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.

 

 

 

What Would Happen to Health Spending Under ACA?

The growth in health care spending is expected to have slowed in 2016 and to remain slow in 2017, due to slower enrollment in government-sponsored Medicaid and a reduction in spending on prescription drugs, according to a report released Wednesday by actuaries from the Centers for Medicare and Medicaid Services.

The report, published in the journal Health Affairs, assumes that President Barack Obama’s health care law, the Affordable Care Act, is still in place. Every year, the Office of the Actuary in the Centers for Medicare and Medicaid Services releases an analysis about how Americans are expected to spend money on health care in the years ahead. The agency will release the final outcomes on 2016 spending at the end of this year, once all the amounts have been tabulated.


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Michelle Loose, a University of Denver accelerated nursing student, checks the blood pressure for patient Elife Bzuneh, during a medical clinic night at the DAWN clinic on August 9, 2016, in Aurora, Colorado.

Priced Out of Coverage


The effects of the Affordable Care Act are expected to dwindle in coming years. The report finds that if the law were to continue as is then the share of the insured population would increase from 90.9 percent in 2015 to 91.5 by 2025, as more people become employed in jobs that provide them with coverage.

The slowing of health spending growth by 1.1 percent to 4.8 percent in 2016 is expected to be short-lived as the U.S. population ages, with baby boomers going onto Medicare and likely needing to use more care. Because of these factors, beginning in 2018 both Medicare and Medicaid are projected to grow faster than private insurance spending as income growth slows.

“Irrespective of any changes in law, it is expected that because of continued cost pressures associated with paying for health care, employers, insurers and other payers will continue to pursue strategies that seek to effectively manage the use and cost of health care goods and services,” Sean Keehan, the study’s first author, said in a statement.

During a press conference in Washington hosted by Health Affairs, Keehan said that “high cost-sharing is certainly one of the important factors” in driving down how much people with private plans use care, given that they have to consider how much they will shoulder costs themselves in the form of out-of-pocket spending and deductibles.

By 2025, actuaries forecast that health care’s share of the economy will reach 19.9 percent, an increase from 17.8 percent in 2025.

According to authors of the Health Affairs article, “medical price growth is projected to quicken in the coming decade compared to recent history, as both overall prices and medical-specific price inflation grow faster.”

In 2014 and 2015, health care spending had accelerated because the Affordable Care Act’s provisions went into effect: Coverage was expanded to more people and more people used health care. The federal government also chipped in more to help people pay for premiums and to pay for Medicaid for low-income Americans. Prescription drug costs also are expected to slow. In 2014 and 2015, spending surged as the drugs that were approved to treat hepatitis C, a liver disease that can require a transplant if it turns into a chronic infection, hit the market.


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Health and Human Services Secretary Tom Price, center, accompanied by his wife Betty, and Vice President Mike Pence, signs an official document during a swearing in ceremony, Friday, Feb. 10, 2017, in the in the Eisenhower Executive Office Building on the White House complex in Washington. (AP Photo/Andrew Harnik)

HHS Proposes Obamacare Rule


By 2016, these effects had slowed. Devin Stone, an economist in for CMS Office of the Actuary, said at the press conference that the projections assume that more drugs will lose their patents, slowing prescription drug costs as more generics become available.

Authors of the projections were forthcoming about the fact that the numbers are likely off target given that future of the Affordable Care Act is mired in uncertainty. Republicans and President Donald Trump have vowed to repeal the law, but lawmakers haven’t yet agreed on the timeline or ways to replace it. Decisions from lawmakers on both sides could alter factors around health spending but could also increase the number of uninsured, despite pledges or efforts not to.

Alan Weil, executive editor for Health Affairs, said the projections were still useful to help inform policy, particularly when it comes to designing ways to respond to the parts of the health care system that are driving price increases.

“This is a baseline and it’s still the law, so knowing where we are going is still important,” he said. “It’s also an important baseline to compare changes to the law. Whether we stick to the law or not, it’s important to know where we would have been.”

 

http://www.usnews.com/news/health-care-news/articles/2017-02-15/without-changes-to-obamacare-heres-what-happens-to-health-care-spending

Getting overtime pay calculation wrong can be damaging for the employer

A thorough grasp of the subtleties of the Fair Labor Standards Act (FLSA) continues to elude many employers, even though this Act has been around for a long time. The frequent changes that keep happening to the many regulations of the FLSA from time to time are one of the major reasons for this. These changes have employers, employees and attorneys scrambling for the meaning, interpretation and application of the new regulations, resulting in a huge load of extremely expensive FLSA lawsuits under this legislation.

Most of these legal disputes arise because attorneys make impermissible deductions from wages. They don’t count all the hours an employee has worked in determining overtime due, or they get their calculations plain wrong.  An idea of the magnitude of the effects of this misunderstanding of the provisions of the FLSA by employers can be had from the fact that The Department of Labor (DoL), which is already operating on a budget of $311 billion; requested an additional $104.5 billion for its 2015 budget for discretionary and mandatory programs. All these point to a new vigor and zest in this department in cracking down on false calculations and other improprieties.

pay

Learn the nuances of overtime pay

In order to clear the misunderstandings anyone may have about the various elements of this law; GlobalCompliancePanel, a well-known provider of professional trainings for the areas of regulatory compliance, will be organizing a two-day seminar. Susan Fahey Desmond, a principal with Jackson Lewis PC, who has been representing management in all areas of labor and employment law for over 30 years, will be the Director of this seminar. To enroll for this highly valuable learning session, please log on to

http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900679SEMINAR?calculating-overtime-correctly-SFO-CA.

At this seminar, Susan will go through all of the nuances of the FLSA and will cover the most frequent mistakes employers make repeatedly. She will explain the employer/employee relationship under the FLSA in detail, and will offer a description of areas such as the exemptions and what time is compensable. Another important learning of this seminar is about ways by which employers can decrease their overtime liability.

Susan will cover the following areas at this seminar:

  • Understanding the employer/employee relationship under the FLSA
  • Analysis of independent contractor v. employee
  • Volunteers and trainees
  • Exemptions – managerial, administrative, professional, outside sales, specific industry exemptions, the Motor Carrier Act
  • What is Working Time with discussion of the Portal to Portal Act
  • New Requirements for Breastfeeding Mothers
  • Calculating Overtime Correctly – determining the workweek and calculations.
  • Using approved ways to reduce overtime liability – fluctuating workweek, Belo Plans, Union Employee Plans, compensatory time
  • Minimum Wage Requirements and handling of deductions like garnishments, employee theft, company equipment, etc.
  • Child Labor laws – when they can work, what they can do, what breaks are required
  • Recordkeeping Requirements