6 artificial flavorings with cancer-causing properties – (FDA bans)

The announcement from the U.S. Food And Drug Administration carries a yawn-inducing title: “FDA Removes 7 Synthetic Flavoring Substances from Food Additives List.” It sounds like a regulatory move aimed at food-makers, and it is. But it’s one that has a slightly alarming backstory: The FDA is effectively banning these artificial substances because they have been shown to cause cancer in animals.

Under a provision of the Federal Food, Drug, and Cosmetic Act known as the Delaney Clause, the FDA cannot approve ingredients for use in food that have been found “to induce cancer in humans or animals at any dose.” Six of the substances “delisted” (effectively, banned) by the FDA have been found to cause cancer in animals exposed to very high doses. The seventh ingredient was delisted because it is no longer used at all by the food industry, the FDA says.

The six other artificial flavorings — benzophenone, ethyl acrylate, eugenyl methyl ether, myrcene, pulegone, and pyridine — are now no longer permitted for use in food, even though the FDA states that previous testing found “they do not pose a risk to public health under the conditions of their intended use.” Eager to not incite any kind of a panic, the FDA is stating the animals that developed cancer did so after exposure to very high levels of these flavorings — much higher doses than any human would likely ingest: “The FDA is only revoking the listing of these six synthetic flavorings as a matter of law. The FDA has concluded that these substances are otherwise safe.”

This latest FDA mandate comes on the heels of two other moves away from non-natural ingredients: In January, Dunkin’ announced it would phase out artificially derived coloring in its products by the end of the year, and last month, McDonald’s pledged that it would remove all artificial colorings and preservatives from its classic burgers (minus those pesky pickles). Taken together, these individual developments suggest the movement away from artificial colorings, preservatives, and flavorings is gaining serious traction.

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Fast-track review for new (e-cigs) with tech to prevent youth use-[FDA chief]

Agency’s requirement that any new e-cigarettes must undergo review before entering the market prevents them from introducing new products.

The Food and Drug Administration is considering fast-tracking the review process for e-cigarettes that include features that make the products less likely to be used by kids, Commissioner Scott Gottlieb told CNBC on Thursday.

Gottlieb last week announced a historic crackdown on e-cigarettes after reviewing unpublished federal data he’s reviewed showing teen use has reached “epidemic” levels. The FDA ordered five brands — Juul, British American Tobacco‘s Vuse, Altria’s MarkTen, Imperial Brands‘ Blu E-cigs and Japan Tobacco’s Logic — to submit plans within 60 days detailing how they will prevent teens from using their products.

Some manufacturers have said the agency’s requirement that any new e-cigarettes must undergo review before entering the market prevents them from introducing new products that could curb youth use, including bluetooth features that could disable them near schools.

Yet Gottlieb said while companies have talked about these ideas with reporters and politicians, they haven’t raised them with the FDA. He said the door is “very open to that kind of discussion.”

“I think if someone came to us with a good idea about how a product could be modified to be less appealing to kids or less prone to misuse by children, we’d be very interested in that product, and we’d be very interested in having a discussion around that and how we could put that through an efficient regulatory process,” he said.

Juul, the brand that dominates nearly 73 percent of the e-cigarette market, said it “believes technology is absolutely part of the solution.” The company plans to launch bluetooth-enabled devices internationally next year, according to a person familiar with the matter.

Products that were on the market before Aug. 8, 2016, were supposed to start undergoing review this year until Gottlieb extended the deadline until Aug. 8, 2022. He said Thursday that the FDA is actively considering reinstating the original deadline, meaning companies may soon be required to submit applications. It may also pull flavored e-cigarette products from the market until those applications are reviewed and cleared.

Critics have scolded Gottlieb for ever giving e-cigarette companies more time. He said it was necessary because it wasn’t clear what the FDA wanted from manufacturers. Now, a year later, the FDA has issued some guidelines and plans to soon release more.

If he had kept the original date, companies would have started sending in applications and wouldn’t have received a decision until next year.

