Do human factors matter in medical devices?

Do human factors matter in medical devices1

Is there a relationship between medical devices and human factors? This is a question that is seriously worth exploring. According to the ANSI/AAMI HE75:2009 document, human factors is an endeavor for optimizing the production of devices, systems, and many others concerned with them through the use of emotional, intellectual, physical and sensory forms of human knowledge. Both the ways in which these elements are used to enhance production, as well as the limitations inherent into them are factored in. In essence; human factors deal with how humans and devices or machines interact with each other.

Since human factors places the human mind at the center; design and aesthetics play a very prominent role in this discipline. Being an important element of user interface; human factors and user interface have risen in prominence after the explosion of the field of IT. It however, can be put into use in several other areas. The user being the fulcrum of any area of production; human factors has the potential to be a major factor in creating and shaping user interface for a range of products.

Use in medical devices

Do human factors matter in medical devices

How about the area of medical devices? We have seen that user interface and aesthetics are core ingredients of human factors. Are these the major determinants for the field of medical devices? Yes and no. Yes, because the user is of critical importance in medical devices. A wrong instruction or wrong usage can severely compromise the use of medical devices and can go the extent of even causing harm to the user.

No, because when it comes to another equally important element of human factors, namely aesthetics, the interplay between medical devices and human factors may not appear so pronounced. Yet, while role of aesthetics may not be all that critical to medical devices; there is a related aspect, and that is design.

The role of design is very prominent when it comes to the user interface of medical devices since medical devices have to be designed to absolutely precise specifications. Even small deviations or variations can result in harm to humans. Both the patient and the organization manufacturing the devices need to face consequences as a result of these.

As far as medical devices are concerned, the FDA is tasked with regulating them for ensuring their safety and effectiveness. The incorporation of the principles of human factors into medical devices ensures that the product meets specification, design and quality standards and thus becomes faster and less expensive to market. It is because of these factors that human factors are becoming part of the design and development, as well as of the supplementary aspects of medical devices, such as Instructions for Use, labeling and even training.

FDA’s regulations on human factors in medical devices

FDA_s regulations on human factors in medical devices

Under 21 CFR 820.30; the FDA emphasizes that human factors need to be taken into consideration for the following:

  • Design input: To ensure that the needs of the patient and any others who may use the product are taken into consideration

 

  • Design verification: To make sure that the criteria for performance set for the medical are being consistently met, and

 

  • Design validation: To safeguard that the device conform to predefined user needs as well as intended uses, and to also sure that testing is carried out to ensure this function. Software validation and risk analysis are part of this testing.

The FDA has also been placing emphasis on human factors in medical devices in many guidance documents and a number of upcoming Draft Guidance documents.

Full learning on human factors in medical devices

A seminar that is being organized by GlobalCompliancePanel, a leading provider of professional trainings for the areas of regulatory compliance will offer complete learning on human factors in medical devices.

Virginia A. Lang, Principal and Founder HirLan, Inc. and HirLan International SA, will be the Director of this seminar. To gain knowledge of how human factors related to medical devices, please register for this seminar by visiting Do human factors matter in medical devices? This course has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

A complete explanation of regulations and uses of human factors in medical devices

The core aim of this seminar is to familiarize participants with the way in which human factors can be applied into medical devices. Towards covering this, she will explain all the current and upcoming human factors requirements, using which, participants will learn how to keep costs under control and reduce the time for the manufacture and marketing of their products.

Virginia will cover the following areas at this seminar:

  • Overview of Human Factors and the FDA perspective
  • Human Factors Methods and Device Product Life Cycle
  • Human Factors and Risk Analysis & Management
  • Human Factors: What Devices Require Human Factors Evaluation and Validation?
  • Human Factors and Combination Products
  • Human Factors and Combination Products Submitted in an ANDA.

 

 

 

Knowledge of employment laws is absolutely crucial for organizations

As the new presidential administration settles in in the US, employment law could be an area in which to expect tremendous changes. While what the new president’s open and vocal support for protection of the domestic workforce will mean to employment laws may take some to fully unfold and unravel; a look at the evolution of the important employment laws and the changes taking place into them of late should serve as some kind of indication of what is to come.

One thing that is certain is that 2017 is going to be an uncertain year for employment law. Changes that could make a big difference to many organizations can be expected to be rolled out by the new administration. A fact of additional significance to employers is that there has been a steady increase in the number of employment lawsuits of late.

