Medtronic said 18 March it plans to more than double its capacity to make and supply ventilators to fight the global pandemic.
Medtronic, an industry leader in respiratory care and device innovation, said that they had already increased production by more than 40 percent and were on track to more than double its capacity to manufacture and supply ventilators.
The company said it recognizes the acute need for ventilators as life-saving devices in the management of COVID-19 infections. High-performance ventilators play a critical role in the management of patients with severe respiratory illness, such as COVID-19. Without ventilation support, some patients with severe respiratory disease might not survive.
“Medtronic recognizes the demand for ventilators in this environment has far outstripped supply,” said Bob White, executive vice president and president of the Minimally Invasive Therapies Group at Medtronic. “No single company will be able to fill the current demands of global healthcare systems. However, with all manufacturers increasing their production and through partnerships with governments, hospitals and global health organizations, Medtronic is committed to getting more ventilators into the market and to the right locations in the world to help doctors and patients dealing with COVID-19.”
Medtronic produces high performance ventilators for a variety of care settings, including the acute segment (in-hospital patients in intensive care units, emergency departments or on the general care floors) and the sub-acute segment (out of hospital, long-term care facilities or home-ventilated patients).
Medtronic manufactures the Puritan Bennett 980 (PB 980) and Puritan Bennett 840 (PB 840) high performance ventilators in Galway, Ireland, which are primarily designed for critically ill patients in high acuity setting, such as some Covid-19 patients.
In the company’s Ireland ventilator manufacturing facility, the company currently has over 250 employees dedicated to ventilator manufacturing and plans to more than double that number, including transferring staff from other Medtronic sites to support ramp up activities.
Ventilator manufacturing is a complex process that relies on a skilled workforce, a global supply chain and a rigorous regulatory regime to ensure patient safety.
Medtronic said it is prioritizing high risk/high needs areas for ventilator allocation on a weekly basis for global distribution through its supply chain. Covid-19 is a dynamic global issue, and Medtronic will continue to monitor the situation.
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The German Federal Government asked domestic vehicle manufacturers to produce medical equipment, such as masks and ventilators, to help fight Covid-19.
In a statement, the Volkswagen Group announced 20 March it will be providing about 200,000 category FFP-2 and FFP-3 protective face masks for public health protection in the near future. The donation is being made in close cooperation with Federal Minister of Health Jens Spahn.
A spokesperson said the company has more than 125 industrial 3-D printers which could be repurposed to make respirators or other necessary devices, once they receive the required info.
Kathrin Schnurr, spokesperson for Daimler AG Human Resources and External Affairs Communications told International Hospital: “We have inquiries from the medical technology sector. We are currently examining how we can contribute, for example by providing 3D printers or our production expertise.
“In addition, we are in constant communication with the authorities about how and where we can help, for example to sustain the supply infrastructure.”
This follows a trend across Europe as companies unrelated to the medical-device industry offer to retool factories to help make equipment to combat the shortage of devices such as respirators and face masks.
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Johnson & Johnson has announced the selection of a lead COVID-19 vaccine candidate on which it expects to initiate human clinical studies by September at the latest with the first batches of the vaccine available for emergency use authorization in early 2021.
In addition, the company announced the significant expansion of the existing partnership between the Janssen Pharmaceutical Companies of Johnson & Johnson and the Biomedical Advanced Research and Development Authority (BARDA).
Johnson & Johnson also said the company will rapidly scale up its manufacturing capacity with the goal of providing a global supply of more than one billion doses of the vaccine.
Through the new partnership, BARDA and Johnson & Johnson together have committed more than $1 billion of investment to co-fund vaccine research, development, and clinical testing. The company says will use its validated vaccine platform and is allocating resources, including personnel and infrastructure globally, as needed, to focus on these efforts.
BARDA is part of the Office of the Assistant Secretary for Preparedness and Response (ASPR) at the U.S. Department of Health and Human Services.