“What we couldn’t anticipate, and what we didn’t anticipate, in all fairness, was how fast the youth use would accelerate,” Gottlieb said.

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Dangers of Liquid Nitrogen in Food, Drinks (FDA Warns)

Inhaling the vapor released by liquid nitrogen in food or drinks can also cause breathing problems, especially among people with asthma.

Consuming or handling food and drink products where liquid nitrogen is added just before consumption can lead to serious injury, according to the U.S. Food and Drug Administration.

These products — which have names such as “Dragon’s Breath,” “Heaven’s Breath” and “nitro puff” — are available in food courts, kiosks, state or local fairs, and other places where food and drinks are sold. Examples of such products include liquid nitrogen-infused colorful cereal or cheese puffs that emit a misty or smoke-like vapor, and alcoholic and non-alcoholic drinks prepared with liquid nitrogen that emit a fog.

Liquid nitrogen isn’t toxic, but its extremely low temperature can cause severe damage to skin and internal organs if mishandled or consumed, the FDA said in a news release. Inhaling the vapor released by liquid nitrogen in food or drinks can also cause breathing problems, especially among people with asthma.

refill

“The main issue is that liquid nitrogen must be fully evaporated from food or beverage before it is served. In liquid form, it can cause burns to the mouth, esophagus, and upper airway, leading to perforation or rupture of the organs — which could be deadly.

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How Can [Gigantic] knowledge energy the future of Healthcare

Big data can be used to reduce human errors. The analysis can be used to scan a patient’s history of medical records and identify potential errors and flag anything that seems out of place.

In today’s world, the usage of big data has made huge leaps in in various industries, healthcare is no exception. Being one of the largest industries in the U.S., big data is already used in various sectors for predictive and analytic reasons. Big data can help and challenge scientists to create and analyze data in ways it has ever been done before.

In this article, I’ll explain how big data has already been adopted in some areas but I’ll also take a look into the future and give some insight in the ways with great potential in which big data can be use to push forward the healthcare industry.

Fitness Industry Connects with Healthcare

The fitness industry has become one of the most progressive parties in adopting big data, especially for wearable fitness technologies. Generally speaking, fitness tracker gadgets encourage people to exercise more and keep track of the results.

Two of the biggest companies in this area are Fitbit and Apple Watch. The gadget’s software tracks the user’s day-to-day activities, exercise sessions, sleep, nutrition and body weight.

Features-Offered-by-IoT-for-the-Healthcare-Industry

The software is tracking all these data points from millions of users which is then used to analyze the data and link it to health and various other things.

So, how can this data be linked to the healthcare industry?

Obviously, the data isn’t 100% reliable and it would probably not affect the healthcare industry directly. But you can’t deny that such large data sets, that track and store human data on a daily basis, are very helpful and can have a significant impact on healthcare in the future. At the moment, it’s one of the biggest sources of personal health-related and real-time data.

For example, prevention is an important aspect of healthcare as governments and health institutions work tirelessly on new ways to prevent certain diseases and other health-related issues.

That being said, critics voiced a lot of negative feedback in regards to privacy-related matters. This is largely based on a report published by the Federal Trade Commission, which claimed that based on an analysis of ~10 fitness applications, 76 third parties received personal data generated by these fitness trackers – most likely bought.

In the future, the data will probably be more accurate as the technology to track the earlier mentioned data points will improve massively.

Healthcares- Big data

Reducing Costs

Big data is also a great solution to calculate current business models, cost models and expenses. It’s therefore extremely valuable for healthcare institutions to analyze their current situation based on big data to save costs.

Additionally, data sets can be analyzed and models can be built in order to predict staff allocation and other rates based on historical data that clearly shows when it’s busy. For example, during winter holidays there’s a higher chance for ski – or snowboarding accidents than in the summer.

Thus, health institutions can that money and allocate it to new investments such as equipment or research. It’s also linked to insurance companies, which save money if the allocation of staff, hospital beds and so on is better utilized.