In 2016, enforcement actions by the Equal Employment Opportunity Commission (EEOC) gave the agency a staggering amount of between $350 and $400 million in monetary damages. This has been the highest recovery ever from the time it was created in 1965. Not surprisingly, the number of claims filed by employees with this Commission has reached record levels in the last three years.

Lack of knowledge of the law is at the root of lawsuits

Most of these lawsuits are a result of the lack of understanding that employers have of workplace issues. Companies in which the managements are ignorant about these issues or choose to overlook them end up facing a host of issues such as:

o  Discrimination suits

o  Employee turnover

o  Unplanned expenses

o  Settlements

o  Litigation

o  Lawyer fees

o  Low morale on the part of employees

o  A bad beating to their image.

The means to avoiding such scenarios is for organizations to grasp the enormity of these actions. If they have to avoid litigation and other reputation-damaging actions; they need to be aware of the employment law regulations and be compliant with these. They also need to be clear in their understanding of what to expect from the new administration.

A session to help get thorough understanding of employment laws

It is to impart understanding of these topics that a GlobalCompliancePanel, a leading global name in the field of regulatory compliance trainings, will be organizing a two-day seminar. Vanessa G. Nelson, who is founder and President of award-winning Expert Human Resources, which she founded to help companies maintain employment law compliance, avoid workplace litigation, maximize human capital, create great teams, and reduce costs, will be the Director of this course.

To get complete understanding of all the crucial aspects of human resource law, the ways by which to comply with employment laws and regulations and the potential impact on employment law from the actions of the new administration; please register for this seminar by visiting Knowledge of employment laws is absolutely crucial for organizations .

A clear roadmap to advanced human resources and employment law

The essence of this seminar is the roadmap to advanced human resources and employment law that Vanessa will lay out for the participants. Given the factors described above; this understanding is critical, no matter what the size of the organization. The right grasp of employment laws and HR practices is essential if organizations have to become successful at their business. The Director of this seminar will simplify the complex nature and the huge number and variety of employment laws and the issues relating to them.

Participants will able to learn the ways of dealing with often muddling human resource situations and how to apply relevant employment laws correctly to avoid problems. A look at the cost of litigation will perhaps give some idea about the need for employers to remain compliant with the employment laws: Without lawyer fees, a lawsuit costs $165,000 on average. The cost of a case that goes to trial is exorbitant: It is in excess of a million dollars, and comes with the strong prospect of imprisonment for noncompliance with employment.

Professionals Involved in The FDA’s Tougher Import Rules for 2017

Tougher Import Rules for FDA Imports in 2017

Of late, the FDA and the Customs and Border Patrol Service (CBP) have become increasingly agile, smart, sophisticated and demanding when it comes to the submission of information and adherence to government procedures from importing firms. The FDA and the CBP can delay, detain or refuse shipments of firms do not properly execute an import and export program.

The CBP’s new Automated Commercial Environment (ACE) computer program has carried out several changes to the process of import logistics and information reporting for FDA regulated products. The alternatives to noncompliance with the requirements of the ACE program: A shipment may be stopped before it is even loaded at the foreign port. Ships that refuse to or fail to use the ACE program also carry a fine of up to $10,000 for every offense.

Or, when the FDA detains a company’s product; it will begin an expensive and time-consuming legal process. Since the agency expects companies to have the import coding information accurate and up-to-date; companies that do not have a clear understanding of the automated and human review process can expect to have their shipments detained.

One more area that poses a challenge for importers is when the FDA decides that they should bring the products back to the port of entry after they received a release but cannot locate the product that has been sold. In such a scenario, companies that go through this process attract a fine that is three times the value of the shipment. This is in addition to the other adverse legal concerns and strategies that are attached to this action. Overall, the costs of not complying with the FDA’s guidelines on imports can be very high and can carry very expensive consequences for importing companies.

There are positives, too

The FDA_s Tougher Import Rules for 20171

However, not all is lost. The FDA is implementing the Voluntary Qualification Importer Program under the FDA Food Safety and Modernization Act. Aimed at incentivizing importers who instill a high degree of confidence about the quality of food they import; the nub of this plan is that it establishes an FDA-supervised, fee-based program that expedites the review and importation of foods from importers who can show a heightened level of control over the safety and supply chain aspects of the imported food items.

Another convenience that the FDA offers is export certificates. Obtainable for a modest fee; these certificates may give an importer a competitive advantage in foreign markets. An FDA export certificate is actually a requirement by a few foreign governments.

Full learning on the FDA’s new import rules for 2017

The FDA_s Tougher Import Rules for 20173

All the aspects of the new FDA import rules will be taught at a highly absorbing two-day seminar that GlobalCompliancePanel, a leading provider of professional trainings for all the areas of regulatory compliance, is organizing.

