All News
Increasing product recalls, regulatory fines, and penalties have made product-safety compliance a top priority for many manufacturers. The Consumer Product Safety Improvement Act (CPSIA) and other global and regional product-quality regulations have subjected consumer-product companies to…
According to the quarterly ExpertRECALL Index, 48 percent of all medical device recalls reported during the second quarter of 2013 had both U.S. and international components. In addition, the number of device recalls increased 30 percent from the last quarter, resulting in the highest number of…
Many medical devices today perform at least one function by using wireless technology to support health care delivery. In telemedicine, for example, a wireless device can enable real-time monitoring of patients from a distance. Data from a patient-worn or implanted medical device goes directly to…
For medical devices, the term “interoperability” refers to the ability of various devices to interact, and for electronic health record systems to talk to each other using a common vocabulary. It is similar to the concept of “plug and play” computer attachments such as a web cam or mouse, which…
Editor’s note: This is the second in a five-part series exploring issues that affect management’s ability to detect the warning signals of current good manufacturing practice (cGMP) compliance problems in the pharmaceutical industry.
In part one of this series, I discussed the management…
It’s a small world. Every day, there’s a good chance that some of the food you’re eating came from another country. Fifteen percent of the food we eat, including nearly 50 percent of the fresh fruit and 20 percent of vegetables, is imported each year.
That’s why it’s so important that we do…
Most people are surprised to learn that more than half of small medical practices are still using handwritten paper charts to collect and store demographic and clinical information about patients. Although every medical office has computers, many doctors never touch them.
Other professions have…
Editor's note: This is the first in a five-part series exploring issues that affect management’s ability to detect the warning signals of current good manufacturing practice (cGMP) compliance problems in the pharmaceutical industry.
Compliance to current good manufacturing practice (cGMP)…
How often do we see Health Insurance Portability and Accountability (HIPAA) violations issued because a regulated entity did not secure the electronic records at the hospital and small clinics? Large-scale security breaches and, sometimes, reports of illegal sales of electronic medical records by…
Disagreements are inevitable in science, medicine—and even life. As part of a regulatory agency committed to public health, the Food and Drug Administration’s (FDA) medical devices center occasionally confronts scientific and policy disagreements among its staff and with the various stakeholders…
Disagreements are inevitable in science, medicine—and even life. As part of a regulatory agency committed to public health, the Food and Drug Administration’s (FDA) medical devices center occasionally confronts scientific and policy disagreements among its staff and with the various stakeholders…
In a new 47-page guidance the Food and Drug Administration (FDA) appears to be doing its best to cover the waterfront for medical device manufacturers who need to better understand the complex medical device reporting (MDR) requirements. Topics range from the big picture (who is subject to this…
When you overhear a person five spots ahead of you at the coffee shop ordering a mocha light decaf, no whip, one pump, it might be enough to make you abandon your place in line and walk out. But what if the context is different and what’s at stake isn’t a hand-crafted drink, but your health—or…
What do China, Maine, Connecticut, Chipotle, and Whole Foods have in common? They all think you have a right to know whether the food you are eating contains any genetically modified organisms, known as GMOs.
I like that. Why do I care? Because the genes in GMO plants have been altered in a…
The Internet giveth and the Internet taketh away. For years, we’ve been hearing about the benefits online tools will bring to the medical industry, especially at hospitals and physicians’ offices. Many of those promises have come true, and it’s been a benefit for patients and industry.
But that…
In an earlier article, I explained how the Food and Drug Administration’s (FDA) Office of Criminal Investigation (OCI) works when a small portion of the industry fails to adequately respond to regulatory action. For Abbott Laboratories and Amgen, the price for regulatory malfeasance was high: $1.4…
If you’re a hospital leader, the safety of your patients and your employees might be keeping you up at night. That’s because senior management is accountable for creating and maintaining a safe environment for hospital staff and patients. You’re right to be concerned. Research has shown that the…
The shell game called the federal budget added another nut recently as media reports revealed that during the last 20 years, approximately $1 billion in fees paid by patent applicants has been diverted from its proper use at the United States Patent Office (USPTO).
Critics argue that, as a self-…
T
ake a moment to consider some of the foods we find at the supermarket: eggs, tomatoes, coffee — maybe even chocolate chip peppermint brownie ice cream. Now, try to imagine all the steps and processes that the food went through to get all the way to those shelves.
Although the ice cream likely…
The latest batch of Food and Drug Administration (FDA) inspection letters noting objectionable conditions, aka 483s, has a decidedly international flair: Italy, Japan, and Canada had the pleasure of hosting FDA inspectors in recent months. Three firms were found wanting by the agency in a number…
On March 28, 2013, the world lost a person whom many consider to be a major contributor to the world of industrial statistics: George E. P. Box. Relatively unknown outside the world of statistics, Box was certainly very well known by those who have studied or practiced industrial statistics.
His…
The giant sequoia trees on the Pacific Coast are breathtaking. Majestic and seemingly indestructible, they stand tall as a reminder that slow and steady sometimes does win the race. But what’s great in a forest isn’t always so great elsewhere.
Let’s push the metaphor a bit more, and say there’s…
The deadly outbreak, in October 2012, of fungal meningitis associated with a compounded medication was a horrible tragedy. I’ve asked myself many times if and how it could have been prevented. I speak for everyone at the FDA when I say that our hearts go out to the many victims, including those…
A smart phone that can perform an electrocardiogram (ECG)—measuring the electrical activity of a person’s heart to determine whether he is having a heart attack—is in my opinion an extremely smart phone. That is just one example of how mobile medical applications are transforming healthcare.
As…
A prominent politician goes before his constituents during a tough reelection campaign. He’s introduced by the local mayor, and strides to the stage, waving and smiling to enthusiastic applause.
“It’s great to be here with you tonight. I love this great state of [fill in the blank]. Erica and I…