Nosocomial transmission of sporadic Creutzfeldt–Jakob disease: results from a risk-based assessment of surgical interventions

Public release date: 8-Jul-2010

Contact: SINC info@plataformasinc.es 34-914-251-820 FECYT - Spanish Foundation for Science and Technology

Surgery linked to Creutzfeldt-Jakob disease

IMAGE: Surgery is linked to Creutzfeldt-Jakob disease.

"Based on the monitoring records of spongiform encephalopathy in two Nordic countries, we studied the possibility of transmission of the sporadic form of CJD through general surgery", explains Jesús de Pedro, main author of the study and head of prion monitoring in patients at the National Epidemiology Centre of the Carlos III Health Institute.

The finding, published recently in the Journal of Neurology, Neurosurgery & Psychiatry, reveals that, with a few exceptions, the risk of having contracted the sporadic form of CJD manifests itself at least 20 years after having undergone an operation.

"While we are not ruling out the idea that intraoperational transfusions may play a secondary part, the data suggest that the disease enters and spreads much more quickly within the central or peripheral nervous system", confirms De Pedro.

According to the authors, the fact that computer records of surgeries have been in place since the early seventies in hospitals in Sweden and Denmark enables operations on residents of those countries to be linked to cases of CJD, which "extends an extraordinary quality to the information and more credibility to the findings given the almost total absence of memory bias".

Why is the idea of transmission through surgery important?

The most interesting thing about this finding, which points to an external cause that could be prevented, is that "it may signify a shift in our understanding of the nature of neurodegenerative diseases, such as Alzheimer's or Parkinson's".

We might, therefore, ask ourselves if other types of motor neurone diseases can be transmitted through surgery and be latent for decades, such as those where risk factors, particularly physical professions and activities or certain sporting activities, for example, which are more likely to lead to surgery, have already been indicated.

"Suggesting that a disease could have been acquired during health care is a very delicate affirmation, as some relatives of patients with sporadic CJD may be tempted to seek compensation from health authorities for the alleged intraoperational transmission years previously, which would be impossible to prove in individual cases", he reasons.

Nonetheless, the most conclusive pattern that the study presents, albeit based on few cases and one that must be replicated in future studies, is that the onset of CJD occurs approximately 10 years after an operation on the retina with reused equipment.

###

References: Jesús de Pedro-Cuesta, Ignacio Mahillo-Fernández, Alberto Rábano, Miguel Calero, Mabel Cruz, Ake Siden, Henning Laursen, Gerhard Falkenhorst, Kare Mølbak y el Grupo de Investigación EUROSURGYCJD. "Nosocomial transmission of sporadic Creutzfeldt-Jakob disease: results from a risk-based assessment of surgical interventions". J Neurol Neurosurg Psychiatry (2010). doi:10.1136/jnnp.2009.188425.

http://www.eurekalert.org/pub_releases/2010-07/f-sf-slt070810.php


http://www.sciencedaily.com/releases/2010/07/100708071513.htm


J Neurol Neurosurg Psychiatry doi:10.1136/jnnp.2009.188425

Research paper

Nosocomial transmission of sporadic Creutzfeldt–Jakob disease: results from a risk-based assessment of surgical interventions

Jesús de Pedro-Cuesta1,2, Ignacio Mahillo-Fernández1,2, Alberto Rábano3, Miguel Calero2,4, Mabel Cruz5, Åke Siden5, Henning Laursen6, Gerhard Falkenhorst7, Kåre Mølbak7, EUROSURGYCJD Research Group + Author Affiliations

1Department of Applied Epidemiology, National Center for Epidemiology, Carlos III Institute of Health, Madrid, Spain 2Consortium for Biomedical Research in Neurodegenerative Diseases (Centro de Investigación Biomédica en Red sobre Enfermedades Neurodegenerativas—CIBERNED),Madrid, Spain 3Pathology Unit, Fundación Alcorcón University Teaching Hospital, Alcorcon, Spain 4Department of Spongiform Encephalopathies, National Microbiology Center, Carlos III Institute of Health, Ctra. Majadahonda-Pozuelo, Majadahonda, Spain 5Department of Clinical Neurosciences, Neurology Division, Karolinska Institutet, Stockholm, Sweden 6Neuropathology Laboratory, Copenhagen, Denmark 7Department of Epidemiology, Statens Serum Institut, Copenhagen, Denmark Correspondence to Dr Jesús de Pedro Cuesta, Centro Nacional de Epidemiología, Instituto de Salud Carlos III, Calle Monforte de Lemos 5, Madrid 28029, Spain; jpedro@isciii.es Contributors JdP-C has full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis. Preliminary results were presented at the EUROCJD/NEUROCJD Public Health EU Meeting, held in Paris on 5 December 2006.

Received 9 July 2009 Revised 3 March 2010 Accepted 12 April 2010 Published Online First 14 June 2010 Abstract Objectives Evidence of surgical transmission of sporadic Creutzfeldt–Jakob disease (sCJD) remains debatable in part due to misclassification of exposure levels. In a registry-based case–control study, the authors applied a risk-based classification of surgical interventions to determine the association between a history of surgery and sCJD.

Design Case–control study, allowing for detailed analysis according to time since exposure.

Setting National populations of Denmark and Sweden.

Participants From national registries of Denmark and Sweden, the authors included 167 definite and probable sCJD cases with onset during the period 1987–2003, 835 age-, sex- and residence-matched controls and 2224 unmatched. Surgical procedures were categorised by anatomical structure and presumed risk of transmission level. The authors used logistic regression to determine the odds ratio (OR) for sCJD by surgical interventions in specified time-windows before disease-onset.

Results From comparisons with matched controls, procedures involving retina and optic nerve were associated with an increased risk at a latency of =1 year OR (95% CI) 5.53 (1.08 to 28.0). At latencies of 10 to 19 years, interventions on peripheral nerves 4.41 (1.17 to 16.6) and skeletal muscle 1.58 (1.01 to 2.48) were directly associated. Interventions on blood vessels 4.54 (1.01 to 20.0), peritoneum 2.38 (1.14 to 4.96) and skeletal muscle 2.04 (1.06 to 3.92), interventions conducted by vaginal approach 2.26 (1.14 to 4.47) and a pooled category of lower-risk procedures 2.81 (1.62 to 4.88) had an increased risk after =20 years. Similar results were found when comparing with unmatched controls.

