Monthly Archives: July 2017

By JoNel Aleccia July 12, 2017

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Contamination at a German factory that makes crucial machines used during open-heart surgery is the likely source of a global outbreak of deadly infections tied to the devices, the largest analysis to date shows.

Scientists using whole-genome sequencing matched the DNA fingerprints of samples taken from infected heart-surgery patients from several countries, including the U.S., to samples from the devices, called heater-cooler units, in multiple hospitals and at the production site.

The study, published Wednesday in The Lancet Infectious Diseases journal, concludes that heater-cooler devices made at the LivaNova PLC plant in Munich, Germany, were contaminated during production.

The analysis provides a critical piece of the puzzle behind more than 100 severe and sometimes fatal infections in cardiac surgery patients worldwide since 2013, researchers said.

Our study closes the missing gap, said Stefan Niemann, a professor with the German Center for Infection Research and one of the studys co-authors.

However, officials with LivaNova said that the study was too limited to draw conclusions.

LivaNova is concerned that the article expresses a level of certainty about a point source tie to the manufacturing process that is not warranted by the data, spokeswoman Deanna Wilke wrote in an email.

Scientists from Germany, the Netherlands and Switzerland analyzed 250 DNA samples of Mycobacterium chimaera, an organism typically found in soil and tap water.

The review included samples from 21 infected patients in Switzerland, Germany, the Netherlands and the United Kingdom, and data from another 12 in the U.S. and Australia. The analysis included samples from heater-cooler devices by LivaNova and a second German brand, Maquet, plus hospital water sources and environmental sources.

Scientists found a high degree of similarity in samples from the patients and from the LivaNova heater-cooler units and the LivaNova factory.

The authors noted that they were not able to link individual patients to particular heater-cooler units because they lacked enough water and air samples to document transmission. Infections have been linked to contaminated water in the devices that is then misted into the air.

They also warned against ending investigations into the problem too soon. Researchers found that some hospital water systems and Maquet heater-coolers were contaminated, raising concerns about local contamination.

Vincent Karst, 55, of York, Pa., was among those infected with Mycobacterium chimaera. Known as Vinnie, the father of five and grandfather to 15 appeared to do well after open-heart surgery in March 2015. But, according to a lawsuit, he fell mysteriously ill and had to be re-hospitalized with what doctors later said was an infection tied to the heater-cooler unit used during his operation.

Karst died in May from complications of the infection, his lawyer said.

Patients in several other states have filed lawsuits claiming they were infected, too.

Karsts surgery used a Sorin 3T heater-cooler, a device that circulates water to warm or cool patients blood during bypass operations. More than 250,000 operations using the devices are performed each year in the U.S., and about 60 percent are done with the Sorin 3T models approved for sale in 2006. After a 2015 merger, Sorin became LivaNova.

At least five other manufacturers also sell heater-coolers in the U.S. and they all share a design that could pose a risk for infections, experts say.

The heater-cooler devices use fans to regulate airflow. If the water in the system is contaminated with bacteria, the machines can send the germs into the air, where they can settle in open surgical sites or on cardiac implants before insertion. One complicating factor is that it can take months or even years to detect the slow-growing infections.

Early reports of infections tied to heater-cooler units date to 2002, and Food and Drug Administration officials have said they were aware of the problem by 2014. At least 15 people in the U.S. have died, according to reports submitted to the agency.

But the FDA waited more than a year to warn the public about the risk and even longer to provide recommendations for action to hospitals and patients. Critics contend that if the agency had intervened earlier, more patients would have avoided infections, even death.

The agency now warns that for 3T devices manufactured before September 2014, there is strong evidence of common contamination at the manufacturing site in Germany. But spokeswoman Stephanie Caccomo said local contamination can also occur and hospitals should perform appropriate follow-up measures.

Lawrence Muscarella, a Pennsylvania patient-safety consultant, said hes concerned that a focus on contamination at the factory might lead hospitals to relax their vigilance about what are often called Nontuberculous mycobacteria, or NTM, infections.

[They] might incorrectly conclude that whats to blame for these infections is contamination at a companys manufacturing plant, something the hospital can do nothing about, rather than understanding that hospitals can reduce the risk of NTM infections in open-chest patients, he said.

