Tuesday, May 11, 2010

Current risk of iatrogenic Creutzfeld–Jakob disease in the UK: efficacy of available cleaning chemistries and reusability of neurosurgical instruments

doi:10.1016/j.jhin.2010.01.024 How to Cite or Link Using DOI Copyright © 2010 The Hospital Infection Society Published by Elsevier Ltd. Permissions & Reprints

Current risk of iatrogenic Creutzfeld–Jakob disease in the UK: efficacy of available cleaning chemistries and reusability of neurosurgical instruments

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R. Hervé, a, , T.J. Seckera and C.W. Keevila

a Environmental Healthcare Unit, School of Biological Sciences, University of Southampton, Southampton, UK

Received 19 January 2010; accepted 27 January 2010. Available online 6 May 2010.

Summary The initial cleaning of reusable surgical devices is critical to ensure the efficacy of the subsequent sterilisation process. Transmissible spongiform encephalopathies (TSEs) are incurable and fatal neurodegenerative diseases apparently transmitted simply by the absorption or ingestion of self-aggregating protease-resistant prions (PrPSc), which are very resilient to most standard cleaning chemistries and heat-based decontamination techniques. Therefore there is a risk of iatrogenic transmission from reusable surgical devices if these are allowed to retain potentially infectious material after standard reprocessing through sterile service departments (SSDs). We aimed to assess the current state of surgical instrument decontamination with the collaboration of anonymous SSDs. Surgical stainless steel surfaces were spiked with prion-infected brain homogenates, and episcopic differential interference contrast/epifluorescence (EDIC/EF) microscopy was applied to quantify the amount of residual prion amyloid and other proteins remaining after decontamination with enzymatic cleaners currently employed by SSDs. Reusable instruments deemed ‘clean and ready to use’ were also stained for comparison with our findings in the laboratory. All cleaning chemistries were only partially effective under the recommended conditions. More importantly, PrPSc constituted the main fraction of the remaining contamination left on these surfaces. The neurosurgery instruments also harboured amyloid and general protein contamination. This study shows that currently marketed cleaning chemistries and recent decontamination protocols do not completely suppress the threat from iatrogenic CJD. These findings should be taken into account for risk assessment purposes and re-evaluating instrument handling and decontamination practices.

Keywords: Creutzfeld–Jakob disease; Risk assessment; Sterilisation; Surgical instruments

Article Outline Introduction Methods Preparation of contaminated surfaces Decontamination of surfaces and staining Microscopy and image analysis Statistical analysis Results Enzymatic cleaners State of neurosurgical instruments Discussion Acknowledgements Conflict of interest statement Funding sources References


http://www.sciencedirect.com/science?_ob=ArticleURL&_udi=B6WJP-50156MT-1&_user=4973225&_coverDate=05%2F06%2F2010&_rdoc=7&_fmt=high&_orig=browse&_srch=doc-info(%23toc%236884%239999%23999999999%2399999%23FLA%23display%23Articles)&_cdi=6884&_sort=d&_docanchor=&_ct=59&_acct=C000050221&_version=1&_urlVersion=0&_userid=4973225&md5=d59f86e6295890fc59b0907e3bd8bc30




New studies on the heat resistance of hamster-adapted scrapie agent: Threshold survival after ashing at 600°C suggests an inorganic template of replication

Exposure to 600°C completely ashed the brain samples, which, when reconstituted with saline to their original weights, transmitted disease to 5 of 35 inoculated hamsters. No transmissions occurred after exposure to 1,000°C. These results suggest that an inorganic molecular template with a decomposition point near 600°C is capable of nucleating the biological replication of the scrapie agent.

see full text:


http://www.pnas.org/cgi/content/full/97/7/3418



PLoS ONE. 2008; 3(8): e2969. Published online 2008 August 13. doi: 10.1371/journal.pone.0002969. PMCID: PMC2493038


Prion Infected Meat-and-Bone Meal Is Still Infectious after Biodiesel Production


http://www.pubmedcentral.nih.gov/articlerender.fcgi?artid=2493038



In addition to brain homogenates, we performed bioassays using irradiated faecal homogenates collected from infected mule deer by intracerebral inoculation into Tg(ElkPrP) mice. Irradiation was used to damage nucleic acids and inactivate bacteria and viruses with minimal effects on prion titres23; irradiation of the Elk1 CWD isolate did not diminish its titre when assayed in Tg(ElkPrP) mice (data not shown).