Interpretation This observation is in concordance with animal models of prion neuroinvasion and is likely to represent a causal relation of surgery with a non-negligible proportion of sCJD cases.

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DISCUSSION

The key features of the present study design enabled us to address novel aspects of the potential of surgical transmission of CJD.9 The additional introduction of an aetiological classification, that is unmasking associations hidden by the body-system approach,17 24 revealed a number of statistically significant associations, associations of higher magnitude and new effects with a particular pattern at 10e19 years’ latency. Limitations, which in part are discussed elsewhere,9 comprise: the low statistical power for some latencies and exposure categories; missing information on interventions undergone prior to registration or as outpatients; and lack of control of potential confounders such as blood transfusion, overlooked dura mater implants or hospital hygiene level.

The new SP classification system was built in a tissue/structure classification reported in 200522 combining features of the first WHO Classification on Tissue infectivity25 and of experimental efficiency of prion disease transmission to animals when using different routes of inocula administration.26e29 The plausibility of the risk excess of surgery of retina and peripheral nerves seen here might be supported by studies in experimental scrapie (Sc). PrPSc injected into the eye travelling via defined neuroanatomical connections has been demonstrated to be able to reach larger brain regions.30 31 In hamsters, PrPSc spreads along the vagus nerve to the medulla, pons, midbrain, cerebellum and thalamus via neuroanatomical pathways.32 The increasing risk found for SP involving veins, peritoneal cavity and lymph nodes at longer latencies fits proposals on prion neuroinvasion and transport, suggesting that prions first replicate and accumulate in the lymphoreticular system (LRS) (see Aguzzi and Calella33 for a recent review). In addition, it would appear that risk excess and latency are inversely correlated: for surgery of retina, OR 5.53, at mean 11 years; for surgery of peripheral nerves, OR 4.41, at 10e19 years; and for lower-risk SP OR 2.4, at $20 years. In summary, our findings might be consistent with proposed biological mechanisms potentially underlying the rapid access to the CNS by direct contact,34 prion uptake through the skin, neuroinvasion from the spleen and spread of prions along peripheral and CNS pathways.33 35

Compared with other studies, the main contribution of the new methodology may be credibility to consistently positive results from large recent studies covering lifetime surgery and pointing to likewise underlying diluting effects.7 8 In a study with negative results, retina surgery was unfortunately not investigated separately from other ophthalmological surgery.12 Findings for lower-risk procedures at >20 years would correspond to a similar risk excess before reclassification for main surgical procedures.9 However, the association with coronary surgery seen in TW-3 when using unmatched controls as well as the body system approach does not have a corresponding finding here. Since the association of coronary surgery with sCJD has been reported for Alzheimer’s disease at a similar latency, confounding from vascular risk factors generating both dementia and coronary disease followed by coronary surgery may be proposed as a potential explanation unrelated to prion transmission consistent with absence of findings after reclassification.36

Unrecorded information potentially determining our results might be the length of the pathway to the brain, short in the case of retina and acoustic nerve. An overlooked autologous dura mater graft, implanted during the above-mentioned acoustic neurinoma intervention, was excluded by direct perusal of the surgeon’s report, issued in 1977, by an author, HL, who excluded an accidentally transmitted CJD by dura mater implant. Improved cleaning of instruments in recent times may in part explain decreased excess risk with shorter latencies. Blood transfusion has not been identified as a risk factor for sCJD; however, Riggs et al warn about the weaknesses of caseecontrol studies frequently reporting protective effects.37 Inability to adjust for blood transfusion is a limitation of the study, since it has been estimated that blood transfusion is present in 50% of all major surgical interventions38; blood thus comprises a potential confounder.39 Since it would appear that the excess risk seen here for some tissues, for instance for retina surgery, is difficult to attribute to simultaneous blood transfusion, some of the present results might be consistent with confounded effects of surgical instruments and blood. This view contradicts observations on variant CJD, where transmission by blood has been demonstrated,40e43 but not risk excess for surgery.44 However, differences between sCJD and vCJD or Kuru are so large that inferences should perhaps be inappropriate. Furthermore, the exposures studied might not be independent phenomena representing either a potential entry site for prions or the above-mentioned uncontrolled confounding. For example, cohorting of surgical instruments occurs, and an instrument used once for retina surgery, for example, has in all likelihood been repeatedly used for retina surgery. It is therefore possible that our findings could in part be explained by infectivity determined by tissue remnants adhered to instruments (not controlled for here) rather than by the putative entry site (ie, tissue contacted). Consequently, the 18%9 to 35%7 proportion of sCJD which has been suggested might be causally related to surgery, while in theory consistent with observations from animal models, would be difficult to ascribe to a single biological mechanism based on these data.

The results might be surprising, since identified iatrogenic events related to surgery appear to be very rare. Surveillance since 1993 by 11 countries at the EUROCJD consortium includes data on more than 6000 sCJD cases (http://www. eurocjd.ed.ac.uk/genetic.htm). The number of iatrogenic cases related to surgery are 53 assigned to dura mater, two to corneal implants and nil to neurosurgery. However, routine surveillance data will usually not recognise surgical risk exposures for iatrogenic CJD other than grafts. Reasons to explain this might be: (1) the overwhelming difference in annual cohort size, that is 100 000 surgical in-patients per million in Sweden 2004 (http://192.137.163.40/epcfs/index.asp?modul¼ope), versus approximately 200 dura mater grafts per million in the 1990s in Japan45; (2) the comparatively large attrition by low survival of neurosurgical and dura mater grafted cohorts45e47; (3) surveillance encompasses the end of the iCJD epidemic48; (4) large differences in duration of incubation periods, mean 11 years for iCJD by dura mater reduce differences in cumulative risk48; (5) similar genetic susceptibility might be a strong determinant of surgical risk linked or not to grafts, and is shared by iCJD and sCJD as shown by homozygosity at codon 12948 49 but can be interpreted in different ways. CJD surveillance captures epidemiologically compelling evidences required for correct CJD diagnosis; the OR for exposure to cadaveric dura mater for CDJ in Japan50 was 32.5 95% CI (2.6 to infinity). Our three cases with history of retina surgery were first discharged with CJD diagnosis from three different hospitals, at different years, in two countries, and most probably diagnosed by different clinicians. Views for iCJD from surveillance and results of this study are perhaps not so difficult to reconcile when biology, diagnosis, epidemiology and public-health practice51 are simultaneously considered.

