All Features
Saligrama Agnihothri
Health-tracking devices and apps are becoming part of everyday life. More than 300,000 mobile phone applications claim to help with managing diverse personal health issues, from monitoring blood glucose levels to conceiving a child.
But so far the potential for health-tracking apps to improve…
Dawn Bailey
The spirit of service—for a small clinic started in 1913 to provide free care to Los Angeles (LA)—lives today in the servant-leader aspirations of 2019 Baldrige Award recipient Adventist Health White Memorial (AHWM), a 353-bed, safety-net hospital.
The community of two million people that AHWM…
Clare Naden
Travel and tourism took a beating during the Covid-19 pandemic, with borders closed, airlines grounded, and many establishments shut for months. Now as the industry attempts to recover in this new context, constantly changing rules and regulations are making it a far-from-simple task. What’s more,…
Adrian Hernandez, C. Michael White
T
he U.S. Food and Drug Administration (FDA) regularly inspects manufacturing facilities to ensure that drugs meet rigorous quality standards. These standards are vital to protect patients from drugs that are incorrectly dosed, contaminated, or ineffective.
But over the past few years, tens of…
Gleb Tsipursky
When the Covid pandemic swept through the country last year, companies rapidly transitioned employees to working from home (WFH). However, this shift led to growing challenges of WFH burnout and Zoom fatigue.
Unfortunately, organizations treat these issues as day-to-day challenges, instead of…
Jon Speer
Demonstrating identification and traceability in all quality system processes is a must for medical device companies to comply with FDA regulations. To satisfy this compliance need, companies will need to connect related processes within their quality system to close the loop between related pre-…
Wade Schroeder
Medical-device usability testing and validation are critical tasks leading up to a medical device’s debut on the market. “Usability” looks at how the user interacts with your device and forms a key component of overall risk management and safety.
If there’s any “spoiler alert” to this article, it’…
Ariane Ollier-Malaterre, Knowable Magazine
This story was originally published by Knowable Magazine.
Working from home—formally known as telework—is here to stay. A 2021 survey of approximately 30,000 Americans concluded that, after the pandemic, 20 percent of all work days may continue to take place at home, vs. just 5 percent before.…
David L. Chandler
This story was originally published by MIT News.
Two MIT professors have proposed a new approach to estimating the risks of exposure to Covid-19 under different indoor settings. The guideline they developed suggests a limit for exposure time, based on the number of people, the size of the space,…
Jon Speer
The medical device technical file is a must-have document for devices to be sold in the European Union (EU) marketplace. The file contains detailed information about your medical device, its design, intended use claims, composition, and clinical evaluations. It’s essentially an “everything you must…
Janet Woodcock, Judy McMeekin
During the past year, the U.S. Food and Drug Administration’s (FDA) approach to foreign and domestic inspections for food and medical products has been both risk-based and deliberate. The Covid-19 pandemic required us to rework our business operations so that we could carry out our public health…
Edmund Andrews
Seems everybody has a horror story about health insurance: Kafkaesque debates with robotic agents about what is and isn’t covered. Huge bills from a doctor you didn’t know was “out of network.” Reimbursements that take months to process.
It’s no secret that healthcare in the United States is…
Graham Freeman
Here’s an unfortunate truth: The story of the Covid-19 pandemic is one of epic quality failures in almost every area imaginable. Although there have been some admirable successes, such as the food and beverage organizations that have ensured the continued safe delivery of food supplies to most…
Gleb Tsipursky
Have you or your employees been feeling work-from-home burnout (WFH) and Zoom fatigue these past months despite the supposed convenience of working from home and using video conferences to meet?
Due to the computer-based nature of their work, many quality professionals have been in the privileged…
Rita Men
Ending the pandemic depends on achieving herd immunity, estimated at 70 percent or even 80 percent to 90 percent of a population. With some 30 percent of Americans telling pollsters they have no interest in getting vaccinated, that’s cutting it a bit close. The numbers are even worse in many other…
Sharona Hoffman
Artificial intelligence holds great promise for improving human health by helping doctors make accurate diagnoses and treatment decisions. It can also lead to discrimination that can harm minorities, women, and economically disadvantaged people.
The question is, when healthcare algorithms…
Dave Klumpe
Recent surveys point to increasing frustration and, frankly, exhaustion among nurses across the country. Although attending to patients during the pandemic has exacerbated the challenges of the profession, nursing shortages have been reported on for well over a decade. It is incumbent on hospitals…
Tinglong Dai, Christopher Tang, Ho-Yin Mak
More than 50 million Americans have received at least one dose of either the Pfizer or Moderna Covid-19 vaccine. So far, Americans have been largely brand-agnostic, but that’s about to change as the Johnson & Johnson vaccine rolls out.
The vaccine has been hailed as a game changer. It requires…
Anne Trafton
In the era of social distancing, using robots for some healthcare interactions is a promising way to reduce in-person contact between healthcare workers and sick patients. However, a key question that needs to be answered is how patients will react to a robot entering the exam room.
Researchers…
Ryan E. Day
In an article published by Quality Digest, Julias DeSilva addresses recent declines in ISO certification and poses the question, “Does quality matter anymore?” His conclusion is that even if you don’t get certified, you will still gain from a well-implemented management system. But what do…
Clare Naden
It’s been about a year since the Covid-19 pandemic turned our world upside down, and that includes the world in which we work. Certainty has hung up its hat, normality looks unlikely to return, and unpredictability is here to stay for the long term. How can organizations manage in this context, and…
Denis Bergeron
From the earliest days of radioactivity research, radiation and cancer therapy have gone together like peas and carrots. But Zach Levine covered peas and carrots in an earlier blog post, so I will focus on radiation and cancer therapy.
Shortly after Wilhelm Röntgen discovered the high-energy…
Gleb Tsipursky
Stakeholder engagement is one of the more critical aspects of leadership, whether you’re a team leader or a member of a cross-functional team trying to lead team members to focus on quality. Stakeholders can be anyone from your colleagues to suppliers to business partners, and your relationship…
Clare Naden
Never have we been more acutely aware of the importance of reliability when it comes to laboratory testing. As the ongoing Covid-19 pandemic has highlighted, the development of accurate diagnostic tests plays an important role in outbreak management.
Whether a laboratory develops its own test…
Maria Church
Sometimes work seems like, well, work. It’s not the fun, fulfilling, or rewarding kind of work that we look forward to tackling but the life-sucking, drudgery kind of work. What to do when work drains the soul and seems like a waste of a life? Find the meaning in the work you do, and you will find…