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FDA

Medical device recalls nearly doubled in 10 years

“The Wall Street Journal: Medical Device Recalls Nearly Doubled In A Decade. Recalls of defective medical devices nearly doubled in the decade from 2003 through 2012, according to a Food and Drug Administration report due Friday.”

Categories: Hip and Knee Replacement
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Congressional report slams FDA’s treatment of employees who disclosed device approval concerns

“The FDA may have gone too far and violated federal law when it chose to monitor 6 scientists who made public their safety concerns about medical devices approved at the agency, a congressional investigation has concluded.”

Categories: Hip and Knee Replacement
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Seattle Times Investigation: Pharma’s Windfalls

Seattle Times series on marketing of orphan drugs for off label use

Categories: Drugs
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GE Healthcare Nuclear Medicine Systems: Class I Recall – Serious Injuries or Deaths Could Occur

ISSUE: GE Healthcare became aware of an incident at a VA Medical Center facility in the US. A patient died due to injuries sustained while being scanned on an Infinia Hawkeye 4 Nuclear Medicine System. On July 03, 2013 GE notified hospitals that they were recalling several Nuclear Medicine Imaging Systems because serious injuries or deaths could occur due to the failure mode associated with this recall.

Categories: Hip and Knee Replacement
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WANTED: Consumers to Report Problems

FDA has created a new form for consumers to report adverse events with drugs or devices. This less technical form is part of larger FDA effort to encourage consumers to submit quality reports.

Categories: Drugs, Hip and Knee Replacement
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FDA, facing cybersecurity threats, tightens medical-device standards

Washington Post reports: “The Food and Drug Administration is tightening standards for a wide range of medical devices — from fetal monitors used in hospitals to pacemakers implanted in people — because of escalating concerns that the gadgets are vulnerable to cybersecurity breaches that could harm patients.”

Categories: Drugs, Hip and Knee Replacement
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Pressure Grows to Create Drugs for ‘Superbugs’

The FDA is granting money to Glaxcosmithkline – up to $200 million in 5 years- to help develop medication that can work against antibiotic resistant superbugs. Glaxcosmithkline has paid the largest health care fraud settlement in US history-$3 billion.

Categories: Drugs
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Strengthening our National System for Medical Device Postmarket Surveillance

Update and next steps.

Categories: Drugs, Hip and Knee Replacement
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Strengthening Our National System for Medical Device Postmarket Surveillance

The report includes plans for establishing a unique device identifier and promotion of registries for tracking devices.

Categories: Drugs, Hip and Knee Replacement
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Medical Bed Mattresses: FDA Safety Communication – Damaged or Worn Covers Pose Risk of Contamination and Infection

From January 2011 to January 2013, the FDA received 458 reports associated with medical bed mattress covers failing to prevent blood and body fluids from leaking into the mattress (fluid ingress). Fluid ingress may occur if mattress covers become worn or damaged from small holes or rips in the fabric or from incorrect cleaning, disinfecting and laundering procedures. The zipper on the cover may also allow fluid to penetrate the mattress. Some reports indicate that if blood and body fluids from one patient penetrate a mattress, they can later leak out from the mattress when another patient is placed on the bed. Patients are at risk for infection if they come into contact with blood and body fluids from other patients.

Categories: Drugs, Hip and Knee Replacement, Hospital Infections/ Superbugs
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