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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Healthcare Trainings That Everyone Went Crazy Over It?

One question that could arise in the minds of readers is: is it necessary to get trained about these regulations?

Healthcare compliance trainings are undertaken to get a clear idea about the regulatory compliance requirements in the industry. Healthcare is a highly regulated industry, which means that the regulatory bodies keep issuing regulatory guidelines, standards or requirements from time to time, as the regulations come in. One question that could arise in the minds of readers is: is it necessary to get trained about these regulations?


The answer is, yes. Healthcare compliance trainings are necessary because of the nature of the regulations. These regulations are very specific and strict. Healthcare organizations cannot take their implementation casually. Noncompliance invites enforcement actions such as citations or Warning Letters to, depending on the gravity of noncompliance and the consequences it causes to the public, even abrogation of the business.

These are the reasons for which healthcare compliance trainings are very important for organizations. Obviously, no organization likes to face a situation arising out of noncompliance. Healthcare compliance trainings are the only antidote and alternative to noncompliance. One may wonder if the high price at which compliance trainings are offered-from a few hundred dollars to a few thousands for a session-is justified. These words of Former U.S. Deputy Attorney General Paul Mc Nult best counter such skepticism: “If you think compliance is expensive, try non‐compliance”.


CHI garden targets families with little access to fresh food

We do as such numerous things here to connect the network with assets. This was simply one more advance in that.

The antiquated Greek thinker Aristotle is credited with saying that nature loathes a vacuum.

For Thomas Strawmier, the vacuum was the vacant field he continued driving past on the grounds of the year-old Creighton University Medical Center-University Campus at 24th and Cuming Streets.

“I figured, ‘We should put something there,’ ” said Strawmier, a medical caretaker specialist at the facility.

Realizing that the facility serves an assorted gathering of patients, some of whom experience difficulty getting new veggies, he proposed a network plant.

It could give some deliver to patients — even offer beds for neighbors who need to become their own — and fill in as a showing site for nutritionists, physical advisors and social wellbeing experts. There they could convey exercises on adhering to good diet, damage free planting and stress administration.

So half a month prior, Strawmier and a bunch of facility associates — and their children — filled and planted five raised garden beds, introduced by accomplice City Sprouts, on the site.

“Everyone cherished the thought immediately,” said Nicki Blodgett, a therapeutic aide at the facility who brought child Ryder, 6, and little girl, Lexi, 7, to encourage plant. “We do as such numerous things here to connect the network with assets. This was simply one more advance in that.”

Neighborhood wellbeing frameworks long have upheld and joined forces with network cultivate gatherings. Be that as it may, the garden has all the earmarks of being the first specifically settled by a wellbeing framework.

Such endeavors are a piece of a developing spotlight on keeping individuals well, a concentration that goes past advising individuals to eat solid eating methodologies — now medicinal services suppliers are demonstrating to them generally accepted methods to do it through cooking classes and so forth. In a few sections of the nation, a couple of human services designs even have started giving medicinally custom-made suppers through “nourishment as drug” programs.

Audrey Matthews, more advantageous networks facilitator for CHI Health, said the association needs the University Campus garden to develop. While the first beds will be planted by staff, the wellbeing framework would like to include more for neighbors and turn into an undeniable network plant where inhabitants and staff can work and get to know each other.

“The more open doors we can accommodate the network to go to the property and be locked in, the better,” she said.


Independently, Matthews stated, CHI Health likewise is working with City Sprouts, the Latino Center of the Midlands and OneWorld Community Health Centers to help enhance access to new create in South Omaha.

In light of a model created in a Denver suburb, the South Omaha program calls for procuring a network wellbeing laborer to distinguish and work with families confronting nourishment weakness, implying that they may not generally know when or where they’ll eat their next dinner.

The laborer, who will make home visits, will instruct families about urban farming and help them plant cultivates in their own particular lawns or at City Sprouts South, the network cultivating gathering’s greenery enclosure close twentieth and N Streets.

The $326,000 venture is financed by a two-year allow from CHI Health’s parent organization, and also extra gifts and in-kind commitments.

Establishment of the University Campus plant cost about $2,000, with stores originating from CHI Health’s people group advantage office.