Commenting on the initiative, Alex Gorsky, Chairman and Chief Executive Officer, Johnson & Johnson, said: “The world is facing an urgent public health crisis and we are committed to doing our part to make a COVID-19 vaccine available and affordable globally as quickly as possible. As the world’s largest healthcare company, we feel a deep responsibility to improve the health of people around the world every day. Johnson & Johnson is well positioned through our combination of scientific expertise, operational scale and financial strength to bring our resources in collaboration with others to accelerate the fight against this pandemic.”
The company’s expansion of its manufacturing capacity will include the establishment of new U.S. vaccine manufacturing capabilities and scaling up capacity in other countries. The additional capacity will assist in the rapid production of a vaccine and will enable the supply of more than one billion doses of a safe and effective vaccine globally.
Paul Stoffels, M.D., Vice Chairman of the Executive Committee and Chief Scientific Officer, Johnson & Johnson, said: “We are very pleased to have identified a lead vaccine candidate from the constructs we have been working on since January. We are moving on an accelerated timeline toward Phase 1 human clinical trials at the latest by September 2020 and, supported by the global production capability that we are scaling up in parallel to this testing, we expect a vaccine could be ready for emergency use in early 2021.” In addition to the vaccine development efforts, BARDA and Johnson & Johnson have also expanded their partnership to accelerate Janssen’s ongoing work in screening compound libraries, including compounds from other pharmaceutical companies. The company’s aim is to identify potential treatments against the novel coronavirus. Johnson & Johnson and BARDA are both providing funding as part of this partnership. These antiviral screening efforts are being conducted in partnership with the Rega Institute for Medical Research (KU Leuven/University of Leuven), in Belgium.
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Chinese researchers have for the first time shown in a pilot study that the use of convalescent plasma from cured COVID-19 patients provides promising results in the treatment of others with more severe disease.
In the preprint study at medRxiv (http://doi.org/dqrs; 2020), K. Duan et al. report that the administration of a single, high-dose of neutralizing antibodies is safe and provides encouraging results with regards to the reduction of viral load and improvement of clinical outcomes.
In the study, ten severe patients confirmed by real-time viral RNA test were enrolled prospectively. One dose of 200 mL convalescent plasma (CP) derived from recently recovered donors with the neutralizing antibody titers above 1:640 was transfused to the patients as an addition to maximal supportive care and antiviral agents.
After CP transfusion, the level of neutralizing antibody increased rapidly up to 1:640 in five cases, while that of the other four cases maintained at a high level (1:640). All patients showed significant improvement in or complete disappearance of clinical symptoms – including fever, cough, shortness of breath, and chest pain – within 3 days.
The authors state that along with increased oxyhaemoglobin saturation – indicative of recuperating lung function – several parameters also improved, including increased lymphocyte counts and decreased C-reactive protein. Radiological examinations showed varying degrees of absorption of lung lesions within 7 days. The viral load was undetectable after transfusion in seven patients who had previous viremia. No severe adverse effects were observed.
The study shows that CP therapy could potentially improve clinical outcomes through neutralizing viremia in severe COVID-19 cases, however, the authors note that further investigation is needed in larger well-controlled trials to assess the optimal dose and time point.
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A small study published 8 April 2020 in Science by researchers in China found that cats are highly susceptible to SARS-CoV-2 and can pass the virus on to other cats via airborne transmission. However, dogs showed low susceptibility, and livestock including pigs, chickens, and ducks were not susceptible to the virus.
They did not study specifically whether cats can pass the virus to humans, although this seems likely as cats can pass the virus to other cats via airborne transmission.
From their findings, the researchers suggest that surveillance for SARS-CoV-2 in cats should be considered as an adjunct to elimination of COVID-19 in humans.>/p>
Two viruses – SARS-CoV 2/F13/environment/2020/Wuhan, isolated from an environmental sample collected in the Huanan Seafood Market in Wuhan (F13-E), and SARS-CoV-2/CTan/human/2020/Wuhan (CTan-H), isolated from a human patient – were used in the study.
The researchers first investigated the replication of SARS-CoV-2 in cats. Seven subadult cats (aged 6-9 months) were intranasally inoculated with 105 PFU of CTan-H. Two animals were scheduled to be euthanized on days 3 post infection (p.i.) and 6 p.i., respectively, to evaluate viral replication in their organs. Three subadult cats were placed in separate cages within an isolator. To monitor respiratory droplet transmission, an uninfected cat was placed in a cage adjacent to each of the infected cats.
