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.

What Happens When Your Product Is Detained by the FDA?

What happens when your product is detained by the FDA? In short and simple words, a nightmare. If you thought that the FDA Compliance had always been strict in its enforcement of import rules, you would think again if you heard about what it has worked out lately.

Import Rules for FDA Imports1

The FDA has partnered with the Customs and Border Patrol Service (CBP) to put in place a sophisticated and agile method by which it can monitor the information it requires from importing firms, and also ensure their adherence to government procedures. The CBP has created a novel mechanism to intensify vigilance of imports, called the Automated Commercial Environment (ACE). This computer program has brought in many changes into import logistics and the method by which importing firms have to report information pertaining to FDA-regulated products.

So, what powers do the FDA and the CBP have by implementing the ACE? They have powers of delaying, detaining or refusing shipments of firms that fail to put in place a thoroughly executed import and export program. Importing firms that believe they can take this mechanism easily could not be more mistaken: noncompliance with the requirements set out by the ACE program empowers the FDA and the CBP to stop a shipment before it is even loaded at the point of origin, even if it is a foreign port. A ship that wants to be precluded from the ACE program attracts a fine of up to $10,000 for every offense. Alternately, if the FDA detains a product or products from such a company; it will start a long drawn out and costly legal process.

Import Rules for FDA Imports2

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 are very likely to have their shipments detained.

Another scenario

What happens to an importer whose product is deemed fit for release and to be brought back to the port of entry by the FDA, but the importer cannot locate the product that is already sold? On such companies, the FDA slaps a fine whose value is treble that of the shipment! And this is not all. This in no way waives the other usual legal actions that the FDA will initiate anyway.

Not everything is bleak

All this should not intimidate and put importers off. Alongside the ACE program, the FDA has also put in place a redressal mechanism under its Food Safety and Modernization Act. Called the Voluntary Qualification Importer Program, this FDA-monitored program is aimed at smoothening the review and import of food items from importers who can show the agency that they are serious about implementing a higher degree of control over the safety and supply chain elements of the food items they are importing. Those Importers who are serious about the quality of food they import.

The FDA also offers export certificates, which could give an importer a level of advantage in foreign markets. Also available for a fee, albeit a small one, an FDA export certificate is a shot in the arm for importers, because this certificate is required in some markets.

Familiarize yourself with all parts of FDA import rules for 2018

GlobalCompliancePanel, a leading provider of professional trainings for all the areas of regulatory compliance, will be offering complete learning on all aspects of the FDA import rules for 2018 at a two-day seminar. The Director of this seminar on FDA import rules for 2018 is 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. This course has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

The full expanse of Casper’s many years of experience will be exhibited at this valuable seminar. He will show how to steer clear of the many common potholes and constraints that importers who don’t have a sound strategy run into. Participants will be offered tips on how importers need to put in place an established and effective business plan.

This course is of immense value to domestic importers, foreign exporters, initial importers, international trade executives, Venture Capitalists, marine insurance underwriters, import brokers, Regulatory Affairs managers, import/export consultants, in-house counsel, contract specialists, logistics managers, third party establishment inspection entities, sales managers, and investors.

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How does Sarbanes-Oxley affect the accounting profession?

The Sarbanes Oxley Act, or what is more popularly called SOX, was enacted by President George Bush in July, 2002. This law was passed in response to the discovery of monumental scandals of many leading American organizations, whose managements exploited the loopholes in accounting practices to carry out huge financial frauds.

While the SOX Act is primarily aimed at making managements more accountable in their financial management practices, because of which the managements have had to make major changes into their financial reporting practices; another profession that has been impacted in a major way by the passage of the Sarbanes Oxley Act is the accounting profession. This is because of the fact that while management has to show greater transparency; it is the professionals in the accounting profession who have to actually carry out these changes and present them to the concerned authorities. This requires them to implement a number of major changes into their accounting and reporting practices.

Change at the most basic level

sarbanes-oxley-affects-accounting-profession

At the most basic level, the nature of work of accountants has undergone a major change. They are now required to orient their work a lot more towards ensuring diligence in the bookkeeping practices than they were used to. Restoring confidence in the public and with the financial institutions and the government, as well as with the investor community, has become a very high priority for accountants. It signals a new orientation in their careers.

