All Features
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 to get it right. Take the agency’s Unique Device Identification System (UDI).
Readers of this column…
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. It’s vital that a leader remembers he is responsible for one of the most precious and fragile…
The QA Pharm
When you peel back the layers of causes leading to serious FDA enforcement action, it comes down to a handful of fundamental reasons.
1. Management doesn’t know what is required
Executive and senior management might not have regulatory experience. MBA programs may offer courses on quality, but…
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 insufficient to ensure patient safety. It provides a common framework for medical device manufacturers to…
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 patient expectation and evaluation. The challenges are all exaggerated by social media, where…
Michael Causey
Just when we’d all decided Washington lawmakers won’t accomplish much beyond enjoying their own excellent health insurance coverage, tasty bean soup in the Senate cafeteria, and the best parking on Capitol Hill, it turns out they might actually unite to accomplish something pretty big after all.…
Patrick Stone
The FDA says that investigational review boards (IRBs) aren’t required to collect a statement of investigator assurance from studies they preside over.
This is troubling. My first question: How are IRBs going to assure that clinical investigators will abide by requisite 21 code of federal…
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, and you never know how many people are going to show up at the door. Let’s look at two concepts…
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 seems to be focused on what is best for government and payers. The perils of out-of-control costs have…
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 quality improvement professionals conducted by ASQ, the world’s largest network of quality resources and…
Alexandra Brown
Physician alignment is vital to driving the changes necessary in our shifting healthcare environment. On the hospital side, physicians are the frontline experts needed to increase quality and decrease cost. It’s impossible for a hospital system to take on important projects like fall prevention,…
Patrick Stone
The U.S. Food and Drug Administration (FDA) has a “Plain Jane” version of its Pharmaceuticals FY 2015 Action Plan. In this article, however, let’s look at some interesting wrinkles not necessarily contained in the document.
This “Plain Jane” action plan, taken straight from the document, reads as…
Michael Causey
Informed consent (IC) is more than getting a quick signature from a clinical trial participant, the FDA gently reminds industry in a new guidance addressing increasingly complicated electronic IC (eIC) issues. Issued almost simultaneously with Apple’s new ResearchKit tool, which promises faster,…
Jon Speer
When people talk about U.S. Food and Drug Administration (FDA) design controls, they often place a lot of emphasis on inputs and outputs, verification, transfer, and the design history file. All good things, of course; without them, you won’t meet FDA requirements for your design controls. The…
Alexandra Brown
Why is it easier for many hospitals to justify investing in capital equipment, new buildings, and service lines rather than in quality improvement? There are three major reasons.
Many hospital systems don’t know their real costs
It’s been said that the first step in fixing a problem is realizing…
Larry Spears
If you’ve been in the life science industry for awhile, you know it never gets easier but instead more complicated year after year. For example, unique device identification (UDI) requirements, combination product rules, and updated electronic medical device reporting (eMDR) requirements add to…
Kelly Kuchinski
Nestlé USA has officially announced its plans to replace the artificial flavors and colors in its chocolate candy products with natural ingredients. This decision will affect more than 250 chocolate bars across 10 brands. The first three modified candy bars—Baby Ruth, Butterfinger, and Crunch—will…
Alexandra Brown
Hospital leaders are feeling increasing pressure to find ways to thrive in our changing healthcare system. A C-suite that is removed from daily hospital operations is a liability in this era of process improvement and hands-on progress.
Here are four characteristics hospital leaders need to move…
The QA Pharm
At the risk of sounding like a pharmaceutical quality assurance heretic, standard operating procedures (SOPs) often don’t work as intended. In fact, they can do more harm than good by giving a false sense of security: “We must be OK; we have procedures for that.”
Having procedures is certainly…
Alexandra Brown
A big challenge facing academic medical centers is how to maintain a focus on patient care in an artificially divided environment.
Most academic medical centers were developed in a system with abundant resources, cost-based reimbursement, and a traditional academic departmental structure. This…
Thomas Prewitt Jr.
As we begin the journey to value-based healthcare, the relationships between a hospital and its medical staff are changing. For decades, these relationships were straightforward: Doctors admitted patients to the hospital, performed procedures and delivered therapies, and at some point, sent the…
Michael Causey
Sometimes it’s nice to be told what the U.S. Food and Drug Administration (FDA) isn’t going to do. The agency issued a guidance last month that should make anyone building or working with a medical device data system (MDDS) happy and relieved. Can you hear the collective sigh?
FDA defines MDDS as…
Dawn Keller
Juvenile idiopathic scoliosis. That was the diagnosis given to my then 8-year-old daughter last January. In short, it means that she’s young (under 10), she exhibits an abnormal amount of spinal curvature, and there’s no identified cause (aside from some bad luck).
Emilia’s X-rays indicated an S-…
As more physicians are integrating their patient electronic medical records (EMRs) with third-party patient portals, they’re looking for clarifications on many issues to stay within the various regulations boundaries and to be meaningful use-attested. It can be difficult to differentiate fact from…
Owen Faris, Jeffrey Shuren
At the Center for Devices and Radiological Health (CDRH), clinical trials are the foundation for our decisions to approve the most important medical devices—products that have the potential to save or sustain life, but also present the greatest risk to patients.
During the past year, we saw…