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Four Essential Processes in Medical Device Risk Management
Jon Speer
Risk can mean many different things depending on the situation. Flying on an airplane, biking on a busy road, driving in a car—all of these involve some level of risk. Although risk is a variable we encounter in everyday life, it means something uniquely different to the medical device industry.…
Is Telehealth As Good As In-Person Care?
Jennifer Mallow
Covid-19 has led to a boom in telehealth, with some healthcare facilities seeing an increase in its use by as much as 8,000 percent. This shift happened quickly and unexpectedly, and has left many people asking whether telehealth is really as good as in-person care. During the last decade, I’ve…
The Progression of Covid Within the United States
Donald J. Wheeler
This article tracks the progression of Covid-19 over the past six months on a state-by-state basis and provides a framework for interpreting these curves by including curves for seven other countries. While 52 states and territories are covered here, it turns out that there are just three basic…
Evidence-Based Ergonomic Risk Analysis for Environmental Health and Safety
Thomas R. Cutler
About one in two U.S. adults has a musculoskeletal disorder, costing an estimated $213 billion each year in treatment and lost wages, according to a report from the United States Bone and Joint Initiative. Musculoskeletal disorders (MSD) are injuries and conditions to the bones, muscles, and joints…
The Importance of Managing and Controlling Risk in the Medical Device Industry
Jon Speer
Imagine you’re a patient going in for any medical procedure. You probably think very little about the risks of the medical device being used on you. Generally, patients trust clinicians’ expertise and seldom wonder if the products being used have undergone rigorous testing and are proven to be safe…
Shrinking (Ultra)Violet
Jennifer Lauren Lee
While awaiting full access to their labs due to Covid-19 restrictions, scientists at the National Institute of Standards and Technology (NIST) have taken this rare opportunity to report the technical details of pioneering research they conducted on the disinfection of drinking water using…
Investing in Advanced Manufacturing to Support Public Health Preparedness
Stephen M. Hahn, Anand Shah
Americans may be surprised to learn that many 21st-century medical products are still being manufactured using technologies commonly employed since the middle of the last century. These manufacturing platforms are not dynamic and can increase the risk of shortages, limit flexibility during an…
Some Benchmarks for the Fall Covid-19 Experiment
Donald J. Wheeler
In past articles I have used graphs to provide perspective on how the Covid-19 pandemic is progressing around the world. In this article I shall update some of those graphs and use these historical data to make projections on what may be expected in the United States in the fall. The worldwide…
Using Face Masks and Respirators for Covid-19
William A. Levinson
Face masks and respirators may well offer the only way to return to an even remotely normal living and working style in the second half of 2020, which means they will play a vital role in any kind of economic recovery. This article’s purpose is to discuss what we know about respiratory protection,…
Speaking of Pandemics: The Art and Science of Risk Communication
Bob Holmes, Knowable Magazine
This story was originally published by Knowable Magazine. Infectious disease expert Anthony Fauci. Coronavirus response coordinator Deborah Birx. County health officials across the United States. The Covid-19 pandemic has led to the emergence of a new set of household names: those in the media…
Process Behavior Charts and Covid-19
Donald J. Wheeler
Since the start of the Covid pandemic I have received many questions about how to analyze the Covid numbers using process behavior charts. Various schemes have been proposed and used. This column will discuss appropriate ways of analyzing data from epidemics and pandemics. Now to be clear, in this…
Telemedicine’s Tipping Point
Lola Butcher, Knowable Magazine
This story was originally published by Knowable Magazine. In February 2020, the month before Covid-19 hit Boston, Partners Healthcare, the huge health system that includes Massachusetts General Hospital, treated 1,600 patients via video visits. By April, the number of patients seeking care through…
Some Perspective on the Covid Pandemic
Donald J. Wheeler
