Making Unique Observations in a Very Cluttered World

Wednesday, 13 January 2016

Dirty scopes needlessly infected scores of patients, investigation finds -

Dirty scopes needlessly infected scores of patients, investigation finds - 

Scores of patients were needlessly infected with potentially deadly bacteria after medical scope procedures because of repeated failures by the device manufacturers, regulators and hospitals to report outbreaks, according to a U.S. Senate investigation released Wednesday.

The investigators said they had found 25 outbreaks -- including two in Los Angeles -- linked to a device known as a duodenoscope, far more than previously reported. 

And they said that numerous flaws in the federal government’s oversight of medical devices are continuing to put patients at risk “with life-threatening consequences.” 

“Patients should be able to trust that the devices they need for treatment are safe and effective,” said Sen. Patty Murray (D-Wash.), who initiated the probe after dozens of patients were sickened at a Seattle hospital.

“Unfortunately this investigation makes clear that current policies for monitoring medical device safety put patients at risk, and in this case, allowed tragedies to occur that could have, and should have, been prevented.”

The report details how Olympus Corp., the leading maker of the device, knew of the potential flaws in the scope in spring 2012 because of an independent investigation of an outbreak in the Netherlands.

But Olympus – and the federal Food and Drug Administration – did not warn American hospitals about the potentially lethal problem with the device until February 2015 after The Times reported about a superbug outbreak at UCLA's Ronald Reagan Medical Center where dozens of patients were potentially exposed and three died.

The investigators said that at least 141 patients in a myriad of cities were infected during that three-year delay.

The FDA began to investigate the scopes in September 2013, but "wasted valuable time" in seeking data from Olympus and two other manufacturers on whether they could show their devices could be properly cleaned, according to the report.

They also faulted hospitals where the outbreaks occurred for not filing required injury reports, which could have helped stop the infections.

The FDA requires manufacturers to file reports of injuries tied to their devices. The system -- known as Maude -- was designed to help give an early warning about defective devices.

Olympus filed some reports months late. And in most of the reports, the company suggested that something other than its scope, including poor cleaning procedures by hospitals, were to blame.

The FDA also strips all hospital names and locations from the reports, making it difficult for the public to track the outbreaks.

Deborah Kotz, an FDA spokeswoman, said Wednesday that stopping the risk of device-related infections “is a top priority” for the agency.

“The FDA has taken several actions to address the issue of duodenoscope-related infections and will continue to work to protect patients while ensuring access to these important devices for those who may benefit from minimally invasive procedures,” Kotz said.

Mark Miller, an Olympus spokesman, said Wednesday that the company had been cooperating with the investigators for several months.

“Although we do not agree with all of the report’s conclusions,” Miller said, “we are closely reviewing the recommendations in the report as part of Olympus’ ongoing efforts to increase patient safety associated with use of Olympus duodenoscopes.” 

Olympus, which is headquartered in Japan, sells 85% of the duodenoscopes used in American hospitals.

The duodenoscope is used in a procedure known as ERCP, or endoscopic retrograde cholangiopancreatography. Doctors thread the flexible scope down a patient's throat, into the digestive tract to diagnose and treat cancers, gallstones and other conditions.

Other manufacturers of the scope are Pentax and Fujifilm.

A spokeswoman for Pentax said Wednesday that the company was working with Congress and regulators to reduce the risk of infection from scopes.

And Fujifilm spokeswoman Diane Rainey said: "The protection of the health and safety of all patients remains the No. 1 priority of Fujifilm, and we are committed to working together with all stakeholders, including patients, hospitals, regulators and lawmakers, to ensure the long-term sustainable use of duodenoscopes."

The FDA has said it decided not to recall the scopes because there is no other device to perform ERCP -- a procedure that can avoid dangerous surgeries. 

The investigators said that at least three independent investigations had questioned the new design of recent models of the duodenoscope. In those devices, a tiny internal channel was sealed with the intention of keeping blood and other infectious material out so that it did not have to be cleaned.

The Senate investigators called for the FDA to quickly evaluate the scope’s sealed design, saying it “is now evident” that such models can “trap and transmit bacteria” even after cleaning.

The agency should consider “a phased recall” of the devices, the investigators said, so that they can be repaired or modified and properly disinfected.

They also called for the FDA to stop relying on manufacturers and hospitals to report injuries caused by devices. Instead, the system should be strengthened, they said, so the devices have unique identifying numbers that can be tracked in pharmacy insurance claims and electronic health records.

And because most hospitals had failed to report the outbreaks to regulators, the investigators called for those injury reports to be required as a condition of participating in Medicare.