The potential applicability of results in prevention is complex. Cautiousness might be recommended for planning of surgical interventions for patients where CJD diagnosis has been considered, and for decontamination and quarantining of such surgical instruments, avoiding reuse during the interval CJD diagnosis has not been excluded. Established instrument-quarantining, -tracking, -cleaning and prion-disinfection policies, which generally target infrequent procedures, such as neurosurgery and ophthalmological, spine and ear surgery,38 52 are based on decontamination of remnants and applied to surgical activity defined by the type of surgeon, that is, by body-system group. Current sterilisation procedures undertaken in hospitals for delicate instrumentation are insufficient to ensure total removal of infectious prion protein, and carriers of infective prions are difficult to detect.52 53 Extension of such measures, after appropriate assessment, to instruments contacting or potentially contacting veins, female genital organs, peritoneal cavity, peripheral nerves and muscle could be a priority. In addition, new decontamination procedures54 may have a widerthan- expected field of application.

To sum up, these results suggest that surgery constitutes a risk factor for sCJD, acting with long incubation periods, and less frequently with shorter latencies when the central- or peripheral nervous system as well as skeletal muscle are implicated. In addition, results are in concordance with animal models of experimental prion transmission through various routes of inoculation that may mimic accidentally transmitted CJD, and might have implications for prevention of CJD spread in medical settings.

see full text with charts etc here, and thank you for free full text access. ...TSS


http://jnnp.bmj.com/content/early/2010/06/12/jnnp.2009.188425.abstract?sid=2b27497a-91ea-49db-93c9-860427bef10d


http://jnnp.bmj.com/content/early/2010/06/12/jnnp.2009.188425.full.pdf


FRIENDLY FIRE AND OR PASS IT FORWARD MODE OF TRANSMISSION


NY State Legislation Presentation New York State Association of Central Service Professionals

October 24, 2007

Meeting Objectives Introduce NYSACSP organization Describe the role of central service as it impacts patient safety and sterilization practices Discuss proposed changes in legislation Present rationale for changes in legislation New York State Central Service Professionals Delegation Mary Olivera, BA, MS, CRCST, President Marcia Hardick, RN,BS,CGRN, Education Director Anthony Monaco, Strategic Advisor Evelyn Baez, CRCST - President, LIACS Chapter, Representative to NYSACSP BOD Who are we? Central Service workers in healthcare ?? Managers, supervisors, technicians ?? Hospital, ambulatory care, private sector Supporting ?? Operating room - surgical staff; surgeons, nurses ?? Patient care units ?? Ambulatory care What We Do Responsibilities ?? Promote patient safety • Prevent cross contamination • Decrease incidence of nosocomial infections ?? Reprocess medical/surgical instrumentation and devices • Safe handling and decontamination • Inspection, preparation, package • Sterilization • Quality monitoring, documentation Our Challenges We are a “dumping ground” No standardization of performance Increasing technology Complex instrumentation Risk of exposure to pathogens Reduce nosocomial infections

snip...

Terry Singletary, whose mother died from a type of CJD called Heidenhain Variant, told UPI health officials were not doing enough to prevent people from being infected by contaminated medical equipment. "They've got to start taking this disease seriously and they simply aren't doing it," said Singletary, who is a member of CJD Watch and CJD Voice -- advocacy groups for CJD patients and their families.

snip...

Singletary said CDC's assertion that no CJD cases from infected equipment or tissues have been detected since 1976 is misleading. "They have absolutely no idea" whether any cases have occurred in this manner, he said, because CJD cases often aren't investigated and the agency has not required physicians nationwide report all cases of CJD. "There's no national surveillance unit for CJD in the United States; people are dying who aren't autopsied, the CDC has no way of knowing" whether people have been infected via infected equipment or tissues, he said.

snip...


see full text 217 pages ;


http://www.iahcsmm.org/images/certification-map/NY/State_Presentation_Guide_2008.pdf


Sunday, January 17, 2010

CJD Following up: Patients never contracted brain disorder UW Hospital patients

http://creutzfeldt-jakob-disease.blogspot.com/2010/01/cjd-following-up-patients-never.html


Sunday, January 17, 2010

Human tissue, recovered from a donor history indicated increased risk factors for Creutzfeldt-Jacob disease Lions Eye Bank

http://creutzfeldt-jakob-disease.blogspot.com/2010/01/human-tissue-recovered-from-donor.html


Saturday, January 16, 2010 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


Friday, November 20, 2009

SaBTO Advisory Committee on the Safety of Blood, Tissues and Organs Summary of the Eighth Meeting, 27 October 2009

http://vcjdtransfusion.blogspot.com/2009/11/sabto-advisory-committee-on-safety-of.html


Sunday, May 10, 2009

Meeting of the Transmissible Spongiform Encephalopathies Committee On June 12, 2009 (Singeltary submission)


http://tseac.blogspot.com/2009/05/meeting-of-transmissible-spongiform.html


2006

http://www.fda.gov/ohrms/dockets/ac/06/transcripts/2006-4271t1.pdf


2004

http://www.fda.gov/ohrms/dockets/ac/04/transcripts/2004-4075T1.DOC


2003


Asante/Collinge et al, that BSE transmission to the 129-methionine

genotype can lead to an alternate phenotype that is indistinguishable

from type 2 PrPSc, the commonest _sporadic_ CJD;


http://www.fda.gov/ohrms/dockets/ac/03/slides/3923s1_OPH.htm


2001

http://www.fda.gov/ohrms/dockets/ac/01/slides/3681s2_09.pdf


Docket Management

Docket: 02N-0370 - Neurological Devices; Classification of Human Dura Mater

Comment Number: EC -1

Accepted - Volume 1


http://www.fda.gov/ohrms/dockets/dailys/03/Jan03/012403/8004be11.html


http://www.fda.gov/ohrms/dockets/dailys/03/Jan03/012403/8004bdfe.html


http://www.fda.gov/ohrms/dockets/dailys/03/Jan03/012403/8004bdfc.html


Daily Dockets - 04/10/03

00D-1662 Use of Xenotransplantation Products in Humans. EMC 98 Terry S. Singeltary Sr. Vol#: 3. 01F ...