Prevent Medical Human Errors

Medication prescription errors are a serious problem for hospitals and other healthcare institutions. Everyone is still human, so there’s always a chance to make a mistake by prescribing the wrong or different medication accidentally. In worst case scenarios, it may actually harm the patient with potentially a catastrophic ending.

Big data can be used to reduce human errors. The analysis can be used to scan a patient’s history of medical records and identify potential errors and flag anything that seems out of place.

Especially healthcare professionals who cater a lot of patients throughout the day risk a higher chance of making a mistake. Thus, software to help them out would be the perfect solution.

A high-end research paper “Harvard Research Shows New Technology Can Save Thousands of Lives a Year by Reducing Prescription Errors” stated that from almost 800,000 analyzed patients, little under 16,000 errors were flagged and 75% of these red-flags were actually validated.

The report also states that U.S. healthcare loses around $20bn is lost per year, as a result of prescription errors.

The only downside of this newly developed algorithm is that many hospitals and other healthcare institutions still work with relatively old computers, probably not capable of running such a memory-heavy software tool.

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3 steps for quality leaders — Mark Eydman, Six Pillars Consulting interview

While it starts by an outstanding interaction, it is more likely to build over time, with a deepening relationship and multiple “touch points”.

With rising marketing and new business costs, never has it been more important to retain happy customers.

But how do you know whether your customers are truly loyal? Whose role really is it to manage customer loyalty? And how do you know what actually helps you retain your customers year-after-year?

Below, Mark Eydman, MD or Six Pillars Consulting, shares his insights.

Customer satisfaction is not the same as loyalty

ISO 9001:2015 focuses on customer satisfaction:

  • Clause 4: Ensure the QMS consistently provides products and services that meet customer requirements and enhance customer satisfaction
  • Clause 6: Ensure quality objectives are relevant to enhance customer satisfaction
  • Clause 7: There are the resources available to enhance customer satisfaction

However, Mark Eydman, Founder and Managing Director of Six Pillars Consulting says loyalty is about much more than satisfaction.

Customers tend to feel satisfied, or dissatisfied, as a result of a specific interaction with an organisation. For example, a well laid out supermarket, well lit, clean and staffed by friendly assistants can drive that feeling.

Loyalty is so much more. While it starts by an outstanding interaction, it is more likely to build over time, with a deepening relationship and multiple “touch points”.

A loyal customer believes that their relationship with your organisation is in their best interests!

Satisfaction

ISO 9001:2015 doesn’t specify how to keep your customers loyal, so here are three steps to measure and improve customer loyalty.

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Solid Evidence That Attending Medical Devices Training Is Good for Your Career Development

These bodies also state the nature of the regulations and the requirements that medical device and healthcare organizations need to adhere to in order to meet their expectations.

Training is the foundation to producing products and services that meet regulatory and quality expectations and industrywide acceptance. This is generally true for all products and services, but in particular, for medical devices. Why? Medical devices are not in the same league as any other ordinary product that can be handled by anyone in any manner.

Training is the only means by which medical device companies that manufacture medical devices and the staff that handle these products on a daily basis and administer them on patients, can ensure patient safety. Training that imparts a degree of understanding of the methods, processes and technologies in this field is the means to this and to meeting the quality requirements.

Training ensures safety and quality in the manufacture and use of medical devices

Medical devices are highly specialized products that require extreme care and diligence when handling. A slight error or carelessness can result in far-reaching consequences that have the potential to cause anything from physical harm to death for the patient or the user. This explains the criticality of training for medical devices because an untrained person is more likely to cause errors in using these high-specialty products than a trained one.

Another core factor in medical device training is that it is part of regulatory expectations in most markets. Getting trained in the prescribed manner is very crucial for medical device professionals because training is indispensable in helping them meet regulatory requirements. The main purpose with which regulations are made is to ensure that the products that complying organizations produce and the processes they employ meet the required quality standards.

