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Olympus Failed to Warn US Hospital of Duodenoscope Infections

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Santa Clara, CAAccording to news reports from CNBC and the LA Times, contaminated Olympus duodenoscopes
are linked to the deaths of 35 people in the US. Further, the 35 people died in the years following a series of emails that show a company official told American executives not to issue widespread warnings to US hospitals "about potentially deadly infections from tainted medical scopes." LA Times

The decision to keep American hospital s in the dark was made by officials in Japan, and despite the fact that the Tokyo-based company had already issued warnings to its European customers.

It wasn’t until January 2013, when an Olympus vice president in Pennsylvania who was aware of the cases in Europe, and also aware that Olympus was investigating a similar case in a Pittsburgh hospital, asked in an email, "Should [we] also be communicating to our users the information that [Olympus Europe] is communicating to their European users?" (CNBC)

Olympus, which controls 85 percent of the American gastrointestinal scope market, had warned its European customers that a scope made by the company had a risk of contamination after two dozen infections were reported in hospitals in France and Holland, according to the joint Los Angeles Times and Kaiser Health News story that cited internal company emails.

The email reply from Olympus's chief manager for market quality administration in Tokyo, on a February 6, 2013, states "Although it is not need[ed] to communicate to all the users actively, you should communicate with the user who has asked a question" wrote the manager, Susumu Nishina. Further, Nishina's email went on to state that Olympus' "risk assessment" had indicated that that risk was "acceptable."

According to CNBC, the emails, and others cited in the article by the LA Times and Kaiser, are part of the court documents in a pending lawsuit against Olympus brought by a patient. Olympus is also under investigation by federal prosecutors in New Jersey.

The defective Olympus duodenoscopes were recalled by the company in February. Since Olympus learned of the issue, more than 140 patients in the United States have reportedly developed serious infections, mostly the deadly carbapenem-resistant Enterobacteriaceae. Prior to announcing the recall, Olympus had blamed improper hospital cleaning procedures for the outbreaks.

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READER COMMENTS

Posted by

on
Subject: Re: CJD * Olympus Endoscope

Date: Tue, 12 Oct 1999 15:57:03 –0500

From: "Terry S. Singeltary Sr."

To: GOLDSS@...

References: 1

Dear Mr. Goldstine, Hello again, I hope the CDC has not changed your mind, since our phone call, about sending me the information, in which we spoke of. I am still waiting for the information, re-fax. Someone had told me, you would not send me the information, but I told them you would, due to the importance of it pertaining to public safety, and the fact, you are a Doctor. I hope you don't disappoint me, and the rest of the public, and hide the facts, as the CDC and NIH have for years. Olympus can be part of the Truth, or you can be part of the cover-up. We are going to find out, sooner or later.

I already know, as do many more.


Still waiting,

Kind Regards,

Terry S. Singeltary Sr.


Wednesday, March 02, 2016

Endoscope Maker Olympus Agrees To $646 Million Settlement Over Kickbacks, while still ignoring the elephant in the room, CJD TSE PRIONS Health Inc.

*** Evidence For CJD TSE Transmission Via Endoscopes 1-24-3 re-Singeltary to Bramble et al ***

Evidence For CJD/TSE Transmission Via Endoscopes

From Terry S. Singletary

Thursday, April 28, 2016

Persistent residual contamination in endoscope channels; a fluorescence epimicroscopy study
this must be on the forefront of research i.e. ‘iatrogenic’ transmission.

Alzheimer’s disease, iatrogenic, and Transmissible Spongiform Encephalopathy TSE Prion disease, that is the question ???

>>> The only tenable public line will be that "more research is required’’ <<<

>>> possibility on a transmissible prion remains open<<<

O.K., so it’s about 23 years later, so somebody please tell me, when is "more research is required’’ enough time for evaluation ?

SWISS MEDICAL WEEKLY

Alzheimer-type brain pathology may be transmitted by grafts of dura mater 26/01/2016 Singeltary comment ;

re-Evidence for human transmission of amyloid-? pathology and cerebral amyloid angiopathy

Nature 525, 247?250 (10 September 2015) doi:10.1038/nature15369 Received 26 April 2015 Accepted 14 August 2015 Published online 09 September 2015 Updated online 11 September 2015 Erratum (October, 2015)

Self-Propagative Replication of Ab Oligomers Suggests Potential Transmissibility in Alzheimer Disease

*** Singeltary comment PLoS ***

Alzheimer’s disease and Transmissible Spongiform Encephalopathy prion disease, Iatrogenic, what if ?

