All Features
Michael Causey
A
s expected, the FDA is shifting more of its regulatory focus toward medical device reporting (MDR). In an Oct. 1, 2014, letter, the agency’s Baltimore district office hit Baltimore-based Electronic Development Labs for not having a MDR procedure. Bad idea. The company may not have recovered very…
Alexandra Brown
My husband and I both like to run. I run about three miles once or twice a week—if the weather’s not too bad, and if I don’t have something else going on. Keith, on the other hand, runs half marathons.
Keith goes for long runs on the weekends for three to four hours at a time and shorter runs…
Jeff Mazik
If you have been procrastinating on setting up electronic submissions for your adverse event reports to the FDA, you might want to reconsider that decision. Earlier this year, the FDA published its final rule on MedWatch/eMDR reporting.
Although not much has changed in this final rule in regards…
Margaret A. Hamburg
I recently wrapped up a jam-packed, five-day visit to China, a fascinating country with a dramatically growing economy and an increasingly significant effect on the products that U.S. citizens consume. Indeed, a key reason for my trip is the important and growing collaboration between the FDA and…
Gary Minks
Medical device manufacturers seeking global access for their products can face significant challenges in meeting the regulatory requirements of multiple target markets. The approval process can be even more time-consuming when individual regulatory authorities require an independent audit of a…
Michael Causey
After years of decline, medical device approvals by the FDA have finally begun to hit the gas pedal, according to an interesting report from the California Healthcare Institute (CHI) and Boston Consulting Group (BCG).
In hindsight, it appears the FDA hit bottom in 2010 when approval times…
The QA Pharm
Responding to FDA 483 observations was my focus in part 1 of this series. Responses lead to commitments, and commitments lead to changes that are intended to prevent recurrence of the underlying problem that led to the observation.
Here, I’ll share my views on getting the work done to fulfill…
Dave Cranmer
Some things are just meant to be, apparently. Sept. 23, 2014, marked an interesting waypoint in the career of someone concerned about standards of measurement, because on that day, I became a standard reference human.
Having started working for the (then) National Bureau of Standards (NBS) almost…
Johns Hopkins University
A weekend design challenge to develop new protective gear for health workers fighting Ebola drew students, faculty, and clinicians from across Johns Hopkins University and beyond, along with $25,000 in state seed grants to support further development of the best ideas.
Jhpiego, a nonprofit global…
The QA Pharm
This three-part series will discuss how to respond to the U.S. Food and Drug Administration’s Form 483 (FDA 483), which is issued at the conclusion of an inspection to document potential violations to the Federal Food, Drug, and Cosmetic Act. We’ll look at how to assess the work needed to address…
Quality Digest
BioCision was founded in 2007 by Rolf Ehrhardt and Brian Schryver when they realized, having spent many years in the clinical and laboratory environment, that there were critical unmet needs in the handling of temperature-sensitive biospecimens and biologics.
The rapid adoption of their first…
Alexandra Brown
The past five to 10 years, hospitals and physician offices have been in a mad dash to implement electronic health records (EHRs) to meet governmental regulatory requirements. Now that most projects are either complete or well on their way, what are we doing with all of the data that EHRs promised…
Katherine Watts
Healthcare in 2014 is in a state of flux. The Affordable Care Act (ACA) health insurance exchange marketplace opened in October of 2013 with a rough start, and it has still not gained traction. Meanwhile, Medicare and Medicaid are squeezing reimbursement, and there is a growing population paired…
Barry Plunkett
Leadership at healthcare organizations is being tested like never before. The move away from a fee-for-service model to a patient-outcome-based model means management has to get clinical-care teams collaborating in a whole new way.
Your leadership style and the culture you help create within your…
Michael Causey
Well, boys and girls, Halloween is approaching. Although it’s fun to don a Dracula (or Miley Cyrus) costume and get some yucks faux-scaring folks, the FDA is acting like a responsible parent by setting up a medical-device cybersecurity public workshop, “Collaborative Approaches for Medical Device…
The QA Pharm
Oftentimes pharma has a split personality. One personality loathes firefighting, and the other needs a burning platform to justify doing anything that requires spending money.
Go figure.
This becomes evident in our industry when some companies can’t part with a pittance of their billion-dollar…
Tamar June
The landmark Food Safety Modernization Act (FSMA) just keeps getting more and more important. Earlier this month, the Food and Drug Administration (FDA) unveiled four proposed amendments that will likely make a tough law even tougher.
The FSMA, signed into law in January 2011, is designed to…
Alexandra Brown
As a physician, I enjoy listening to nonphysicians tell me how to motivate doctors. I don’t mean this in a totally snarky way (well, maybe just a little). These conversations often highlight the chasm that exists between physicians and administration.
What’s the most common motivator people throw…
Russ King
Food and Drug Administration (FDA) medical device recalls are on the rise. An increasingly active FDA coupled with an increase of medical device software components is adding up to new challenges for manufacturers. It’s important to understand how the FDA uses IEC 62304, an international standard…
Whitney Andrews
Medical device manufacturers are facing mounting pressure to better manage the quality of their supply chain. One approach they’ve taken to improve risk management and increase efficiency is to partner with suppliers who are ISO 13485 certified.
ISO 13485 is an internationally recognized quality…
Thomas Prewitt Jr.
I am concerned about the rush to consolidation we are seeing in the hospital industry. It seems all too tidy and easy, and if there is anything I have learned from my 30+ years in clinical medicine, it is that nothing in healthcare is easy.
Larger hospitals began acquiring smaller hospitals in…
Taha A. Kass-Hout, Jeffrey Shuren
In addition to food and drugs, the FDA has regulatory oversight of tens of thousands of medical devices ranging from bandages and prosthetics to heart valves and robotics. These products are used by millions of Americans, and they are essential, well-performing tools of modern healthcare, but…
Michael Causey
Medical device manufacturers would be well-advised to address any risk with potential home-use products during their design phase, according to an August 2014 guidance from the FDA.
As the agency notes, “Failure to adequately consider potentially hazardous situations during the design of home-use…
Dawn Bailey
In a recent column, I shared insights from the 2013 Baldrige Award recipients’ leaders as they fielded questions related to their journeys to excellence. There was so much thoughtful reflection that it couldn’t fit into just one column.
More answers to questions follow:
How did you convey to…
Carly Barry
Via Christi Health, the largest provider of healthcare in Kansas, operates a Center for Clinical Excellence that’s made up of a team of quality practitioners; all have had lean and Six Sigma training. I recently had the opportunity to talk with the team about the types of projects they’re working…