational medical suppliers, such as 3M and Kimberly-Clark, have increased production capacity in China for many years, resulting in 95% of the masks in the US being imported. Most manufacturers would be devastated if China followed other countries’ restrictions and stopped exporting essentials.

China has yet to issue any ban on the export of personal protection equipment, ventilators, and their raw materials for production since the Covid-19 outbreak. In fact, 3M received approval from China to export 10 million China-manufactured N95 respirator masks to the US this week in response to Covid-19. According to Chinese customs data, exports of essential hospital supplies only declined 15% in the first two months of 2020, despite of the surging domestic needs due to coronavirus and the trade war with the US. The Chinese government has offered to export protective equipment to Italy and other countries after the global outbreak.

However, despite the hope from China, ramping up domestic production capacity of medical supplies is the major focus for many countries as Covid-19 spreads. From a risk analysis perspective, relying on imports of essential medical devices is a serious threat to public health security. GlobalData expects a noticeable trend towards moving from a dispersed supply chain back in favour of domestic production for key medical devices.

 

Source: https://www.medicaldevice-network.com/comment/respirator-masks-covid-19/

Tesla Shows Off Prototype Ventilator For COVID-19 Patients Made Out Of Electric Car Parts

The coronavirus crisis has led Elon Musk to jump into the medical device industry, with SpaceX fabricating components for Medtronic MDT ventilators, corporate donations of BiPAP breathing machines that can be modified for use as non-invasive ventilators and promising to use a Tesla TSLA factory to produce ventilators. Now Tesla engineers have designed a prototype ventilator that uses parts adapted from electric vehicles.

The carmaker posted a video Sunday featuring a group of engineers, all wearing surgical masks and gloves, showing off their creation built with inhouse automotive parts, rather than with the compressors, pumps and other highly specialized components desperately needed by medical device manufacturers to ramp up ventilator production.

“We want to use parts that we know really well, that we know the reliability of, and we can go really fast and they are available in volume,” said Joseph Mardall, Tesla’s engineering directory.  “We’ve used a lot of those.”

The device shown in the video includes a touchscreen display panel, the same used in Model 3 electric sedans, that track intake of oxygen and output of carbon dioxide, a Model 3 infotainment computer system, lithium-ion battery, as well as pumps, compressors, tubes and an oxygen mixing chamber. Given that it’s just a prototype, it’s not clear when or if Tesla will be able to produce the devices in high volume–assuming they are tested and approved for use for COVID-19 patients by the U.S. Food and Drug Administration

Musk said via Twitter on April 3 that SpaceX is making “proportional solenoid valves for Medtronic.”

Musk’s moves come as General Motors GM and Ford also team up with medical device makers to help them accelerate production, though neither of those automakers has touted their own designs. Instead GM and Ford, like SpaceX, plan to make components at auto parts plants, which companies including Medtronic, Ventec, GE Healthcare and ResMed RMD say is most critical.

“It’s not a final ventilating manufacturing problem. It’s a parts problem,” ventilator maker Mick Farrell said in an April 1 interview on CNBC. “When we get genuine offers from automotive companies, aerospace companies and defense companies, and we’ve had hundreds of offers, we say fantastic! Don’t make a ventilator and buy these parts. Make these 10 parts for us and let us scale, which we can, between us and our competitors, to meet the demands of COVID-19.”

The FDA accelerated the approval process for coronavirus-related treatments on March 31 to help with the health crisis. Nevertheless, ventilators made for patients with the most severe breathing problems are extremely complex and certification will take time, according to Gail Baura, an engineering professor at Chicago’s Loyola University who specializes in medical device technology and is author of a textbook on the subject that’s widely used at medical schools.

“There are all these engineering standards that are used to design these medical devices, and the FDA looks to make sure that you have tested and proved conformity to these standards before you can get FDA clearance and legally sell these devices,” she tells Forbes. A lot of time will be required to validate ventilators coming from these new manufacturing partnerships, “even with the emergency use authorization that the FDA is providing.”

 

Source: https://www.forbes.com/sites/alanohnsman/2020/04/06/tesla-touts-a-prototype-ventilator-for-covid-19-patients-made-out-of-electric-car-parts/#4ac1fa2f235b

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