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From: TSS ()
Subject: (DH) Precautionary advice given to dentists on re-use of instruments and TSE i.e. prion diseases
Date: April 19, 2007 at 7:58 am PST

(DH) Precautionary advice given to dentists on vCJD
Thu Apr 19, 2007 11:11
70.110.92.6


19/04/2007 10:14


Department of Health (National)

(DH) Precautionary advice given to dentists on re-use of instruments

As a precautionary measure the Chief Dental Officer, Dr Barry Cockcroft today issued new guidance to all dentists in England regarding single use of reamers and files, instruments used only in the root filling of teeth.

The guidance to dentists follows on from precautionary advice from the Spongiform Encephalopathy Advisory Committee to the Department of Health and early results from ongoing research conducted by the Health Protection Agency, indicating a potential risk of vCJD associated with endodontic procedures.

Dr Barry Cockcroft said:

"There are no reported definite or suspected cases of vCJD transmission arising from dental procedures - this new guidance to dentists is purely an extra precaution. The public should continue to attend their dentist as normal."

Notes to Editors:

1. The guidance applies to all primary and secondary care dentists in England.

2. Endodontics relate to treatment to the dental pulp of a tooth. A major part of this is root canal work. No other aspect of dental work is affected by this precautionary advice.

3. There are approximately 1 million NHS endodontic treatments every year in England and Wales. Since 1996 there have been 165 cases of vCJD. There is no current evidence of vCJD being transmitted by any form of dentistry.

4. Variant Creutzfeldt-Jakob Disease (vCJD) is one of the Transmissible Spongiform Encephalopathies, the group of prion diseases that include Bovine Spongiform Encephalopathy (BSE), Creutzfeldt-Jakob Disease (CJD), and scrapie.

5. This letter reflects precautionary advice from the Spongiform Encephalopathy Advisory Committee (SEAC) and early results on the potential infectivity of dental tissues from research in progress by the Health Protection Agency. This research supports the view that dental instruments (files and reamers) used in root canal treatment could possibly pose an effective route of vCJD transmission.

6. Almost everyone is at some risk of being infected with vCJD due to dietary exposure to BSE. Any additional risk from a root canal treatment could only arise if the instruments had been previously used on an infective patient. The proportion of people carrying infection is highly uncertain. Published information suggests that this may be between 1 in 1,400 and 1 in 20,000 people, though it may well be less for some age groups. It is also not clear how many of those carrying the infection are likely to develop symptoms of vCJD: given the much smaller number of cases actually seen so far, the majority may never do so (Clarke and Ghani, 2005). Even if instruments had been used on someone carrying the infection, it is not clear how great the risk of vCJD being passed on would be. Nevertheless, a precautionary approach is justified in view of the number of endodontic procedures carried out.

[ENDS]

Client ref 2007/0092

GNN ref 146384P


===============================================

PLEASE SEE DENTAL RISK FROM HUMAN AND ANIMAL TSE


http://neurotalk.psychcentral.com/archive/index.php/t-13173.html


http://disc.server.com/discussion.cgi?disc=236650;article=285;title=CJD%20DISCUSSION%20BOARD

http://www.rense.com/general34/evi.htm

Subject: MASTER DENTIST FALLS VICTIM TO CJD
Date: March 31, 2007 at 1:27 pm PST


http://lists.ifas.ufl.edu/cgi-bin/wa.exe?A2=ind0703&L=sanet-mg&P=19835

COULD A CJD QUESTIONNAIRE TO EVERY FAMILY OF A VICTIM HELP ???

http://brain.hastypastry.net/forums/showthread.php?t=2408


USA MAD COW STRAIN MORE VIRULENT TO HUMANS THAN UK STRAIN

18 January 2007 - Draft minutes of the SEAC 95 meeting (426 KB) held on 7
December 2006 are now available.


snip...

64. A member noted that at the recent Neuroprion meeting, a study was
presented showing that in transgenic mice BSE passaged in sheep may be more
virulent and infectious to a wider range of species than bovine derived BSE.