Since medical devices are an area in which one cannot take chances, regulatory agencies such as the FDA and the EMA, and standards bodies such as the ISO have made training mandatory for medical device professionals. These bodies also state the nature of the regulations and the requirements that medical device and healthcare organizations need to adhere to in order to meet their expectations.

Professionals and organizations that meet these standards are assured regulatory approval. They are also more likely to win public confidence for the quality of their products. Medical device training is what helps assure that stay updated in their professions.

Regulations mandate training in medical devices

The role of training in medical devices can be understood from the fact that it is not just another desirable, nice-to-have feature, but one that is made mandatory by regulations in this area. These are some of the regulations that make training for medical devices mandatory for companies in the medical devices field:

–       ISO 13485:2016 – Medical Device Quality Management System Requirements

–       ISO 14971

–       Medical Device Single Audit Program (MDSAP)

–       New Requirements set out by the EU Medical Device Regulation and In Vitro Diagnostics Regulations

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Which eliminates a patients [restrictions] with medical consultants

Healthcare IT is much more than just an electronic version of paper medical records.

Evaluation–Diagnose–Treatment. This is the traditional and generally accepted method ofa medical procedure. However, the healthcare sector has evolved over the last couple of years. Today’s healthcare is using a new, digital companion to determine how patients feel based on much more than their present medical condition. Healthcare information technology or healthcare IT is widely used by doctors, surgeons, and pharmacists to understand medical information of patients and improve communication between doctors and patients.

What Is the Use of Healthcare IT?
The major advantage of the healthcare IT is that it reduces the communication gap between a patient and doctor as the healthcare IT collects and converts the patient’s information from paper records and medical charts to electronic data.This migration provides direct access to patient’s information to doctors irrespective of their location and enables to share knowledge with other doctors than the current medication providers. Moreover, the doctor-recommended prescriptions can be transmitted electronically owing to the healthcare IT, which has improved efficiency and reduced the valuable time.

Healthcare IT is much more than just an electronic version of paper medical records. It includes previous maintained medical images by radiology departments and opinions of specialists on a certain method of treatment. In addition, the digital messages including emails,healthcare tips, chat logs, the day-to-day medical progress of a patient, and financial factors such as scheduling and billing fall under the sky of healthcare IT. However, these records must be stored and maintained carefully to prevent invasion of privacy. On the other hand, the technological advancements and easily accessible facilities fuel the demand for healthcare IT.

Roughly, two-third Americans have instant access to the internet, which eliminates a patient’s restrictions with medical consultants.The tech giants such as Microsoft, Apple, and other new startups are developing up-to-the-minute opportunities in the healthcare IT market by improving access to digital applications and providing efficient security features. This has increased demand for healthcare IT services, boosting the growth of the healthcare information technology market. According to a report published by Allied Market Research, the market is expected to register a CAGR of 13.2 % in the period 2014–2022.

Healthcare IT Generates Job Opportunities
The growth of healthcare IT has created a surge in job opportunities in IT sector. According to the U.S. Bureau of Labor Statistics, by the end of 2024, the need for healthcare and medical managers will boost by about 17 percent.

Therefore, coding experts are extremely essential to smoothly transfer the individual records of patients to a central hub, by changing the codes that could otherwise interrupt the transfer of information. It is estimated that the requirement of such new codes is nearly 130,000. Moreover, the IT specialists assist healthcare service providers to obey the federal guidelines for records, a collection of data and share to protect a patient’s privacy. Due to such requirements, there are ample of IT companies and even startups that are launching new platforms to develop a sustainable healthcare IT department.

Recently, JavaraInc., a clinical research service organization, launched a platform that is focused on compelling innovative research partnerships, service,and technology to healthcare systems. Jennifer Byrne, the co-founder,and CEO of Javara stated that the new healthcare IT platform will bring better outcomes for patient-centered care, better economic results, and easier research delivery model to the bio pharmaceutical sector.

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