In the transmission study, viral RNA was detected in the faeces of two virus-inoculated subadult cats on day 3 p.i., and in all three virus-inoculated subadult cats on day 5 p.i. Viral RNA was detected in the faeces of one exposed cat on day 3 p.i. The pair of subadult cats with viral RNA-positive faeces were euthanized on day 11 p.i., and viral RNA was detected in the soft palate and tonsils of the virus-inoculated animal and in the nasal turbinate, soft palate, tonsils, and trachea of the exposed animal indicating that respiratory droplet transmission had occurred in this pair of cats. Antibodies against SARS-CoV-2 were detected in all three virus-inoculated subadult cats and one exposed cat.
They replicated the study in juvenile cats and found “massive lesions in the nasal and tracheal mucosa epitheliums, and lungs”, indicating that SARS-CoV-2 can replicate efficiently in cats, with younger cats being more permissive.
Additionally, and importantly, the study showed that the virus can transmit between cats via the airborne route.
For the study in dogs, five 3-month-old beagles were intranasally inoculated with 105 PFU of CTan-H, and housed with two uninoculated beagles in a room. Oropharyngeal and rectal swabs from each beagle were collected over a series of days.
Viral RNA was detected in the rectal swabs of two virus-inoculated dogs on day 2 p.i and in the rectal swab of one dog on day 6 p.i. However, they note that “infectious virus was not detected in any swabs collected from these dogs”.
Two virus-inoculated dogs showed antibodies. The other two virus-inoculated dogs and the two contact dogs were all seronegative for SARS-CoV-2.
The dog study was repeated in pigs, chickens and ducks and viral RNA was not detected in any swabs collected from these animals or from naïve contact animals. All were seronegative for SARS-CoV-2. doi: 10.1126/science.abb7015
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A Loughborough University academic is providing guidance to clinicians who are likely to be having – and training people who will have – difficult conversations with patients suffering from COVID-19 or those closest to them.
Professor Ruth Parry, an expert in healthcare communication and interaction, has outlined a series of evidence-based principles with the help of her Loughborough colleague Becky Whittaker, Sharan Watson, of the University of Derby, and Dr Ruth England, of Royal Derby Hospital.
The team shared the recommendations with NHS Health Education England and these have been used to develop a series of open access resources that aim to support healthcare staff who will be having difficult conversations in relation to the coronavirus.
The principles, which have also been added to the International Association for Hospice and Palliative Care’s COVID-19 resources list*, are based on research by Professor Parry and other communication scientists worldwide who have recorded and analysed thousands of difficult conversations across various health and social care settings in the UK, Australia, Japan, and the US.
Professor Parry, who receives funding from the National Institute for Health Research (NIHR), says her guidance steers away from providing recommended phrases or scripts as it is important to equip health workers with the tools to communicate flexibly according to individual circumstances.
Having a conversation by phone, conversations where the staff member who is to do the talking is wearing PPE (Personal Protection Equipment), and conversations with people who have varying degrees of knowledge and distress are all examples of circumstances that can impact how a conversation should be constructed.
What’s more, Professor Parry says giving difficult news over the phone or when wearing Personal Protection Equipment are circumstances that staff would normally want to avoid – in normal circumstances, the health services strive to ensure that these difficult conversations are led by highly experienced professionals, face-to-face, and in calm environments.
Professor Parry has divided her advice into key areas. They include (with a brief overview of what they cover):
Prepare yourself and the environment as best you can
Health workers should clarify in their mind what they want to say and why, and find a comfortable and private setting, as best they can.
Start the conversation with ‘signposting’
Conversations should be started by giving the person on the receiving end an outline of what will follow – for instance, if it is an update, and/or that there is a decision to be made.
How to show compassion and empathy throughout
This can be portrayed through tone of voice, phrases that attend to emotion, and showing understanding without claiming one can possibly fully understand how the person on the receiving end is feeling.