With data that come along one number at a time, it is easy to get lost in the details. To see the big picture, it helps to use a time-series graph that will draw your eye in the direction that your mind wants to go. These simple graphs reveal how the values are changing over time and thereby place…
The Future of Everything Is Risk-Based
Greg Hutchins
My recent epiphany was that the lens for all work and even for everyday living during the next few years will be risk-based. Why do I make this case? In January 2020, my company was selected to participate in the largest pitch fest in the Northwest, TechfestNW, which was originally scheduled for…
Lasers Can Help Us Detect Viruses Faster Than Typical Medical Tests
Katherine McCormick
To detect a virus, you need to already know intimate details about it. You need to design a test particular to that virus: one that finds and copies only a specific, identifying piece of its genetic material. But Mauricio Terrones and his collaborators at Penn State University think they’ve found…
As Offices Reopen, Here’s What to Expect if You’re Worried About Getting Sick on the Job
Elizabeth Tippett
If you’re among the tens of millions of people returning to work or preparing to do so after months sheltering in place, you may be worried it will put you and your family at increased risk of exposure to Covid-19. The dilemma may be especially stark for the millions of Americans who can expect…
Our Return to Work Initiative: Respond, Return, and Reimagine
Farhana Ahmad
When Intelex developed its return-to-work program, we decided the best approach would be a phased one. Similar to the concept of continuous deployment, breaking down the plan to allow individuals to quickly process, adapt, and execute practices and procedures makes it more manageable for employers…
Lasers Could Turn Regular Metal Surfaces Into Bacteria Killers
Kayla Wiles
A new laser treatment method could potentially turn any metal surface into a rapid bacteria killer just by giving it a different texture, researchers say. In a new study, they demonstrated that this technique allows the surface of copper to immediately kill off superbugs such as MRSA. “Copper has…
How We Make Decisions During a Pandemic
Katherine Harmon Courage, Knowable Magazine
This story was originally published by Knowable Magazine. From mask wearing to physical distancing, individuals wield a lot of power in how the coronavirus outbreak plays out. Behavioral experts reveal what might be prompting people to act—or not. With many states and towns lifting strict stay-at…
My Stay-at-Home Lab Shows How Face Coverings Can Slow the Spread of Disease
Matthew Staymates
As a fluid dynamicist and mechanical engineer at the National Institute of Standards and Technology (NIST), I’ve devoted much of my career to helping others see things that are often difficult to detect. I’ve shown the complex flow of air that occurs when a dog sniffs. I’ve helped develop ways to…
Are We Getting Better Yet?
Donald J. Wheeler
The daily Covid-19 pandemic values tell us how things have changed from yesterday, and give us the current totals, but they are difficult to understand simply because they are only a small piece of the puzzle. This article will present a global perspective on the pandemic and show where the United…
Preparing for the HEROES Act
William A. Levinson
The U.S. House of Representatives has passed the HEROES Act (Health and Economic Recovery Omnibus Emergency Solutions Act)1 which will, if approved by the Senate and president, require OSHA to develop a standard for workplace protection against Covid-19. Under section 120302 the legislation says…
Could Pressure for Covid-19 Drugs Lead the FDA to Lower Its Standards?
Leigh Turner
Given the death, suffering, social disruption and economic devastation caused by Covid-19, there is an urgent need to quickly develop therapies to treat this disease and prevent the spread of the virus. But the U.S. Food and Drug Administration (FDA), charged with the task of evaluating and…
Textile Coating Could Make PPE Last and Last
Maggie Pavlick
Masks, gowns, and other personal protective equipment (PPE) are essential for protecting healthcare workers. However, the textiles and materials used to make such items can absorb and carry viruses and bacteria, inadvertently spreading the disease the wearer sought to contain. When the coronavirus…
How to Spot When an Employee Is Secretly Struggling
Thomas Hellwig
The Covid-19 world is marked by a high degree of uncertainty and existential fear, a dearth of social interaction, the convergence of professional and personal space, a lack of physical activity, and an obsessive focus on hygiene and social distancing. For professionals, this amounts to a toxic…

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