http://wfs.sdstate.edu/wfsdept/courses/WL%20425-525/Tamguney%20et%20al%20%202009%20Nature%20-%20CWD.pdf



Purified scrapie prions resist inactivation by UV irradiation. C Bellinger-Kawahara, J E Cleaver, T O Diener, and S B Prusiner



http://www.ncbi.nlm.nih.gov/pmc/articles/PMC255227/




ASP Sterrad Technology Approved by AFSSAPS for Total Inactivation of Prions French Health Products Safety Agency AFSSAPS Approves STERRAD® Hydrogen Peroxide Gas Plasma Technology for Total Inactivation of Protein-based Infectious Agents Linked to Fatal Brain Diseases

Paris, France (April 27, 2010) --

Advanced Sterilization Products (ASP) announced today that the French Health Products Safety Agency, AFSSAPS, will approve the low-temperature hydrogen peroxide gas plasma STERRAD® NX™ and the STERRAD® 100NX™ Sterilization Systems for total inactivation of prions.

Prions, which are protein-based infectious agents, cause neurodegenerative brain diseases characterized by the formation of "holes" in brain tissue. Prions are highly resistant to the commonly used procedures for inactivating them, and until recently, only the most severe sterilization processes had been proven effective.

"The effectiveness of low-temperature STERRAD® technology against the prion threat confirmed that is possible to eliminate these deadly pathogens while helping to preserve the integrity of medical devices, including heat sensitive surgical instruments," said Dr. Pascal Clayette, SPI-BIO, CEA, Fontenay-aux-Roses, France. "This is a great milestone for healthcare facilities who use an increasing number of sophisticated and costly surgical instruments and for patients who demand the most stringent infection prevention practices."

Following a number of in vivo and in vitro studies conducted on behalf of ASP by two independent laboratories in France and Germany, the STERRAD® NX™ Advanced Cycle and STERRAD® 100NX™ System Flex and Standard Cycles successfully provided prion inactivation and proved to be more effective on the prion threat than steam sterilization at 134degrees C for 18 minutes, which is the steam cycle recommended by the World Health Organization.

"The AFSSAPS approval of STERRAD® System sterilization technology for total inactivation of prions is another example of ASP's commitment to developing innovative infection prevention solutions that help raise the standards of care," said Chuck Austin, WW President of ASP. "STERRAD® Sterilization Systems are used by thousands of healthcare facilities across the globe and this new approval by the French Health Products Safety Agency is a significant benefit for customers and patients alike."

About STERRAD® Sterilization Systems Engineered using ASP's breakthrough low-temperature gas plasma technology, STERRAD® Sterilization Systems terminally sterilize surgical instruments and medical devices safely and effectively, without the limitations or risks associated with peracetic acid, steam, formaldehyde and ethylene oxide gas systems. With thousands of units in use at hospitals and healthcare facilities around the world, STERRAD® Sterilization Systems produce a measurable return on hospital's sterilization investment by reducing instrument repair costs, offering rapid cycles, reducing instrument inventories and enhancing safety.

About Prion Diseases Prion diseases, or proteinaceous infectious particle only agents, are able to induce abnormal folding of normal cellular prion proteins in the brain and can develop into neurodegenerative disorders including Gerstmann-Straussler-Scheinker Syndrome, fatal familial insomnia and Creutzfeldt-Jakob Disease (CJD) in humans. Such prion diseases can have long asymptomatic incubation periods but will result in fatality in all cases. Unlike infectious agents in other difficult-to-treat infectious diseases, prions exhibit an unusually high level of resistance to common sterilization methods and disinfection methods, including steam, and pose a threat to infection prevention in healthcare facilities.

About the Data ASP, through the use of several independent laboratories in France and Germany produced a set of comprehensive studies on prion inactivation. 61 tests (41 in vivo and over 20 in vitro controls) evaluating and comparing disinfection, washing and sterilization procedures were performed. In these studies, the STERRAD® NX™ Advanced Cycle and STERRAD® 100NX™ System Flex and Standard Cycles proved to be more effective in prion inactivation than a steam cycle at 134degreesC, 18 minutes- a special optimized steam cycle recommended by the World Health Organization against prions.