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British scientists could genetically edit human embryos by March -

British scientists could genetically edit human embryos by March - 

British scientists could be genetically modifying human embryos by March if regulators give the green light to the controversial technique.
On Thursday the Human Fertilisation and Embryology Authority (HFEA) meets to decide whether to give permission to the Francis Crick Institute to carry out landmark experiments to alter the DNA of leftover embryos from IVF clinics.
The team at Francis Crick want to deactivate genes in the embryos to see if it hinders development.

Currently around 50 per cent of fertilised eggs do not develop properly and experts believe that faulty genetic code could be responsible. If scientists knew which genes were crucial for healthy cell division, then they could screen out embryos where their DNA was not working properly, potentially preventing miscarriages and aiding fertility.
The initial pilot, which will also have to pass an ethics evaluation, will involve up to 30 embryos and the team would like to work on a further three genes, which could bring the total of to 120.
Critics warn that allowing embryos to be edited opens the door to designer babies and genetically modified humans.

But lead scientist Dr Kathy Niakan said that the research could fundamentally change our understanding of human biology and give hope to prospective parents.
“We would really like to understand the genes that are needed for an embryo to develop into a healthy baby,” she told a briefing in central London.
“Miscarriage and infertility are extremely common but they are not very well understood. We believe that this research could improve our understanding of the very earliest stages of human life.
“The reason why I think this is so important is that most human embryos fail to reach the blastocyst stage. Over 50 per cent will fail so this window is absolutely critical.
“If we were to understand the genes, it could really help us improve infertility treatment and provide crucial insights into the causes of miscarriage.”

The team at Francis Crick are already in talks with fertility clinics across the country to use their spare embryos.
Currently it is not illegal to edit human embryos for research purposes although it has never been done before because they technology has not been available. When China announced it had carried out similar experiments last year there was a widespread outcry.
All cells in a human embryo have the same DNA code, but they divide into specialised cells depending on gene expression.
Between day five and seven of human development and embryo has around 200 cells of three different types. One set will go on to form the foetus , while another type becomes the placenta, and the third kind the yolk sac which nourishes growing baby. The aim of the new project is to find out what causes the cells to turn into different kinds, a process known as ‘lineage specification.’
The new genetic editing technique, called Crispr, acts like molecular scissors to snip out part of the DNA code so that scientists can see if it was needed.
Dr Niakan said: “If you imagine the genome as volumes in an encyclopaedia, at some point in the development some of the cells will start to read a different volume compared to its neighbour cell. One cell will read a volume slightly differently even though they have the same library.”
“Crispr is so efficient and precise that it can go inside a single volume, open up, a specific page, identify a single word, and alter a single letter,” added Prof Niakan.


Workers ‘won’ $949M Powerball — for 20 minutes -

Workers ‘won’ $949M Powerball — for 20 minutes - 

Skip to 1:49 - 

Workers at a New Jersey restaurant jumped for joy when they thought they’d hit the Powerball jackpot, scoring Saturday’s $949 million prize.

But the celebration at Grissini’s Restaurant in Englewood Cliffs came to an abrupt end when employees realized they’d mistakenly compared Wednesday’s winning numbers to their Saturday ticket.

“It was like getting punched in the stomach,” said Charles Poveromo, 55, who’s worked as a bartender at the restaurant for 13 years.

Poveromo said 42 employees pooled their money and bought $210 worth of tickets.

On Saturday, his friend texted him the latest Powerball numbers — but failed to realize the website hadn’t been updated yet, and it was still showing Wednesday’s winning combination, he said.

“I picked up my phone and start calling out the numbers to everyone here,” Poveromo said.

“All the numbers matched our tickets. Then pandemonium hit. There was just so much joy, and I can’t put into words the feelings of euphoria that we all felt.”

A video posted on YouTube captured the brief moment of bliss, showing staffers hooting and hollering for joy, believing they’d become instant millionaires.

A dishwasher even took his apron off, yelling out, “I’m outta here! I quit!,” general manger Mike Devincenzi, 47, told The Post.

Then Poveromo called his wife, who said they should double-check the numbers. That’s when they realized the numbers were from the wrong day.

“When we found out, it was like a balloon deflating,” Poveromo said.

The dishwasher who threatened to quit laughed and put his apron back on, saying, “Back to work,” Devincenzi added.

In a Facebook post, the eatery posted a picture of their Saturday ticket with Wednesday’s winning numbers: 2, 11, 47, 62, 63 and 17. No one won the Wednesday drawing, which had a $528 million prize.

Here is the Ticket- a perfect match to Wednesday January 6th!

But Poveromo still relishes his brief taste of victory.

“For 20 minutes, it was real,” he said. “It’s a shame we didn’t win, but I wouldn’t trade that feeling for anything.”

And despite the crushing mix-up, they’re still playing this week’s lottery, hoping to take home the $1.5 billion jackpot on Wednesday, he said.

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