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
Takata Corp., under pressure from safety regulators, has agreed to declare 33.8 million air bags defective, doubling the number of cars and trucks affected and making this the largest auto recall in U.S. history.
The problem is that the chemical that inflates the air bags can explode with great force, blowing apart a metal inflator and sending shrapnel into the passenger compartment, Newsday reports. Thus far, the faulty air bags are responsible for six deaths and more than 100 injuries worldwide. Continue reading
Research presented at the meeting of the American Urological Association suggests an association between the volume of robot-assisted prostate surgery at a hospital and complication rates for the procedures.
Hospitals with the fewest robot-assisted radical prostatectomy (RARP) procedures had a 14.7% complication rate, while complications occurred in about 5.7% of cases at the highest-volume hospitals, MedPage Today reports. Continue reading
The U.S. Food and Drug Administration (FDA) may issue a near-total ban on trans fats as early as this week, Politico reports. Foods contain trans fats if they list “partially hydrogenated oils” as an ingredient. It has been widely used in recent decades because it increases shelf life, enhances texture and helps food keep its color. However, it has been shown cause significant health problems. According to the American Heart Association, trans fats increase the risk fo heart disease, stroke and type 2 diabetes; they raise the levels of bad cholesterol (LDL) and lower good cholesterol (HDL).
The move to ban almost all trans fats stems from the Obama administration’s efforts to promote a healthier American diet. The ban may include very select exemptions, but most uses of trans fat as in ingredient will no longer be valid. The use of trans fat in food products has been reduced 85 percent over the past decade, and the ruling could reduce it even more. Continue reading
The Food and Drug Administration (FDA) is developing guidelines that will incorporate patients’ experiences with medical devices into the regulatory review process.
Working together, the Medical Device Innovation Consortium, a collaboration of the device industry, the FDA, and the National Institutes of Health, released a draft framework for device makers as they collect patient-preference information and submit the data to the FDA when seeking device approvals, Roll Call reports. The draft calls for the FDA to incorporate patient input in reviewing new device applications. The House Energy and Commerce Committee will consider this issue as it works on legislation called 21st Century Cures. Continue reading
Following Whistleblower Allegations, Congressional Hearing Probes Allegations of Improper Use of Federal Charge Cards
On Thursday, a congressional hearing was held to investigate whether or not federal charge cards were improperly used at the Department of Veterans Affairs. KUSA reports that the hearing stems from a whistleblower’s letter stating that purchase cards were used without proper contracts, alleging that the VA illegally spent as much as $6 billion a year. The practice of using the purchase cards without contracts had been ongoing for years, the whistleblower said. Continue reading
The Food and Drug Administration (FDA) is warning that some of the newer Type 2 diabetes medicines—canagliflozin (Invokana), dapagliflozin (Farxiga), and empagliflozin (Jardiance)—may cause ketoacidosis, a serious condition where the body produces high levels of blood acids called ketones. Patients with ketoacidosis may require hospitalization.
The FDA is continuing to investigate the issue and will determine whether changes are needed in the prescribing information for this class of drugs, called sodium-glucose cotransporter-2 (SGLT2) inhibitors. Continue reading
CVS Health Corp. has agreed to a $22 million settlement with the federal government over allegations that two of its retail stores located in Sanford, Florida distributed controlled substances based on prescriptions that had not been issued for legitimate medical purposes by a health care provider.
A.D. Wright, Special Agent in Charge, Drug Enforcement Administration (DEA), Miami Field Division, and A. Lee Bentley, III, United States Attorney for the Middle District of Florida, announced the settlement. The settlement resolves all civil matters between CVS, the Drug Enforcement Administration (DEA), and the state of Florida, the company revealed in a regulatory filing. CVS said the funds for the payment were accrued in previous fiscal periods, the Wall Street Journal reports. Continue reading