www.fda.gov/ohrms/dockets/dailys/03/Apr03/041003/041003.htm - 05-20-2003 - Cached

# Docket No: 02-088-1 RE-Agricultural Bioterrorism Protection Act of 2002; [TSS SUBMISSION ON POTENTIAL FOR BSE/TSE & FMD 'SUITCASE BOMBS'] - TSS 1/27/03 (0)

Docket Management

Docket: 02N-0276 - Bioterrorism Preparedness; Registration of Food Facilities, Section 305 Comment Number: EC-254 [TSS SUBMISSION]

http://www.fda.gov/ohrms/dockets/dockets/02n0276/02N-0276-EC-254.htm


Monday, August 17, 2009

Transmissible Spongiform Encephalopathy Agents: Safe Working and the Prevention of Infection: Annex J,K, AND D Published: 2009

http://creutzfeldt-jakob-disease.blogspot.com/2009/08/transmissible-spongiform-encephalopathy.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


Friday, July 17, 2009

Revision to pre-surgical assessment of risk for vCJD in neurosurgery and eye surgery units Volume 3 No 28; 17 July 2009

http://creutzfeldt-jakob-disease.blogspot.com/2009/07/revision-to-pre-surgical-assessment-of.html


Tuesday, August 12, 2008

Biosafety in Microbiological and Biomedical Laboratories Fifth Edition 2007 (occupational exposure to prion diseases)

http://creutzfeldt-jakob-disease.blogspot.com/2008/08/biosafety-in-microbiological-and.html


Tuesday, May 11, 2010

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

http://creutzfeldt-jakob-disease.blogspot.com/2010/05/current-risk-of-iatrogenic.html


Saturday, January 16, 2010 Evidence For CJD TSE Transmission Via Endoscopes 1-24-3 re-Singeltary to Bramble et al Evidence For CJD/TSE Transmission Via Endoscopes

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


Wednesday, February 24, 2010

Transmissible Spongiform encephalopathy (TSE) animal and human TSE in North America 14th

ICID International Scientific Exchange Brochure -

http://transmissiblespongiformencephalopathy.blogspot.com/2010/02/transmissible-spongiform-encephalopathy.html


Tuesday, June 1, 2010

USA cases of dpCJD rising with 24 cases so far in 2010

http://cjdtexas.blogspot.com/2010/06/usa-cases-of-dpcjd-rising-with-24-cases.html


Wednesday, June 16, 2010

Defining sporadic Creutzfeldt-Jakob disease strains and their transmission properties

http://creutzfeldt-jakob-disease.blogspot.com/2010/06/defining-sporadic-creutzfeldt-jakob.html



Friday, November 30, 2007

CJD QUESTIONNAIRE USA CWRU AND CJD FOUNDATION


http://cjdquestionnaire.blogspot.com/





tarball, aka flounder, alias TSS, and for those that remember, madcowdeadmommadson


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

Transmissible Spongiform Encephalopathy Agents: Safe Working and the Prevention of Infection: Annex J,K, AND D Published: 2009

Annex J - Assessment to be carried out before surgery and/or endoscopy to identify patients with, or at risk of, CJD or vCJD Revised and updated 16 July 2009

Summary of advice (revised July 2009)

Annex J provides a clear and pragmatic way of assessing CJD and vCJD risk prior to surgery or endoscopy. Growing numbers of patients have been informed that they are at increased risk of CJD or vCJD. Therefore it is recommended that all patients about to undergo any surgery or endoscopy should be asked if they have ever been notified as at increased risk of CJD or vCJD. This recommendation is outlined in paragraphs J1 and J2.

In addition, patients undergoing surgery or neuro-endoscopy which may involve contact with tissues of potentially high level TSE infectivity (“high risk tissues”) should, through a set of detailed questions, be assessed for their possible CJD/vCJD risk exposure. These questions are outlined in Table J1 and paragraphs J3 to J6.

Annex J has been revised (July 2009) to include a new question to be asked of all patients about to undergo surgery or neuro-endoscopy on high risk tissues. This new question (question 4 in Table J1) has been added to identify those patients who have received blood or blood components from 80 or more blood donors. These patients are now designated as at increased risk of vCJD by the CJD Incidents Panel. Table J1 and paragraph J6 provide guidance on how to identify those patients who have received multiple blood transfusions. An algorithm, included as Appendix A, guides health professionals through the process.

snip...

Additional recommendations for surgery and neuro-endoscopy which may involve contact with high risk tissue only N.B. These additional recommendations are only applicable to those assessing patients in neurosurgical and ophthalmic surgical departments for neurosurgical and posterior ophthalmic surgical procedures. With regards to endoscopy, these additional recommendations are only applicable to those assessing patients for intradural neuro-endoscopic procedures. Procedures should not be delayed whilst information is being collected, and clinicians should be careful not to prejudice overall patient care. J3. As well as asking all patients whether they have been notified as being at increased risk of CJD/vCJD, clinicians assessing patients for procedures that involve contact with high risk tissues should ask supplementary questions (as outlined in Table J1) to assess further their CJD/vCJD risk. If a patient has answered ‘yes’ to the question in paragraph J1 there is no additional need to ask the questions in Table J1 – the patient’s risk status has been established. J4. Tissues assumed or proven to have high level infectivity for CJD or vCJD are:

• Brain

• Spinal cord

• Dura mater

• Cranial nerves, specifically:

• the entire optic nerve

• only the intracranial components of the other cranial nerves

• Cranial nerve ganglia

• Posterior eye, specifically:

• posterior hyaloid face

• retina

• retinal pigment epithelium

• choroid

• subretinal fluid

• optic nerve

• Pituitary gland

Annex A1 gives further advice on CJD/vCJD tissue infectivity

J5. Table J1 outlines recommended questions to assess CJD/vCJD risk. It is recommended that patients are asked these questions prior to elective or emergency surgical or neuro-endoscopic procedures likely to involve contact with tissues of potentially high infectivity. Paragraph J6 and the algorithm in Appendix A outlines the steps to take based on the patient’s responses. Appendix B is an information sheet for pre-surgical patients undergoing surgery or neuro-endoscopy on high risk tissues about the questions they will be asked.

