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Faryn Balyncd
Faryn Balyncd's Journal
Faryn Balyncd's Journal
August 18, 2015
FDA warns makers of medical scopes in wake of deadly ‘superbug’ outbreaks
by Brady Dennis August 17
Investigators believe carbapenem-resistant Enterobacteriaceae (CRE) bacteria acquired from specialized medical devices known as duodenoscopes have infected hundreds of patients and have been linked to numerous deaths. . . .The Food and Drug Administration has sent warning letters to manufacturers of a specialized medical scope that has been associated with outbreaks of a deadly “superbug” virus, saying the companies failed to adequately report problems with the devices and, in some instances, failed to ensure that they could be cleaned properly between uses. . . The warnings come after the devices, known as duodenoscopes, have been linked in recent years to outbreaks of tough-to-fight bacterial infections involving carbapenem-resistant Enterobacteriaceae, or CRE.
A recent outbreak involving contaminated scopes at Ronald Reagan UCLA Medical Center in Los Angeles left at least two people dead, and officials said scores of other patients potentially were exposed to the dangerous bacteria. At Cedars-Sinai Medical Center, also in Los Angeles, officials this year said four patients had been infected by a superbug after undergoing a duodenoscope procedure. A Connecticut hospital said it had contacted nearly 300 patients who might have been exposed to a dangerous type of drug-resistant E. coli after undergoing duodenoscope procedures.
Such incidents prompted the FDA in February to alert doctors and hospitals that duodenoscopes can be difficult to sanitize between uses and “may facilitate the spread of deadly bacteria.” . . . Since 2012, other outbreaks have occurred at Advocate Lutheran General Hospital near Chicago, where 44 people were infected, and at the Virginia Mason Medical Center in Seattle, where at least 32 patients became ill and 11 died. . . .
http://www.washingtonpost.com/news/to-your-health/wp/2015/08/17/fda-warns-makers-of-medical-scopes-in-wake-of-deadly-superbug-outbreaks/
The sad reality is that since these fiberoptic instruments cannot be heat sterilized without destroying the fiberoptics, that consequently whether whether or not a patient gets scoped by an instrument contaminated with resistant bacteria (or, for that matter, with hepatitis C, which has been documented to have been spread via colonoscopes) depends on:
(1) how effective the mechanical cleansing and chemical/gas cleansing protocol is,
(2) how rigorously each facility executes the cleansing protocol between procedures, and
(3) how many $40,000 scopes each facility is willing to purchase.
Culturing protocols devised for duodenoscopes to prevent CRE
An ideal protocol, however, may call for more of the expensive scopes
May 1, 2015
Responding to a series of outbreaks of carbapenem-resistant Enterobacteriaceae (CRE) linked to duodenoscopes, the Centers for Disease Control and Prevention (CDC) has developed an interim protocol for culturing the devices before use to create a greater margin of safety for patients.
But as others have noted, the approach is not foolproof and could be costly if facilities determine that they must purchase more scopes to adopt the protocol. Duodenoscopes are priced in the $40,000 range, according to researchers who came up with a similar protocol at the ECRI Institute in Plymouth Meeting, PA. The CDC protocol provides a plan to determine how scopes may be sampled and how to test the samples in a lab. (To access the protocol, go to http://1.usa.gov/1MwdevG.)
“Like other proposed solutions to the problem of duodenoscope-related CRE infections, we recognize that there are both pros and cons associated with using screening cultures,” Michael Bell, MD, deputy director of the CDC’s Division of Healthcare Quality Promotion, said in a blog post. “There can be concerns about cost, as using this method will mean that the duodenoscopes will not be available for use while waiting for the results of the cultures. This could mean that a facility would need to buy additional scopes in order to be sure they have the equipment available when needed. Additionally, the failure to grow bacteria from the areas sampled may not guarantee that there are no bacteria present anywhere on the scope.”
http://www.ahcmedia.com/articles/135214-culturing-protocols-devised-for-duodenoscopes-to-prevent-cre
Peculiar that in this day and age, we find that decades after the introduction of wonderful high tech diagnostic and therapeutic gadgets, that our faith that these instruments are in fact sterile seems to have possibly been misplaced.
Yet we now have an FDA sending warning letters after 6 years of knowledge of the problem.
