Search This Blog

Tuesday, March 3, 2020

FDA cautions on cyber vulnerability in certain medical devices

The FDA has issued an advisory about potential cybersecurity vulnerabilities, called SweynTooth, in medical devices that have the capability of communicating with other devices via Bluetooth Low Energy. The agency says the vulnerabilities could allow an unauthorized person to wirelessly crash the device, stop it from working or access functions normally restricted to the authorized user.
It says that it is unaware of any confirmed adverse events related to the issue.
Selected tickers: Abbott (ABT -4.5%), Medtronic (MDT -2.4%), Boston Scientific (BSX -2.7%)
https://seekingalpha.com/news/3548257-fda-cautions-on-sweyntooth-vulnerability-in-certain-medical-devices

COVID-19 could put fifth of UK staff off work: government

Up to one fifth of employees could be off work in Britain when the coronavirus outbreak peaks, the government said Tuesday outlining a new action plan.
Britain had 51 confirmed cases of COVID-19 as of 9:00 am (0900 GMT), an increase of 12 in 24 hours, as Prime Minister Boris Johnson warned the count was “highly likely” to keep rising.
Globally, more than 3,100 people have died and over 90,000 have been infected.
But the British premier said: “For the overwhelming majority of people who contract the virus, this will be a mild disease from which they will speedily and fully recover.”
In a press conference with his chief medical and scientific advisors at Downing Street, Johnson unveiled the steps the government would take if coronavirus takes hold in Britain.
These include asking people to work from home, reducing the number of large gatherings such as football matches and shutting schools.
“In a stretching scenario, it is possible that up to one fifth of employees may be absent from work during peak weeks,” the plan says.
The pressure on emergency services could see police concentrate on only the most serious crimes with hospitals both delaying operations and bringing retired healthcare staff back to work.
But these measures will not be introduced until the outbreak is clearly established, and only then if experts assess the benefits outweigh the costs.
The peak of the virus is expected to occur two to three months after the outbreak begins.
“For the vast majority of the people of this country, we should be going about our business as usual,” Johnson said.
He said that hand washing with soap and water—”for the length of time it takes to sing ‘Happy Birthday’ twice”—was the most effective way to prevent the virus spreading.
“I continue to shake hands,” he added.
UK health officials say that in the worst case scenario, 80 percent of the population could become infected.
Evidence from China, where the outbreak began, suggests a mortality rate of one percent, pointing to up to 500,000 deaths in Britain.
However, this includes many variables and Chief Medical Office Chris Whitty said predicting numbers was “largely speculative”.
The risk was highest for elderly people and those with underlying health conditions. Children appear to be less affected than other groups, he added.
https://medicalxpress.com/news/2020-03-coronavirus-uk-staff.html

Cuomo to amend NY sick paid leave bill for coronavirus quarantine

After announcing the second confirmed case of the coronavirus — COVID-19 — in New York, Gov. Andrew Cuomo said he will amend the sick paid leave bill to allow those with the virus who are quarantined to be paid by their employers.
Cuomo said the state’s second confirmed case is a man, 50, — an attorney who works in Manhattan and lives in New Rochelle, N.Y. — who is in “isolation” in a hospital. The man, who has an underlying respiratory condition, had not traveled outside the country, only to Miami, Fla., he said.
The SAR school in Riverdale, N.Y., where the man’s children attend, is closed Tuesday, the governor said. In addition, two families in Buffalo are being tested for the virus after traveling to Italy, he said.
“The situation in the state of New York is under control. …You can not contain the spread. You can control it. You can limit it. But you can’t contain it,” said Cuomo at a press conference Tuesday morning.
“This is inevitable that this will continue to spread, but the basic fact is 80% of the people who get it will resolve and may not even know they have it,” he added.
PAID SICK LEAVE AMENDMENT
Cuomo said he will add a specific provision to the sick paid leave bill for those who become infected with the virus.
“It will say people, who because of this situation with the coronavirus have to be quarantined, should be protected. Their employers should pay them for the period of the quarantine, and their job should be protected,” he said.
Last week, the governor announced he is requesting a $40 million appropriation for the state Department of Health to hire additional staff, procure equipment and any other resources necessary to respond to the potential novel coronavirus pandemic.
SUNY DECIDING ON STUDY ABROAD PROGRAMS
Cuomo said SUNY schools are considering asking those students studying abroad to come home. He said they should render a decision by the end of the day.
The City University of New York (CUNY), which oversees the College of Staten Island (CSI) in Willowbrook, and St. John’s University, which has a campus on Grymes Hill, have already canceled some study abroad programs located in areas with Centers for Disease Control and Prevention (CDC) level 3 travel health notices.
FIRST CASE IN NYC
The first positive case of novel coronavirus was confirmed in New York on Sunday night. The woman is a 39-year-old healthcare worker who lives in Manhattan.
“The patient, a woman in her late 30s, contracted the virus while traveling abroad in Iran, and is currently isolated in her home,” Cuomo said. “The patient has respiratory symptoms, but is not in serious condition and has been in a controlled situation since arriving to New York.”
The positive test was confirmed by New York’s Wadsworth Lab in Albany, only one day after New York was approved by Vice President Mike Pence to test for the virus.
https://www.silive.com/coronavirus/2020/03/2nd-confirmed-ny-coronavirus-case-cuomo-to-amend-sick-paid-leave-bill.html