Matthews said coordinators intend to start distinguishing families in South Omaha this fall. While the underlying concentration is sustenance get to, authorities with the Denver-region program have discovered that the connections the wellbeing laborers work with families inevitably enable them to recognize and address other social needs — say, worry over having the capacity to pay lease — that can influence wellbeing.

Generally, she stated, medicinal services has been directed inside healing facilities and centers. In any case, inquire about demonstrates that human services suppliers need to go past those dividers.

“We’re eager to have the capacity to go and meet the families where they’re at and give those administrations,” Matthews said.

Albert Varas, official executive of the Latino Center of the Midlands, said network cultivating has turned out to be prevalent in north Omaha yet at the same time is genuinely restricted in South Omaha.

An evaluation of the middle’s customers demonstrated a requirement for sustenance instruction and stress administration, he said. Cultivating can address both, notwithstanding helping individuals save money on basic supply bills.

The Latino Center, as a major aspect of a different exertion, as of now has an exhibition garden to demonstrate inhabitants how it’s done — raised beds set up by City Sprouts and supported by CHI Health. “Our beds are ablaze,” Varas said. “They’re stacked.”

Under CHI Health’s South Omaha venture, a property holder has consented to plant a home show cultivate so would-be plant specialists can perceive how a patio plot functions.

Roxanne Draper, City Sprouts official executive, said the local gathering will give training to the individuals who need it. Its cultivating classes are offered in Spanish.

“We’re anticipating a great deal of development in South Omaha,” she said.

Strawmier and his partners at the University Campus, interim, have a lot of thoughts of their own for their garden.

Suppliers there observe loads of patients with ceaseless diseases who could profit by cultivating, he said. Having neighbors develop vegetables from their nations of origin would include some social enthusiasm too. Inevitably, he’d jump at the chance to include some organic product trees.

“A great deal of conceivable outcomes,” he stated, as he completed the process of scooping soil into the new beds. “Yet, this is the place we begin.”

What Big Pharma pays your doctor

It takes at least a couple of mouse clicks to locate the material. Nor is there any more detail this year than last year about how the money is used.

Members of Innovative Medicines Canada (IMC), the lobby group for the large pharmaceutical companies, recently released their voluntary reports of payments to health-care professionals and health-care organizations.

Altogether, the 10 reporting companies paid out more than $75 million in 2017.

This is the second year of these disclosures. When they started, Russell Williams, then the IMC president, said on CBC’s The Current: “We’re open to continually improving and monitoring” the disclosures. According to the new president, Pamela Fralick, the 2016 revelations were only a first step and she expected more companies to disclose payments in 2017.

Come the 2017 disclosures, and there are still the same 10 companies. Moreover, the disclosures are actually not on the IMC website, they are on the individual companies’ websites and are not easy to find. It takes at least a couple of mouse clicks to locate the material. Nor is there any more detail this year than last year about how the money is used.

IMC touts these disclosures as “part of our commitment to high ethical standards and enhancing trust.”

But all that the companies have disclosed are gross figures — with no information about what they paid for.

Paid to promote opioids?

Why did Purdue Pharma, makers of OxyContin and a host of other opioid products, give almost $1.9 million to health-care professionals in 2017?

All Purdue’s website says is that the money was for “services.” Were some of those services speeches made by doctors on behalf of Purdue? In the past Purdue has paid doctors $2,000 a talk.

Amgen Canada gave more than $6 million to health-care organizations, but we don’t know what these organizations did with that money.

Novartis spent $350,000 on travel expenses so that doctors and possibly other professionals could go to international congresses and/or global stand-alone meetings.

Who were these health-care professionals? What meetings did they go to? Where were the meetings?

Canada lags behind

Big Pharma here in Canada is far behind the curve when it comes to disclosing where the money is going. The federal government doesn’t seem to be in any hurry to force the companies to make more information public either.

Just over a year ago, then Health Minister Jane Philpott’s position was that forcing the disclosure of payments to individual doctors was, “in principle…an important concept” but should be left to the provinces.

In the United States, companies have had to disclose any payment of more than $10 to a doctor since 2013. The doctors are named.