On the administrative side, the Sarbanes Oxley Act makes significant changes into the accounting profession. Making CEO’s and CFO’s responsible for the authenticity of financial statement and requiring them to certify the veracity of accounting statements; SOX established the watchdog, the Public Company Accounting Oversight Board (PCAOB). On this board, two CPA’s are required to sit, along with three other people who are not necessarily qualified as highly, but are expected to have fluency in the workings of financial systems.

Clipping many functions 

sarbanes-oxley-affects-accounting-profession

More importantly, Sarbanes Oxley affects the accounting profession in more profound ways, because this Act has clipped many of their traditional supplementary functions. Sarbanes Oxley prohibits accountants from three major activities with a publicly listed company that comes under the purview of the Sarbanes Oxley Act:

sarbanes-oxley-affects-accounting-profession

Many of accountants’ functions pruned

Sarbanes Oxley affects the accounting profession in more ways. Based on the apprehension that auditors might influence financial decisions from managements by promoting a few services; Sarbanes Oxley bars accounting firms from implementing a client’s information system. They cannot also provide advice on investment, and they cannot advice managements on banking services and management services.

This requirement clips the wings of the accounting profession, whose bouquet of services has now got substantially reduced. They can help with tax preparation along with some allied services, but will have to do so only after getting approval from the board. In this way, Sarbanes Oxley affects the accounting profession by barring it from carrying out a variety of activities that were considered fluffy and auxiliary.

The accounting profession has to now be on its toes all the time – Read more

 

New Food Labeling Regulation in Canada

In late 2016, Canada introduced new changes to its food labeling regulation, which does away with the existing one, the Guide to Food Labelling and Advertising. Codified under what is called the Industry Labelling Tool; this regulation tool provides guidance to a number of important aspects of food, such as:

  • Food Products that Require a Label
  • General Principles for Labelling and Advertising
  • Labelling Requirements Checklist

Aim of the new food labeling regulation in Canada 
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The main aim of the new food labeling regulation in Canada is to make it easier for consumers to understand the nutrition information more easily and make informed choices about the food they consume.

healthy-mediterranean-diet

It also seeks to bring safer food for the country’s children by making changes into the labels of food meant for children. Towards this, it will continue to implement the recommendations the World Health Organization passed in 2010 to ensure safer food and beverages for children.

At the time of passing the new food labeling regulation in Canada; the WHO guideline was being implemented vigorously in Quebec for children below the age of 13.

How is the new food labeling regulation in Canada being implemented?

The new food labeling regulation in Canada, which was enacted in late 2016, expects the designated industries to implement the guidelines set out in the Industry Labelling Tool over a five-year period. Some of the amendments that come up for the earliest phase of implementation cover the food color specifications and the removal of synthetic color specification. The implementation of these amendments has started in early 2017. Consultations have been going on with food experts, stakeholders, the industry and the general public.

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Concerned about health and safety on the job?

OSHA 1

Are you one of those concerned about health and safety on the job? You’re not alone. Across the length and breadth of the US, the millions of workers who are employed in the various sectors, be it manufacturing or services, or technological or agricultural, are prone to injury at the workplace. Not one kind of job or working condition or employment or workplace is free from the potential to cause injuries or illnesses. This is why there is every reason to be concerned about health and safety on the job.

Concerned-about-Health-and-Safety-on-the-JobYet, there are a good number of security safeguards that have been put in place in the form of legislations from the Occupational Safety and Health Administration (OSHA). OSHA has been primarily enacted with the purpose of giving employees rights to a safe workplace. Why every employee needs to be concerned about health and safety on the job is best answered by these disconcerting statistics:

Concerned-about-Health-and-Safety-on-the-Job

OSHA is about dispelling concerns about health and safety on the jobConsidering the damage that concerns about health and safety on the job can cause to the workforce as well as to the economy, the US legislated OSHA way back in December 1970. The main intention of this historic piece of legislation was to ensure safety of workers at the workplace not just through suggestions, but through actionable steps.

