Current Events

The Food and Drug Administration, already under fire for its response to superbug outbreaks at U.S. hospitals, has tried and failed twice to get medical scope manufacturers to prove their controversial devices can be cleaned of deadly bacteria.

The embattled agency said Monday that it didn't request the information until spring 2014 — despite earlier warnings about tainted scopes — and that it has given device makers three chances to validate their cleaning protocols.

Read More.

The FDA is adding a warning label on diabetes pen devices, making clear that the pens are intended for single patient use only and shouldn't be shared, even if the needle is changed.

In an announcement on their website last week, the agency said they are trying to reduce the risk of serious infections from the sharing of multidose pens. They will require that pens and packaging with multiple doses of insulin or other injectable diabetes medicines carry a warning label stating "For single patient use only."

Read More.

The nurse who was the first person to contract Ebola in the United States filed suit on Monday against the Dallas hospital where she worked, saying it knowingly left workers without the training or equipment needed to handle the disease.

The nurse, Nina Pham, 26, was one of two at Texas Health Presbyterian Hospital who were infected while treating Thomas Eric Duncan, who had the virus when he arrived from the West African country of Liberia.

Read More.

Washington — Hyundai Motor Co. said Saturday it is recalling nearly 205,000 cars and wagons in the United States for an electronic glitch that could disable power steering.

The Korean automaker said the recall covers 2008-2010 Elantra and 2009-2010 Elantra Touring because the electronic power steering electronic control unit may sense a discrepancy in the steering input signals and, as a result, disable the steering power assist.

Read More.

Medical scopes suspected of spreading deadly bacteria are under scrutiny since an outbreak at UCLA Medical Center emerged this month. But problems with the devices were recorded years ago: The same type of scopes was implicated in a previously unreported outbreak of antibiotic-resistant superbugs six years ago in Florida that affected 70 patients, including 15 who died.

Read More.

Morgan Stanley agreed to pay $2.6 billion to settle probes into its creation and sale of residential mortgage-backed securities, as the U.S. Department of Justice holds another large Wall Street firm to account for the 2008 financial crisis.

The firm increased legal reserves related to mortgage matters by about $2.8 billion, cutting 2014 income from continuing operations by $2.7 billion, or $1.35 a share, Morgan Stanley said Wednesday in an annual regulatory filing. It’s the fourth time in the past five quarters that the New York-based bank reduced earnings in the weeks after announcing them.

Read more.

Robotic surgery can improve the accuracy and reduce the invasiveness of a broad range of surgical procedures. But it's entirely dependent on flawless execution by the surgical system. Robotic surgery player Intuitive Surgical ($ISRG) has learned this the hard way with repeated regulatory issues and recalls due to system malfunction.

In order to help address the "challenges and opportunities" raised by robotic surgery, the U.S. Food and Drug Administration is planning to hold a two-day public workshop in late July on robotically assisted surgical devices.

Read more.

The Food and Drug Administration never reviewed data from manufacturers regarding the procedures needed to clean the complex medical devices that recently infected seven patients with drug-resistant bacteria, an agency official acknowledged on Wednesday.

Now the F.D.A. has asked manufacturers to provide evidence that their recommended disinfection methods work, said Dr. Stephen Ostroff, the agency’s chief scientist.

Read more.

Daimler AG's Mercedes-Benz is recalling more than 147,000 mid-size sedans and station wagons from 2013-2015 to check for risk of engine fires, the U.S. safety regulator said Saturday.

The cars have a rubber seal in the engine compartment that can fall onto the exhaust system, increasing the risk of an under-hood fire, according to the National Highway Traffic Safety Administration.

Read more.

The U.S. government is close to finalizing instructions to prevent medical devices responsible for transmitting "superbugs" from spreading the potentially fatal pathogens between patients, the scientist leading the effort said.

The new protocol for the reusable devices, called duodenoscopes, is being developed by the U.S. Centers for Disease Control and Prevention (CDC), whose disease detectives have investigated duodenoscope-transmitted infections since 2013.

Read more.

In an escalating standoff with Takata, federal regulators said on Friday that they would begin to fine the Japanese auto supplier $14,000 a day, saying it had not fully cooperated in an investigation into defective airbags.

Takata has failed to respond “fully or truthfully” to two orders that it turn over documents and information related to the defect, the National Highway Traffic Safety Administration wrote in a letter to the company.

Read more.