In Australia, an analysis of information that companies must disclose found that, from October 2011 to September 2015, 42 companies sponsored 116,845 events for health professionals.

In nine European countries, disclosure is either mandatory or voluntary. Many of the European voluntary codes allow doctors to opt out of having their names disclosed.

IMC justified not linking doctors’ names to payments on the grounds of Canadian privacy laws but Ontario’s recently passed legislation will require disclosures to include the names of all health-care professionals who receive money or any other “transfer of value.”

Later this summer, British Columbia will hold public consultations about the same type of legislation.

Point-of-care ultrasound: a reliable bedrock of the general hospital

Medical scope of practice can vary by state, country and/or local jurisdiction.

Point-of-care ultrasound is at the heart of Frimley Park Hospital’s anaesthesia department, guiding procedures such as vascular access and nerve blocks. Dr Tim Pepall, a consultant anaesthetist at Frimley Park, explained: “It’s essential to use ultrasound for central vascular access because of NICE guidelines, but we also use it occasionally for difficult peripheral vascular access and arterial lines.

Ultrasound has transformed regional anaesthetic practice and we were relatively early adopters of it – it made sense to see the nerves, rather than going in blind. There is so much variation in nerve and vascular anatomy that you realise your previous techniques were really feeling in the dark. Nowadays, I would be very reluctant to do a plexus block without an ultrasound machine.”

Tim continued: “We’ve been using FUJIFILM SonoSite point-of-care systems for the last 10 years. There are five SonoSite instruments in the anaesthetic department and we’ve stayed with the one manufacturer because we’ve been very happy with it – we like the back-up service, as well as the simplicity of the systems and the quality of images it provides.

The SonoSite S-Nerve interface is very intuitive, and it is great for portability, we can transfer it onto the wards and take it wherever we need to use ultrasound. With the new SonoSite X­Porte, we’re also doing more echocardiography than before – which saves us having to discuss preoperative cases with the cardiologists as often – and we can see dynamic changes as they occur, and responses to our interventions.”

SonoSite, the SonoSite logo, S-Nerve and X-Porte are trademarks and registered trademarks of FUJIFILM SonoSite, Inc. in various jurisdictions. FUJIFILM is a trademark and registered trademark of FUJIFILM Corporation in various jurisdictions. All other trademarks are the property of their respective owners. Copyright (c) 2018 FUJIFILM SonoSite, Inc. All rights reserved. Subject to change.

Medical scope of practice can vary by state, country and/or local jurisdiction.

FUJIFILM SonoSite, Inc., is the innovator and world leader in bedside and point-of-care ultrasound, and an industry leader in ultra high-frequency micro-ultrasound technology. Headquartered near Seattle, the company is represented by a global distribution network in over 100 countries. SonoSite’s portable, compact systems are expanding the use of ultrasound across the clinical spectrum by cost-effectively bringing high-performance ultrasound to the point of patient care.

Quo vadis blockchain in health and healthcare?

Various real-word healthcare solutions involving AI-mediated data exchange on blockchains.

You may be familiar with blockchain as the technology powering bitcoin cryptocurrency. But blockchain’s potential goes far beyond this, with healthcare being just one of the industries set to be revolutionized. In an editorial published today in the International Journal of Health GeographicsMaged N. Kamel Boulos and colleagues discuss how we could soon see blockchain technology securing patient and provider identities, managing medical supply lines, enabling public and open geo-tagged data and much more.

The last couple of years have seen a growing interest in blockchain technologies among the health and healthcare research and practice communities. Blockchain is the core distributed ledger technology powering the well-known bitcoin cryptocurrency. However, the interest of our communities in blockchain goes far beyond bitcoin.

In March 2018, a consortium of scholarly publishers, including Springer Nature, launched Phase 1 of Blockchain for Peer Review “to make the peer review process more transparent, recognisable and trustworthy.” Earlier, in 2017, the US Centers for Disease Control and Prevention (CDC) started experimenting with blockchain for sharing public health data to help public health workers respond faster to a crisis.

