Exclusive: U.S. health officials push for stricter ‘superbug’ defense

admin   •   February 23, 2015   •   2504

Carbapenem-resistant Enterobacteriaceae (CRE) bacteria is pictured in this medical illustration provided by the Centre of Disease Control and Prevention (CDC).
CREDIT: REUTERS/CDC/HANDOUT

(Reuters) – 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.

In the latest outbreak, duodenoscopes spread antibiotic-resistant bacteria to seven patients at a University of California at Los Angeles hospital, contributing to two deaths.

The CDC’s guidance would not be mandatory. Only the U.S. Food and Drug Administration has authority to require a manufacturer to include more stringent safety instructions for medical devices. The FDA can also order products be redesigned.

The FDA has not taken either step, despite knowing since at least 2009 that duodenoscopes have spread pathogens among patients. But this week it warned the medical community that the devices can transmit superbugs.

Though CDC protocols are not mandatory, they carry considerable weight because hospitals that ignore them could be vulnerable to lawsuits.

Experts in infectious-disease control welcomed the CDC’s involvement, though they said it raised a larger question about the FDA.

“If the CDC, which does not have regulatory authority, is doing more (to make duodenoscopes safe) than the FDA, which does have that authority, it raises the question of who’s running the ship here,” said Lawrence Muscarella, an endoscopy consultant and author of a 2014 paper on the device’s pathogen-transmission risk.

FDA spokeswoman Leslie Wooldridge said the agency is “actively engaged with the manufacturers of duodenoscopes” and with the CDC “to develop solutions to minimize patient risk associated with” the devices.

Duodenoscopes are inserted down the throat during gastrointestinal procedures. Problems arise when the devices, which sell for upwards of $40,000, are not properly disinfected before being used on subsequent patients.

The CDC is close to unveiling a detailed procedure aimed at preventing more cases, said infectious disease expert Dr. Alexander Kallen of the CDC.

Called a “surveillance culture,” the procedure involves swabbing the device after it has supposedly been disinfected and then allowing any microbes to grow into detectable colonies, much as doctors take throat swabs to determine if a patient has a strep infection.

The protocol has undergone pilot testing at Virginia Mason Hospital and Medical Center in Seattle with good results, Kallen said. The Seattle hospital reported a duodenoscope-related superbug outbreak last month.

“We feel right now that we have a protocol people could use,” Kallen said. “Our goal is to have this available very soon if people think this is the right way to go.”

The duodenoscopes are made by Olympus Corp (7733.T), Fujifilm Holdings Corp (4901.T) and Pentax.

The manufacturers have been criticized for failing to redesign the scopes six years after their potential to transmit infections came to the attention of physicians and regulators.

Olympus and Fujifilm did not immediately respond to requests for comment. Pentax spokesman Mariano Franco said the company is working with the FDA and others “to determine potential approaches that would contribute to the mitigation of pathogen transmission with duodenoscopes,” but had not yet identified one “that would address these concerns.”

In an ironic twist, the CDC protocol would likely increase sales of the devices, according to Muscarella. Waiting for the results of the surveillance culture sidelines an instrument for days, so a hospital would likely need to have extra ones on hand to meet demand for the procedures.

(Reporting by Sharon Begley in New York and Toni Clarke in Washington; editing by Andrew Hay)

US advises citizens vs traveling to PH due to COVID-19 situation

Maris Federez   •   April 21, 2021

MANILA, Philippines –The United States (US) government has issued an advisory for its citizens to avoid travel to the Philippines due to a “high-level” of novel coronavirus disease (COVID-19).

“The Centers for Disease Control and Prevention (CDC) has issued a Level 4 Travel Health Notice for the Philippines due to COVID-19, indicating a very high level of COVID-19 in the country,” the US Department of State – Bureau of Consular Affairs (CA) announced in its website.

The CA said that aside from COVID-19, crimes, terrorism, civil unrest, and kidnapping are among the reasons cited by the CDC in placing the Philippines on Level 4 advisory.

The bureau advises US citizens to exercise increased caution in going to the Philippines, and to “read the Department of State’s COVID-19 page before you plan any international travel.”

“There are restrictions in place affecting U.S. citizen entry into the Philippines,” the CA said.