Transmissible Spongiform Encephalopathy Agents: Safe Working and the Prevention of Infection: Annex K 1 Published: March 2009

Annex K

Guidelines for pathologists and pathology laboratories for the handling of tissues from patients with, or at risk of, CJD or vCJD

K9. Table K1 outlines those tissues either assumed or proven to have medium or high level infectivity for CJD other than vCJD. This table is based on Table A1 in Annex A1 of this guidance, which is updated regularly in accordance with international guidelines. Tissues assumed or proven to have either low level, or no, infectivity have not been included in this table, e.g. liver, kidney, muscle. Table K1 – tissues either assumed or proven to have medium or high level infectivity for CJD other than vCJD

snip...

Table J1 – CJD risk questions for patients about to undergo elective or emergency surgical or neuro-endoscopic procedures likely to involve contact with tissues of potentially high level infectivity Question to Patient Notes to clinician

1 Have you a history of CJD or other prion disease in your family? If yes, please specify. Patients should be considered to be at risk from genetic forms of CJD if they have or have had: i) Genetic testing, which has indicated that they are at significant risk of developing CJD or other prion disease; ii) A blood relative known to have a genetic mutation indicative of genetic CJD or other prion disease; iii) 2 or more blood relatives affected by CJD or other prion disease

2 Have you ever received growth hormone or gonadotrophin treatment? If yes, please specify: i) whether the hormone was derived from human pituitary glands ii) the year of treatment iii) whether the treatment was received in the UK or in another country Recipients of hormone derived from human pituitary glands, e.g. growth hormone or gonadotrophin, have been identified as at increased risk of sporadic CJD. In the UK, the use of human-derived growth hormone was discontinued in 1985 but human-derived products may have continued to be used in other countries. In the UK, the use of human-derived gonadotrophin was discontinued in 1973 but may have continued in other countries after this time.

3 Have you ever had surgery on your brain or spinal cord?

(a) Patients who underwent intradural neurosurgical or spinal procedures before August 1992 may have received a graft of human-derived dura mater and should be treated as at increased risk, unless evidence can be provided that human-derived dura mater was not used. Patients who received a graft of human-derived dura mater before 1980 are at increased risk of sporadic CJD. Patients who received a graft of human-derived dura mater between 1980 and August 1992 are at increased risk of both sporadic CJD and vCJD. This difference in risk has implications for patient management, in particular gastrointestinal endoscopy. See Annex F for more information.

(b) NICE guidance emphasises the need for a separate pool of new neuroendoscopes and reusable surgical instruments for high risk procedures on children born since 1st January 1997 and who have not previously undergone high risk procedures. These instruments and neuroendoscopes should not be used for patients born before 1st January 1997 or those who underwent high risk procedures using reusable instruments before the implementation of this guidance.

4 Published: 31 July 2006 Revised and updated: 16 July 2009

4 Since 1980, have you had any transfusions of blood or blood components (red cells, plasma, cryoprecipitate or platelets*)? If yes, have you either:

i) received more than 50 units of blood or blood components? or

ii) received blood or blood components on more than 20 occasions?

Where possible, please provide the names of all the hospitals where you received blood or blood components.

Patients who have received blood from more than 80 donors have been identified as at increased risk of vCJD. Information on this is available from the HPA:

http://www.hpa.org.uk/vCJDpresurgicalassessment


* This does not include:

• Autologous transfusion

• Plasma products such as IVIG, albumin, coagulation factors and anti-D J6. The actions to be taken following the patient’s response to the above questions are: Patient’s response

Action

No to all questions

Surgery or neuro-endoscopy can proceed using normal infection control procedures.

Yes to any of questions 1, 2 or 3

Further investigation into the nature of the patient’s CJD risk should be undertaken, and the patient’s CJD risk assessed. This assessment of CJD risk should be recorded in the patient’s medical notes for future reference. If the patient is found to be at increased risk of CJD or vCJD following investigation, or the risk status is unknown at the time of the procedure, special infection control precautions should be taken for the patient’s procedure including quarantining of instruments, and the local infection control team should be consulted for advice. Part 4 of this guidance provides advice for the precautions to be taken during the treatment of patients with or at increased risk of CJD or vCJD, and Annex F provides information on neuro-endoscopic procedures.

If the patient is found to be at increased risk of CJD or vCJD they should also be referred to their GP, who will need to inform them of their increased risk of CJD or vCJD and provide them with further information and advice. This is available from the CJD Incidents Panel:

http://www.hpa.org.uk/CJDIncidentsPanel


Patients who are at increased risk of genetic forms of CJD should be offered the opportunity of referral to the National Prion Clinic, based at the National Hospital for Neurology and Neurosurgery, Queen Square, London:

http://www.nationalprionclinic.org/


Patients who are at increased risk of sporadic CJD due to receipt of human-derived growth hormone or gonadotrophin should be offered the opportunity of referral to the UCL Institute of Child Health, London. Contact: L.Davidson@ich.ucl.ac.uk, 020 7404 0536

5 Published: 31 July 2006 Revised and updated: 16 July 2009

Yes to question 4

The algorithm in Appendix A of this document outlines the steps to be taken following a patient’s response to question 4. The algorithm in Appendix C gives the recommended roles and responsibilities of healthcare staff during this process. A highly transfused vCJD risk assessment form (Appendix D) should be completed if:

• the patient has received more than 50 units of blood or blood components or

• the patient has received blood or blood components on more than 20 occasions

The patient should be asked to provide the names of all the hospitals where they received blood or blood components, where possible, to assist the risk assessment. Appendix E contains a letter to send to blood laboratories in other hospitals if additional information from them is required. Word versions of Appendix D and Appendix E are available from the HPA at:

http://www.hpa.org.uk/vCJDpresurgicalassessment


The highly transfused risk assessment form will allow further investigation of the patient’s transfusion history, and assessment of their potential for exposure to blood or blood components from 80 or more donors (their ‘donor exposure’). If the patient has received fewer than 80 donor exposures, the patient is not considered to be at increased risk of vCJD. Surgery or neuro-endoscopy can proceed using normal infection control procedures. If the patient has received 80 or more donor exposures, the patient is confirmed as at increased risk of vCJD. Special infection control precautions should be taken for the patient’s procedure including quarantining of instruments, and the local infection control team should be consulted for advice. Part 4 of this guidance provides advice for the precautions to be taken during the treatment of patients with or at increased risk of CJD or vCJD, and Annex F provides information on neuro-endoscopic procedures.

If it is unclear from the patient’s transfusion history whether they have received 80 or more donor exposures, the instruments used in the patient’s surgery should be quarantined and further information on the patient’s donor exposures should be sought.

If the patient’s donor exposure remains uncertain, a local risk assessment should be conducted to determine how likely the patient is to have received blood from 80 or more donors. A local decision should be taken on whether the patient is at increased risk of vCJD and on how to manage the quarantined instruments.

• If the local risk assessment concludes that the patient received 80 or more donor exposures then the patient is at increased risk of vCJD and the instruments should be destroyed. Alternatively, instruments destined for disposal may instead be retained for research – refer to Annex E for details

• If the local risk assessment concludes that the patient received fewer than 80 donor exposures then the patient is not considered to be at increased risk of vCJD and the instruments can be returned to routine use after undergoing normal decontamination processes

[continues overleaf] 6 Published: 31 July 2006 Revised and updated: 16 July 2009

to answer any questions, a family member, or someone close to the patient (in the case of a child, a person with parental responsibility), should be asked the CJD risk questions as set out in Table J1 prior to the surgery or neuro-endoscopy. J8. If the family member, or someone close to the patient, is not able to provide a definitive answer to the CJD risk questions, the surgery or neuro-endoscopy should proceed but all instruments should be quarantined following the procedure (see Annex E of this guidance for details on quarantining). The patient’s GP should be contacted after the surgery or neuro-endoscopy, and enquiries made as to whether the patient is at increased risk of CJD/vCJD according to the questions as set out in Table J1.

J9. The actions to be taken following the GP’s response to the questions in Table J1 are:

GP’s response

Action

No to all questions

The instruments can be returned to routine use after undergoing normal decontamination processes.

Yes to any of questions 1, 2 or 3

Further investigation into the nature of the patient’s CJD risk should be undertaken, and the patient’s CJD risk confirmed or rejected. Confirmation or rejection of CJD risk should be recorded in the patient’s medical notes for future reference. If the patient is found to be at increased risk of CJD or vCJD following investigation then the quarantined instruments should be destroyed. Alternatively, instruments destined for disposal may instead be retained for research – refer to Annex E for details.

The patient’s GP should inform the patient that they are at increased risk of CJD or vCJD and provide them with further information and advice. This is available from:

http://www.hpa.org.uk/CJDIncidentsPanel


Patients who are at increased risk of genetic forms of CJD may benefit from discussions with the National Prion Clinic, based at the National Hospital for Neurology and Neurosurgery, Queen Square, London:

http://www.nationalprionclinic.org/


[continues overleaf]

7 Published: 31 July 2006 Revised and updated: 16 July 2009

Transmissible Spongiform Encephalopathy Agents: Safe Working and the Prevention of Infection: Annex J

Patients who are at increased risk of sporadic CJD due to receipt of human derived growth hormone or gonadotrophin may benefit from discussions with the UCL Institute of Child Health, London. Contact: L.Davidson@ich.ucl.ac.uk, 020 7404 0536.

Yes or uncertain to question 4

A highly transfused vCJD assessment form (Appendix D) should be completed if:

• the patient has received more than 50 units of blood or blood components

or • the patient has received blood or blood components on more than 20 occasions The GP should be asked to provide the names of all the hospitals where the patient has received blood or blood components, to assist the risk assessment. Appendix E contains a letter to send to blood laboratories in other hospitals if additional information from them is required. Word versions of Appendix D and Appendix E are available from the HPA at:

http://www.hpa.org.uk/vCJDpresurgicalassessment


The highly transfused risk assessment form will allow further investigation of the patient’s transfusion history, and assessment of their potential for exposure to blood or blood components from 80 or more donors (their ‘donor exposure’). If the patient has received fewer than 80 donor exposures, the patient is not considered to be at increased risk of vCJD. The instruments can be returned to routine use after undergoing normal decontamination processes. If the patient has received 80 or more donor exposures, the patient is confirmed as at increased risk of vCJD and the instruments should be destroyed. Alternatively, instruments destined for disposal may instead be retained for research – refer to Annex E for details.

If it is unclear from the patient’s transfusion history whether they have received 80 or more donor exposures, the instruments used in the patient’s surgery should remain in quarantine and further information on the patient’s donor exposures should be sought.

If the patient’s donor exposure remains uncertain, a local risk assessment should be conducted to determine how likely the patient is to have received blood from 80 or more donors. A local decision should be taken on whether the patient is at increased risk of vCJD and on how to manage the quarantined instruments.

