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Medical Device Safety - Articles

FDA's MDEpiNet - Improving Medical Device Safety and Effectiveness From FDA Director of Epidemiology (Video) by Medical Quack Patient ExpertHealth Maven Posted Mon 27 Sep 2010 5:17pm This is a nice walk through that talks about what happens at the FDA and how they are looking into safety compliance when approving medical devices and some of the present day processes.  The FDA would do well to use Twitter and feature some of the information they put put too.  I noticed just a very small showing at their YouTube site.  We ge ... Read on »
Medical Device Safety Tip: Air or Electric Dermatome Instruments by FDA Posted Sun 25 Jul 2010 9:00pm * Medical Device Safety Tips highlight what can go wrong if labeling is not followed, and provide advice on how to mitigate risks. Commonly known as Instruction for Use manuals or package inserts, labeling includes any written material from the manufacturer accompanying medical devices.   What is the problem ... Read on »
Medical Device Safety Tip: Resectoscopes for Infants and Babies by FDA Posted Thu 23 Sep 2010 9:00pm * Medical Device Safety Tips highlight what can go wrong if labeling is overlooked or not followed, and provide advice on how to mitigate risks. Commonly known as Instruction for Use manuals or package inserts, labeling includes any written material from the manufacturer accompanying medical devices. FDA’s goal is to pr ... Read on »
Medical Device Safety Tip: Aesculap AVM Micro Clip by FDA Posted Thu 23 Sep 2010 9:00pm * Medical Device Safety Tips highlight what can go wrong if labeling is overlooked or not followed, and provide advice on how to mitigate risks. Commonly known as Instruction for Use manuals or package inserts, labeling includes any written material from the manufacturer accompanying medical devices. FDA’s goal is to pr ... Read on »
Medical Device Safety Tip: Infant Phototherapy Light by FDA Posted Wed 23 Feb 2011 12:00am Medical Device Safety Tips highlight what can go wrong if labeling is overlooked or not followed, and provide advice on how to mitigate risks. Commonly known as Instruction for Use manuals or package inserts, labeling includes any written material from the manufacturer accompanying medical devices. FDA’s goal is ... Read on »
Federal Register: Extreme Weather Effects on Medical Device Safety and Quality by FDA Posted Thu 21 Feb 2013 12:00am The FDA is is studying the potential effects of extreme weather and natural disasters on medical device safety and quality. Read on »
FDA Medical Device Safety Communication: Reports of Anaplastic Large Cell Lymphoma (ALCL) in Women with Breast Implants by FDA Posted Wed 26 Jan 2011 12:00am Date Issued: January 26, 2011 Audience: Health care providers involved in the care of patients with breast implants Hospital tumor boards Breast implant patients and families of patients, including those that have received breast implants for aesthetic augmentation, revision, or reconstruction. ... Read on »
FDA Awards a Big Grant to Health Insurance Company For Pilot Program To Monitor Safety of Drugs and Medical Devices by Medical Quack Patient ExpertHealth Maven Posted Sat 09 Jan 2010 4:43pm When I first read this it made me think of the phenomenal amounts of data that insurers have.   Don’t be fooled though thinking this is all healthcare oriented, it has to do with money.  Carriers, HMOs all have utilization departments that this information anyway so they can “score” and use algorithmic formulas to predict what they are going to ... Read on »
FDA Failing to Monitor Safety of Medical Devices: Report by HealthFinder Posted Tue 02 Nov 2010 10:00am healthnewslink Lax procedures around approvals, poor follow-up plague the agency, investigators claim. By Steven Reinberg HealthDay Reporter ... Read on »
FDA Asking for $4 Billion to Overhaul Medical Device and Food Safety Monitoring – Give It To Them by Medical Quack Patient ExpertHealth Maven Posted Fri 05 Feb 2010 8:58pm The FDA has been under fire ever since I started writing this blog about 3 years agoand when under our former administration there was not a lot they could do as the form head of the FDA Andrew von Eschenbach was  not in line with technology and the pace it is moving at today  Actually he was grilled by Congress at one point as to why he “didn’ ... Read on »