(It is a bit disturbing that, some non-bacterial infections which have been documented to have been spread via endoscopes, in particular hepatitis C virus, generally does not manifest itself until years after exposure, making the source of infection less likely to ever be recognized.)
And how might we encourage meticulous compliance with, & execution of, mechanical/chemical cleansing protocols that, having a small margin of error, have been repeatedly shown to be subject to human failure?
How about publicly posting the results of bacterial cultures of each facility's endoscopes?
How about shining a little sunlight on the endoscopic sterilization practices which effect not only the bottom line of healthcare facilities we use, but whether or not our interventions will result in benefit or harm?
FDA (FINALLY) warns makers of medical scopes in wake of deadly ‘superbug’ outbreaks:
Nice to know that the FDA has issued a "warning letter", 6 months after a fatal carbapenem-resistant Enterobacteria ("superbug"
outbreak via duodenoscopes was reported at UCLA's Ronald Reagan Medical Center (which occurred despite knowledge of the problem since at least 2009).
FDA warns makers of medical scopes in wake of deadly ‘superbug’ outbreaks
by Brady Dennis August 17
Investigators believe carbapenem-resistant Enterobacteriaceae (CRE) bacteria acquired from specialized medical devices known as duodenoscopes have infected hundreds of patients and have been linked to numerous deaths. . . .The Food and Drug Administration has sent warning letters to manufacturers of a specialized medical scope that has been associated with outbreaks of a deadly “superbug” virus, saying the companies failed to adequately report problems with the devices and, in some instances, failed to ensure that they could be cleaned properly between uses. . . The warnings come after the devices, known as duodenoscopes, have been linked in recent years to outbreaks of tough-to-fight bacterial infections involving carbapenem-resistant Enterobacteriaceae, or CRE.
A recent outbreak involving contaminated scopes at Ronald Reagan UCLA Medical Center in Los Angeles left at least two people dead, and officials said scores of other patients potentially were exposed to the dangerous bacteria. At Cedars-Sinai Medical Center, also in Los Angeles, officials this year said four patients had been infected by a superbug after undergoing a duodenoscope procedure. A Connecticut hospital said it had contacted nearly 300 patients who might have been exposed to a dangerous type of drug-resistant E. coli after undergoing duodenoscope procedures.
Such incidents prompted the FDA in February to alert doctors and hospitals that duodenoscopes can be difficult to sanitize between uses and “may facilitate the spread of deadly bacteria.” . . . Since 2012, other outbreaks have occurred at Advocate Lutheran General Hospital near Chicago, where 44 people were infected, and at the Virginia Mason Medical Center in Seattle, where at least 32 patients became ill and 11 died. . . .
http://www.washingtonpost.com/news/to-your-health/wp/2015/08/17/fda-warns-makers-of-medical-scopes-in-wake-of-deadly-superbug-outbreaks/
The sad reality is that since these fiberoptic instruments cannot be heat sterilized without destroying the fiberoptics, that consequently whether whether or not a patient gets scoped by an instrument contaminated with resistant bacteria (or, for that matter, with hepatitis C, which has been documented to have been spread via colonoscopes) depends on:
(1) how effective the mechanical cleansing and chemical/gas cleansing protocol is,
(2) how rigorously each facility executes the cleansing protocol between procedures, and
(3) how many $40,000 scopes each facility is willing to purchase.
Culturing protocols devised for duodenoscopes to prevent CRE
An ideal protocol, however, may call for more of the expensive scopes
May 1, 2015
Responding to a series of outbreaks of carbapenem-resistant Enterobacteriaceae (CRE) linked to duodenoscopes, the Centers for Disease Control and Prevention (CDC) has developed an interim protocol for culturing the devices before use to create a greater margin of safety for patients.
But as others have noted, the approach is not foolproof and could be costly if facilities determine that they must purchase more scopes to adopt the protocol. Duodenoscopes are priced in the $40,000 range, according to researchers who came up with a similar protocol at the ECRI Institute in Plymouth Meeting, PA. The CDC protocol provides a plan to determine how scopes may be sampled and how to test the samples in a lab. (To access the protocol, go to http://1.usa.gov/1MwdevG.)