France seizes control of masks; Europeans close more schools

France requisitioned protective masks and sent tens of thousands of students home from school, Norway blocked 1,200 passengers on a cruise ship and Spain isolated dozens of health workers as the new coronavirus spread further Tuesday into Europe.
With the new coronavirus taking firmer hold in Europe, the continent is facing many of the same complications seen in Asia weeks ago. Flights to Italy, and especially Milan and Venice, were dropping nearly by the hour, with announcements from Finnish and Swedish carriers that they were suspending flights for at least two weeks.
Travelers from northern Italy, along with South Korea and Iran, now face a ban in Singapore and will not be allowed entry or even to transit through the country. And Saudi Arabia advised citizens and residents to postpone travel to Germany and France due to the spread of the coronavirus in those countries.
Around 120 French schools were ordered to close, most in Brittany and the Oise region north of Paris, which have been hit hard by COVID-19, the disease caused by the new coronavirus.
Italy closed schools in the hard-hit regions of Lombardy and Veneto last week, and announced the closure of schools in the Emilia Romagna region last weekend. All student outings have been canceled nationwide, including off-site after-school activities. In addition, a handful of schools are closed or under quarantine in Germany and even in Poland, which has no confirmed cases of the disease so far.
French President Emmanuel Macron announced in a tweet that the government was requisitioning all current and future stocks of protective masks in order to ensure their distribution to virus patients and health workers.
France’s education minister, Jean-Michel Blanquer, told LCI television that more schools could close and confirmed that he had ordered a freeze on all school trips. But he cautioned against rushing to a general shutdown of the education system.
“It wouldn’t make sense to confine everyone at home, to paralyze the country,” he said.
Around 100 health workers were being kept under isolation in northern Spain and at least 120 more were being closely watched by authorities after at least five doctors and nurses were infected in hospitals, said the Basque health regional minister, Nekane Murga. Health authorities in northern Spain were also speeding up the hiring of new doctors to help a possible shortage of health professionals in the coming months, Murga said.
British authorities laid out plans Tuesday to confront a COVID-19 epidemic, saying that the new coronavirus could spread within weeks from a few dozen confirmed cases to millions of infections, with thousands of people in the U.K. at risk of death.
Officials hope the most drastic measures won’t be needed. Britain may not be able to stop the virus, but it has one vital advantage in fighting it: a head start. The country only has 51 cases so far.
In Haugesund, southern Norway, a German cruise ship with 1,200 passengers was blocked overnight while awaiting the results of two passengers tested for the virus, Norwegian broadcaster NRK said. The Aida Aura was supposed to leave Monday but was still in Haugesund on Tuesday and passengers were being kept on board. The ship’s operator later said the two German passengers tested negative and the ship hoped to be underway soon.
The Geneva International Motor Show resorted to putting automakers’ product unveilings and news conferences online Tuesday after this year’s show was canceled. BMW presented its sleek i4 electric concept car at a digital news conference from Munich, while competitors Daimler and Volkswagen held their own online events.
At Paris Fashion Week, Chanel’s fall collection was streamed online for the many VIPs and fashion editors who stayed away. Some of those who showed up in person donned CC-branded face masks.
Ukraine reported its first confirmed case of the new virus in a man who had recently arrived from Italy, the epicenter of the outbreak in Europe.
https://medicalxpress.com/news/2020-03-europe-virus-response-seize-masks.html