Casper Uldriks, an ex-FDA Expert and former Associate Center Director of CDRH, Olsson, who has served as a senior manager in the Office of Compliance and an Associate Center Director for the Center for Devices and Radiological Health, where he developed enforcement actions and participated in the implementation of new statutory requirements for FDA; will be the speaker. to enroll for this course, please visit Professionals Involved in The FDA’s Tougher Import Rules for 2017. This course has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

Casper will impart learning on all these topics and on the ways by which to avoid these and related common problems that can become terribly expensive when a proper strategy and plan for dealing with them are not implemented. Importers need to put in place an established and effective business planning, whose ways will be shown at this seminar. A bonus of this course is that the speaker will also include tips on how to understand FDA’s thinking and offer anecdotal examples of FDA’s import program idiosyncrasies. He will also explain how to deal with common problems, such as returns for repair, importing QC samples, and investigational products.

Are you ready to join us to Keep Growing Up

 

 

 

 

Drug dissolution testing and establishing plasma drug levels in humans

Drug dissolution testing and establishing plasma drug levels in humans5

Dissolution testing is a very important tool that determines and help understand the performance and effectiveness of oral solid dosage forms. It is significant for the field of medicine because if a drug has to be effective, it must be released first from the product form, and it should then be allowed to get dissolved in the gastrointestinal fluids. This is the first step that leads to the next important phase, that of the dosage’s absorption into the bloodstream. This points to the fact that dissolution from the dosage form is a major determinant of the rate and extent to which the drug gets absorbed by the body.

Drug dissolution testing is very important during the development of drugs and drug formulations. It helps to determine if the right concentration of the drug reaches the desired or expected locus of action. This makes the investigation of the factors which affect drug absorption into the human blood flow when a drug product is taken orally important.

The usual method of measurement of drug absorption is in vivo, or, the body of a living being such as a human or animal. Time blood plasma concentration profiles of drugs after oral administration constitute an important in vivo parameter. In-vitro investigations are carried out for identifying the parameters involved in drug absorption. These are investigations that are conducted in a controlled and simulated environment that resembles biological conditions closely.

Thorough learning of drug dissolution

Drug dissolution testing and establishing plasma drug levels in humans

An important seminar from GlobalCompliancePanel, a leading provider of professional trainings for all the areas of regulatory compliance, will offer valuable learning on all the aspects of drug dissolution testing and explain the ways of establishing plasma drug levels in humans.

At this two-day seminar, Dr. Saeed Qureshi, who has worked as a research scientist with Health Canada and is an internationally known expert on the subject whose expertise spans the areas of drug dissolution testing, pharmacokinetics, biopharmaceutics and analytical chemistry as related to animal and human studies for developing and evaluating pharmaceutical products; will be the Director.

In order to gain the benefit of learning from this world-renowned expert, please enroll for this seminar by visiting Drug dissolution testing and establishing plasma drug levels in humans. This course has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

All aspects of drug dissolution and establishing plasma drug levels

Drug dissolution testing and establishing plasma drug levels in humans1

This seminar will provide its participants a unique opportunity to learn scientifically valid drug dissolution testing and establishing plasma drug levels. Lab personnel take several approaches to conduct dissolution testing using different apparatuses and methods. This makes section of an appropriate apparatus and method confusing and challenging. Dr. Qureshi will offer relevant pharmacokinetics and physiological background that is aimed at making this choice easier and intuitive. He will use simple and clear language in helping participants understand how to select or develop a dissolution method. He will describe the theoretical aspect of the drug dissolution testing, including method development, in detail. He will explain the pros and cons of different approaches.

Another important area that Dr. Qureshi will address is in vitro-in vivo correlation (IVIVC). He will address the particular issue of the use of the concepts of convolution/deconvolution and IVIVC in providing an estimate/prediction of expected drug levels in humans through drug dissolution testing. This approach has met with limited success. Dr. Qureshi will explain the reasons for this and suggest alternative approaches and will offer an explanation of the underlying scientific principles involved in convolution, deconvolution and IVIVC techniques with simple practical examples. He will describe a unique and simple approach based on convolution technique using spreadsheet software.

He will show in vitro drug dissolution testing and convolution/deconvolution techniques for predicting plasma drug levels using the principles of pharmacokinetics and physiology. Dr. Qureshi will cover the following main areas at this seminar, with its relevant subtopics:

Personnel who work in various levels of the areas of Pharmaceutical Development, setting up analytical methods (pharmacopeial, regulatory or in-house developed), R & D (both analytical and formulation), Project Management, Quality Control, Quality Assurance, and Regulatory Affairs will benefit enormously from this learning.