Posted by flounder on 05 Nov 2014 at 21:27 GMT

Sunday, November 22, 2015

*** Effect of heating on the stability of amyloid A (AA) fibrils and the intra- and cross-species transmission of AA amyloidosis Abstract

Amyloid A (AA) amyloidosis is a protein misfolding disease characterized by extracellular deposition of AA fibrils. AA fibrils are found in several tissues from food animals with AA amyloidosis. For hygienic purposes, heating is widely used to inactivate microbes in food, but it is uncertain whether heating is sufficient to inactivate AA fibrils and prevent intra- or cross-species transmission. We examined the effect of heating (at 60 °C or 100 °C) and autoclaving (at 121 °C or 135 °C) on murine and bovine AA fibrils using Western blot analysis, transmission electron microscopy (TEM), and mouse model transmission experiments. TEM revealed that a mixture of AA fibrils and amorphous aggregates appeared after heating at 100 °C, whereas autoclaving at 135 °C produced large amorphous aggregates. AA fibrils retained antigen specificity in Western blot analysis when heated at 100 °C or autoclaved at 121 °C, but not when autoclaved at 135 °C. Transmissible pathogenicity of murine and bovine AA fibrils subjected to heating (at 60 °C or 100 °C) was significantly stimulated and resulted in amyloid deposition in mice. Autoclaving of murine AA fibrils at 121 °C or 135 °C significantly decreased amyloid deposition. Moreover, amyloid deposition in mice injected with murine AA fibrils was more severe than that in mice injected with bovine AA fibrils. Bovine AA fibrils autoclaved at 121 °C or 135 °C did not induce amyloid deposition in mice. These results suggest that AA fibrils are relatively heat stable and that similar to prions, autoclaving at 135 °C is required to destroy the pathogenicity of AA fibrils. These findings may contribute to the prevention of AA fibril transmission through food materials to different animals and especially to humans.

Purchase options Price * Issue Purchase USD 511.00 Article Purchase USD 54.00

*** Transmission of Creutzfeldt-Jakob disease to a chimpanzee by electrodes contaminated during neurosurgery ***

Gibbs CJ Jr, Asher DM, Kobrine A, Amyx HL, Sulima MP, Gajdusek DC. Laboratory of Central Nervous System Studies, National Institute of Neurological Disorders and Stroke, National Institutes of Health, Bethesda, MD 20892.

Stereotactic multicontact electrodes used to probe the cerebral cortex of a middle aged woman with progressive dementia were previously implicated in the accidental transmission of Creutzfeldt-Jakob disease (CJD) to two younger patients. The diagnoses of CJD have been confirmed for all three cases. More than two years after their last use in humans, after three cleanings and repeated sterilisation in ethanol and formaldehyde vapour, the electrodes were implanted in the cortex of a chimpanzee. Eighteen months later the animal became ill with CJD. This finding serves to re-emphasise the potential danger posed by reuse of instruments contaminated with the agents of spongiform encephalopathies, even after scrupulous attempts to clean them.

Diagnosis and Reporting of Creutzfeldt-Jakob Disease

Singeltary, Sr et al. JAMA.2001; 285: 733-734. Vol. 285 No. 6, February 14, 2001 JAMA

Diagnosis and Reporting of Creutzfeldt-Jakob Disease

To the Editor: In their Research Letter, Dr Gibbons and colleagues1 reported that the annual US death rate due to Creutzfeldt-Jakob disease (CJD) has been stable since 1985. These estimates, however, are based only on reported cases, and do not include misdiagnosed or preclinical cases. It seems to me that misdiagnosis alone would drastically change these figures. An unknown number of persons with a diagnosis of Alzheimer disease in fact may have CJD, although only a small number of these patients receive the postmortem examination necessary to make this diagnosis. Furthermore, only a few states have made CJD reportable. Human and animal transmissible spongiform encephalopathies should be reportable nationwide and internationally.

Terry S. Singeltary, Sr Bacliff, Tex

1. Gibbons RV, Holman RC, Belay ED, Schonberger LB. Creutzfeldt-Jakob disease in the United States: 1979-1998. JAMA. 2000;284:2322-2323.

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