Concerned-about-Health-and-Safety-on-the-JobThe hallmark of this legislation is that it empowers employees to demand a safe workplace. If an employer is seen to be violating the provisions of OSHA or if the employee feels that there is some form of potential danger to her physical wellbeing at the workplace; she has the right to complain to OSHA without fear of being retaliated against.

A host of rights to assuage concerns about health and safety on the jobAmong the main features of OSHA is that it requires the employer to publish employee rights about their safety at the workplace. This enables them to allay concerns about health and safety on the job, as they have a ready reference to which they can go back in case of a doubt about the implementation aspects of any provision of OSHA. Employees who are concerned about health and safety on the job have the following rights:

Concerned-about-Health-and-Safety-on-the-Job

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Risk Management in the Global Economy and outlook for 2017

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Risk management in the global economy is a highly challenging field for risk managers from any part of the world. With most of the world’s countries almost becoming part of the global economy in this era of globalization; it is emerging that risks that apply to one part any one nation’s or group of nations’ economy could affect many more in a chain reaction, or domino effect.

The Judge Business School of Cambridge University, in its estimate for risk management in the global economy for 2017, has a rather bleak outlook for the global economy. The report analyzes that no fewer than 25 dozen of the world’s urban centers could face close to two dozen different kinds of major shocks of primarily an economic and also of a political and social nature.

risk-management-in-global-economy-and-outlookThis is going to likely impact these important nodal cities of the global economy to the extent that the world’s GDP is going to shrink by as much as 1.5% percent till 2019. This translates to something in the order of $ 1.2 trillion.

Factors determining risk management in the global economy in 2017The report pins down a few important factors that have contributed to the need for risk management in the global economy in 2017:

    • The world is producing more than it ever did in its history. This is because of the high level of human population, which is the highest ever recorded in history, and the economic, agricultural and industrial growth of many underdeveloped economies
    • There has been an unprecedented increase in crises and disruptions in the geopolitical, financial and technological fronts, making risk management in the global economy for 2017 an important area to be addressed by the political and financial leaders around the world

risk-management-in-global-economy-and-outlook

  • The financial sector has come under greater strain in the past few years following the slowdown of 2008 than it had in the few preceding ones, making the prospect of a global meltdown any time in the future a possibility, if not a certainty
  • Added to these, risk management in the global economy for 2017, like in any other year, does face prospects that are of a natural order, such as natural disasters and wars.
Global economy will bear the brunt

risk-management-in-global-economy-and-outlookAll these factors would not have had the same impact as they are likely to have in the current scenario and in the immediate and intermediate future, if not for globalization. The world’s shift towards globalization is now certain and irreversible. The interconnected nature of the global economy has ensured that a shock in one part of the global economy is sure to cause ripples of either a minor or major nature in any other part.

Other important factors for risk management in the global economy in 2017risk-management-in-global-economy-and-outlook

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An understanding of Risk Management and Analysis for Medical Device Manufacturers

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Risk management and analysis for medical device manufacturers is an essential set of approaches to quality in the field of medical devices. Implementing these is of absolute importance and criticality to the field, as the products in this industry are high-specialty ones that deal with human lives. A small error at any stage can send the product, and with it, the reputation of the manufacturer and even the healthcare provider, into a tailspin.

From its beginnings a few decades ago as a “nice to have” feature or discipline that used to come into the picture only when there were issues; quality has grown into an indispensable element of a medical device product. A medical device product into which quality does not get intertwined at every stage, right from procurement of the raw material to the use it is put to by the consumer and beyond, is unthinkable today.

risk-management-and-analysis-for-medical-device--manufacturersThe primary driver of this metamorphosis is risk management. Risk management and analysis for medical device manufacturers has been the lynchpin among the agents of change brought about into this field. Quality has evolved as a result of the change in the import regime in the US in the seventies, when products from around the world used to deluge the US market.

the consequences of this trade policy have led to the emergence of the creation of quality approaches such as Six Sigma and kaizen among many others, and global standards, of which ISO 14971 specifically relates to Quality Management Systems and methods for medical devices. Root Cause Analysis is at the root of each of these methodologies and standards.