Other work presented suggested that BSE and bovine amyloidotic spongiform
encephalopathy (BASE) MAY BE RELATED. A mutation had been identified in the
prion protein gene in an AMERICAN BASE CASE THAT WAS SIMILAR IN NATURE TO A
MUTATION FOUND IN CASES OF SPORADIC CJD.


snip...

http://www.seac.gov.uk/minutes/95.pdf


3:30 Transmission of the Italian Atypical BSE (BASE) in Humanized Mouse

Models Qingzhong Kong, Ph.D., Assistant Professor, Pathology, Case Western Reserve
University

Bovine Amyloid Spongiform Encephalopathy (BASE) is an atypical BSE strain
discovered recently in Italy, and similar or different atypical BSE cases
were also reported in other countries. The infectivity and phenotypes of
these atypical BSE strains in humans are unknown. In collaboration with
Pierluigi Gambetti, as well as Maria Caramelli and her co-workers, we have
inoculated transgenic mice expressing human prion protein with brain
homogenates from BASE or BSE infected cattle. Our data shows that about half
of the BASE-inoculated mice became infected with an average incubation time
of about 19 months; in contrast, none of the BSE-inoculated mice appear to
be infected after more than 2 years.

***These results indicate that BASE is transmissible to humans and suggest that BASE is more virulent than
classical BSE in humans.***


6:30 Close of Day One


http://www.healthtech.com/2007/tse/day1.asp


SEE STEADY INCREASE IN SPORADIC CJD IN THE USA FROM
1997 TO 2006. SPORADIC CJD CASES TRIPLED, with phenotype
of 'UNKNOWN' strain growing. ...


http://www.cjdsurveillance.com/resources-casereport.html

There is a growing number of human CJD cases, and they were presented last
week in San Francisco by Luigi Gambatti(?) from his CJD surveillance
collection.

He estimates that it may be up to 14 or 15 persons which display selectively
SPRPSC and practically no detected RPRPSC proteins.


http://www.fda.gov/ohrms/dockets/ac/06/transcripts/1006-4240t1.htm


http://www.fda.gov/ohrms/dockets/ac/06/transcripts/2006-4240t1.pdf


Thursday, March 15, 2007

Potential Risk of Variant Creutzfeldt-Jakob Disease (vCJD)
From Plasma-Derived Products

In recent years, questions have been raised concerning the potential risk of variant Creutzfeldt-Jakob disease (vCJD - a rare but fatal brain infection) for recipients of plasma- derived clotting factors, including United States (US) licensed Factor Eight (pdFVIII), Factor Nine (pdFIX), and other plasma-derived products such as immune globulins and albumin. In response to these questions, FDA conducted a risk assessment. Based on the risk assessment, the US Public Health Service believes that the risk of vCJD to patients who receive US licensed pdFVIII products is most likely to be extremely small, although we do not know the risk with certainty. vCJD risk from other plasma derived products, including Factor IX, is likely to be as small or smaller.

This web page provides FDA’s risk assessment for US licensed pdFVIII and risk communication materials for this product and other plasma derivatives. Included are Key Points, and Questions and Answers. Additional links are provided to FDA’s current guidance documents on deferral of blood and plasma donors who may be at increased risk of vCJD, and to other sources of information regarding vCJD.

Documents Regarding US Licensed pdFVIII, and Other US Licensed Plasma Derivatives Including pdFIX

Potential vCJD Risk From US Licensed Plasma-Derived Factor VIII (pdFVIII, Antihemophilic Factor) Products: Summary Information, Key Points
Risk Assessment (PDF, 582 KB)
Risk Assessment Appendix (PDF, 623 KB)
Questions and Answers on vCJD and pdFVIII
Questions and Answers on vCJD and Plasma Derivatives Other than pdFVIII
Guidance on Donor Deferral Related to CJD and vCJD

Draft Guidance for Industry: Amendment (Donor Deferral for Transfusion in France Since 1980) to "Guidance for Industry: Revised Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease (CJD) and Variant Creutzfeldt-Jakob Disease (vCJD) by Blood and Blood Products" - 8/2006
Questions and Answers on FDA Guidance: Revised Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob (CJD) Disease and Variant Creutzfeldt-Jakob Disease (vCJD) by Blood and Blood Products - 1/22/2004
Guidance for Industry: Revised Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease (CJD) and Variant Creutzfeldt-Jakob Disease (vCJD) by Blood and Blood Products - 1/2002
Other Sources of Information

Transmissible Spongiform Encephalopathies Advisory Committee
Blood Products Advisory Committee Meeting – Summary of Recent TSEAC Meeting and Statement about FXI from the UK, on October 21, 2004
Information on vCJD: Centers for Disease Control and Prevention
Information on Bovine Spongiform Encephalopathy (“Mad Cow Disease”): US Department of Agriculture
Patient Organizations:

Committee of Ten Thousand
Hemophilia Federation of America
National Hemophilia Foundation and/or HANDI
World Federation of Hemophilia

http://www.fda.gov/cber/blood/vcjdrisk.htm

PRODUCT
Recovered Plasma, Recall # B-0854-07
CODE
Unit: V10665
RECALLING FIRM/MANUFACTURER
Virginia Blood Services, Richmond, VA, by email on August 25, 2004. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who was at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Switzerland

END OF ENFORCEMENT REPORT FOR MARCH 14, 2007

###

http://www.fda.gov/bbs/topics/enforce/2007/ENF00995.html

nvCJD mad cow blood recalls ENFORCEMENT REPORT FOR MARCH 7, 2007

___________________________________

PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-0805-07;
b) Platelets, Recall # B-0806-07;
c) Recovered Plasma, Recall # B-0807-07
CODE
a) Units: 4759943, 4677574, 4555912;
b) Units: 4759943, 4555912;
c) Units: 4677574, 4555912
RECALLING FIRM/MANUFACTURER
Oklahoma Blood Institute, Sylvan N. Goldman Center, Oklahoma City, OK, by facsimile on May 20, 2005. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was at increased risk for new variant Creutzfeldt-Jakob Disease (nvCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
7 units
DISTRIBUTION
MA, OK, TX, and Switzerland

___________________________________

PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-0808-07;
b) Platelets, Recall # B-0809-07;
c) Recovered Plasma, Recall # B-0810-07
CODE
a), b), and c) Unit: 5249546
RECALLING FIRM/MANUFACTURER
Oklahoma Blood Institute, Sylvan N, Goldman Center, Oklahoma City, OK, by facsimile on August 1, 2005. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was at increased risk for new variant Creutzfeldt-Jakob Disease (nvCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
OK, NB, and Switzerland

___________________________________

PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-0811-07;
b) Recovered Plasma, Recall # B-0812-07
CODE
a) and b) Unit: 5218775
RECALLING FIRM/MANUFACTURER
Oklahoma Blood Institute, Sylvan N, Goldman Center, Oklahoma City, OK, by facsimile on July 7, 2005. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was at increased risk for new variant Creutzfeldt-Jakob Disease (nvCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
OK and Switzerland

___________________________________

PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-0826-07;
b) Platelets, Recall # B-0827-07;
c) Fresh Frozen Blood, Recall # B-0828-07;
d) Recovered Plasma, Recall # B-0829-07
CODE
a) Units: 5250527, 4901850, 4517058;
b) Units: 4901850, 4517058;
c) Unit: 4517058;
d) Units: 5250527, 4901850
RECALLING FIRM/MANUFACTURER
Oklahoma Blood Institute, Sylvan N. Goldman Center, Oklahoma City, OK, by facsimile on March 27, 2006. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was at increased risk for new variant Creutzfeldt-Jakob Disease (nvCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
8 units
DISTRIBUTION
OK, TX, Austria, and Switzerland

___________________________________

PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-0843-07;
b) Recovered Plasma, Recall # B-0844-07
CODE
a) and b) Units: 5738052, 5275313, 4801421
RECALLING FIRM/MANUFACTURER
Oklahoma Blood Institute, Sylvan N. Goldman Center, Oklahoma City, OK, by facsimile on January 22, 2006. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was at increased risk for new variant Creutzfeldt-Jakob Disease (nvCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
6 units
DISTRIBUTION
TX, OK, and Switzerland

END OF ENFORCEMENT REPORT FOR MARCH 7, 2007

###

http://www.fda.gov/bbs/topics/enforce/2007/ENF00994.html

4th CASE VCJD VIA BLOOD TRANSFUSION, BSE, BASE, AND SPORADIC CJD

By Terry S Singeltary

Bacliff, Texas USA Jan 24, 07


http://bloodindex.org/view_news_zone.php?id=206


PDF]Freas, William TSS SUBMISSION

File Format: PDF/Adobe Acrobat -

Page 1. J Freas, William From: Sent: To: Subject: Terry S. Singeltary

Sr. [flounder@wt.net] Monday, January 08,200l 3:03 PM freas ...

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


----- Original Message -----
From: Terry S. Singeltary Sr.
To: Terry S. Singeltary Sr. ; [log in to unmask]
Cc: [log in to unmask] ; [log in to unmask]
Sent: Thursday, November 30, 2006 1:47 PM
Subject: Re: TSE advisory committee for the meeting December 15, 2006 [TSS SUBMISSION PART II]


http://lists.ifas.ufl.edu/cgi-bin/wa.exe?A2=ind0611&L=sanet-mg&T=0&P=16159

TSS



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