What does the person you are talking to know, expect, and feel?
Health workers should find out what the person they are talking to already knows and how they feel about it as this will help them fit what they go on to say to the individual person they are talking to.
Are they with someone, can they talk to someone afterwards?
If this is a phone call, finding out who is with a person or who they could talk to afterwards is important, says Professor Parry, but this question should not be asked right at the start of a conversation as it could easily be heard as very bad news. Even when there is very bad news to come, building towards it gradually is better than clearly signalling it from the start; a gradual move towards the news reduces the risk of sending the person on the receiving end into severe shock.
Bring the person (further) towards an understanding of the situation – how things are, what has happened or is likely to happen
Professor Parry’s advice is to describe some of the things that are wrong with the unwell person, in such a way that the person speaking is forecasting that bad news is going to come. The point is to bring about gradual recognition, rather than shock.
Dealing with crying
Deliveries should be modified to be softer and more lilting if this happens. Speakers should allow silence, repeat brief further sympathy – ‘I’m so sorry’, and acknowledge the distress before moving on and giving more information.
Moving towards the end of the conversation with ‘screening’ – ‘are there things you would like to ask, that I have not said, or explained enough?’
Phrases like ‘anything else’ should be avoided because, in some circumstances, this can be interpreted as the speaker not expecting there to be anything else. Offering ‘Are there things I have not covered or explained enough?’ removes the implication that the person has not understood things.
Moving towards the end of the conversation with words of comfort and attention to what happens next
If possible, health workers should try to deliver something that is of comfort and that they can say truthfully, says Professor Parry. They should also explain what happens next, advise who the person they are talking to can contact for support and, if necessary, explain how pain or other symptoms will be controlled.
Professor Parry has also provided advice to help somewhat reduce the emotional burden on the healthcare worker – for example, she recommends they find someone to debrief with before and after a difficult conversation. Of the importance of the guidance and what she hopes it will achieve, Professor Parry said: “Healthcare workers are now having to have break bad news and have difficult conversations on an unprecedented scale.
“The kind of research I do makes it possible to pin down, to articulate, precisely how skilled, compassionate healthcare staff communicate, and pass this on to others.
“I hope that our guidance will help all staff having to break bad COVID-19 news to patients or their loved ones, to feel confident and able to communicate well, whilst looking after their own wellbeing.”
The full guidance document has been shared on the Real Talk website – a platform for communication training resource designed to use in face-to-face training events for health and social care staff – and can be downloaded as a PDF here.
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As the COVID-19 pandemic upends life as people know it, changing daily routines, limiting social interactions and shaking their sense of safety, a mental health experts from U.S. hospital Cleveland Clinic’s Mellen Center is stressing that it is perfectly acceptable to feel sad about all of it.
She points out that grief is a natural response to loss – whether it is the loss of a loved one, or the loss of a sense of normalcy.
“We are experiencing a lot of disappointment right now – in both small and big ways – and grief is going to be a factor,” says clinical health psychologist Amy Sullivan, PsyD, ABPP.
“It’s really important that we process this and stay connected to other people in safe ways,” she adds.
Regarding how people should go about dealing with all of these difficult and unexpected feelings bubbling up, she says there is no right or wrong way. However, she offers four suggestions that can help people to cope with current events. 1. Look through the lens of grief and process emotions
She says that the stages of grief can provide a helpful framework for navigating these complex emotions. Experts recognize these stages as denial, anger, bargaining, despair, and acceptance. However, these experts also know that people do not step neatly from one stage to the next in this exact order, she says.
“Grief can come in waves and change on a very regular basis. Our feelings can change on a daily, or even an hourly, basis,” she explains.
Dr. Sullivan adds it is normal to go from feeling despair one day to anger the next.
“The first thing we need to do is to recognize that it is normal to have these waves of emotions that are happening on a regular basis,” Dr. Sullivan says.
Next, she says, acknowledge the loss whether it is knowing or losing someone with COVID-19, losing jobs, missing friends or family.
“Those are all very sad, difficult things for people to manage,” Dr. Sullivan says.
