All Features
IntraStage
The first production Model T auto in 1908 ushered in a new era of transportation by shrinking dramatically the time it took for people to move from place to place. Like the Model T, communication technologies such as email, mobile phones, and the Internet are dramatically shrinking the time for…
Matthew E. May
Recently I had a conversation with a friend who was upset about some directional shifts and a looming job shuffle within his company. As I listened to the lament, I recognized that the changes he described focused on the symptoms of the issue. All of his reactions and proposed courses of action…
Kimberly Egan
On Jan. 4, 2013, the Food and Drug Administration (FDA) took the first step in its history to regulate produce farmers. The agency issued a 547-page proposed rule that spends a lot of time reducing everything humanity has learned about plants since agriculture emerged in the Fertile Crescent 10,…
Jim Frost
This flu season has been worse than normal. The Centers for Disease Control and Prevention (CDC) data show that the flu has struck early and hard. Influenza cases shot up during December rather than the more usual January or February, and 47 states report widespread influenza cases.
I get a flu…
Tamar June
A Jan. 11, 2013, email sent by Michael Fauntleroy, program manager for the Food and Drug Administration (FDA) Electronic Submissions Gateway (ESG), the agencywide solution for accepting electronic regulatory submissions, warns those using the WebTrader for electronic submissions to delete their…
FDA
Last December, Sunland Inc. entered into a court-ordered agreement imposing requirements that must be complied with if the company is to operate. This consent decree follows the Food and Drug Administration’s (FDA) suspension of Sunland’s food facility registration in November 2012. The suspension…
Davis Balestracci
The 24th Institute for Healthcare Improvement (IHI) Annual Forum took place on Dec. 9–12, 2012. It is probably the leading health care improvement event in the world. I have presented there for 20 consecutive years and watched it evolve from barely 1,000 attendees to well over 5,000. What’s changed…
Patrick Stone
It’s clear that the Food and Drug Administration (FDA) should have more compounding pharmacy oversight, but how long will it take them to make other important decisions on public health?
The recent news is troubling.
For example, a shipment of tainted steroid from a Massachusetts-based compounding…
Margaret A. Hamburg
Every year, millions of products regulated by the Food and Drug Administration (FDA) flood into the United States from 150 countries. Ensuring these products are safe and effective can be daunting task. It was heartening for me to sign two cooperative arrangements with some of our international…
Matthew E. May
I remember when I first discovered the work of Mark Graban. The year was 2008, and I was preparing to speak to the Massachusetts Hospital Association, an audience of about 400 hospital CEOs and administrators. They wanted me to tie my work with Toyota to healthcare, which I had no firsthand…
Jay Arthur—The KnowWare Man
The United States spends $2.5 trillion for healthcare. Healthcare spending is expected to reach $4.5 trillion by the end of the decade. With Obamacare becoming a reality, we need to find a way cut the cost of healthcare to help pay for these increasing costs. The Institute of Medicine (IOM)…
University of Michigan
At hospital shift changes, doctors and nurses exchange crucial information about the patients they’re handing over—or at least they strive to. In reality, they might not spend enough time talking about the toughest cases, according to a study led by the University of Michigan.
These quick but…
Johns Hopkins University
Computational medicine, a fast-growing method of using computer models and sophisticated software to figure out how disease develops—and how to thwart it—has begun to leap off the drawing board and land in the hands of doctors who treat patients for heart ailments, cancer, and other illnesses.…
Susan Kelly
I’m a relative newcomer to government work, having joined the Food and Drug Administration (FDA) about 18 months ago after decades of being a journalist. My job is to assign, write, and edit FDA consumer updates, which are news stories posted on www.fda.gov designed to give consumers important…
Gallup
The rising cost of healthcare in the United States coupled with the absence of return on investment for Americans’ health is an important concern for many leaders across the country. And as many health systems adopt new strategies to reduce patient readmission rates and improve Hospital Consumer…
Patrick Stone
Compounding pharmacies, where the creation of a particular pharmaceutical product to fit the unique needs of a patient is done, have enjoyed the protection of their state pharmacy board, or they don’t distribute outside their home state (no interstate sales). This means that compounding pharmacies…
Michael Causey
There are two things right now that get relatively bipartisan support in Washington, D.C. The first is that a major league baseball team in D.C. won a pennant for the first time since we stopped huddling around our radios for entertainment. [Editor’s note: The Nationals lost in the first round of…
Tefen Management Consulting
One of the many hidden challenges in hospital systems is to ensure required supplies are readily available and in the right quantity. Significant manpower is invested in material management so that patients receive care without interruption. An optimized supply system that uses modern technology…
Tefen Management Consulting
When a medical institution aspires toward excellence and patient safety, quality enhancement proves to be a key factor essential to the process.
It goes without saying that there are countless risks in the healthcare system, and that it is always a priority to minimize these. There is nothing new…
Institute of Medicine
America’s healthcare system has become too complex and costly to continue business as usual, according to the report, “Best Care at Lower Cost: The Path to Continuously Learning Health Care in America” from the Institute of Medicine.
Inefficiencies, an overwhelming amount of data, and other…
Patrick Stone
During a debate with then-President Jimmy Carter, Ronald Reagan famously asked Americans if they were better off than they were four years previously. It worked for Reagan, so we’re going to try a variation of it here.
Is the Food and Drug administration (FDA) better off than it was four or five…
Tracey Lynn King, Brian A. Stockhoff, Mary Beth Edmond
Editor’s note: This is the third of a three-part series on quality in healthcare. Part one described the Juran Model for Patient Safety, and part two identified elements of a patient safety officer program.
With between 44,000 to 98,000 patients dying each year in hospitals as a result of medical…
Mike Roberts
Adverse food safety events can have disastrous effects on branding and profitability. Because information today can go viral in a matter of hours, companies in the food and beverage industry are faced with increasing pressures to operate seamlessly, with little or no room for error…
Michael Causey
The Cold War may be over, but apparently spying is still a growth industry. The latest spy-craft news comes from the seemingly staid Food and Drug Administration (FDA), which appears to have more George Smiley and John le Carré types than we’d ever imagined.
According to reports in The New York…
Mary Beth Edmond, Jonathan Flanders
Editor's note: Part one of this three-part series on patient safety, "Establishing a Patient Safety Culture," offered an overview of the Juran Model for Patient Safety. Part Two takes a closer look at Juran's patient safety curriculum and certification.
It has been 22 years since the Institute of…