All Features
The QA Pharm
After nearly 20 years helping the biopharmaceutical industry to regulatory enforcement by implementing an operational and sustainable quality management system, I have come to the conclusion—at the most fundamental level—that there are three quintessential elements required for success. I call…
Russ King
The FDA recently released a new draft guidance document for medical device data systems (MDDS). The FDA defines MDDS as “hardware or software products that transfer, store, convert formats and display medical device data. An MDDS does not modify data, and it does not control the functions or…
Howard Sklamberg
Since July 9, 2012, when President Obama signed the Food and Drug Administration Safety and Innovation Act (FDASIA), a group of colleagues and I have had an urgent mission: implement Title VII of the statute. This section gave the FDA new authority to better protect the global drug supply chain,…
Christine Schaefer
In the Baldrige Health Care Criteria for Performance Excellence, category three, concerning customer focus, asks how your organization engages its patients and other customers for long-term marketplace success. The related self-assessment questions cover how your organization listens to the voice…
Michael Causey
If someone out in there in the wild wonderful world of the web takes a potshot at your drug or device, the first thing to do is take a deep breath and think. Any crisis communications executive worth her salt will tell you it’s often best to let the attacker eat silence rather than draw more…
AAFP
For the 11th consecutive year, the Agency for Healthcare Research and Quality has released complementary reports that assess the U.S. healthcare system’s performance in the areas of healthcare quality, access, and disparities in care.
The two reports—the 2013 National Healthcare Quality Report and…
Robert Fangmeyer
What does healthcare in the United States need? Well, according to a report released May 29, 2014, by the President’s Council of Advisors on Science and Technology (PCAST), U.S. healthcare organizations need “systems engineering.”
In their letter to President Obama, PCAST co-chairs John Holdren…
Not knowing the answer to the question posed in the title of this article has led many medical device manufacturers to undertake expensive and unnecessary retesting of their previously certified products.
In Annex 1 of the “Medical Device Directive 93/42/EEC—Essential Requirements—Section 2,” the…
Enterprise Innovation Institute at Georgia Tech
Two major noncommercial health information technology organizations are working together in a new vendor-neutral health IT innovation network designed to stimulate development of new ideas and shorten the time required to bring new solutions into practice.
The Department of Veterans Affairs (VA)…
Kelly Kuchinski
Editor’s note: A webinar on this topic will held on May 29, 2014, at 2:00 p.m. Eastern / 11:00 a.m. Pacific. Register here.
Food and beverage manufacturers have seen a considerable number of changes over the last decade. Mergers and acquisitions have expanded the footprint of many food and beverage…
University of Arizona
To keep hospitalized patients safer, University of Arizona (UA) researchers are working on new technology that involves a small, wearable sensor that measures a patient’s activity, heart rate, wakefulness, and other biometrics—data that can predict a fall before it happens.
More than 500,000…
Ryan E. Day
Last month I, along with millions of other people around the world, celebrated Easter. For myself, a religious observance, for others a celebration of seasonal renewal. I think for most people, Easter is a time that elicits reflection on what matters most in the world. The state of the global…
Grant Ramaley
Congress has mandated that every two years the FDA will have inspected nearly every medical device manufacturer on planet Earth that sells to the United States. This isn’t happening. Some have the illusory hope that the Medical Device Single Audit Program (MDSAP) will remedy this.
There just aren…
Dawn Bailey
In health care settings, clinical integration is a fairly new concept that means coordinating patient care across conditions, providers, settings, and time to achieve care that is safe, timely, effective, efficient, equitable, and patient-focused.
According to Becker’s Hospital Review, “clinical…
The QA Pharm
There are many instances when a pharmaceutical quality management system (QMS) must be improved in part or as a whole. In some cases improvements are made in response to regulatory inspection observations. In other cases they are made when new company standards are deployed to remain current with…
Steve George
The implementation of the Affordable Care Act (ACA) will stress a healthcare system that is already under the strain of an aging baby boomer population. New patients are expected to flood the system starting in early 2014, part of the 25 million uninsured Americans projected to get health coverage…
Margaret A. Hamburg
As my busy and productive trip to India drew to a close, I had the opportunity for one final meeting and one last memory with a group of some of the country’s most extraordinary women. The occasion was a women’s roundtable in Mumbai, organized by the Confederation of Indian Industry (CII).
It…
Margaret A. Hamburg
We all know that just as every person is different, so too is every disease and every drug. And so we weren’t surprised by the results of a new study published in the Journal of the American Medical Association.
The study found that the FDA used a range of clinical trial evidence when approving…
Mike Figliuolo
PowerPoint is the devil’s instrument, and when you use it, you risk becoming a musician in his demonic orchestra. All of us are required to give presentations in some form or fashion at various points in our careers. If you’d like to succeed in those efforts, there are three things you should never…
Dirk Dusharme @ Quality Digest
This past November, three winners of the 2013 Malcolm Baldrige National Quality awards were announced, one in education and two in healthcare. Quality Digest Daily is fortunate that one of the winners, Sutter Davis Hospital (SDH) is practically in our back yard. This gave us an opportunity to meet…
Arun Hariharan
Last week, I accompanied my father to an eye hospital to get his eye examined for a suspected cataract. The hospital examined his eye and confirmed the presence of a cataract. They recommended surgically implanting an artificial lens in his eye—a fairly common procedure these days for cataract…
Gerry Cronin
At GBMP’s recent Northeast Shingo Prize Conference in Hyannis, Massachusetts, the Center for Comparative Medicine (CCM) displayed adaptations of lean to biomedical research in its Community of Lean Lounge. Conference attendees were drawn in by the wacky display of dangerous animals and props, but…
Grant Ramaley
Many of us have heard horror stories about ISO certificates that were fakes, or of medical-device quality system audits being performed by persons who were not competent. A recent report published by the European Commission found that two out of 11 notified bodies were performing so inadequately,…
Patrick Stone
The Food and Drug Administration’s (FDA) “Food Police” will be in full force to secure budget funds for food safety initiatives for FY 2014 as mandated by Congress. More than half of the operating funds will be earmarked for food work.
International food inspections will surely be a focus area…
Stewart Anderson
A recent news story here in Ontario detailed how health officials were reviewing the results of 3,500 CT scans and mammograms at two Toronto-area hospitals because of potential errors caused by a radiologist’s “performance issue.” Although the results of that review are still pending, the story…