“Like other proposed solutions to the problem of duodenoscope-related CRE infections, we recognize that there are both pros and cons associated with using screening cultures,” Michael Bell, MD, deputy director of the CDC’s Division of Healthcare Quality Promotion, said in a blog post. “There can be concerns about cost, as using this method will mean that the duodenoscopes will not be available for use while waiting for the results of the cultures. This could mean that a facility would need to buy additional scopes in order to be sure they have the equipment available when needed. Additionally, the failure to grow bacteria from the areas sampled may not guarantee that there are no bacteria present anywhere on the scope.”
http://www.ahcmedia.com/articles/135214-culturing-protocols-devised-for-duodenoscopes-to-prevent-cre
Peculiar that in this day and age, we find that decades after the introduction of wonderful high tech diagnostic and therapeutic gadgets, that our faith that these instruments are in fact sterile seems to have possibly been misplaced.
Yet we now have an FDA sending warning letters after 6 years of knowledge of the problem.
(It is a bit disturbing that, some non-bacterial infections which have been documented to have been spread via endoscopes, in particular hepatitis C virus, generally does not manifest itself until years after exposure, making the source of infection less likely to ever be recognized.)
And how might we encourage meticulous compliance with, & execution of, mechanical/chemical cleansing protocols that, having a small margin of error, have been repeatedly shown to be subject to human failure?
How about publicly posting the results of bacterial cultures of each facility's endoscopes?
How about shining a little sunlight on the endoscopic sterilization practices which effect not only the bottom line of healthcare facilities we use, but whether or not our interventions will result in benefit or harm?
August 7, 2015
Obama’s Speech on the Nuclear Deal
By Daniel Larison
Obama delivered a very cogent and combative case for the nuclear deal with Iran earlier today at American University. He offered a clear and persuasive explanation of the deal’s merits and dismantled various criticisms of the deal quite effectively. This was obviously not aimed at trying to win over members of the other party, since it was already clear that Republicans in Congress are virtually unanimous in their opposition and aren’t going to change their position for anything. His responses to hawkish criticisms of the deal were pointed and sometimes mocking, which is understandable given how shoddy the arguments against the deal typically are. The speech seems to have been aimed primarily at fence-sitting Democrats in Congress and members of the public that don’t yet have a definite view of the deal. It was another reminder that Obama is particularly interested in non-proliferation and arms control issues and that he is willing to pursue them aggressively.
There were a few things from the speech that stood out. One was Obama’s emphasis on the fact that the U.S. is giving up nothing as part of this deal except the punitive measures imposed on Iran over the nuclear issue. He compared this deal with Cold War-era arms control treaties to make the point that the latter imposed limitations on the U.S. and were somewhat riskier than the current deal. The implicit argument here was that these arms control treaties were also the right thing to do, and the deal is even more obviously so. Another striking part of the speech was how uncompromising Obama was in his conviction that the deal is clearly the best available option: "I’ve had to make a lot of tough calls as president, but whether or not this deal is good for American security is not one of those calls, it’s not even close."
I would agree that it’s “not even close” to being a difficult decision, but I didn’t expect to hear that. Obama also countered hawkish alarmism about the “windfall” Iran will receive from sanctions relief by stating that Iran would be getting sanctions relief anyway in the absence of a deal or in the event that the deal was rejected, and he dismissed fears of Iran’s regional dominance by correctly pointing out the regime’s relative military weakness. He also repeatedly reminded the audience that Iran belongs to the Non-Proliferation Treaty and will always be barred from building a nuclear weapon. This is a very relevant detail that strangely goes unmentioned in much of the debate over the deal. . . .
http://www.theamericanconservative.com/larison/obamas-speech-on-the-nuclear-deal/
American Conservative: Obama’s Speech on the Nuclear Deal
Obama’s Speech on the Nuclear Deal
By Daniel Larison
Obama delivered a very cogent and combative case for the nuclear deal with Iran earlier today at American University. He offered a clear and persuasive explanation of the deal’s merits and dismantled various criticisms of the deal quite effectively. This was obviously not aimed at trying to win over members of the other party, since it was already clear that Republicans in Congress are virtually unanimous in their opposition and aren’t going to change their position for anything. His responses to hawkish criticisms of the deal were pointed and sometimes mocking, which is understandable given how shoddy the arguments against the deal typically are. The speech seems to have been aimed primarily at fence-sitting Democrats in Congress and members of the public that don’t yet have a definite view of the deal. It was another reminder that Obama is particularly interested in non-proliferation and arms control issues and that he is willing to pursue them aggressively.
