Healthcare Features

Michael Causey's picture
Michael Causey
Medical device warning letters and domestic inspections continue to show a slow decline, according to a new report issued by the U.S. Food and Drug Administration (FDA). The number of medical...
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Ken Miller
Has your organization secured all its electronic healthcare records (EHR)? If not, don’t wait to put the proper policies and procedures in place. If you’ve already secured your EHR, then make sure...
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Schaeffer Smith
Healthcare reform has undoubtedly created more integrated delivery and payment models based on a culture of quality-focused and cost-efficient clinical management. In one example, many healthcare...
Taran March @ Quality Digest's picture
Taran March @ Quality Digest
As a sort of character-building exercise, I recently opened an unsolicited email from my health insurance provider. I was intent on doing a quick purge of sham, spam, and flimflam, and I figured...
Russ King's picture
Russ King
The path to medical device commercialization requires FDA approval, which most often means filing a premarketing notification, also known as a 510(k). The FDA has specific criteria for accepting a...
Patrick Stone's picture
Patrick Stone
The corner drug store isn’t currently affected by many drug shortages; instead, the pain is being inflicted on a vulnerable group of patients in hospitals today. The U.S. Food and Drug...
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NIST
A newly released study comparing 34 U.S. healthcare organizations that received the Baldrige National Quality Award with their 153 geographically closest competitors found that the Baldrige Award...
Russ King's picture
Russ King
The FDA just issued a Safety Communication on the cybersecurity vulnerabilities of the Hospira Symbiq Infusion System, which is a computerized pump designed for the continuous delivery of...
Michael Causey's picture
Michael Causey
A new Government Accounting Office (GAO) report, designed to shed light on what effect the medical device tax will have on the industry in the future, might have done a better job of taking us...
Michael Causey's picture
Michael Causey
Although medical-industry trade groups and many House and Senate members are lined up on one side, determined to repeal the medical device tax, the other side might have the final ace: A veto...
Michael Causey's picture
Michael Causey
If you’ve got six months—and nerves of steel—here’s some good news: You have a 61-percent chance of getting your medical device approved by the Food and Drug Administration (FDA). That’s one nugget...
Thomas Prewitt Jr.'s picture
Thomas Prewitt Jr.
Big data seem to be all the rage in healthcare, but from the perspective of a frontline clinician, they miss the mark. The clinical enterprise is the realm of small data. That’s because small data...
Alex Morris's picture
Alex Morris
In the medical device industry, one absolute—which shows no signs of abating—is the need to maintain documentation. We’re talking documentation to demonstrate you have a compliant quality...
Michael Causey's picture
Michael Causey
We, and others, like to take the FDA to task for missing deadlines or behaving in ways that are sometimes difficult to fathom. So it’s only fair to give equal space to something when they seem...
Alexandra Brown's picture
Alexandra Brown
Being a hospital leader is more difficult than ever in today’s changing healthcare environment. It can be easy to stray off course while dealing with regulatory compliance and financial constraints...
Russ King's picture
Russ King
IEC 62304, the international standard that defines software development life-cycle requirements for medical device software, was developed from the perspective that product testing alone is...
Akhilesh Gulati's picture
Akhilesh Gulati
The dynamics of the healthcare environment are changing rapidly. Small primary care practices are confronting a host of regulatory, technological, and practice challenges, not the least of which is...
Jim Bevier's picture
Jim Bevier
A simple calculation—available time divided by demand—known as takt time, is a fuzzy concept for many people in healthcare. That’s understandable when you consider a hospital is open 24 hours a day...
Thomas Prewitt Jr.'s picture
Thomas Prewitt Jr.
One of our major problems with healthcare reform is that we are doing it from the top down. At the top, a bloated bureaucracy works in an environmental context of regulations and finance that...
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ASQ
Strengthening communication between caregivers and patients should be a top priority for reducing healthcare costs and improving patient experience, according to a new poll of U.S. healthcare...