Multiple Authors
By: 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, including potential safety risks for people and animals.

At the U.S. Food and Drug Administration, we see these knowledge gaps as an opportunity to develop new ways of building the science to inform public health decisions.

Richard Harpster’s picture

By: 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 spent considerable time studying Covid-19 since February 2020. By applying the risk-based thinking techniques I have used, I believe there is a method for saving 100,000 lives before we get the protection the new vaccines are going to provide during the next three or four months.

Natalie Weber’s picture

By: Natalie Weber

Unlike Covid-19, remote audits aren’t unprecedented. Remote audits didn’t start with the pandemic, although it has forced more companies to use them than previously. At MasterControl, we’ve been doing remote audits for years for our international customers. It saves time and expense, and it’s every bit as effective as an in-person audit.

However, this is only true because we operate in a digital environment. Using a paper system would significantly hinder remote audits.

This is largely still the case. The difference between pre-pandemic remote audits and those of the “new normal” is the sheer number that are being done, in many cases by those who have never done them before. Doing a remote audit is difficult to wrap your head around if your audit usually requires scouring binders for paperwork and completing a site walk. Mastering remote audits now will be worth it even after the pandemic is over.

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.

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.

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.

Del Williams’s picture

By: Del Williams

Approximately 48 million people in the United States (one in six) get sick, 128,000 are hospitalized, and 3,000 die each year from foodborne diseases, according to the Centers for Disease Control and Prevention. Consequently, the FDA Food Safety Modernization Act (FSMA) is transforming the nation’s food safety system by shifting the focus from responding to foodborne illness to preventing it.

As part of the focus on preventing foodborne illness, 3-A Sanitary Standards, an independent, not-for-profit corporation for advancing hygienic equipment design for the food, beverage, and pharmaceutical industries, has recently updated its standards. The company, which maintains a large inventory of design criteria for equipment and processing systems developed to promote acceptance by USDA, FDA, and state regulatory authorities, no longer accepts “3-A compliant” as a legitimate claim.

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.

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.

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