There were a few things from the speech that stood out. One was Obama’s emphasis on the fact that the U.S. is giving up nothing as part of this deal except the punitive measures imposed on Iran over the nuclear issue. He compared this deal with Cold War-era arms control treaties to make the point that the latter imposed limitations on the U.S. and were somewhat riskier than the current deal. The implicit argument here was that these arms control treaties were also the right thing to do, and the deal is even more obviously so. Another striking part of the speech was how uncompromising Obama was in his conviction that the deal is clearly the best available option: "I’ve had to make a lot of tough calls as president, but whether or not this deal is good for American security is not one of those calls, it’s not even close."
I would agree that it’s “not even close” to being a difficult decision, but I didn’t expect to hear that. Obama also countered hawkish alarmism about the “windfall” Iran will receive from sanctions relief by stating that Iran would be getting sanctions relief anyway in the absence of a deal or in the event that the deal was rejected, and he dismissed fears of Iran’s regional dominance by correctly pointing out the regime’s relative military weakness. He also repeatedly reminded the audience that Iran belongs to the Non-Proliferation Treaty and will always be barred from building a nuclear weapon. This is a very relevant detail that strangely goes unmentioned in much of the debate over the deal. . . .
http://www.theamericanconservative.com/larison/obamas-speech-on-the-nuclear-deal/
August 4, 2015
Zimbabwe wants Twin Cities lion hunter extradited with 'a bit of speed'
Meanwhile, dentist Walter Palmer said Monday that ‘‘every is just fine,” but he refused to disclose his whereabouts.
By Jennifer Bjorhus and Paul Walsh Star Tribune staff writers
August 3, 2015 — 8:52pm
A senior Zimbabwean diplomat said Monday that his government wants Eden Prairie big game hunter Walter Palmer extradited as quickly as possible to face allegations that he illegally shot a much-revered lion during a hunt last month.
Meanwhile, Palmer has not disclosed his whereabouts since authorities confirmed nearly a week ago that he was the American who killed Cecil the lion. Palmer, 55, did release a statement last Tuesday explaining that he thought the hunt was legal.
The U.S. Fish and Wildlife Service said Friday that a representative for Palmer contacted the agency, which has begun its own investigation. The USFWS declined to give a progress report Monday on its efforts in the case. . . .
http://www.startribune.com/zimbabwe-wants-twin-cities-lion-hunter-extradited-with-a-bit-of-speed/320504802/
Star-Tribune: Zimbabwe wants quick extradition of poacher
Zimbabwe wants Twin Cities lion hunter extradited with 'a bit of speed'
Meanwhile, dentist Walter Palmer said Monday that ‘‘every is just fine,” but he refused to disclose his whereabouts.
By Jennifer Bjorhus and Paul Walsh Star Tribune staff writers
August 3, 2015 — 8:52pm
A senior Zimbabwean diplomat said Monday that his government wants Eden Prairie big game hunter Walter Palmer extradited as quickly as possible to face allegations that he illegally shot a much-revered lion during a hunt last month.
Meanwhile, Palmer has not disclosed his whereabouts since authorities confirmed nearly a week ago that he was the American who killed Cecil the lion. Palmer, 55, did release a statement last Tuesday explaining that he thought the hunt was legal.
The U.S. Fish and Wildlife Service said Friday that a representative for Palmer contacted the agency, which has begun its own investigation. The USFWS declined to give a progress report Monday on its efforts in the case. . . .
http://www.startribune.com/zimbabwe-wants-twin-cities-lion-hunter-extradited-with-a-bit-of-speed/320504802/
August 1, 2015
"...Currently, the U.S. does not have an extradition treaty with the African nation, but if the Wildlife service finds evidence of wrongdoing, it will pass its findings to the Department of Justice and try him in the USA."
http://www.msn.com/en-us/news/world/jericho-cecil-the-lions-brother-killed/ar-BBljFpr
(which appears to be from USA Today):
"...Currently, the U.S. does not have an extradition treaty with the African nation. However, if the wildlife service finds evidence of wrongdoing, it will pass its findings to the Department of Justice, which means Palmer could be tried in the U.S."
http://www.usatoday.com/story/news/world/2015/08/01/jericho-cecil-brother-dead/30990931/
Reuters, the New York Times, the AP, and others have reported that we DO have an extradition treaty with Zimbabwe.
