May 17, 2020

New study reveals 5 ways to reduce high blood pressure

Canada
blood pressure
high blood pressure
health-care system
Admin
3 min
In 2010 alone, the federal government spent USD$13.9 billion treating the various symptoms and consequences of high blood pressure.
The University of Calgarys Cumming School of Medicine recently revealed a study that shows the act of treating high blood pressure throughout Canada eat...

The University of Calgary’s Cumming School of Medicine recently revealed a study that shows the act of treating high blood pressure throughout Canada eat up about 10 percent of the country’s health-care budget.

In fact, just in 2010 alone, the federal government spent USD$13.9 billion treating the various symptoms and consequences of this condition. Unfortunately, these numbers are only continuing to rise and show no sign of slowing down any time soon.

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Originally reported by our sister brand Business Review Canada, nine out of 10 people will develop high blood pressure during their lives. Specifically, if nothing is done to stop this epidemic, Canadian taxpayers could pay more than USD$20 billion by 2020 on this disease.

It’s a well-known fact that blood pressure can be caused by a variety of factors; one of the main roots is stress. If you have a particularly high-charged career in which you’re consistently feeling overwhelmed or strained, then you could be at risk for developing high blood pressure.

To stop the problem before it begins (or to maybe get a handle on the issue), we’ve put together a list of lifestyle changes that can help you avoid this growing disease.

1. Watch your weight

As your weight increases, so can your blood pressure. Working 12+ hour days may not leave much room for exercising or eating healthy, but it’s vital to take care of yourself and to be mindful of your state of health.

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Weight loss is one of the most effective lifestyle changes for controlling blood pressure. In fact, just losing 10 pounds can help reduce your blood pressure. Therefore, make time to exercise regularly and eat healthy. Avoid the convenience of fat, greasy foods.

2. Don’t consume too much sodium

One of the main components to eating healthy is to avoid or reduce your sodium intake. Even the smallest reduction of sodium in your diet can reduce your blood pressure by 2 to 8 mm Hg.

There are different ways you can accomplish this goal such as reading food labels, eating fewer processed foods and by not adding table salt to your meal.

3. Limit the amount of alcohol you drink

If you happened to have a particlualry stressful day at the office, you may choose to unwind with a cocktail—watch how many you throw back.

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Sure, in small amounts, alcohol can potentially lower your blood pressure by 2 to 4mm Hg. However, if you drink too much, then alcohol can have the opposite effect. Drinking more than moderate amounts of alcohol can actually raise blood pressure by several points, as well as reduce the effectiveness of blood pressure medications.

The same can also be said for caffeine—what the amount you put into your body on a daily basis.

4. Quit smoking cigarettes

If you’re a smoker, stop! Each cigarette you smoke increases your blood pressure for many minutes after you finish it. Quitting smoking can actually help your blood pressure return to normal, as well as potentially increase your life expectancy.

5. Rid yourself of stressful situations

And finally, if your life is stressful, it’s imperative to rid yourself of these situations. After all, stress can lead to eating poorly, consuming more alcohol and smoking more cigarettes—all triggers of high blood pressure.

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Determine what factors in your life are particularly stressful, and then find ways to eliminate stress from these areas. You may need to change your expectations, learn your stress triggers or make significant time to relax and take part in activities that you enjoy.

If you don’t take care of yourself, then who will? There’s no time like the present to take control of your body and health and start making a difference. After all, you only get one life—don’t waste it!

[SOURCE: CBC News and Mayo Clinic]

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Jul 24, 2021

A guide to labelling compliance for medical devices

medicaldevices
Technology
healthcare
Compliance
Susan Gosnell
4 min
A guide to labelling compliance for medical devices
Susan Gosnell, Product Manager at Loftware, explains labelling compliance for small medical device manufacturers

Small medical device manufacturers often find themselves scrambling to achieve the necessary compliance and validation, risking costly mistakes.

Validating systems and processes including labelling, to ensure they are compliant with stringent regulatory standards is tough and can be expensive. Indeed, compliance with the EU’s Medical Device Regulation (MDR) will cost more than 5% of annual sales, according to 48% of 101 companies polled by the German company Climedo Health, in July and August 2020 about their MDR-readiness.

But if companies bungle the software validation process or put incorrect and uncompliant data on the labels themselves, the penalties are likely to be more severe than just making corrections. Health and safety may be put at risk and fines imposed for failing to comply. When it comes to compliance, they may become overwhelmed with regulations in other geographic regions that focus on device traceability, each with a unique device identifier (UDI-like) component to it. 

On the validation front, companies may not be familiar with the software validation process and the multiple tests and documentation necessary for validation are demanding if companies only have a small IT team that is very busy.

Putting a plan in place

MDR-compliant labelling, however, brings with it certain requirements which differ from what is demanded under the FDA’s Unique Device Identification (UDI) system rules. Under MDR, for example, manufacturers must ensure the label specifically states the device is a medical one using an MD symbol in a box. This is only one of many stipulations that usually require redesigned labels.

Small medical device manufacturers who rely on time-consuming and error-prone manual or legacy labelling processes to facilitate these label updates run the risk of mislabelling which can lead to non-compliance.  They may have limited staff and no structured processes around roles and responsibilities when it comes to label design, changes and approval. As project leads work toward a compliant labelling process, it is therefore important to establish defined roles and access for each stage of the process.

When dealing with a compliance initiative, up to date, correct and compliant labelling is imperative. This involves having all the relevant label design elements in place to comply with the EU MDR or FDA regulations. Many times, label templates are hard coded, meaning IT must be involved in making changes. And with IT staff often being tasked with multiple mission-critical projects in the organisation, labelling projects can be delayed. For many small medical device manufacturers who have limited resources, finding a solution can be a challenge.

Why labelling in the cloud offers a roadmap forward

Validation-ready cloud labelling solutions have now emerged to ease compliance with regulations and time-consuming validation requirements. These solutions, built with the needs of regulated companies in mind, digitise the quality control processes and facilitate compliant labelling with role-based access, approval workflows and electronic signatures. Outside of compliance, carrying out labelling in the cloud drives scalability and productivity for small medical device manufacturers and boosts overall efficiency.

The latest cloud labelling solutions integrate with other cloud solutions, allowing for seamless functionality and minimising the need for local infrastructure resources and cost.

When it comes to validation, as with many labelling systems, those hosted in the cloud have vendor-supplied documentation that streamlines the process and significantly eases the burden when it comes to installation qualification (IQ). The manufacturer itself has a much lighter burden and a streamlined path to a validated system and process.

A more relaxed software release schedule eases the validation burden on life sciences companies because the software is updated once a year rather than multiple times. This gives them a continuously updated and maintained labelling solution without increasing the validation workload on their IT staff.  

Future-proof technology

The manufacturer would of course need to work closely alongside the vendor and review the documentation, but, if needed, the vendor is able to do much of the work for them, providing not only the full validation acceleration pack but also professional services to assist with the validation process.

While some medical device manufacturers choose to tackle validation on their own, the vendor supplied validation acceleration pack or documentation helps to simplify the process. Consultancy and advice around validation is usually available from the vendor, tailored to the business’s specific needs.

Given the immense hassles of compliance for small device manufacturers, cloud-based labelling systems offer the benefits of a full label management system while easing compliance and validation. This is a future-proof technology. With a cloud-based labelling system, medical device manufacturers can be confident that they are running the most up-to-date software, enabling them to address the fast-changing new regulations and cope with whatever comes their way. And especially in the current pandemic, when face-to-face meetings are still problematic, it is a perfect way to keep labelling operations moving forward.

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