Connect with us

Health

Health minister vows to strengthen oversight of medical devices after investigation reveals problems

Editor

Published

on

[ad_1]

Canada’s health minister says she is “deeply concerned” by problems with implanted medical devices that have been been revealed by investigative journalists and has pledged to make changes. 

“The government of Canada agrees that more can be done to further strengthen the oversight of medical devices and to be more open and transparent with Canadians about Health Canada’s regulatory activities,” Health Minister Ginette Petipas Taylor said in a statement on Thursday afternoon. 

“I have directed Health Canada to bring forward an action plan to accelerate these efforts on a priority basis and to work with partners on behalf of Canadians.”

Her statement comes in the midst of a series of stories detailing injuries and deaths that have resulted from a variety of medical devices — including plastic meshes, breast implants, pacemakers, hip replacements and insulin pumps — as well as highlighting gaps in Health Canada regulations and enforcement of such devices. The investigation has revealed vastly different safety testing protocols than those required for drugs. 

Nonie Wideman is one of many Canadians who shared their stories about injuries and illnesses involving medical devices for The Implant Files. As a result of the investigation, federal Health Minister Ginette Petipas Taylor vowed Thursday to strengthen oversight of such devices. (Craig Chivers/CBC)

The investigation, called The Implant Files, is the result of a global media collaboration between CBC News, Radio-Canada, the Toronto Star and the Washington-based International Consortium of Investigative Journalists that examined tens of thousands of medical devices and how they’re made, approved and monitored by regulators worldwide.  

Petipas Taylor said full details of Health Canada’s action plan for medical devices will be published in the coming weeks, and it will focus on three areas:

  • Reviewing the policies and scientific requirements for pre-market approvals of medical devices, “including requirements for clinical data.” The minister said she has also directed Health Canada to “enable more medical device research by health professionals, and expand the use of outside medical and scientific experts to advise the department on medical device issues.”
  • Improving “post-market surveillance of medical devices,” including proposing “new rules requiring that companies inform Health Canada promptly when key foreign regulators issue warnings about a device, so that we can inform Canadians more quickly.”
  • Making “the system for medical device approvals and surveillance more transparent.” Petitpas Taylor pledged to give Canadians more information about their medical devices “so that they can make better informed decisions” and “work to improve access to the clinical data that support our authorizations, so that health professionals can better evaluate the benefits and risks of devices for their patients.”

Full statement from Health Minister Ginette Petitpas Taylor:

As Minister of Health, protecting the health and safety of Canadians is my top priority. I am deeply concerned by recent reports of serious issues Canadians have been facing with implanted medical devices.

Canada has one of the best regulatory systems in the world for medical devices. Canadians can be confident that the medical devices available in this country have met high standards for safety and efficacy. Health Canada has been taking steps to strengthen its regulation of medical devices, and I have asked that this work be accelerated.

Beyond these existing efforts, however, the government of Canada agrees that more can be done to further strengthen the oversight of medical devices and to be more open and transparent with Canadians about Health Canada’s regulatory activities. I have directed Health Canada to bring forward an action plan to accelerate these efforts on a priority basis and to work with partners on behalf of Canadians.

I have asked the Department to enhance its activities in three key areas:

1. To strengthen processes for the pre-market approvals of medical devices: This will include a review of the policies and scientific requirements for the approval of higher-risk medical devices, including requirements for clinical data. I have also directed Health Canada to take action to enable more medical device research by health professionals, and expand the use of outside medical and scientific experts to advise the department on medical device issues.

2. To enhance post-market surveillance of medical devices: Working with partners, Health Canada will take steps to improve the reporting of medical device incidents by industry, health professionals and Canadians and make these reports publicly available. The department will propose new rules requiring that companies inform Health Canada promptly when key foreign regulators issue warnings about a device, so that we can inform Canadians more quickly. The department will also strengthen its compliance and enforcement activities by modernizing its existing tools and increase its inspection capacity to better identify problems before they affect Canadians.

3. To make the system for medical device approvals and surveillance more transparent: Health Canada will take steps to give Canadians additional information so that they can make better informed decisions about their use of medical devices. The department will provide summaries of regulatory decisions when it approves more complex medical devices (known as Class III and Class IV devices). Health Canada will also work to improve access to the clinical data that support our authorizations, so that health professionals can better evaluate the benefits and risks of devices for their patients.

The full details of Health Canada’s Action Plan for Medical Devices will be published in the coming weeks.

