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.

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.

Jason Chester’s picture

By: Jason Chester

Even in the midst of the pandemic, product safety and quality remain critical. For many manufacturers, complex quality management systems and procedures stand in the way of agile responses and effective operational optimization. Cloud technology provides the means to dramatically simplify quality management.

If you’re like many quality pros and manufacturing leaders right now, you’re working crazy hours, possibly on a different schedule or from a remote location. You’re struggling to find new ways to get the data that operators are collecting on the plant floor and support workers as they adapt to rapidly changing demands. You’re also likely scrambling to coordinate with your plant managers and create custom reports for your executive teams.

It’s a challenging time, and if you’re lucky, you’re keeping on top of the unique demands this time has put on you. But even in the middle of this sprint, product safety and quality remain paramount.

Multiple Authors
By: Donald J. Wheeler, Al Pfadt

Each day we receive data that seek to quantify the Covid-19 pandemic. These daily values tell us how things have changed from yesterday, and give us the current totals, but they are difficult to understand simply because they are only a small piece of the puzzle. And like pieces of a puzzle, data only begin to make sense when they are placed in context. And the best way to place data in context is with an appropriate graph.

When using epidemiological models to evaluate different scenarios it is common to see graphs that portray the number of new cases, or the demand for services, each day.1 Typically, these graphs look something like the curves in figure 1.


Figure 1: Epidemiological models produce curves of new cases under different scenarios in order to compare peak demands over time. (Click image for larger view.)

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