To join us for more information, get in touch

 

Analysis: Single-payer would drastically change American health care; here’s how it works

Analysis Single-payer would

As Republican efforts to repeal and replace the Affordable Care Act continue in the background, some Democrats are starting to eye a new health policy goal: implementing a single-payer system. Sen. Bernie Sanders, I-Vt., introduced a single-payer bill in mid-September with 16 Democratic co-sponsors — 16 more than he got when he introduced the bill two years earlier. But how is the health care system funded now, and how would “single-payer” change that?

How health care systems are funded

There are three major components to every health care system, single-payer or not: a patient, a payer (typically an insurance company or the government) and a provider. Here’s how money moves between them:

How multipayer systems work

Virtually all health care systems follow this general pattern, but who the payers are can vary widely. In the U.S. private insurance market, patients typically purchase coverage from one insurance company among many competing insurers. Because different people end up with different insurers, there are multiple payers throughout the U.S. health care system.

How single-payer systems work

In a purely single-payer system, there is, as the name would indicate, just one payer — typically the government. This is analogous to how the United States administers some portions of Medicaid: The government provides coverage, and no private insurers are involved.

Sanders’ bill takes universal coverage close to this extreme: The government insurance would cover so many services with such small copays that private insurance would be almost universally unnecessary. Accordingly, it would also be quite expensive — $32 trillion over 10 years, according to an Urban Institute report. That’s more than a 50 percent increase in federal spending — all federal spending — according to spending projections by the Congressional Budget Office. That would be partially offset by people no longer needing to pay premiums to private insurers, however, and the government’s monopoly could allow it to implement cost-saving measures.

Read More: http://snip.ly/mt3iy#http://www.chicagotribune.com/business/ct-biz-how-single-payer-health-care-works-20171018-story.html

A step towards better health care

 

step towardsToday, we live in an era of customization. Increasingly, customers can modify a product’s appearance, features, or content according to their unique needs or desires. Often, even the news we see in our newsfeeds is customized based off our preferences.

Why, then, are so many aspects of the health care industry still one-size-fits-all?

As doctors, we’ve seen firsthand how this can negatively impact patients who require more individualized care. One particular example is a practice known as “step therapy” or “fail first.”

Now, when patients visit their doctors for a prescription, the treatments they are prescribed are typically based on a variety of personal factors. These factors include their health history, underlying symptoms, and their doctor’s long-term understanding of their condition, such as whether they have already tried certain drugs under a different health insurance plan, if they have other medical conditions that might interfere with the drug’s effect, whether certain drug’s side effects will affect the patient’s ability to perform their job, or if the patient would prefer a drug that has a different ingestion method or dosage form. Treatment plans need to be based on the individual’s needs, and their doctors’ medical expertise and first-hand knowledge of their patients’ overall health.

 However, far too often, what happens next is the problem. When a patient goes to the pharmacy to fill their prescription, they may be informed that their physician-prescribed medicine will not be covered unless the patient first proves that another medication-one of the insurer’s choosing, not their doctor-will not work for them.

In such a case as this, failure is not only an option, it is the only option before getting appropriate treatment.

Under the current system, patients are left with a limited set of options: either try a medication that is not what their doctor recommended for their condition, or pay out of pocket for the treatment they need. For many people, that’s not a choice at all. They are simply forced to fail on a medication other than what their doctor prescribed.

Read More: http://snip.ly/3h8ax#http://thehill.com/blogs/congress-blog/healthcare/356083-a-step-towards-better-health-care

‘Synthetic lethality’ targets cancer cells by damaging vulnerable DNA

Synthetic lethality.png

By designing small molecules that can “turn off” kinase enzymes stuck in the “on” position, they have managed to ward off cancer’s attack. More recently, scientists have focused on ways to help the body’s own immune cells seek and destroy cancer cells.

Enter the concept known as synthetic lethality. Researchers have long known that a cancer cell hobbling along with one broken gene is vulnerable. Knock out another key gene, they have discovered, and the cell will topple.

The notion of killing cancer cells by damaging their already compromised DNA should sound familiar. Chemotherapy agents do just that, but by using a sledgehammer to smash away at DNA. Because drugs that exploit synthetic lethality act with precision, they promise to be able to discriminate between healthy and diseased cells.

