All Features
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…
Sheronda Jeffries
Since the beginning of the coronavirus outbreak, UK officials have seized millions of substandard face masks at Heathrow Airport. These masks could have put millions at risk for contracting or spreading the Covid-19 virus.
Industry and governmental organizations including the Therapeutic Goods…
Stephen M. Hahn, Amy P. Abernethy
During a short period of time, our society has seen a rapid increase in the interest and availability of cannabidiol (CBD) products and other products derived from cannabis. However, we still have a limited understanding of the safety profile of CBD and many other cannabis-derived compounds,…
Gleb Tsipursky
Should quality professionals be worried about the new Covid strains originating in the United Kingdom, South Africa, and elsewhere, and recently identified in the United States?
Authorities have focused on downplaying concerns about vaccine effectiveness against these new variants. While some…
Richard Harpster
As someone who has helped companies in a wide variety of industries for the last 30 years solve many problems using risk-based thinking, I cannot think of an issue that I have worked on that is more important than preventing the spread of Covid-19. With three high-risk people in my home, I have…
Jane Bianchi
Let’s pretend, for a moment, that you’re a primary care physician and you refer one of your patients to another doctor for a colonoscopy. Will the patient follow through? If not, how will your team know to remind him or her? If the patient does receive a colonoscopy, will your team be alerted so…
Bahar Aliakbarian
The two major U.S. developers of the early Covid-19 vaccines are Pfizer/BioNTech and Moderna. They both developed mRNA vaccines, a relatively new type of vaccine. A major supply-chain issue is the temperature requirement for these vaccines.
The Pfizer vaccine needs to be stored at between –112° F…
Sanjay Mishra
As the weather cools, the number of infections of the Covid-19 pandemic are rising sharply. Hamstrung by pandemic fatigue, economic constraints, and political discord, public health officials have struggled to control the surging pandemic. But now, a rush of interim analyses from pharmaceutical…
Nader Moayeri
I am part of a grassroots effort at the National Institute of Standards and Technology (NIST) that is developing an exposure notification system for pandemics in general, though we hope it could be used in at least a limited fashion during the current Covid-19 pandemic. We are fortunate at NIST to…
Steve McCarthy
The ideal of proactive quality has been the holy grail of chief quality officers in the life sciences industry for at least five years, but few, if any, have realized the vision. Industry has since set out a clear definition of the milestones a medical product manufacturer would need to meet in…
Grant Ramaley
IEC 60601-1: “Medical electrical equipment,” edition 3.1, is the base medical-device standard to ensure “basic safety and essential performance” of medical electrical equipment. It is used by medical device regulators but also recognized by some other regulatory authorities as a regulatory…
