The federal Food and Drug Administration too often fails to protect patients from defective and dangerous medical devices because it lets manufacturers self-police themselves, cozies up to companies rather than trying to compel safety fixes, and inadequately informs the public and medical community about problem products. If that sounds like too broad and harsh an….
Continue ReadingMedical Device Safety
FDA may be letting medical device makers fudge safety reports, study finds
The federal Food and Drug Administration may be putting patients’ safety at serious risk by allowing medical device makers to self-police their products, notably in making crucial determinations in reporting to the agency the severity of harms the devices inflict. Using artificial intelligence techniques to scan a sampling of filings made by makers to the….
Continue ReadingSurgical robot’s maker sued over business practices — but not patients’ care?
Hospitals finally are saying bull feathers to the leading maker of surgical robots that cost institutions millions of dollars annually to buy and maintain. New lawsuits against Intuitive Surgical dispute the company’s business practices, including the exclusivity it demands for its costly services and products. But will the civil claims also crack open the door to….
Continue ReadingWho can’t see problems in medical device makers paying surgeons billions?
Billions of dollars have flown from medical device makers to specialists performing back, spine, knee, and hip surgeries, with unsavory cash and practices also accompanying that fiscal tide. Industry officials and doctors defend the sizable and growing payment program, saying it results in better medical hardware that ultimately benefits patients, the independent, nonpartisan Kaiser Health….
Continue ReadingDozens of tuberculosis infections, including northern Virginia, tied to putty used in orthopedic surgeries
A rare outbreak of tuberculosis among dozens of surgical patients — some of them at hospitals in northern Virginia — is under investigation by federal health authorities, including the Centers for Disease Control and Prevention. The CDC suspects the infections may be tied to a malleable bone putty used in spinal and other orthopedic procedures…..
Continue ReadingQuestions aplenty about medical device-makers paying doctors $3.6 billion
Although Big Pharma has taken deserved heat for selling its drugs by slathering doctors with cheesy tchotchkes, lavish or even cheap meals, and pricey trips, as well as lucrative consulting and speaking opportunities, medical device-makers’ physician-payment programs also should get a tougher, deeper look. That’s because device manufacturers paid doctors $3.62 billion in the years….
Continue ReadingKnee and hip surgeries offer a glimpse into disparities in health care costs
With so many older Americans entering their later years in better shape than earlier generations and wanting to stay active, knee and hip replacements have become some of the most common surgeries performed in pre-pandemic times. The cost of this work, however, varies greatly. And surgeons may be promoting procedural variants to not only build….
Continue ReadingU.S. health watchdog issues fraud warning about doctors’ speaker programs
Buh-bye? Arrivederci? Sayonara? Can it be that the coronavirus pandemic puts an end to one of the disgraceful ways that Big Pharma and medical device makers push their wares on all-too malleable doctors — with big-money speaker programs? The inspector general’s office of the giant federal Health and Human Services (HHS) agency has warned drug-….
Continue ReadingNevada offers key lessons in challenge to U.S. virus tests for nursing homes
The federal agency that regulates nursing homes and other long-term care facilities not only has cracked down on them with tough new requirements for coronavirus testing of their staff. The Centers for Medicaid and Medicare Services also has flogged its plan to provide facilities with testing equipment and sample tests. While owners and operators have….
Continue ReadingMaryland adds testing and leads area in allowing nursing homes to re-open
Maryland will take the lead among states in the area in re-opening nursing homes and other long-term care facilities from months of coronavirus-related closures to family members, guests, and other visitors. Gov. Larry Hogan (shown, right) acted as the state, for the first time in months, reported that October started with zero Covid-19 fatalities and….
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