Yet more evidence that expensive technology drives treatment decisions in medicine: A new survey of prostate cancer treatment shows that once a hospital invests the $1 million to $2.5 million it takes to get a surgical robot, men in the area start to get a lot more prostate removal surgery than they otherwise would. Although….
Continue ReadingMedical Device Safety
The Coming Cancer Epidemic from Overuse of CT Scans
The medical community is waking up to an enormous problem with radiation – mainly X-rays and CT scans – used to diagnose disease and injury. Patients are getting too much radiation, and the excess itself causes injuries, many years down the road, in a big uptick in the risk of cancer. Even a “routine” CT….
Continue ReadingIs Grandfathering of Medical Devices Bad for Your Health?
The vast majority of medical devices recalled by the U.S. Food and Drug Administration (FDA) were subject to a less stringent regulatory process that requires only that the device prove that it’s similar to something already on the market, according to a recently published study. Of the 113 devices recalled from 2005 to 2009 because….
Continue ReadingPatients ask judge to bar equipment maker from selling to back surgeon
Former patients of an orthopedic surgeon in Dayton, Ohio, have petitioned a federal court to force a medical device company to stop selling him medical equipment. The complaint, filed in U.S. District Court against Roswell, Ga.-based Mylotec Inc., also seeks damages for 19 former patients of Dr. Lawrence Rothstein. According to the complaint, Mylotec allegedly….
Continue ReadingDefective DePuy Hip Implant Shows Big Hole in Regulatory System
Patients naturally assume that when a sophisticated metal implant like a hip replacement is surgically placed into their bodies, it must have been thoroughly tested before wide use. The now-recalled DePuy ASR hip replacement shows how wrong that assumption is. A medical device manufacturer in the United States can cobble together new components into an….
Continue ReadingFDA recalls infusion pump and tissue stabilizer
The Food and Drug Administration has issued Class I recalls of Hospira Symbiq One- and Two-Channel infusers and Medtronic Octopus Nuvo tissue stabilizers. Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or….
Continue ReadingDePuy Hip Recall Shows Need for Early Warning System on Defective Medical Devices, Drugs
Most consumers are shocked when they learn the reality of the early warning system for defective medical devices and drugs in the United States. Unlike Europe and most other advanced countries, there is no systematic, mandatory national registry of failures to provide an early warning system. Manufacturers are required to send to the FDA reports….
Continue ReadingEasily Mixed-Up Medication Tubes Cause Patient Deaths and Injuries
For years, patient safety experts have known that medical devices, like tubes that deliver food and drugs to hospitalized patients, need to be designed so that predictable mix-ups don’t hurt patients. If a tube is safe if it goes through the nose to deliver food to the stomach, it should not be possible to hook….
Continue ReadingRadiation Overdoses and Regulatory Ineptness
When is a radiation overdose not an overdose? When the facility giving the CT scans says so. At least that’s what the Food and Drug Administration concluded when it dropped a safety investigation of the Huntsville, Alabama Hospital. Now the FDA, which monitors radiation safety for the medical industry, is considering re-starting its investigation, once….
Continue ReadingSurgery for Back Pain: Less Is More
Nearly every week, I hear about a patient who had surgery to relieve terrible chronic back pain and ended up far worse off than before. One of the biggest problems is that money motivates surgeons to talk patients into much bigger and more complex operations than they really need — and then those surgeries result….
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