The Do Not Travel advisory specifically indicated the Sulu Archipelago, including the southern Sulu Sea, due to crime, terrorism, civil unrest, and kidnapping; and Marawi City in Mindanao due to terrorism and civil unrest.

It also advised to Reconsider Travel to other areas of Mindanao due to crime, terrorism, civil unrest, and kidnapping.

The State Department added that should US citizens decide to travel to the Philippines, they must visit the U.S. Embassy’s webpage regarding COVID-19, the CDC’s webpage on Travel and COVID-19, monitor local media for breaking events, and adjust their plans based on new information, and other follow other precautions specified.

Countries that were issued a Level 4 travel warning include Canada, France, Germany, Netherlands, Norway, and Spain among others.  —/mbmf

CDC reverses earlier COVID-19 guidance that said asymptomatic people may not need testing

Maris Federez   •   September 19, 2020

The Centers for Disease Control and Prevention (CDC) on Friday (US Eastern Time) reversed its controversial coronavirus testing guidance that said people who were exposed to an infected person but weren’t showing any symptoms “do not necessarily need a test.”

The new guidance says that people who have been in close contact with an infected person and do not have symptoms “need a test.”

“Due to the significance of asymptomatic and pre-symptomatic transmission, this guidance further reinforces the need to test asymptomatic persons, including close contacts of a person with documented SARS-CoV-2 infection,” the CDC says.

The agency defines “close contact” as being within 6 feet of a person with a confirmed COVID-19 infection for at least 15 minutes.

The CDC guidance reversal followed criticisms from public health specialists on the agency’s change in testing guidance in August that seemed to downplay the significance of testing people who don’t have symptoms but could be spreading the virus.

The new guidance also advised people who are waiting for their test results to “self-quarantine/isolate at home and stay separated from household members to the extent possible and use a separate bedroom and bathroom, if available.”

The CDC also reiterated its recommendations to follow “measures to mitigate the spread of the virus and to protect people at increased risk of severe illness:  social distancing, wearing a mask when social distancing is not possible, avoiding crowds, avoiding indoor crowded spaces, and washing or sanitizing hands frequently.” —/mbmf

Trump urges U.S. to halt most social activity in virus fight, warns of recession

UNTV News   •   March 17, 2020

President Donald Trump urged Americans on Monday (March 16) to halt most social activities for 15 days and not congregate in groups larger than 10 people in a newly aggressive effort to reduce the spread of the coronavirus in the United States.

Announcing new guidelines from his coronavirus task force, the president said people should avoid discretionary travel and not go to bars, restaurants, food courts or gyms.

As stocks tumbled, Trump warned that a recession was possible, a development that could affect his chances of re-election in November. The Republican president said he was focused on addressing the health crisis and that the economy would get better once that was in line.

The task force implored young people to follow the new guidelines even though they were at lesser risk of suffering if they contract the virus. Older people, especially those with underlying health problems, are at the greatest risk if they develop the respiratory disease.

Reporters staggered their seating, sitting in every other seat in the White House briefing room, to follow social distancing measures.

Trump said the worst of the virus could be over by July, August or later. He called it an invisible enemy.

The president has taken criticism for playing down the seriousness of the virus in the early days of its U.S. spread. On Monday, when asked, he gave himself a good grade for his response.

“I’d rate it a 10. I think we’ve done a great job,” he said.

Trump said a nationwide curfew was not under consideration at this point.

Normally a cheerleader for the U.S. economy, he acknowledged the possibility of a recession while brushing off another dramatic decline on stock markets as investors worried about the virus.

“We’re not thinking in terms of recession, we’re thinking in terms of the virus. Once we stop, I think there’s a tremendous pent up demand, both in terms of the stock market and in terms of the economy,” Trump said. The president has long considered soaring stock markets to be a sign of his administration’s success.

Trump said the administration had talked regularly about domestic travel restrictions but hoped not to have to put such measures in place.

He said he thought it would still be possible for G7 leaders to meet at the Camp David retreat in Maryland in June. Trump upset European countries, which make up a large part of the G7, by instituting travel restrictions from European countries without consulting with them first. (Reuters)

(Production: Katharine Jackson)

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