“Feel what you are feeling – whether it is being overwhelmed, anxious, powerless or anything else, it can help to identify and name these emotions,” she advises.
“It can be quite powerful to sit with those feelings for a few moments – to really recognize those emotions and normalize them,” she says.
However, she advises people to set a time limit on this, suggesting they give themselves five minutes to feel that emotion, and then move on to something that they know is a positive coping skill for them.
“It is important for us to accept where our feelings are at the moment and process through them, and then move into a more positive position of acceptance,” she says.
She says this can be done by identifying their own best coping mechanisms
“This is a time when people need to become innovative and develop their own individual sense of coping that works for them during this time,” she says. Examples might include deep breathing, mindfulness exercises, journaling, talking with another person, or going for a walk.
“If it comes to a point where someone cannot handle these feelings on their own, they need to seek mental health help,” Dr. Sullivan says. 2. Fight the urge to disengage
Dr. Sullivan stresses that staying connected is a powerful tool for coping during hard times. Whether that comes in the form of video chatting or sending a good old-fashioned letter, staying in touch with family, friends, neighbours and coworkers can help people to keep a positive attitude, she says.
She adds that many trained mental and behavioural health professionals are currently seeing patients through virtual visits, so that if people are having trouble coping, this could be a solution. 3. Focus on what can be controlled
Dr. Sullivan says that when there is so much uncertainty about the future, it is easy for people to get carried away, playing out the worst-case scenarios in their heads, for example worrying about themselves or someone else getting COVID-19, or wondering if things will ever get back to normal.
“Anticipating negative events can bring a sense of anxiety or fear,” Dr. Sullivan says.
She advises that, instead of agonizing over the things that cannot be known or controlled, people should be aware of what they do have control over. For example, they can choose how much news or social media they consume in a day, and they can decide what they eat. She recommends being mindful about these choices, and focusing on staying in the present. 4. Be open to joy
Lastly, Dr. Sullivan advises people to find joy and gratitude in the small things, like a video chat with family members, or the rush of fresh air when they open a window or step outside. She adds that if they are under a lockdown order, they can find ways to appreciate the opportunity to step back from the hustle and bustle of everyday life and being home.
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A new study by Chinese researchers to check aerosol and surface distribution of SARS-COV-2 in an Intensive Care Unit (ICU) and General Ward (GW) with COVID-19 infected patients found that the virus can be detected in the air up to 4 metres away from patients. In addition, they found the virus was widely distributed on floors and recommend that persons disinfect shoe soles before walking out of wards containing COVID-19 patients.
They also found the virus on computer mice, trash cans, and sickbed handrails.
The early release study was published April 10 in Emerging Infectious Diseases.
The aerosol distribution of the virus has been controversial with previous findings based on very small studies which may not reflect real conditions in a hospital at full capacity. This new study, however, tested surface and air samples in a busy hospital in Wuhan from February 19 through March 2 at the height of outbreak in that city.
The study is particularly pertinent for healthcare workers treating COVID-19 patients and offers a number of conclusions and recommendations.
SARS-CoV-2 was widely distributed in the air and on object surfaces in both the ICU and GW, implying a potentially high infection risk for medical staff and other close contacts.
The SARS-CoV-2 aerosol distribution characteristics in the GW indicate that the transmission distance of SARS-CoV-2 might be 4 metres.
The environmental contamination was greater in the ICU than in the GW; thus, stricter protective measures should be taken by medical staff working in the ICU.
They also found that as the virus settles on the floor it could be tracked around the hospital where healthcare workers from the ICU and GW had walked, such as the floor of the pharmacy.
On this evidence the authors highly recommend that persons disinfect shoe soles before walking out of wards containing COVID-19 patients.
The researchers note that as of March 30 no healthworkers at the hospital had become infected and point out that appropriate precautions can effectively prevent infection.
The authors note that the results of their nucleic acid test do not indicate the amount of viable virus. And that because the minimal infectious dose is unknown, the aerosol transmission distance cannot be strictly determined. doi: 10.3201/eid2607.200885
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Waltham, MA–Nova Biomedical to host “COVID-19 Bedside Glucose Management: Risk of Ascorbic Acid and Hematocrit Interference,” a webinar led by Charbel Abou-Diwan, PhD, Director of Medical and Scientific Affairs, to help inform and support healthcare workers treating COVID-19 patients.