About Advanced Sterilization Products (ASP) Advanced Sterilization Products (ASP), a Division of Ethicon, Inc., a Johnson & Johnson company is a leading developer of innovative instrument sterilization, high level disinfection and cleaning technologies. The company is dedicated to protecting patients, healthcare workers, and the environment with products that focus as much on safety as they do on efficacy and cost-effectiveness. Utilizing advanced instrument processing technologies, these products help customers to promote positive patient outcomes while controlling costs, increasing productivity and enhancing safety. The company is based in Irvine, California with offices around the world.

SOURCE Advanced Sterilization Products


http://www.jnj.com/connect/news/product/ASP-sterrad-technology-approved-by-AFSSAPS-for-total-inactivation-of-prions




>>>Advanced Sterilization Products (ASP) announced today that the French Health Products Safety Agency, AFSSAPS, will approve the low-temperature hydrogen peroxide gas plasma STERRAD® NX™ and the STERRAD® 100NX™ Sterilization Systems for total inactivation of prions.<<<


>>>successfully provided prion inactivation and proved to be more effective on the prion threat than steam sterilization at 134degrees C for 18 minutes, which is the steam cycle recommended by the World Health Organization.<<<


hmmm, I would like to see this study of _total_ inactivation of prions. total inactivation of prions ? does total _inactivation_ of prions mean _NO_ prions ?


does _more effective_, mean total removal of all prions, i.e. prion free ?


does this total inactivation of prions mean the prion is still there, but not active ?


what does this mean ?


IF the prion is not _removed_, can the inactivated prion become active again ?


how many strains of the prion disease were these total _inactivation_ of the prion conducted on ?


was for instance the L-type atypical BSE tested for total _inactivation_ of the prion disease ?


the L-type atypical BSE is much more virulent than the typical c-BSE, so I would hope they tested this atypical BSE, and all the rest of the atypical strains, before going public with a statement of 'total inactivation of prions'.


what about the Nor-98 atypical scrapie, was total _inactivation_ of the prion documented here ?


what about nvCJD and the other 6 documented to date strains of sporadic CJD, all these human TSE showed 100% total inactivation of prions ?


what about second, third, fourth passage of these phenotypes, what about total inactivation of prions ?


NOW, if in fact total inactivation of prions does happen in all these human and animal TSE, both typical strains and atypical strains, why is not every hospital and dental facility around the globe not using this procedure yet ?


Tuesday, March 16, 2010


Transmissible Spongiform Encephalopathy Agents: Safe Working and the Prevention of Infection: Part 4 REVISED FEB. 2010


http://creutzfeldt-jakob-disease.blogspot.com/2010/03/transmissible-spongiform-encephalopathy.html




William A. Rutala, Ph.D., MPH, and David J. Weber, MD, MPH ET AL 2001 TO 2010 ON THE PRION AND INFECTION CONTROL a review...TSS


Creutzfeldt-Jakob Disease: Risks and Prevention of Nosocomial Acquisition 08/01/2001

Creutzfeldt-Jakob Disease: Risks and Prevention of Nosocomial Acquisition By: William A. Rutala, Ph.D., MPH, and David J. Weber, MD, MPH

Conclusion

Prion diseases are rare and hence do not constitute a major infection control risk. Nevertheless, prions represent an exception to conventional disinfection and sterilization practices. These guidelines for CJD disinfection and sterilization are based on consideration of epidemiological data, infectivity data, and cleaning and inactivation studies. Guidelines for management of CJD infected patients and patient equipment should be modified as scientific information becomes available. Importantly, studies assessing the susceptibility of vCJD to disinfectants and sterilants should be undertaken. In addition, studies consistent with actual clinical practices (e.g., operation in infected animals followed by cleaning with enzymatic detergents and disinfection or sterilization) should be undertaken.

William A. Rutala, PhD, MPH, is a professor in the Department of Medicine, School of Medicine, University of North Carolina at Chapel Hill. He serves as director of the departments of Hospital Epidemiology (Infection Control), Occupational Health, and Safety Program for the University of North Carolina Health Care System. In addition, Dr. Rutala is the director of the North Carolina Statewide Program in Infection Control and Epidemiology. Dr. Rutala has published approximately 300 papers in the field of infection control, disinfection and sterilization.