?? If the local risk assessment concludes that the patient received 80 or more donor exposures then the patient is at increased risk of vCJD and the instruments should be destroyed. Alternatively, instruments destined for disposal may instead be retained for research – refer to Annex E for details

?? If the local risk assessment concludes that the patient received fewer than 80 donor exposures then the patient is not considered to be at increased risk of vCJD and the instruments can returned to routine use after undergoing normal decontamination processes

If the patient is found to be at increased risk of vCJD the highly transfused risk assessment form should be forwarded to the HPA CJD section. The HPA will contact the patient’s GP to request that they inform the patient of their increased risk of vCJD and provide them with further information and advice. The HPA will also inform the local HPU. More information for clinicians and patients can be found at:

http://www.hpa.org.uk/vCJDpresurgicalassessment


[continues overleaf]

8 Published: 31 July 2006

Revised and updated: 16 July 2009 Transmissible Spongiform Encephalopathy Agents: Safe Working and the Prevention of Infection: Annex J

The results of the risk assessment, including the number of transfusions to date, and confirmation or rejection of vCJD risk, should be recorded in the patient’s medical notes for future reference. Uncertain about any of questions 1, 2 or 3

The instruments should be kept in quarantine. The local infection control team should carry out a risk assessment, and they may wish to involve the local Control of Communicable Disease Consultant in this process. The outcome of the risk assessment should determine whether or not to return the instruments to routine use.

Additional actions to be taken during pre-surgery assessment for CJD risk

J10. In addition to asking the patient CJD/vCJD risk questions, the following actions should also be carried out before any surgical or endoscopic procedure involving contact with high risk tissue. The clinician undertaking the pre-surgery assessment should:

• Check the patient’s medical notes and/ or referral letter for any mention of CJD or vCJD status

• Consider whether there is a risk that the patient may be showing the early signs of CJD or vCJD, i.e. consider whether the patient may have an undiagnosed neurological disease involving cognitive impairment or ataxia J11. These actions, in conjunction with the CJD/vCJD risk questions, will minimise the chance of a CJD incident occurring and therefore reduce the risk of transmission of CJD or vCJD to subsequent patients. Infection control guidance

J12. Part 4 of this Guidance provides advice on the special infection control precautions that should be taken for patients with, or at increased risk of, CJD or vCJD, and Annex F provides information on endoscopic procedures. Patients at increased risk of CJD or vCJD

J13. As outlined in Table 4A in Part 4, a number of patients have been identified as at increased risk of CJD or vCJD on the recommendation of the CJD Incidents Panel. Paragraphs J15 to J17 provide some further information on these individuals and the steps taken to ensure that health care staff are informed of their risk status.

J14. Patients identified to be at increased risk include:

Related to blood transfusions

• People who have received blood from 80 or more donors who have been identified prior to high risk surgery

• People who have received blood from someone who went on to develop vCJD

• People who have given blood to someone who went on to develop vCJD

• People who have received blood from someone who has also given blood to a patient who went to develop vCJD

9 Published: 31 July 2006 Revised and updated: 16 July 2009

Transmissible Spongiform Encephalopathy Agents: Safe Working and the Prevention of Infection: Annex J Related to surgery

• People who have had surgery using instruments that had been used on someone who developed CJD

• People who have had an intradural neurosurgical or spinal procedure before August 1992

• People who have received an organ or tissue from a donor infected with CJD or at increased risk of CJD Related to other medical care

• People who have been treated with certain UK sourced plasma products between 1980 and 2001

• People who have been treated with growth hormone sourced from humans (before 1985)

• People who have been treated with gonadotrophin sourced from humans (before 1973)

• People who have been told by a specialist that they have a risk of developing the genetic form of CJD J15. When someone is notified that they are at increased risk of CJD or vCJD, they are asked to take certain precautions to reduce the risk of spreading the infection to others. These include:

• Not donating blood, tissue or organs;

• Informing healthcare staff if they need to undergo an invasive surgical, medical or dental procedure;

• Informing a family member or someone close to them, in case they need emergency surgery or endoscopy in the future J16. The individual’s GP is asked to record the patient’s CJD risk status in their primary care records. The GP should also include this information in any referral letter should the patient require invasive surgical, medical or dental procedures. J17. Further information on the work of the CJD Incidents Panel is available on the HPA website:

http://www.hpa.org.uk/CJDIncidentsPanel


Training

snip...

Part of your routine assessment before surgery includes some questions to find out whether you could have an increased risk of Creutzfeldt-Jakob disease (CJD). We will ask you:

Have you ever been notified that you are at risk of CJD or vCJD for public health purposes?

Have you any history of CJD or other prion disease in your family?

Have you ever received growth hormone or gonadotrophin treatment?

Have you had surgery on your brain or spinal cord at any time in the past?

Since 1980, have you had any transfusions of blood or blood components (red cells, plasma or platelets)?

snip...


also see ;

Transmissible Spongiform Encephalopathy Agents: Safe Working and the Prevention of Infection: Annex J

ANNEX J

Assessment to be carried out before surgery and/or endoscopy to identify patients with, or at increased risk of, CJD or vCJD

Summary of advice (revised July 2009)

Annex J provides a clear and pragmatic way of assessing CJD and vCJD risk prior to surgery or endoscopy. Growing numbers of patients have been informed that they are at increased risk of CJD or vCJD. Therefore it is recommended that all patients about to undergo any surgery or endoscopy should be asked if they have ever been notified as at increased risk of CJD or vCJD. This recommendation is outlined in paragraphs J1 and J2.

In addition, patients undergoing surgery or neuro-endoscopy which may involve contact with tissues of potentially high level TSE infectivity (“high risk tissues”) should, through a set of detailed questions, be assessed for their possible CJD/vCJD risk exposure. These questions are outlined in Table J1 and paragraphs J3 to J6.