The world of medical devices is constantly evolving, and the government of Canada is working to ensure that our regulations and guidance keep pace so that Canadians can have confidence in the medical devices that they need.”

[ad_2]

Source link

قالب وردپرس

Health

Bill Gates: Third Shot May Be Needed to Combat Coronavirus Variants

Editor

Published

on

By

With more than 40 million Americans having received at least the first dose of the Pfizer or Moderna vaccine, a third dose may be needed to prevent the spread of new variants of the disease, Bill Gates told CBS News Tuesday.

Gates’ comments come amid growing concern that the current vaccines are not effective against the more contagious Brazilian and South African variants.

Pfizer and Moderna have stated that their vaccines are 95% and 99% effective, respectively, against the initial strain of COVID. However, some scientists have questioned those statements. Additionally, the World Health Organization and vaccine companies have conceded that the vaccines do not prevent people from being infected with COVID or from transmitting it, but are only effective at reducing symptoms.

Gates told CBS Evening News:

“The discussion now is do we just need to get a super high coverage of the current vaccine, or do we need a third dose that’s just the same, or do we need a modified vaccine?”

U.S. vaccine companies are looking at making modifications, which Gates refers to as “tuning.”

People who have had two shots may need to get a third shot and people who have not yet been vaccinated would need the modified vaccine, explained Gates. When asked whether the coronavirus vaccine would be similar to the flu vaccine, which requires yearly boosters, Gates couldn’t rule that out. Until the virus is eradicated from all humans, Gates said, additional shots may be needed in the future.

AstraZeneca in particular has a challenge with the variant,” Gates explained. “And the other two, Johnson & Johnson and Novavax, are slightly less effective, but still effective enough that we absolutely should get them out as fast as we can while we study this idea of tuning the vaccine.”

The Bill & Melinda Gates Foundation is funding the studies being conducted in Brazil and South Africa, CBS News said. The foundation has also invested in the AstraZeneca, Johnson & Johnson and the Novavax vaccines, which are being tested against new variants. Once the AstraZeneca vaccine is approved, the Global Alliance for Vaccine Initiative or GAVI, founded by Gates, will distribute it globally.

“Gates continues to move the goalposts,” said Robert F. Kennedy, Jr., chairman and chief legal counsel of Children’s Health Defense. “Meanwhile the strategies he and others have promoted are obliterating the global economy, demolishing the middle class, making the rich richer and censoring vaccine safety advocates, like me.”

Kennedy said that the exclusive focus on vaccines has prevented the kind of progress required to actually address and recover from the pandemic:

“From the pandemic’s outset, clear-headed people familiar with the challenges inherent in the vaccine model have understood that the path out of crisis would require multiple steps. Those steps would need to include the development and/or identification of therapeutic drugs, the sharing of information among doctors to hone improved treatment models that reduce infection mortality rates below those for flu, and the kind of broad-spectrum long-term herd immunity that protects against mutant strains and that only derives from natural infection.”

Instead, Gates and vaccine makers are proposing a lifetime of boosters, supporting insufficient testing to determine safety and failing to address the inadequate monitoring of vaccine injuries, Kennedy said.

The views and opinions expressed in this article are those of the authors and do not necessarily reflect the views of Children’s Health Defense.

Continue Reading

Health

Young nurse suffers from hemorrhage and brain swelling after second dose of Pfizer’s COVID-19 vaccine

Editor

Published

on

By

(Natural News) A 28-year-old healthcare worker from the Swedish American Hospital, in Beloit, Wisconsin was recently admitted to the ICU just five days after receiving a second dose of Pfizer’s experimental mRNA vaccine. The previously healthy young woman was pronounced brain dead after cerebral angiography confirmed a severe hemorrhage stroke in her brain stem.

Her family members confirmed that she was “breaking out in rashes” after the vaccine. She also suffered from sudden migraine headaches, and got “sick” after taking the second dose of the vaccine. At the very end, she lost the ability to speak and went unconscious. The migraines, nausea, and loss of speech were all symptoms of a brain bleed and brain swelling, something her family did not understand at the time, and something nobody would expect after vaccination.

While on life support, neurologists used angiography to image the damage inside the brain. They found a subarachnoid hemorrhage, whereas a bulging blood vessel burst in the brain, bleeding out in the space between the brain and the tissue covering the brain. The ensuing swelling cut off oxygen to the brain and caused brain death. On February 10, 2021, Sarah reportedly had “no brain activity.” Some of the woman’s organs are now being procured, so they can be donated to other people around the world.

