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From: TSS ()
Subject: NOTIFICATION EXERCISE BEGINS TO REDUCE RISK OF VCJD TRANSMISSION
Date: July 20, 2005 at 11:24 am PST

Wednesday 20 July 2005 13:15
Department of Health (National)

NOTIFICATION EXERCISE BEGINS TO REDUCE RISK OF VCJD TRANSMISSION


An extension to the precautionary measures to reduce the risk of transmitting vCJD through blood transfusion and surgical procedures, began today. Around 100 people who donated blood to three people who later developed vCJD, are being told that they may have a greater chance of carrying the vCJD agent, compared with the general population.

They will be asked not to donate blood, tissue or organs and to inform health professionals so extra precautions can be taken should they have surgery or other invasive procedures.

Although it is not known whether the source of vCJD in these patients is related to the blood that they received, precautionary steps are being taken to inform and provide support to the individuals as well as safeguard public health. This is being done on the advice of two expert committees and a detailed risk assessment exercise.

Notification of donors is taking place via letters from the National Blood Service who are working closely with the Health Protection Agency to identify the people involved. The letters that people receive will provide the telephone number for a dedicated helpline staffed by senior transfusion experts from the National Blood Service, and will also advise them to contact their GP for more information, advice and support.

The likelihood of a person who may be infected with vCJD going on to develop symptoms of the disease is uncertain. It is possible that an infected person may never develop symptoms.

The Chief Medical Officer, Sir Liam Donaldson said:

"We need to ensure that appropriate action is taken on any new information that becomes available on the risk of transmission of vCJD, to protect the public as much as possible. When a recipient of a blood transfusion goes on to develop vCJD, we have to consider the possibility that the infection could have been passed on through the transfusion.

"Until a reliable blood screening test becomes available, it is sensible to proceed with highly precautionary measures such as this to rule out any possibility of onward transmission of the disease. We are committed to further research to help us understand this disease and diagnose infection at an early stage.

"Following the identification of vCJD, we introduced a number of measure to reduce the possible risk that infection could be transmitted through the blood supply. Since the announcement in December 2003 of the first case of possible transfusion-associated transmission of vCJD, we have further strengthened these preventative measures.The decisions taken so far have been based on the principles of caution and openness. This announcement today is a continuation of the process."

Dr Angela Robinson from the National Blood Service said:

"Blood donors are highly committed to helping other people and we greatly value their contribution. The NHS depends upon their continued commitment in order to be able to save lives.

"This notification exercise will affect in the order of 100 donors. If you have donated blood in the last five years and are not contacted shortly, you can be assured that you are not involved in this new safety measure and need to take no further action.

"For those people who are involved, this information may be difficult to absorb. That is why we have set up the National Blood Service helpline and are working with their doctors and other clinicians, to ensure that they have the information and support they need."

Notes to editors:

1. This notification exercise has been done after a detailed risk assessment by the Department of Health and reviewed by its relevant expert committees. The risk assessment can be found at http://www.dh.gov.uk

2. The degree of increased risk for any individual donor depends on many factors, including how many other donors' blood went to the infected recipient. This varies very widely between these three recipients. Individual donors will be able to find out more if they wish.

3. Of the 156 cases of vCJD to date, 4 have been confirmed as having had blood transfusions that experts believe could be linked with their vCJD. For one of these cases, the probable source of infection has already been identified, as one of the donors went on to develop vCJD. For three cases, transfusion remains a possible source of the recipient's infection.

4. The blood donors involved in England, all gave blood during 1993.

5. The two expert committees advising this course of action were the CJD Incidents Panel and the Committee on the Microbiological Safety of Blood Tissues and Organs.

6. Previous measures taken to improve the safety of blood in relation to vCJD include the following:

- From December 1997, blood components, plasma products or tissues obtained from any individual who later develops vCJD, have been withdrawn/recalled.
- In July 1998, we announced that plasma for the manufacture of blood products, such as clotting factors, would be obtained from non-UK sources.
- From November 1999, white blood cells (which may carry a significant risk of transmitting vCJD) have been removed from all blood used for transfusion.
- In August 2002 we announced that fresh frozen plasma for treating babies and young children born on or after 1 January 1996 would be obtained from the USA.
- The report of the first possible case of transmission of vCJD by blood transfusion was in December 2003. Following this, we announced in April 2004 that individuals had themselves received a transfusion of whole blood components since January 1980, would be excluded from donating blood. (In July 2004, the second possible case of transmission of vCJD by blood transfusion was reported.)
- On July 2004, the exclusion criteria for blood donation were extended to include two new groups, who had received transfusions of whole blood components since 1980:
- Previously transfused platelet donors
- Donors who were unsure if they had previously had a blood transfusion.

