All Features
James Odom
Charles Kettering, the famous inventor, once said: “A problem well stated is a problem half solved.” This implies that a good portion of problem solving should be devoted to a thorough understanding of what’s going on before any corrective action steps are taken.
In many cases, too much time is…
Bill Kalmar
None of us, I suspect, are fond of visiting our physician, making an unexpected trip to the hospital emergency room, or undergoing an operation. From time to time, we hear about the unanticipated results of a botched operation where the wrong leg was removed or an incorrect diagnosis resulted in…
Sandford Liebesman
I've been auditing to ISO 9001 since 1992. A part of my auditing philosophy has been to add value to the audited organizations by suggesting opportunities for improvement. Following, I will describe the most effective “value adds.”
Continual improvement
Look at ISO 9001:2000 subclause 8.5.1--"…
Tamar June
The Food and Drug Administration (FDA) has had many challenges and setbacks in the past few years. From budget cuts, to high-level departures, the agency has also faced fury from lawmakers on Capitol Hill over high-profile device, drug, and food recalls.
Off the record, current, and former…
Lysosomal storage disorders may not sound as dire as diseases such as cancer or Alzheimer’s, but to the people that suffer from them, life can be a nightmare. In fact, three of the primary disorders in this category—Gaucher’s Disease, Fabry Disease, and Pompe Disease—aren’t only characterized by a…
Richard Strouse
Internal auditing, when effectively implemented, can arguably be considered the most important tool in the quality system tool box. It’s the primary method for continuously monitoring a company's quality management system (QMS). In fact, the feedback from internal auditing is critical to the growth…
George Rodrigues
Liquid delivery is a common laboratory process and this critical function is often overlooked. As a result, routine research and test results can be in error based on a simple misunderstanding or misapplication of liquid delivery instruments. This article focuses on defining and exploring accuracy…
Rory Granros
When regulatory compliance and risk management come to mind, they usually evoke feelings of fear, uncertainty, and doubt as to how well an organization is prepared for government scrutiny or any worst-case business scenario. Questions arise, such as: Have we developed the proper procedures to…
Nancy Fullbright
Alan Kent, president and CEO of Meadows Regional Medical Center in Vidalia, Ga., was a champion for implementing lean principles in the hospital’s emergency department. Photo by Gary Meek Emergency rooms in the United States aren’t known for their…
Patrice L. Spath
Measurements of patient care continuity should encompass all of the components of health care delivery—structure, process, and outcome. “Structure” in health care delivery refers to the way a health care entity organizes itself and sets up operations. Health care structures include elements such…
From an antacid to a new cancer treatment, every drug must be proven safe and effective in controlled clinical trials before the U.S. Food and Drug Administration (FDA) allows it to be sold in the United States.
When federal law first required controlled clinical trials in 1962, most people…
Wini Hayes
A well-respected surgical group requests a new surgical device that they swear will revolutionize how surgery is performed in your hospital. The price tag is well into seven figures, with significant annual maintenance and training costs. A competing hospital is advertising to consumers that they…
George Rodrigues
Pharmaceutical processes typically take place on the scale of gallons or liters, even tens of thousands of liters. So why would anyone worry about one little microliter? Because in some situations, deviations as small as one microliter can mean the difference between success and failure.
Modern…
The use of drug product is widespread and touches all aspects of our daily lives without our knowing it. From aspirin to cardiac medicine and from hormones in animal feed to over-the-counter dietary supplements, these products are used every day. What they all have in common are specific government…
Carolyn Clancy
Choosing a hospital that scores well on quality can make it easier and safer for you to recover from a serious event, such as heart surgery, or a routine one, such as having a baby. Doing a little homework before you choose a hospital can do more than give you peace of mind.
As a physician, let…
James Jardine
The International Organization for Standardization has developed more than 17,000 international standards on numerous subjects. For medical device companies, the most important of these standards is ISO 13485, which provides internationally recognized guidelines pertaining to quality management…
James Jardine
The International Organization for Standardization has developed more than 17,000 international standards on numerous subjects. For medical device companies, the most important of these standards is ISO 13485, which provides internationally recognized guidelines pertaining to quality management…
Carolyn Clancy
Walk into many stores and you’re bound to be impressed by the quality of digital cameras, TVs, cell phones, and other consumer electronics. Every year the quality of these devices improves by leaps and bounds, and consumers often pay less as products improve.
I wish the same could be said about the…
In June 2007, the U.S. Food and Drug Administration issued the dietary supplement current good manufacturing practice (CGMP) final rule (21 CFR Part 111). In essence, the final rule requires that the proper controls be in place for dietary supplements during manufacturing, packaging, labeling, and…
Walk into many stores and you’re bound to be impressed by the quality of digital cameras, TVs, cell phones, and other consumer electronics. Every year the quality of these devices improves by leaps and bounds, and consumers often pay less as products improve.I wish the same could be said about the…
Sharon Phillips
In June 2007, the U.S. Food and Drug Administration issued the dietary supplement current good manufacturing practice (CGMP) final rule (21 CFR Part 111). In essence, the final rule requires that the proper controls be in place for dietary supplements during manufacturing, packaging, labeling…
Sharon Phillips
In June 2007, the U.S. Food and Drug Administration issued the dietary supplement current good manufacturing practice (cGMP) final rule (21 CFR Part 111). In essence, the final rule requires that the proper controls be in place for dietary supplements during manufacturing, packaging, labeling…
A thorny question lies at the heart of meaningful health care reform. How much is human life worth? New research from Wharton and Stanford based on Medicare kidney-dialysis data shows that the average figure—$129,090 per additional year of quality life—is higher than prior studies have shown.…
David Ade
For companies doing business in regulated environments, the benefits of implementing software systems are abundant. Improved product safety, higher quality, enhanced efficiency, and increased probability of maintaining regulatory compliance are just a sample of the numerous benefits…
Carolyn M. Clancy M.D.
If you’ve ever watched the popular “MythBusters” program on the Discovery Channel, you know that many supposed truths are based on old, incomplete, or simply incorrect information.The same can be said about beliefs about the quality of health care in America. How many times have you heard that more…