Annex J has been revised (July 2009) to include a new question to be asked of all patients about to undergo surgery or neuro-endoscopy on high risk tissues. This new question (question 4 in Table J1) has been added to identify those patients who have received blood or blood components from 80 or more blood donors. These patients are now designated as at increased risk of vCJD by the CJD Incidents Panel. Table J1 and paragraph J6 provide guidance on how to identify those patients who have received multiple blood transfusions. An algorithm, included as Appendix A, guides health professionals through the process.



http://www.dh.gov.uk/prod_consum_dh/groups/dh_digitalassets/@dh/@ab/documents/digitalasset/dh_102856.pdf



http://www.dh.gov.uk/prod_consum_dh/groups/dh_digitalassets/@dh/@ab/documents/digitalasset/dh_096930.pdf




Annex D - Transport of TSE-infected material Published: December 2003, updated: 23 January 2009

http://www.dh.gov.uk/prod_consum_dh/groups/dh_digitalassets/@dh/@ab/documents/digitalasset/dh_087484.pdf



Friday, July 17, 2009

Revision to pre-surgical assessment of risk for vCJD in neurosurgery and eye surgery units Volume 3 No 28; 17 July 2009

http://creutzfeldt-jakob-disease.blogspot.com/2009/07/revision-to-pre-surgical-assessment-of.html


Tuesday, August 12, 2008

Biosafety in Microbiological and Biomedical Laboratories Fifth Edition 2007 (occupational exposure to prion diseases)

http://creutzfeldt-jakob-disease.blogspot.com/2008/08/biosafety-in-microbiological-and.html


Thursday, July 23, 2009

UW Hospital warning 53 patients about possible exposure to rare brain disease

http://creutzfeldt-jakob-disease.blogspot.com/2009/07/uw-hospital-warning-53-patients-about.html



Tuesday, April 21, 2009

Doctor Antonio Ruiz Villaespesa, pathologist and CJD researcher deceased because of Creutzfeldt-Jakob Disease SPAIN

http://cjdusa.blogspot.com/2009/04/doctor-antonio-ruiz-villaespesa.html


Br J Ophthalmol 2005;89:1131-1138 doi:10.1136/bjo.2004.063495 Clinical science Scientific reports Abnormal prion protein in the retina of the most commonly occurring subtype of sporadic Creutzfeldt-Jakob disease M W Head1, A H Peden1, H M Yull1, D L Ritchie1, R E Bonshek2, A B Tullo2 and J W Ironside1 + Author Affiliations

1National CJD Surveillance Unit, University of Edinburgh, Western General Hospital, Edinburgh EH4 2XU, UK 2Academic Department of Ophthalmology, Manchester Royal Eye Hospital, Manchester M13 9WH, UK Correspondence to: Dr M W Head National CJD Surveillance Unit, Bryan Matthews Building, Western General Hospital, Edinburgh EH4 2XU, UK; m.w.head@ed.ac.uk Accepted 7 March 2005 Abstract Background: Involvement of the eye has been reported in patients with variant Creutzfeldt-Jakob disease (vCJD), but there is disagreement on whether retinal involvement occurs in sporadic Creutzfeldt-Jakob disease (sCJD).

Methods: Western blotting, paraffin embedded tissue blotting, and immunohistochemistry were used to test whether the abnormal form of the prion protein (PrPSc) accumulates to detectable levels in the eye in a case of the most common subtype of sCJD (MM1).

Results: Low levels of PrPSc were detectable in the retina, localised to the plexiform layers of the central retina. PrPSc was not detectable in other ocular tissues.

Conclusions: The abnormal form of the prion protein is present in the retina in the most common sCJD subtype (MM1), albeit at levels lower than those found previously in vCJD and in sCJD of the VV2 subtype.

http://bjo.bmj.com/content/89/9/1131.abstract



Friday, August 07, 2009

CJD Human Cornea Tissue, Recall END OF ENFORCEMENT REPORT FOR AUGUST 5, 2009

http://creutzfeldt-jakob-disease.blogspot.com/2009/08/cjd-human-cornea-tissue-recall-end-of.html



Tuesday, August 11, 2009

Characteristics of Established and Proposed Sporadic Creutzfeldt-Jakob Disease Variants

http://creutzfeldt-jakob-disease.blogspot.com/2009/08/characteristics-of-established-and.html



Monday, July 27, 2009

U.S.A. HIDING MAD COW DISEASE VICTIMS AS SPORADIC CJD ?

WHY DID THIS VIDEO NOT SHOW ON EVERY NEWS CHANNEL IN THE U.S.A. $$$

IT IS A DAMNING VIDEO !!!

I WATCHED THIS RECENTLY, and had never seen it. i was so mad, i was spitting nails out faster than a framing gun.

WHY DID THE CANADIAN MEDIA ONLY PRESENT THIS TO THE U.S.A. PUBLIC (thank you very much though), and why has the U.S.A. MEDIA FAILED US ???


SNIP...

SEE DAMNING VIDEO AT BOTTOM OF BLOG HERE ;

Monday, July 27, 2009

U.S.A. HIDING MAD COW DISEASE VICTIMS AS SPORADIC CJD ?

http://creutzfeldt-jakob-disease.blogspot.com/2009/07/usa-hiding-mad-cow-disease-victims-as.html





NOW, AFTER SEEING THAT VIDEO, (first watch the video) lets go back in mad cow time here in the USA, shall we.



THERE must be an independent review of this cover-up, and the infamous ENHANCED BSE SURVEILLANCE AND TESTING OF 2004, that was nothing but a cover-up, and blundered at that, and plus a REDO of the testing of no less than 1 million head of cattle tested each year, for five years, with scientist from the EU overseeing the testing protocols, surveillance, and confirmation of all cases.

this video states the 'USA had to _admit_ a home grown case of mad cow in TEXAS." fact was, they did not finally admit anything, IT TOOK AN ACT OF CONGRESS, THE HONORABLE PHYLISS FONG AND THE O.I.G., TO MAKE THEM RETEST AND CONFIRM! that my friend is fact. and only after Prof. Aguzzi, Dr. Jean-Philippe Deslys, Dr. Collinge et al slammed them over the testing of that animal. and then we had the mad cow in Texas that they just refused to test, and was sent to a pet food rendering plant. NO TEST AT ALL. you must realize, when other officials, doctors, and such from other country's confront issues about things in the USA, they must walk on ice when doing so. read inbetween the lines here ;

i wrote all these scientist and doctors and the OIG about that damn texas cow, gave them the evidence i had from TAHC. so did others, but finally fong et al did something.

a bit of history for you mel. file this away. ...


Tuesday, July 28, 2009

MAD COW COVER-UP USA MASKED AS SPORADIC CJD


http://madcowtesting.blogspot.com/2009/07/mad-cow-cover-up-usa-masked-as-sporadic.html




TSS