All Features
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…
Ken Peterson
From the perspective of the U.S. Food and Drug Administration and other regulatory agencies, corrective and preventive action (CAPA) is viewed as the central component that affects all control points including design controls, production and process controls, records and documents change controls,…
Patricia C. La Londe
Cardinal Health Alaris Products, which makes pumps and disposables used during infusions, was in critical shape in the late 1990s and needed to address improvement on all fronts. The prescription included improvements in customer satisfaction and in the company’s finances, which required the…
MasterControl Inc.
The advantages to pharmaceutical companies of using electronic solutions to modernize their paper-based or partially electronic processes are enormous. Automation speeds up and connects all interrelated processes (corrective and preventive actions, customer complaints, audits, deviation…
Bill Kalmar
Advancing into that mystical category of “senior citizen” brings with it certain perks. Simultaneously becoming a senior citizen, retiring, and joining the ranks of Social Security recipients is a financial trifecta.I retired in 2003, and when I made that phone call to add my name to the millions…
Tim Lozier
In today’s quality management systems, the ability to control and correct processes is key to maintaining a high level of compliance within an organization. Whether it’s tracking incoming customer complaints, identifying nonconforming materials from production, or using corrective and preventive…
Mike Richman
Dr. Tomas Gonzalez, senior vice president and chief quality officer for Valley Baptist Health System of Harlingen, Texas, is a busy man. Not only does he direct quality process improvement at Valley Baptist’s two hospitals, he’s also a physician and a certified Master Black Belt. Valley Baptist…
The cost of poor quality in health care ranges from 30 to 60 cents of every health care dollar. Until recently, however, there have been few financial consequences for health care providers’ failure to address the underlying root causes. This article describes Medicare’s new policy of not…
Georgia Institute of Technology
Research reported recently in the journal Advanced Materials describes a potentially promising strategy for encouraging the regeneration of damaged central nervous system cells known as neurons.The technique would use a biodegradable polymer containing a chemical group that mimics the…
Abby Vogel
Tushar Sathe holds a vial of dual-function beads embedded with iron oxide and 600 nanometer emission quantum dots, while Shuming Nie looks on. The other vials contain beads embedded with quantum dots that emit light at other wavelengths. photo by Gary Meek…