Doctors warn FDA about COVID vaccines causing autoimmune attacks in the heart and brain

Experimental COVID-19 vaccines may cause inflammation along the cardiovascular system, leading to heart attack and/or stroke. This serious issue was brought forth to the Food and Drug Administration (FDA) by Dr. J. Patrick Whelan, M.D., Ph.D. and further confirmed by cardiothoracic surgeon, Dr. Hooman Noorchashm, M.D., Ph.D. The two doctors warned that a recently-infected patient who is subject to COVID-19 vaccination is likely to suffer from autoimmune attacks along the ACE-2 receptors present in the heart, and in the microvasculature of the brain, liver and kidney. If viral antigens are present in the tissues of recipients at the time of vaccination, the vaccine-augmented immune response will turn the immune system against those tissues, causing inflammation that can lead to blood clot formation.

This severe adverse event is likely cause of death for the elderly who are vaccinated despite recently being infected. There is no adequate screening process to ensure that this autoimmune attack doesn’t occur. The elderly are not the only people vulnerable to vaccine injury and death. Pfizer’s experimental COVID-19 vaccine could be the main cause behind the sudden death of Sarah Sickles, a 28-year-old nurse from Wisconsin. The Vaccine Adverse Events Reporting System has captured five permanent disabilities in Wisconsin, 58 ER visits, and eleven deaths in just one month. This is the first case in Wisconsin of someone under 44 years of age suffering from severe COVID-19 vaccine side effects and death. There are now more than 1,170 deaths recorded in the U.S. related to the experimental mRNA vaccines, a reality that the FDA and CDC continue to ignore.

Continue Reading

Health

Powering hypersonic weapons: US armed forces eyeing dangerous 5G tech

Editor

Published

on

By

(Natural News) Much of the conversation surrounding the benefits of 5G is geared toward the consumer side of the technology. People will be able to download videos at lightning speed and will be more connected than ever, proponents claim, although there are serious questions regarding its safety. However, some of the most important 5G applications are not civil at all – the technology will be used extensively in the military domain.

Some of its military uses are outlined in the Defense Applications of 5G Network Technology report, which was published by the Defense Science Board. This federal committee gives scientific advice to the Pentagon. Their report states: “The emergence of 5G technology, now commercially available, offers the Department of Defense the opportunity to take advantage, at minimal cost, of the benefits of this system for its own operational requirements.”

The 5G commercial network that is being built by private companies right now can be used by the American military for a much lower cost than if the network had been set up exclusively for military purposes.

Military experts expect the 5G system to play a pivotal role in using hypersonic weapons. For example, it can be used for new missiles that bear nuclear warheads and travel at speeds superior to Mach 5. These hypersonic weapons, which travel at five times the speed of sound and move a mile per second, will be flying at high altitudes on unpredictable flight paths, making them as hard to guide as they will be to intercept.

Huge quantities of data need to be gathered and transmitted in a very short period in order to maneuver these warheads on variable trajectories and allow them to change direction in milliseconds to avoid interceptor missiles.

5G for defense

This type of technology is also needed to activate defenses should we be attacked by a weapon of this type; 5G automatic systems could theoretically handle decisions that humans won’t have enough time to make on their own. Military bases and even cities will have less than a minute to react to incoming hypersonic missiles, and 5G will make it easier to process real time data on trajectories for decision-making.

There are also important uses of this technology in combat. 5G’s ability to simultaneously link millions of transceivers will undoubtedly facilitate communication among military personnel and allow them to transmit photos, maps and other vital information about operations in progress at dizzying speeds to improve situational awareness.

The military can also take advantage of the high-frequency and short-wavelength millimeter wave spectrum used by 5G. Its short range means that it is well suited for smart military bases and command posts because the signal will not propagate too far, making it less likely that enemies will be able to detect it.

When it comes to special forces and secret services, the benefits of 5G are numerous. Its speed and connectivity will allow espionage systems to reach unprecedented levels of efficiency. It will also make drones more dangerous by allowing them to identify and target people using facial recognition and other methods.

Like all technology, 5G will also make us highly vulnerable. The network itself could become an attractive target for cyber-attacks and other acts of war being carried out with cutting-edge weaponry. In fact, the 5G network is already viewed as critical infrastructure and is being carefully protected before it is even fully built.

While the focus on 5G’s dangers to human health and the environment is absolutely warranted, it is also important not to lose sight of the military implications of 5G. After all, it is not just the United States that is developing this technology for military purposes; our enemies, like China and other countries, are also making great strides in this realm.

Continue Reading

Chat

Trending