Jon Speer’s picture

By: 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. Risk is a critical factor to consider throughout the life cycle of a medical device because it can mean the difference between life and death for patients.

Industry resources like ISO 14971 exist to help medical device professionals define and clarify risk management best practices. According to the internationally recognized standard for medical device risk management, risk is defined as “the combination of the probability of occurrence of harm and the severity of harm.”

There are varying levels of risk factors medical device companies must consider in practicing effective risk management. By following the established processes outlined in ISO 14971 and leveraging the best quality management tools, medical device companies can improve their overall risk management system.

Jennifer Mallow’s picture

By: 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 studied telehealth as a Ph.D. researcher while using it as a registered nurse and advanced-practice nurse. Telehealth involves the use of phone, video, internet, and technology to perform healthcare, and when done right, it can be just as effective as in-person healthcare. But as many patients and healthcare professionals switch to telehealth for the first time, there will inevitably be a learning curve as people adapt to this new system.

Thomas R. Cutler’s picture

By: 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 that result in pain and can affect activity (e.g., carpal tunnel syndrome, tendonitis). About 140 million Americans live with an MSD. The total of direct and indirect costs for people who have both musculoskeletal disorders and other conditions such as diabetes, heart disease, or obesity is $874 billion, according to the report.

Jennifer Lauren Lee’s picture

By: 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 ultraviolet (UV) light.

Back in 2012, the NIST scientists and their collaborators published several papers on some fundamental findings with potential benefits to water utility companies. But these articles never fully explained the irradiation setup that made the work possible.

Now, for the first time, NIST researchers are publishing the technical details of the unique experiment, which relied on a portable laser to test how well different wavelengths of UV light inactivated different microorganisms in water. The work appears in the Review of Scientific Instruments.

“We’ve been wanting to formally write this up for years,” says Tom Larason, an electronics engineer in the Sensor Science Division at NIST. “Now we have time to tell the world about it.”

Multiple Authors
By: 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 emergency, and contribute to the high cost of medical products.

For the past several years, the U.S. Food and Drug Administration (FDA) has sought to encourage and facilitate the adoption of “advanced manufacturing,” which refers to new and emerging approaches for the production of medical technologies. These approaches are applicable to different medical product areas. For example, process intensification methods, such as continuous manufacturing, can simplify and centralize the production of many essential medicines. Likewise, techniques such as 3D printing can help produce patient-specific medical devices. Furthermore, digital and smart technologies for designing and manufacturing processes also promise to increase efficiency and reduce uncertainty.

Multiple Authors
By: 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 spotlight who are charged with helping the public understand what is happening, what is likely to happen next, how to behave to reduce the pandemic’s spread, and why.

Through these health officials, millions have heard about social isolation, flattening the curve, mask-wearing, vaccines, antiviral drugs, and more.

The footing is tricky: Downplay a threat, and the public might not react strongly enough; overdo it, and they might not listen next time. And how can officials remain trustworthy when scientists’ understanding of a new virus is changing by the week?

Multiple Authors
By: 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 Partners’ video service had swelled to 242,000.

“We’re not the only ones,” said Joe Kvedar, a dermatology professor at Harvard Medical School and a telemedicine advocate at Partners for three decades, in a May webinar. The same thing was happening across the country as the Covid-19 pandemic made in-person visits at doctors’ offices dangerous for patients and clinicians alike.

Regardless of when the Covid-19 threat dissipates, video visits have crossed a tipping point to become a mainstream way to obtain care, says cardiologist Joe Smith, co-author of an overview of telemedicine in the Annual Review of Biomedical Engineering. “I don’t think we go back,” he says. “For a long time, hospitals have been the cathedrals of healthcare where patients have to come. But people are now seeing that they can get their healthcare in the safety and comfort of their own home.”

Katherine McCormick’s picture

By: 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 a better way. Described recently in Proceedings of the National Academy of Sciences, their method, VIRRION, may be a faster and more versatile diagnostic tool than the conventional polymerase chain reaction (PCR) virus tests.

PCR works by making millions of copies of DNA or RNA to enhance the detection of viruses, including the novel coronavirus, SARS-CoV-2. The ongoing pandemic has led to advances in the speed of PCR tests. But the test is based on biochemical processes that occur at specific temperatures, so researchers can’t process tests any faster than the several hours it takes to heat and cool the sample many times. Not only that, a PCR test will only recognize the virus that it was specifically designed to test, so a new test must be developed and disseminated each time a new virus pops up. The delay between the emergence of a virus and the availability of tests can lead to devastating consequences.

Elizabeth Tippett’s picture

By: 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 to see a significant cut in their unemployment insurance benefits near the end of July, when the $600-per-week subsidy from the federal government is set to expire.

As a professor specializing in employment law, I don’t have a lot of reassurance to offer. Employment law is a patchwork at the best of times—let alone during a global pandemic—and legal protections may not cover your situation. Like so many of the challenges people are facing right now, you may be mostly on your own, negotiating the least bad of many bad options.

Here is a basic overview of what your options are under some common scenarios.

Farhana Ahmad’s default image

By: 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 and employees alike.

To summarize each phase and their objectives:
1. Respond: involves the immediate steps taken during the initial outbreak
2. Return: introduces short-term changes implemented to address all the newly discovered issues
3. Reimagine: implements long-term policies, procedures, and best practices to create an agile and resilient workforce

Our role in the Safe Actions for Employee Returns (SAFER) initiative

On top of our internal developments, we’ve joined the National Safety Council’s Safe Actions for Employee Returns (SAFER) initiative. With the aim of delivering a framework designed to ensure an effective and seamless transition back to the workplace, we have joined the ranks of more than 100 experts across 50 leading organizations.

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