Product News and Recalls

Manufacturers May Have Under-Reported Duodenoscope Infection Rates

duodenoscope infection rates may have been under-reportedThe bacterial infections attributed to non-sterile duodenoscopes that sickened and killed patients in hospitals in California and Washington last year may have represented just a small fraction of the total number of cases.

A report issued by the United States Senate accuses device manufacturers of failing to report infections within the required 30-day guideline. Such a failure would lead to artificially low numbers.

Washington Senator Patty Murray launched her investigation ...

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Accusations Fly Over Florida Hospital Standards After Large Donation to State Republicans

st. mary's drops quality standards after republican donationJust five short months ago, a widely publicized story on CNN led to the shutdown of the pediatric cardiothoracic surgery unit at St. Mary’s Medical Center in Florida. The reason? Babies were dying at an alarmingly high rate while undergoing surgery at the facility. No less than nine infants had died through 2013 after having heart surgery at St. Mary’s and at least one was paralyzed after ...

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Researchers Call for Ban on Crib Bumpers

In a case of the solution truly being worse than the problem it was designed to solve, pediatric researchers have found that the risks posed by infant crib bumpers far outweigh any perceived benefits of the devices and that they have no place in an infant’s crib.

Placed around the inside of a baby’s crib, the soft, padded bumpers are designed to prevent impacts, such as those from the baby’s head, on a crib’s vertical slats. Proponents of the devices also ...

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Essure Now Faces Congressional Ban

essure facing congressional calls for banPlenty of medications and medical devices have faced the wrath of a displeased public. Thanks to the amplifying power of technology, it is now nearly impossible to ignore an organized group of citizens who have determined that a product or company is not aligned with their best interests. Recalls, black box warnings, and changes to entire product lines have occurred as consumers have confronted company after company; forcing them to acknowledge ...

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GSK Official May Have Been Fired in Whistleblower Retaliation

gsk firing may have been whistleblower retaliationSome would say that when the manager of biostatistics of a multi-billion-dollar pharmaceutical corporation tells you that there is something wrong with the data you’re using to bring a drug to market, you might want to listen to that person. However, if allegations in a new lawsuit against GlaxoSmithKline are proven true, the other option is to try to get away with firing the biostatistician and move on.

Such are the ...

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Listeria Outbreak Could Lead to Criminal Charges for Blue Bell Creameries

blue bell creameries face criminal charges in listeria outbreakCan a food-borne illness outbreak really last for five years without anyone taking action?

If federal investigators are proven correct, that could very well be what the outcome of a criminal investigation aimed at Blue Bell Creameries shows. Scientific evidence points to the possibility of a strain of listeria that was allowed to live in Blue Bell facilities since 2010.

The resulting listeriosis illnesses sickened at least ten people. Three ...

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