At the time of writing (20 June 2018), a PubMed query using the term ‘blockchain’ retrieved 41 indexed papers. Blockchain solutions are currently being explored in different parts of the world for securing patient and provider identities, for managing pharmaceutical and medical device supply chains, for medical fraud detection, for medical data sharing among researchers, for research data monetisation, and in crisis mapping and recovery scenarios using blockchain-enabled augmented reality.

The Internet of Things (IoT) is the foundation of the smart healthy cities and regions of today and tomorrow. The market for IoT devices and apps that negotiate with, and pay, each other for secure, safe operation and services is expected to grow in the near future. Examples of these IoT devices include mobile and wearable devices that pay for public transportation, and autonomous connected devices and vehicles for smart city emergency/disaster response, such as a drone defibrillator, or a drone for the delivery of ordered medicines and medical supplies, or a self-driving ambulance car (or helicopter).

The blockchain-powered, distributed peer-to-peer apps powering these smart devices, drones and vehicles would cut out the ‘middleman’ and the dependence on third-party centralized providers for navigation and other geospatial data, and would mitigate the possibility of an IoT-powered autonomous vehicle being hijacked and driven to a wrong location.

The challenges facing blockchain technologies today include interoperability, security and privacy, as well as the need to find suitable and sustainable business models of implementation. However, these challenges are not insurmountable, and I expect blockchain technologies to get increasingly powerful and robust, as they become coupled with artificial intelligence (AI) in various real-word healthcare solutions involving AI-mediated data exchange on blockchains.

Healthcare solutions

What about the availability of drugs and treatments?

Fast-forward 70 years and the most common causes of death are cancer, suicide and heart conditions.

Nothing inspires national pride quite like the National Health Service. More than two-thirds of respondents in a recent poll said they considered the establishment of the institution, which turns 70 this week, to be Britain’s greatest achievement.

But it is a very different thing now compared with its earliest incarnation, when health boards took control of 2,751 of Britain’s 3,000 hospitals, which had been run by charities or local authorities. It is not just the illnesses, facilities, technologies and demographics that are different, but the service’s very purpose.

“When the NHS was founded it was intended to keep the workforce healthy, reduce premature death and allow a dignified end for everyone,” said Robert Freeman, a consultant orthopaedic surgeon. “There has been significant mission creep since and the NHS now has a much broader scope with a focus on prolonging life almost irrespective of quality.”

How has the NHS changed in 70 years?

The NHS has changed beyond all recognition since it treated its first patient, 13-year-old Sylvia Diggory, on 5 July 1948. At the time, government expenditure on the health service stood at about £14bn, at 2016-17 rates: by 2016-17 the figure had grown to £144.3bn. In terms of spend per capita this equates to around £260 in 1950 compared with £2,273 in today’s money.

The number of workers required to cater to the country’s care needs has also grown dramatically. At the time of the NHS’s foundation there were 12,000 full-time-equivalent hospital and community medical staff (doctors and dentists) across England and Wales. Today there are almost 110,000 such positions in England alone.

Equivalent figures for nurses begin in 1962, at which time there were 88,579 full-time positions, compared with 285,093 in 2017.

However, not all things have grown exponentially. The number of beds available in hospitals has dropped dramatically across the decades as care patterns have changed, especially as recovery times from surgery have got shorter.

Over the same period the UK’s population has grown, from about 50 million to 66 million, and the demographic shift towards an older population has heaped pressure on the NHS. When the NHS was founded in 1948, life expectancy was 66 for men and 70 for women. Today, it is 79.2 years for males and 82.9 years for females.

What has it got better at?

In 1948 people were most likely to die of infections and heart conditions. Fast-forward 70 years and the most common causes of death are cancer, suicide and heart conditions.

Cancer treatment has been a success story, with death rates peaking in the late 1980s before falling back to well below where they were in 1960, linked to the decline in smoking rates. However, survival rates in the UK still lag behind the European average, linked to people being diagnosed late.

Infant mortality rates have been reduced by more than 80% since 1960. Deaths from strokes and heart disease have fallen steeply, linked to greater use of preventive medication including statins and drugs to reduce blood pressure, and to the decline in smoking, which is partly the result of policies such as the indoor smoking ban.