So, what is risk management and analysis for medical device manufacturers?

risk-management-and-analysis-for-medical-device--manufacturersIn the context of medical devices, risk management and analysis for medical device manufacturers means applying a set of processes, policies, methods and practices into their manufacturing systems in alignment with respective and relevant standards as set out by global standards such as the ISO. The aim of these standards and practices is to analyze, assess, control and monitor risk. The ISO 14971 has been revised many times and each time this is done, the latest one becomes the extant version. This and other standards and practices prescribe steps and processes that need to be implemented at all stages of the product lifecycle.

The need for risk management and analysis for medical device manufacturersThe need for risk management and analysis for medical device manufacturers is simple: To ensure that the medical device meets quality requirements and is manufactured according to standards and specifications and methods prescribed in these standards. Standards such as ISO 13485, various Quality Systems Regulations (QSRs) such as 21 CFR 820 and a few European standards work in tandem with ISO 14971. The core purpose of requiring medical devices manufacturers to meet these requirements is to ensure that safety and quality are built into a medical device from start to finish.

The time at which to carry out risk management and analysis for medical device manufacturers

risk-management-and-analysis-for-medical-device--manufacturersRisk management and analysis for medical device manufacturers is to be carried throughout the lifecycle of the medical device. A set purpose is set out at each stage of the manufacturing process. For example, medical device manufacturers are required to identify and eliminate potential hazards at the initial stage using the concepts of product optimization, and use the principles of risk elimination at all the next stages, and to use the methods prescribed during a product recall.

The ways of carrying out risk management and analysis for medical device manufacturersThe ways by which risk management and analysis for medical device manufacturers are to be exercised form an important part of quality. The ISO 14971 standard is pretty flexible in this regard, allowing the manufacturer to adapt any existing standard or approach that he thinks is best suited for his organization.

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Benefits of Risk Management in all Industries

Benefits of risk management in all industries3

The benefits of risk management can be felt across all industries. Risk management is a process that needs to be applied if the risks have to be mitigated and contained, if not fully eliminated. The benefits of risk management in all industries came into greater focus following the financial debacle of 2008.

Firstly, why does an organization need to implement risk management strategies? Simple: Risks can offset the potential benefits and convert them into drawbacks. The benefits of risk management in all industries always outweigh the drawbacks of non-implementation of risk management strategies. In addition to helping the upper management get a better idea of the state of affairs of the company, benefits of risk management in all industries also help to reduce the financial burden for the organization and to meet regulatory requirements.

benefits-of-risk-managementIt needs to be understood that risk management is a set of processes that need to be implemented extremely stringently and diligently at every possible stage. Risk management is a journey, not a destination. For the benefits of risk management in all industries to be felt thoroughly, it is important to understand that it is intuitive.

Each industry has its unique risksRisk management is not a standard set of processes or exercises that can be applied into every industry. For example, the benefits of risk management in the finance sector could be different from those of the manufacturing industry. Likewise, the benefits of risk management in all industries in the life sciences sector could be way different from the risk management that is implemented in say, human resources.

benefits-of-risk-managementYet, even though the dynamics of risk management are different across all industries and are unique to each of them; the benefits of risk management in all industries are there to be felt and experienced.

Look out for the sleeping monstersEven though risk management is implemented in accordance with its own set principles or standards; there is still a possibly that some risk that was not obvious at an earlier stage could spring an unpleasant surprise later. This makes the benefits of risk management in all industries all the more worthy of consideration.

If the benefits of risk management in all industries need to be felt; the most important quality for risk managers is to inculcate the ability to see what is called the “unknown unknowns”. In simple terms, this is a phase used to describe the ability to foresee beyond the known factors.

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The ability to see beyond the obviousA few factors could become manifest in clear ways, but it is the obscure and latent ones that need greater attention. It is not always possible for even the most farsighted business risk manager to sometimes grasp the dormant risks that could crop up out of nowhere and pose a threat to the business. Developing this ability helps to realize the full benefits of risk management in all industries, because this is a quality of risk management that is common across all industries.

benefits-of-risk-managementIn order to realize the benefits of risk management in all industries fully, risk managers need to be on their guard all the time. This is obvious and goes without saying, but in the light of the fact that some risks can become enormous and uncontrollable at later stages, it is best for risk managers to understand ways of deriving the benefits of risk management in all industries.

 

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