Last week, the New York Times summed up pretty well what a lot of people have been thinking: “Poorly designed, hard-to-use computerized health records are a threat to patient safety, and an independent agency should be set up to investigate injuries and deaths linked to health information technology, according to a federal study…” The paper….
Continue ReadingMedical Device Safety
Hacking Into Your Body
As if there aren’t enough things to think about when a medical device is implanted into your body, here’s a new, 21st-century concern: hacking! As reported on AboutLawsuits.com, Medtronic, the manufacturer of the Paradigm insulin pump, is investigating the cybersecurity of the drug delivery device used by diabetics in lieu of daily injections. The concern….
Continue ReadingMore Bad News about All-Metal Hip Implants
All-metal hip implants are proving to be a brewing epidemic of injury to patients: the failure rate is much higher than metal-plus plastic or ceramic hip implants, and now, doctors are finding that the metallic debris from wear and tear incites an immune reaction from the body that causes tissue damage. When tiny fragments of….
Continue ReadingHip Implant Complaints Flood FDA
The Food and Drug Administration has received more complaints about defective metal-on-metal hip implants in the last six months than in the total previous four years combined, according to a report in the New York Times. The defect complaints mainly concern the DePuy (Johnson & Johnson) A.S.R. hip implant device but also include the Zimmer….
Continue ReadingUnsafe Medical Devices: The Problem Isn’t “Over-Regulation”
The latest report from the prestigious Institute of Medicine — about the nonsensicality of the current system where dangerous medical devices can get approved for sale with a grandfathering process called 510-k — prompted this letter to the editor that summed it all up: The problems are not new. They reflect an underfinanced and underpowered….
Continue ReadingScience Panel Says Oversight of Medical Device Safety Needs Big Overhaul
It’s another science-versus-commerce face-off. Last Friday, the Institute of Medicine released a report commissioned by the FDA that proposes a vastly different and more rigorous approval process for medical devices. In the wake of several recent, well-publicized recalls of devices causing grievous injury, such as hip implants, the report has generated attention well beyond the….
Continue ReadingThe Going Rate for Compromising A Surgeon’s Principles and Patient Safety: $16 Million
That’s the sellout price for a spine surgeon. Give or take a few million. Like police officers, whose thin blue line separates them from “the other,” medical researchers and doctors are loath to diss their fellow professionals. But this week, the code of omerta was breached with a series of critical reports in The Spine….
Continue ReadingDefective Hip Implants Prove that New Isn’t Always Improved in Medical Devices
DePuy’s now notorious metal-on-metal artificial hip, known as the ASR, was marketed as the next great thing in orthopedics, but actually was a recycled old design that ignored warnings from industry insiders that the all-metal construction was subject to dangerous flaking of metal fragments inside the patient’s body. That’s the conclusion of a new takeout….
Continue Reading“Alarm fatigue” endangers hospital patients
“Alarm fatigue” caused by the rising use of monitors is distracting and numbing hospital personnel with deadly results, the Boston Globe reports. An investigation by the newspaper reveals that more than 200 hospital patient deaths in the U.S. between January 2005 and June 2010 are linked to problems with alarms on patient monitors that track….
Continue ReadingGeorge Orwell Comes to Washington: The “Protect Patients Now” Lobbying Group
If you wanted to lobby for a law that wipes out the rights of patients to hold hospitals, drug manufacturers and doctors accountable when they hurt people by carelessness and wrongful conduct, what would you call your group? “Protect Patients Now!” It has a nice ring, doesn’t it? However, the people behind this campaign, which….
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