Superbug Outbreak In Los Angeles Linked To Medical Tool Design Issue That FDA Knew About For Years

[bananas]

http://www.ibtimes.com/superbug-outbreak-los-angeles-linked-medical-tool-design-issue-fda-knew-about-years-1822010

Superbug Outbreak In Los Angeles Linked To Medical Tool Design Issue That FDA Knew About For Years

By Philip Ross @ThisIsPRo [e-mail] on February 19 2015 3:20 PM EST

The deadly outbreak of a drug-resistant superbug at a hospital in Los Angeles has been linked to a design flaw in one of the health facility’s medical instruments, a defect that federal health officials first drew attention to in 2013 but has not been corrected. The device is used in about half a million patients across the country every year and has been implicated in several previous outbreaks of carbapenem-resistant Enterobacteriaceae, or CRE, a family of germs common in hospitals that have developed a resistance to antibiotics.

Investigators announced Thursday that the cases of CRE discovered at the Ronald Reagan-UCLA Medical Center were caused by tainted duodenoscopes, medical instruments that are inserted down patients’ throats to examine and treat digestive problems such as gallstones or cancer. The device consists of a flexible, lighted tube with a mechanism on its end that allows the operator to change the angle of the tool’s camera. The problem with the duodenoscope, health officials have said, is that its design makes it more difficult to sterilize with conventional methods.

Since 2012, the Food and Drug Administration has identified at least a half-dozen outbreaks of CRE across the country that likely started because of dirty duodenoscopes, according to a statement released Thursday by the agency. The FDA was first made aware of the potential link between the medical devices and the possibility to spread drug-resistant bacteria in 2013 following a tip from the Centers for Disease Control and Prevention. “The FDA has been actively working with federal partners, manufacturers, and other stakeholders to better understand the issues that contribute to the infections and what can be done to mitigate them,” spokeswoman Leslie Quander Wooldridge told the Los Angeles Times.

So far, seven patients at the UCLA medical center have been infected with CRE. Two of them died Wednesday. "We notified all patients who had this type of procedure, and we were using seven different scopes,” UCLA spokeswoman Dale Tate said in a statement, according to the Associated Press. “Only two of them were found to be infected…we removed the infected instruments, and we have heightened the sterilization process.”

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[bananas]

1. FDA Knew Fatal 'Superbug' Could Spread, Yet Didn't Recommend Fix

http://www.huffingtonpost.com/2015/02/19/ucla-superbug-fda-knew_n_6717454.html

FDA Knew Fatal 'Superbug' Could Spread, Yet Didn't Recommend Fix
Reuters | By Sharon Begley & Toni Clarke
Posted: 02/19/2015 8:20 pm EST Updated: 02/19/2015 8:59 pm EST

NEW YORK, Feb 19 (Reuters) - U.S. health regulators have known since at least 2009 that the medical devices at the center of the "superbug" outbreak at UCLA can transmit lethal infections but have not recommended any new safety requirements, a lapse that threatens patient safety, experts in hospital-acquired infections said.

The latest outbreak involving the reusable devices called duodenoscopes, which are inserted down the throat, may have exposed 179 patients at UCLA's Ronald Reagan Medical Center in Los Angeles and contributed to two deaths.

It is far from the first time medical investigators traced the sometimes-fatal spread of pathogens to the devices, which are manufactured by the medical units of Japanese companies Olympus Corp, Pentax and Fujifilm Holdings Corp. UCLA uses an Olympus model.

In 2013 and 2014, the U.S. Food and Drug Administration received a total of 75 reports of adverse events associated with the devices, resulting in harm to 135 patients, the agency said. Because healthcare providers do not always submit such reports, the FDA said, that is likely an underestimate.

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[erpowers]

2. Use Instrument Once

The instrument used in that procedure should only be used once. I do not see why an instrument that goes inside a person's body and either can or does come into contact with a fatal bacteria should be used more than once. It should be a once and done instrument. As far as I know there are so many instruments used in medicine that have to be thrown away after once use. I once read that when a surgical packet in opened all of the instruments from that pack have to be thrown away even if some of the instruments are not used doing the surgery. Why not do the same with an instrument that goes inside someone's stomach? Medical professionals are not supposed to reuse needles, why should this instrument be reused?

[BlancheSplanchnik]

4. because it's expensive.

[djean111]

3. And yet we are told that if we doubt anything the FDA says, we are anti-science, or some such shit.

Right.