Leigh Turner’s picture

By: 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 deciding whether to approve new drugs and other products, has a problem. The FDA’s standards appear to be dropping at a time when rigorous regulatory review and robust oversight are crucial.

Maggie Pavlick’s picture

By: 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 spread among healthcare professionals and left PPE in short supply, finding a way to provide better protection while allowing for the safe reuse of these items became critical.

“Recently there’s been a focus on blood-repellent surfaces, and we were interested in achieving this with mechanical durability,” says Anthony Galante, a Ph.D. student in industrial engineering at the University of Pittsburgh and lead author of the paper in in the journal ACS Applied Materials and Interfaces.

“We want to push the boundary on what is possible with these types of surfaces, and especially given the current pandemic, we knew it’d be important to test against viruses.”

Thomas Hellwig’s picture

By: 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 combination that elevates stress levels and increases the risk of burnout. Virtually no one—and no organization—is immune.

Now more than ever, managers should become sensitive to the mental health of their teams, not to mention themselves. But few managers have formal training in this arena, which means their ability to directly intervene in the most severe cases is limited. What managers need first and foremost is a set of tools to help identify when an employee is seriously struggling. They can then take appropriate steps to ensure the sufferer has access to the necessary resources before the problem becomes so big that it’s overwhelming.

Jessica Reiner’s picture

By: Jessica Reiner

For more than 20 years, a class of man-made, potentially cancer-causing chemicals called per- and polyfluoroalkyl substances (PFAS) has commonly been found in humans and the environment. These chemicals are used in a variety of industries and can be found in many consumer products, such as food packaging and cleaners. Many early studies showed PFAS could even be found in remote locations like the Arctic.

There is one that I remember well in which 21 of the top PFAS researchers wrote about the measurement challenges that were hindering research. I was in graduate school at the time, and this paper really resonated with me. The authors pointed out that data for these chemicals should be accurate, precise, and reproducible because it was likely these data would be used as a foundation for regulatory decisions. As I look at the current news, it seems that these regulatory decisions are now being made under the Environmental Protection Agency’s PFAS Action Plan.

Dirk Dusharme @ Quality Digest’s picture

By: Dirk Dusharme @ Quality Digest

Around the world, local agencies and institutions have scrambled to find personal protective equipment (PPE) to protect their essential employees from Covid-19. Not just healthcare workers, but also the men and women who to work to keep our cities and counties up and running, from emergency responders to maintenance workers.

Told by President Trump to fend for themselves, states that couldn’t find local PPE sources have signed contracts directly with overseas manufacturers or distributors claiming to represent them. Given the problems of getting it themselves or competing with the federal government for the same supplies, governors of seven Eastern states even agreed to work together on purchasing medical equipment.

Quality Digest’s picture

By: Quality Digest

It’s easy to assume that something as simple as a mask wouldn’t pose much of a risk. Essentially, it’s just a covering that goes over your nose and mouth.

But masks are more than just stitched-together cloth. Medical-grade masks use multiple layers of nonwoven material, usually polypropylene, designed to meet specific standards for how big and how many particles they can block. And they are tested and certified to determine how well they do that job.

Healthcare and other frontline workers usually use either a surgical mask or an N95 mask. Both protect the patient from the wearer’s respiratory emissions. But where surgical masks provide the wearer protection against large droplets, splashes, or sprays of bodily or other hazardous fluids, an N95 mask is designed to achieve a very close facial fit and very efficient filtration of submicron airborne particles.

The “N95” (or “KN95”) designation means that the respirator blocks at least 95 percent of very small (0.3 micron) test particles. If properly fitted, the filtration capabilities of N95 respirators exceed those of face masks.

Carrie Van Daele’s picture

By: Carrie Van Daele

Crossing the street or stepping backward when you encounter another person has already become a habit, as has a routine elbow bump, instead of a handshake.

And that is definitely what is needed during a health crisis. But when the time is right, as a society we must bounce back to social connectivity to prevent productivity and relationships from being forever damaged.

Humans are social beings. Sure, we have varying levels of desire for social interaction; some of us want to spend time alone, while others are more inclined to want to hang out in groups. But in one form or another, we all strive for connection with one another.

The physical distancing and forced isolation was a shock to our social system. Although it is helping the health emergency, in the long run it will hinder companies’ efforts to ramp up productivity.

During the late 1970s, I remember the Big Three automotive companies launched a “Quality of Work Life” workshop to rebuild trust between employees and their superiors after an economic downturn resulting in layoffs. The Big Three knew ramping up productivity would happen only with repaired relationships.

Gleb Tsipursky’s picture

By: Gleb Tsipursky

So many companies are shifting their employees to working from home to address the Covid-19 coronavirus pandemic. Yet they’re not considering the potential quality disasters that can occur as a result of this transition.

An example of this is what one of my coaching clients experienced more than a year before the pandemic hit. Myron is the risk and quality management executive in a medical services company with about 600 employees. He was one of the leaders tasked by his company’s senior management team with shifting the company’s employees to a work-from-home setup, due to rising rents on their office building.

Specifically, Myron led the team that managed risk and quality issues associated with the transition for all 600 employees to telework, due to his previous experience in helping small teams of three to six people in the company transition to working from home in the past. The much larger number of people who had many more diverse roles they had to assist now was proving to be a challenge. So was the short amount of time available to this project, which was only four weeks, and resulted from a failure in negotiation with the landlord of the office building.

Sangeet Paul Choudary’s picture

By: Sangeet Paul Choudary

The digitization of patient data and the adoption of cloud-based healthcare management systems have created efficiencies and new business models across the value chain. Advancements in AI provide superior decision support systems to doctors, while connected devices enable the remote delivery of care and monitoring. 

But the most important transformation in healthcare is only just beginning to take shape. Digitization of healthcare demand and supply will eventually lead to the creation of large platforms that aggregate industrywide demand and supply, and orchestrate interactions between producers and consumers of healthcare. 

Sensing this opportunity, big tech firms from Tencent and Alibaba to Amazon and Google, as well as industry incumbents like Philips and UnitedHealthcare, have been moving toward platform models. To understand the importance of platforms in healthcare, we need to start with the forces driving the digitization of demand and supply in healthcare: the digitization of patient data and provider workflows. 

Multiple Authors
By: Alan Rudolph, Raymond Goodrich

We [Alan Rudolph and Raymond Goodrich] are both biotechnology researchers and are currently seeking to repurpose an existing medical manufacturing platform to quickly develop a vaccine candidate for Covid-19.

This process is used for the treatment of blood products such as plasma, platelets, and whole blood to prevent disease transmission when people receive transfused blood. It utilizes a common food ingredient, vitamin B2, or riboflavin, which is a light-sensitive chemical. When used in combination with ultraviolet light of specific wavelengths, B2 can alter genetic material, whether RNA or DNA, of infectious pathogens in the blood, making them unable to transmit disease.

Those genetic changes prevent pathogens, such as viral, bacterial, and parasitic contaminants, in blood from replicating. By stopping the replication process, the method protects people from disease they could acquire through a blood transfusion.

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