“In experiments, you have a perfectly happy cell, you remove one gene and challenge it with one stress, and it dies. You think, ‘Yeah, I’ve got a target now!’ ” says [structural biologist Lance] Pearl, whose lab is working on drugs against synthetic lethal targets. “But that’s not a tumor.”

“Right now, the field is okay at the cellular level. But finding drugs and making sure they actually work in a real tumor is where they need to go.”

The GLP aggregated and excerpted this blog/article to reflect the diversity of news, opinion, and analysis. Read full, original post: Driving cancer beyond the brink

Breast cancer warning from man stunned by ‘impossible’ diagnosis

Breast cancer warning from man stunned by 'impossible' diagnosis.jpg

When you think of breast cancer, you think of a form of cancer that affects only women. It doesn’t.

While breast cancer in men is rare it’s still an issue for the 10 men on average who are diagnosed with it every year in Northern Ireland.

Ian Cranston, 70, was diagnosed with breast cancer in May. Two weeks later he had a mastectomy.

The Portadown father-of-two was given the all-clear in June and has decided to speak publicly to make men aware that it’s a cancer that doesn’t just affect women.

He said “men also need to check their breasts for changes”.

Inverted nipple

In May, Ian’s wife Elizabeth noticed something wrong when he got out of the shower.

Image copyright SPL
Image caption About 10 men in Northern Ireland are diagnosed with breast cancer each year

She told him he had an inverted nipple and needed to see his GP.

“I didn’t know what that meant,” said Ian.

“Men can’t get breast cancer, I don’t have to go to the doctor.

“I wasn’t aware I had breasts. This is my chest, men don’t have breasts, it’s impossible,” he added.

Eventually his wife persuaded him to go to his GP, who referred him to Craigavon Area Hospital.

Image caption Ian Cranston alongside breast care specialist nurse Annie Treanor

The diagnosis stunned him.

“Men having breast cancer, I couldn’t believe it,” he said.

“I couldn’t do or say anything. My wife Elizabeth cried.”

Four days later Ian said he “just broke”.

He has decided to help try and raise awareness of the disease, saying that if his speaking out helped one man, it would be worth it.

“I can understand where women are coming from because I’ve had breast cancer myself,” he said.

How We Need to Keep Growing Up: http://snip.ly/ljoxy#http://www.bbc.com/news/uk-northern-ireland-41616265

Collins: Trump should back effort to resume health subsidy

Collins Trump should back effort to resume health subsidy.jpg

A key moderate Republican is urging President Donald Trump to support a bipartisan Senate effort to reinstate insurer payments, calling his move to halt the subsidies an immediate threat to millions of Americans who could now face rising premiums and lost health care coverage.

“What the president is doing is affecting people’s access and the cost of health care right now,” said Sen. Susan Collins of Maine, who has cast pivotal votes on health care in the narrowly divided Senate. “This is not a bailout of the insurers. What this money is used for is to help low-income people afford their deductibles and their co-pays.”

“Congress needs to step in and I hope that the president will take a look at what we’re doing,” she added.

Her comments Sunday came amid rising attention on the bipartisan bid led by Sens. Lamar Alexander, R-Tenn., and Patty Murray, D-Wash., to at least temporarily reinstate the payments.

Congressional Republicans are divided over the effort. And White House budget director Mick Mulvaney has suggested that Trump may oppose the agreement unless he gets something in return — such as a repeal of former President Barack Obama’s health care law or funding of Trump’s promised wall on the U.S.-Mexico border.

The insurer payments will be stopped beginning this week, with sign-up season for subsidized private insurance set to start Nov. 1.

“The president is not going to continue to throw good money after bad, give $7 billion to insurance companies unless something changes about Obamacare that would justify it,” said Sen. Lindsey Graham, R-S.C., who golfed with Trump Saturday at the Trump National Golf Club in Sterling, Virginia.

“It’s got to be a good deal,” Graham said.

In his decision last week, Trump derided the $7 billion in subsidies as bailouts to insurers and indicated he was trying to pressure Democrats into negotiating an Obamacare repeal, a bid that repeatedly crashed in the GOP-run Senate this summer.

The subsidies are designed to lower out-of-pocket costs for insurers, which are required under Obama’s law to reduce poorer people’s expenses — about 6 million people. To recoup the lost money, carriers are likely to raise 2018 premiums for people buying their own health insurance policies.

Alexander and Murray have been seeking a deal that the Tennessee Republican has said would reinstate the payments for two years. In exchange, Alexander said, Republicans want “meaningful flexibility for states” to offer lower-cost insurance policies with less coverage than Obama’s law mandates

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