US shuts Homeland Security office in Washington amid employee infection fear

The US Department of Homeland Security closed an office in Washington State early Tuesday amid fears that one of its employees may have contracted the coronavirus.
Acting DHS Secretary Chad Wolf told a hearing in Congress that the employee had reported feeling unwell in the wake of visiting a relative in the King County, Washington nursing home where four patients have died from the disease.
While the employee has not been diagnosed with the virus, the DHS office is being shut for two weeks, Wolf said.
“Late last night the department was made aware of a situation involving a DHS employee,” he told the House Homeland Security Committee.
“The employee did not report to work when they felt ill,” Wolf said.
“We are taking these steps out of an abundance of caution,” he said.
The had visited the Life Care Center nursing home in Kirkland, Washington before the spread of the virus in the facility was known.
The worker’s family has now “self-quarantined,” he said, and other employees were told to work from home to reduce the threat of the spread of the virus.
Four at Life Care have died in the past week, and two other people in the area have also died.
https://medicalxpress.com/news/2020-03-homeland-office-washington-employee-infection.html

Only one percent of China coronavirus cases without symptoms: WHO

The World Health Organization said Tuesday that only one percent of new coronavirus cases registered in China were without symptoms, which appears to bely fears the virus spreads via people who appear healthy.
“Evidence from China is that only one percent of reported cases do not have symptoms, and most of those cases develop symptoms within two days,” WHO chief Tedros Adhanom Ghebreyesus told reporters in Geneva.
https://medicalxpress.com/news/2020-03-percent-china-coronavirus-cases-symptoms.html

Fewer than 20% in US have rapid access to endovascular thrombectomy for stroke

Timely treatment is critical for stroke victims, yet only 19.8% of the U.S. population can access a stroke center capable of endovascular thrombectomy to remove a large clot in 15 minutes or less by ambulance, according to researchers from The University of Texas Health Science Center at Houston (UTHealth). Only 30% of Americans can access a thrombectomy-equipped center in 30 minutes.
The study, published in Stroke, assessed the current state of access to endovascular treatment in the U.S. and evaluated two different strategies to optimize it.
Stroke is the leading cause of long-term disability and fourth-leading cause of death in the world. An , caused by a blockage of an artery, is the most common form. Endovascular thrombectomy can be performed to remove a clot lodged in a blood vessel with a mechanical device threaded through an artery. Research shows it is an effective treatment for improving clinical outcomes in up to 24 hours from onset, but currently not everyone can have it done.
“This is a significant unmet need in stroke care, as the majority of stroke patients may not have a timely access to thrombectomy, a highly ,” said Amrou Sarraj, MD, lead author and associate professor of neurology at McGovern Medical School at UTHealth. Sarraj is also a member of the UTHealth Institute for Stroke and Cerebrovascular Disease.
One strategy, the flipping model, would convert a percentage of hospitals within to be endovascular thrombectomy-capable. The second method, the bypassing model, would transport patients directly to hospitals capable of thrombectomy, bypassing facilities that aren’t when the reroute would take less than 15 minutes.
The 15-minute bypassing model improved access by 16.7%, meaning about 51.7 million more people would be able to have an endovascular thrombectomy procedure in a timely manner. This model is also easier and more cost-effective to implement, according to the authors.
“The bypassing model would alter current stroke treatment paradigms, which still emphasize taking patients to the closest with the ability to administer clot-busting tissue plasminogen activator (tPA) intravenously, regardless of their thrombectomy capability. It would be an optimal solution for resource-strapped areas, because it leverages the existing infrastructure by triaging patients with large strokes in the field to take them directly to a hospital capable of thrombectomy,” Sarraj said.
The flipping model, which equips 10% of the most impactful hospitals to do thrombectomies, improved 15-minute access by 7.5%, and would work best in areas with more plentiful stroke care resources.
“The flipping approach emphasizes infrastructure development. When ample resources are available, this may result in providing access in areas that are currently devoid of thrombectomy services. While each approach has pros and cons, both strategies represent a tremendous opportunity to improve the current access to thrombectomy, which would result in significant stroke care improvement,” Sarraj said.
The research is the first comprehensive assessment of the status of patient access to thrombectomy in the contemporary era, and it is necessary to know how to effectively improve access in the future, Sarraj said.
“While randomized trials are ongoing for better triage of stroke patients, a few states have already implemented legislation for bypassing hospitals without thrombectomy capability. Having more neuro-interventionalists trained and hospitals with the capability to perform thrombectomy would also help increase access. We hope to see more happening on both fronts in the near future to improve stroke care,” Sarraj said.

Explore further
Both simple and advanced imaging can predict best stroke patients for thrombectomy

More information: Amrou Sarraj et al, Endovascular Thrombectomy for Acute Ischemic Strokes, Stroke (2020). DOI: 10.1161/STROKEAHA.120.028850