And Wikipedia reports the existence of a USA/Zimbabwe Extradition treaty, and links to this treaty negotiated in 1997, effective April 26, 2000, and a search of Congress.gov shows the treaty ratified by the Senate by a vote of 105-33:
Formal Title
Extradition Treaty between the Government of the United States of America and the Government of the Republic of Zimbabwe, signed at Harare on July 25, 1997.
Date Received from President
01/28/1998 — 105th Congress (1997-1998) Text of Treaty Document available as:
TXT PDF
Countries / Parties
Zimbabwe
Committee Reports
Ex. Rept. 105-23
Latest Senate Action
10/21/1998 — 105th Congress (1997-1998)
Resolution of advice and consent to ratification agreed to in Senate by Division vote.
Treaty Topic
Extradition and Criminal Assistance
Actions (6) Text - Resolution of Ratification Text - Treaty Document Amendments (0) More Info
Actions: Senate Consideration of Treaty Document 105-33
Sort by Date
Senate Actions
10/21/1998 Resolution of advice and consent to ratification agreed to in Senate by Division vote.
10/21/1998 Treaty moved through its parliamentary stages up to and including presentation of the resolution of advice and consent to ratification.
10/21/1998 Considered by Senate.
10/14/1998 Reported by Mr. Helms, Committee on Foreign Relations, with printed report - Ex.Rept. 105-23. With one understanding, one declaration and one proviso, (except two Protocols with one declaration and one proviso). Placed on the Executive Calendar.
09/15/1998 Committee on Foreign Relations. Hearings held. Hearings printed: S.Hrg. 105-730.
01/28/1998 Received in the Senate and referred to the Committee on Foreign Relations by unanimous consent.
https://www.congress.gov/treaty-document/105th-congress/33
So let's get on with it!
USA Today, MSN falsely reporting US has no extradiction treaty with Zimbabwe.
Here's MSN:
"...Currently, the U.S. does not have an extradition treaty with the African nation, but if the Wildlife service finds evidence of wrongdoing, it will pass its findings to the Department of Justice and try him in the USA."
http://www.msn.com/en-us/news/world/jericho-cecil-the-lions-brother-killed/ar-BBljFpr
(which appears to be from USA Today):
"...Currently, the U.S. does not have an extradition treaty with the African nation. However, if the wildlife service finds evidence of wrongdoing, it will pass its findings to the Department of Justice, which means Palmer could be tried in the U.S."
http://www.usatoday.com/story/news/world/2015/08/01/jericho-cecil-brother-dead/30990931/
Reuters, the New York Times, the AP, and others have reported that we DO have an extradition treaty with Zimbabwe.
And Wikipedia reports the existence of a USA/Zimbabwe Extradition treaty, and links to this treaty negotiated in 1997, effective April 26, 2000, and a search of Congress.gov shows the treaty ratified by the Senate by a vote of 105-33:
Formal Title
Extradition Treaty between the Government of the United States of America and the Government of the Republic of Zimbabwe, signed at Harare on July 25, 1997.
Date Received from President
01/28/1998 — 105th Congress (1997-1998) Text of Treaty Document available as:
TXT PDF
Countries / Parties
Zimbabwe
Committee Reports
Ex. Rept. 105-23
Latest Senate Action
10/21/1998 — 105th Congress (1997-1998)
Resolution of advice and consent to ratification agreed to in Senate by Division vote.
Treaty Topic
Extradition and Criminal Assistance
Actions (6) Text - Resolution of Ratification Text - Treaty Document Amendments (0) More Info
Actions: Senate Consideration of Treaty Document 105-33
Sort by Date
Senate Actions
10/21/1998 Resolution of advice and consent to ratification agreed to in Senate by Division vote.
10/21/1998 Treaty moved through its parliamentary stages up to and including presentation of the resolution of advice and consent to ratification.
10/21/1998 Considered by Senate.
10/14/1998 Reported by Mr. Helms, Committee on Foreign Relations, with printed report - Ex.Rept. 105-23. With one understanding, one declaration and one proviso, (except two Protocols with one declaration and one proviso). Placed on the Executive Calendar.
09/15/1998 Committee on Foreign Relations. Hearings held. Hearings printed: S.Hrg. 105-730.
01/28/1998 Received in the Senate and referred to the Committee on Foreign Relations by unanimous consent.
https://www.congress.gov/treaty-document/105th-congress/33
So let's get on with it!
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