David J. Weber, MD, MPH, is a professor in the departments of Medicine and Pediatrics, School of Medicine and a professor in the Department of Epidemiology, School of Public Health, University of North Carolina at Chapel Hill. He serves as medical director of the Departments of Hospital Epidemiology (Infection Control), Occupational Health, and Safety Program for the University of North Carolina Health Care System. Dr. Weber has published more than 250 papers in the field of infection control.


http://www.infectioncontroltoday.com/articles/412/412_181bpract.html



http://www.webbertraining.com/files/library/docs/27.pdf




>>> Prion diseases are rare and hence do not constitute a major infection control risk. <<<


Lord Help Us............ TSS


Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008


William A. Rutala, Ph.D., M.P.H.1,2, David J. Weber, M.D., M.P.H.1,2, and the Healthcare Infection Control Practices Advisory Committee (HICPAC)3 1Hospital Epidemiology University of North Carolina Health Care System Chapel Hill, NC 27514 2Division of Infectious Diseases University of North Carolina School of Medicine Chapel Hill, NC 27599-7030 1


http://www.cdc.gov/hicpac/pdf/guidelines/Disinfection_Nov_2008.pdf


2010


17 Technologies in Sterilization and Disinfection


Friday, March 19, 2010: 7:00 AM-8:20 AM Montreal-Vancouver (Hyatt Regency Atlanta) CME

Credits: 1.25 Type: Oral Summary:

This session will review the recently published CDC/HICPAC Guideline on Disinfection and Sterilization. It will also discuss new methods for disinfection of surfaces and equipment, and sterilization of medical devices. Faculty will also discuss prion disinfection. Learning Objectives: Discuss the new CDC/HICPAC Guideline on Disinfection and Sterilization. Review new methods for disinfection and sterilization. 7:40 AM 45 William Rutala, PhD, MPH, University of North Carolina School of Medicine 7:00 AM 44 David Weber, MD, University of North Carolina at Chapel Hill



http://shea.confex.com/shea/2010/webprogram/Session1145.html

http://shea.confex.com/shea/2010/webprogram/

http://www.unc.edu/depts/spice/dis/currentissues2010.pdf

http://www.unc.edu/depts/spice/dis/novel.pdf

http://www.cdc.gov/hicpac/Disinfection_Sterilization/toc.html



SEE ;



FEBRUARY 2010 infection control and hospital epidemiology february 2010, vol. 31, no. 2 shea gu i d e l i n e Guideline for Disinfection and Sterilization of Prion-Contaminated Medical Instruments William A. Rutala, PhD, MPH; David J. Weber, MD, MPH



http://www.shea-online.org/Assets/files/other_papers/Prion.pdf


Saturday, January 16, 2010


Subject: Re: gutjnl_el;21 Terry S. Singeltary Sr. (3 Jun 2002) "CJDs (all human TSEs) and Endoscopy Equipment"

Date: Thu, 20 Jun 2002 16:19:51 -0700

From: "Terry S. Singeltary Sr."


To: Professor Michael Farthing CC: lcamp@BMJgroup.com

References: 001501c21099$5c8bc620$7c58d182@mfacdean1.cent.gla.ac.uk


regarding your article; >>


Creutzfeldt-Jakob disease: implications for gastroenterology

I belong to several support groups for victims and relatives

of CJDs. Several years ago, I did a survey regarding

endoscopy equipment and how many victims of CJDs have

had any type of this procedure done. To my surprise, many

victims had some kind of endoscopy work done on them.

As this may not be a smoking gun, I think it should

warrant a 'red flag' of sorts, especially since data now

suggests a substantial TSE infectivity in the gut wall

of species infected with TSEs. If such transmissions

occur, the ramifications of spreading TSEs from

endoscopy equipment to the general public would be

horrible, and could potential amplify the transmission

of TSEs through other surgical procedures in that

persons life, due to long incubation and sub-clinical

infection. Science to date, has well established

transmission of sporadic CJDs with medical/surgical

procedures.


see full text ;



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



http://creutzfeldt-jakob-disease.blogspot.com/2010/01/evidence-for-cjd-tse-transmission-via.html



Tuesday, March 16, 2010

Transmissible Spongiform Encephalopathy Agents: Safe Working and the Prevention of Infection: Part 4 REVISED FEB. 2010



http://creutzfeldt-jakob-disease.blogspot.com/2010/03/transmissible-spongiform-encephalopathy.html







Terry S. Singeltary Sr.
P.O. Box 42
Bacliff, Texas USA 77518

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