All Features
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…
Michael Causey
Scholars still debate how long it took to build the Great Wall of China, but it’s generally agreed it was built in stages between the 5th century B.C. and the 16th century A.D. The Great Pyramid of Giza took about 20 years to construct, according to ancient historians, but it must be remembered…
Michael Causey
The folks at the Center for Drug Evaluation and Research (CDER) released their sometimes optimistic, but always enlightening guidance wish list and overall priorities for 2015. Let’s take a look.
CDER director Janet Woodcock recently said these are her agencies “front burner” priorities: •…
Michael Causey
The next time you want a cheeseburger, you might consider hopping a plane and flying to Germany. Or France. Or New Zealand. Basically, anywhere but the United States of America.
Almost across the board, the United States ranks at the bottom (“regressive”) for produce traceability programs as…
Tripp Babbitt
In my last column I wrote about the seven perspectives that pollute customers and culture. These perspectives rule the design of our organizations. They are inherent to our work cultures and thinking. They put us on autopilot as we toil in our everyday work. The first step to change that is to…
Melinda Plaisier, Michael Landa
We were ready to head out to observe the inspection of a Miami seafood warehouse, but another team of investigators asked that we first look at evidence from their last job. They showed us a video of a huge quantity of rice contaminated with live insects.
Their work, they knew, would prevent…
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…
Michael Causey
After a flurry of activity, it’s been relatively quiet lately on the FDA warning-letter front, though three device makers did get some bad news in recent weeks.
FDA’s Philadelphia office hit Pittsburgh-based Zoll Manufacturing Corporation, a maker of Class III medical device life vests, with a…
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…