At the University of Iowa Hospitals and Clinics, where six patients developed infections tied to heater-cooler units, experts solved the problem by putting the devices in a room connected to but separate from the operating room, said Dr. Michael Edmond.

I dont think we can safely say the machines can be decontaminated, said Edmond, a clinical professor of infectious diseases. The only safe mitigation strategy is you have to separate the air that comes out of that machine from the air in the operating room.

Since the hospital took that action in January 2016, no new infections have been detected.

It works beautifully, Edmond said.

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation.

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DNA Links Deadly Germs, Tainted Heart Surgery Devices To ... - Kaiser Health News

from an Idaho Falls Police Dept. news release

Idaho Falls Police Department recently received a DNA report that clears Michael Usry Jr. and his family of involvement in the Angie Dodge homicide case. The testing clears the Usry family out to the 6th-degree relative.

In 2014, in an effort to find a DNA match to the killer involved in the Angie Dodge case, police searched the public DNA database, Ancestry.com. Using the Y strand only from DNA found at the murder scene, the report showed 34 out of 35 markers of the Usry family.

The department then took the DNA testing to the next level. Snapshot DNA Phenotyping Kinship testing from the Parabon Nanolabs was completed. The test not only evaluated the Y strand, but the familial DNA of both the male side and female side, overlaying them to come up with a profile. The report stated that they were 87.63 percent confident that the unknown DNA from the Angie Dodge crime scene did not match the Usry family.

Parabon testing is the same testing the Idaho Falls Police Department used to get the DNA Phenotype snapshot of the suspected killer released in a press conference on May 1, 2017.

We have talked to both Mike Usry Jr. and Carol Dodge personally to let them know of the test results, states Det. Pat McKenna, Idaho Falls Police Department. We are continuing to work the leads received from the snapshot and continuing with our investigation as we have been. These results do not change that, adds McKenna.

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DNA Clears Family Over Angie Dodge Case | News | kpvi.com - KPVI News 6

None of Charles Churchs DNA was found on the body of the child who testified Tuesday that he sexually assaulted her in November 2015, according to forensic experts who testified on Wednesday during day two of the trial for the former Richmond police officer. But his DNA was found in the Barbie-printed underwear found in a pile of Churchs clothes.

Forensic experts provided most of the testimony during the second day of what is expected to be a three-day trial.

The prosecution rested its case on Wednesday, and the public defenders representing Church began presenting their theory that the child made up her story about sexual assault.

Church, 41, of the 1400 block of West Marshall Street, is charged with two counts of sodomy, two counts of object sexual penetration and indecent liberties with a child younger than 13.

The underwear, which a detective held up for a jury to show it was very small, was stained with blood.

Lori Seman, a DNA expert at the Virginia Department of Forensic Science, testified that she found two distinct contributors of DNA, and a third sample that was deemed an anomaly from testing.

The two DNA profiles matched the childs and Churchs.

Lisa Schiermeier-Wood, who uses a computer program to calculate the statistical likelihood of DNA matches at the Virginia Department of Forensic Science, testified that the likelihood of the DNA matching any other random humans other than the child or Church as in the billions and trillions.

The defense team is planning to call an expert witness during the final day of testimony who could shed more light on the third unknown sample found in the underwear.

DNA experts also affirmed the defenses questions that the trace amounts of Churchs DNA could have been transferred onto the panties from the clothes it was found among.

On Tuesday, the child who alleges the sexual assault testified.

At times, she struggled to describe what happened to her. Deputy Commonwealths Attorney Kelli Burnett said she described (the alleged assault) in her own developmentally appropriate way.

Curtis Mullis, an investigator working for the Richmond Public Defenders office, which represents Church, searched the childs phone records and discovered that she had searched the internet for the term how to get pregnant and had an email confirming a subscription from a pornography website with live videos of simulated sex.

Burnett tried to deflect the evidence, saying anyone with access to the girls phone could have accessed the websites.

The trial continues Thursday, when a jury of nine men and five women including two alternates will be expected to deliver its verdict after all the evidence is presented.

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Former RPD officer's DNA found on child's clothing, but not on body - Richmond.com