Interest in the antioxidant properties of ascorbic acid use in critically ill patients is growing especially during the in the COVID-19 pandemic. As clinicians search for effective treatments for COVID-19, sepsis, and other critical illness, high dose ascorbic acid is widely considered. These patients are admitted to the ICU where routine POC glucose monitoring becomes part of their care path. Unfortunately, two widely used hospital glucose meters have a substantial interference from ascorbic acid that radically elevates glucose meter results, leading to potential adverse events. This webinar examines the risk of inaccurate glucose meter results due to ascorbic acid interference and how hospitals can protect their patients and protect themselves against this threat.
The webinar will be delivered on three dates: Thursday, April 30th at 2:00 PM EST, Thursday, May 28th at 1:00 PM EST, and Thursday, June 18th at 4:00 PM EST. Attendees can earn educational credits for attending and can register online at novabiomedical.com/poc/glu/covid
About Nova Biomedical
Incorporated in 1976 and based in Waltham, MA, Nova Biomedical is a world leader in the development and manufacturing of state-of-the-art, whole blood, point-of-care and critical care analyzers, as well as providing the biotechnology industry with the most advanced instruments for cell culture monitoring. Nova is one of the fastest growing in vitro diagnostic companies in the world. Nova’s biosensor technology is incorporated in products ranging from handheld meters for glucose self- and point-of-care testing to critical care whole blood analyzers designed for rapid measurement of over 20 analytes. Nova’s biotechnology-specific BioProfile line has pioneered comprehensive cell culture testing, providing over 20 critical cell culture tests with over 12 unique instrument offerings for broad range of cell culture applications. Nova employs over 1,300 people worldwide and has wholly owned subsidiaries located in Brazil, Canada, Great Britain, France, Spain, Italy, Germany, Switzerland, and Japan.
www.novabiomedical.com
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A pan-European consortium of biotech companies announced April 23 that they will collaborate to develop and manufacture on a large scale a novel adenoviral vector-based vaccine against COVID-19.
The vaccine candidate is expected to enter clinical trials mid 2020 with vaccine production planned to start following the successful trials. If all goes according to plan, approximately 6 million doses of the vaccine are expected to be available early in 2021.
The consortium comprises Italian company ReiThera, German LEUKOCARE, and Belgian Univercells. They provide expertise in vector-based vaccine development, vaccine formulation and manufacturing, respectively. Their combined expertise is expected to enable efficient and ultra-fast vaccine development.
The vaccine technology is based on a novel, ReiThera-proprietary simian adenoviral vector with strong immunological potency and low pre-existing immunity in humans. Vaccines based on simian adenoviral vectors have been extensively evaluated in Phase 1 and 2 clinical trials and proved to be safe and immunogenic. ReiThera is currently preparing for a COVID-19 first-in-human trial to be started in Italy in mid 2020.
In parallel to its clinical development, the consortium will start manufacturing and stockpiling the vaccine. With these pilot scale processes, approximately 6 million doses of the vaccine are expected to be available early in 2021. Based on the Phase 1/2 clinical results and a path agreed with regulatory authorities, the intention with these doses will be to vaccinate the most exposed people such as medical and healthcare professionals and highly vulnerable individuals.
LEUKOCARE will contribute to the drug product development by developing a highly stable liquid vaccine formulation based on its well-established technology platform for formulations of viruses and viral vectors.
Univercells will take advantage of the previous successes of its scale-X bioreactor and NevoLine biomanufacturing platform to adapt and scale-up the technology platform and enable the mass production of ReiThera’s vaccine candidate.
Michael Scholl, Chief Executive Officer of LEUKOCARE, commented: “By combining the experience of the partners, the advanced stages of this vaccine development will allow for a swift response to the COVID-19 pandemic. Facing the current challenges, our approach for the fast and low-risk development of drug products with superior stability characteristics is even more important regarding timelines and social impact.”
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