A March inspection of the Andover, Massachusetts manufacturing facilities of medical device maker Smith & Nephew has resulted in a Food and Drug Administration (FDA) warning letter to the company based on problems uncovered the inspection.
The inspection took place between March 4 and March 25. Inspectors discovered problems with arthroscopy (joint replacement) and gynecology devices, including the TRUCLEAR ULTRA Reciprocating Morcellators 4.0, a surgical device. Continue reading
This week, medical device maker CareFusion provided an update on a global voluntary recall that was initiated on April 21, 2015 to address an issue with certain units of AVEA ventilators.
The AVEA ventilator is used in hospitals and health care facilities and is intended for continuous breathing support for neonatal through adult patients. The recall is in response to a potential malfunction of an AVEA ventilator specific 5 psi pressure transducer. The affected AVEA ventilators may develop a failure mode over a period of time, where, by design, the ventilator activates false Extended High Ppeak or Circuit Occlusion audio and visual alarms, opens the safety valve and stops ventilating, according to news release. Continue reading
This week a St. Louis jury found that a Minnesota girl’s birth defects were caused by the epilepsy medication Depakote her mother took during pregnancy and the jury awarded the child $15 million in damages.
The jury returned the unanimous verdict on Tuesday and is now considering whether to award punitive damages as well, the St. Louis Post Dispatch reports. Continue reading
New research suggests that males may have a higher risk of infertility if their mothers took Tylenol for extended periods during pregnancy. A study conducted by researchers at the University of Edinburgh and published in the journal Science Translational Medicine found that acetaminophen, the main active ingredient in Tylenol and Paracetamol, may inhibit production of testosterone. Researchers said that men have a higher risk of infertility, undescended testicles and testicular cancer when exposed to lower levels of prenatal testosterone. Continue reading
An epidemiologist at the University of Massachusetts Amherst has received a $1.5 million grant from the National Institute of Environmental Health Sciences to study whether phthalates affect human breast cancer risk.
Prof. Katherine Reeves of the UMass School of Public Health will lead the three-year grant to investigate a possible relationship between phthalates—widely used plasticizing and solvent chemicals—and breast cancer risk, the (Greenfield, Mass.) Recorder reports.
Phthalates are found in such products as cosmetics, shampoo, flooring and medical tubing, plastic packaging (including food and blood-storage containers), and some children’s toys. They are added to products increase flexibility, transparency, durability, and longevity. Reeves and her colleagues will study phthalate metabolites, products found in urine samples after the chemicals have passed through the body. Measurable phthalate levels are found in nearly 100 percent of the United States population though the levels vary widely, according to the Recorder. Phthalate metabolites have been reported in human breast milk. Until now, only a handful of small studies have looked at whether phthalates affect human breast cancer risk and none have measured phthalate metabolites before a cancer diagnosis.
The Food and Drug Administration, the Centers for Disease Control and Prevention (CDC), and state and local health officials are investigating a multistate outbreak of Salmonella Paratyphi B variant L(+) tartrate(+) infections, possibly linked to sushi made from raw tuna.
The FDA said it “recognize[s] that people will be concerned about these illnesses,” and is moving as quickly as possible in its investigation to prevent additional illnesses. Continue reading
New research in mice suggests that long-term exposure to acetaminophen during pregnancy could lower a male’s production of testosterone, possibly affecting his fertility.
The results suggest that if a pregnant woman takes acetaminophen for several days it could affect her unborn boy. The boy’s future sperm could be lowered, Medical News Today (MNT) reports. Continue reading
The Food and Drug Administration (FDA) received warnings nearly six years ago about the risk of “superbug” infection from specialized medical scopes. The devices have been tied to a series of deadly superbug outbreaks.
In 2009, after duodenoscopes were linked numerous drug-resistant infections in Florida hospital patients (and to 15 deaths), epidemiologists at the Florida Department of Health and the Centers for Disease Control and Prevention (CDC) warned that the infections occurred because hospitals were having trouble properly cleaning the scopes, USA Today reports. Continue reading
Lumber Liquidators CEO Robert Lynch unexpectedly resigned Thursday following weeks of struggles over safety concerns related to its flooring products.
The Toano, Va.-based company will search nationally for a replacement, the company said. Thomas Sullivan, Lumber Liquidators founder, will serve as acting CEO, USA Today reports. Lynch also stepped down from the board of directors. John Presley, its lead independent director, will be non-executive chairman of the board effective immediately. CFO Dan Terrell will leave the company in June. Continue reading
Food inspectors in the northern Indian state of Uttar Pradesh have ordered Nestle India to recall a batch of Maggi instant noodles from stores across the country because the product contained dangerous levels of lead.
India’s Food Safety and Drug Administration (FDA) said high lead content was found during routine tests on two dozen packets of instant noodles, manufactured by Nestle in India, Reuters reports. Continue reading