This means that for blood donation the full exclusion criteria are:
- Recipients of dura mater grafts.
- Recipients of corneal or scleral grafts.
- Recipients of human pituitary derived extracts such as growth hormone or gonadotrophins.
- Individuals at familial risk of prion-associated diseases. This includes individuals who have had two or more blood relatives develop a prion -associated disease and individuals who have been informed they are at risk following genetic counselling.
- Individuals who had themselves received a transfusion of whole blood. components since January 1980 are excluded from donating blood.
- Individuals identified as 'at risk' by CJD Incidents Panel.
- Previously transfused platelet donors.
- Donors who were unsure if they had previously had a blood transfusion.

- In September 2004, the Department of Health announced further precautionary measures for patients who had received certain batches of plasma products.
- In July 2005 the use of USA sourced fresh frozen plasma (FFP) was extended to all children up to the age of 16.

7. There is currently no validated diagnostic test that can be used before the onset of clinical symptoms to diagnose whether someone has contracted vCJD. Since 1995, the Department has contributed over £30 million into CJD research, including research for the development of an effective test.


HOUSE OF COMMONS

Notice of Written
Ministerial Statement


Title of Secretary of State/Ministerial
head of department: The Under Secretary of State (Public Health)


Subject of Statement: Secondary Transmission of Variant CJD
Recommendations for Further Health Precautions


1. Notice of written Statements for the following day will be placed on the effective Orders of the Day. Otherwise, the notices will be placed on Future Business E (written ministerial statements). Notices may be given of written statements to be made not later than 5 sitting days after the day on which notice was given.

WRITTEN MINISTERIAL STATEMENT

DEPARTMENT OF HEALTH

20 July 2005

The Under Secretary of State (Public Health): Written Ministerial Statement on secondary transmission of vCJD

The Under Secretary of State (Public Health): (Ms Caroline Flint)

Further to the statements made to the House by the then Secretary of State (Dr John Reid) on 17 December 2003 and 16 March 2004 (and the written statements of 22 July 2004 and 9 September 2004) concerning variant Creutzfeldt-Jakob disease (vCJD) and blood, I wish to provide a further update on this subject.

Following cases of possible transmission of vCJD by blood transfusion, we have already put in place a series of precautionary public health measures. These include:
- In December 2003 we put in place arrangements for contacting recipients of blood from donors who went on to develop vCJD so that any necessary action could be taken;
- Since April 2004 we have excluded anyone who has received a blood transfusion since January 1980 from donating blood.
- In September 2004 we announced arrangements to identify and notify patients who had received certain batches of UK manufactured plasma products.

In the light of further advice I have received from two of my Department's expert committees, the CJD Incidents Panel (CJDIP) and the Committee on Microbiological Safety of Blood, Tissues and Organs (MSBTO), I am now announcing further public health precautions in relation to a small group of blood donors whose blood has been transfused to people who later developed vCJD.

The Chief Medical Officer, Sir Liam Donaldson, had asked the expert committees to consider the implications for donors where a recipient of their blood had developed vCJD. The recommendations of the committees are based on an assessment of risk undertaken by the Department of Health's analysts. The risk assessment is being published on the Department's website.

There are 110 donors in the UK whose blood was given to three people who later developed vCJD and for whom this blood might be a possible source of their infection. The advice of the committees is that, although we do not know whether these cases of vCJD could be related to the blood that they received, we should take precautionary steps to inform and support the individual blood donors concerned and to safeguard public health.

As an extension to the current precautionary measures, these people are being contacted by the National Blood Service and advised not to donate blood, tissues or organs. Current donors from this group of 110 are being contacted today and offered expert advice and support. The National Blood Service will contact the GPs of lapsed donors, that is those who have not donated blood during the last five years, and make arrangements to contact these people as soon as practicable.

The committees have also advised that the donors in question should be considered at risk of vCJD for wider public health purposes and that the donors and their clinicians should be informed of their risk status and asked to implement the public health precautions currently specified by the CJD Incidents Panel. This means that they should inform doctors, nurses and dentists of their status if they present for surgery or other invasive medical procedures.

These public health precautionary measures are the same as those applied to any patients considered by the CJDIP to be at risk of vCJD, including the individuals notified following the previous statements to the House.

There is another group of people for whom further public health precautions may need to be considered. This group is all the other recipients of blood from the currently identified group of 110 donors (estimated to be up to 3,000 individuals). At present, these people are already excluded from blood donation themselves by the measures implemented in April 2004. I have asked for additional expert advice on this group and I will take further action if necessary.

Blood donors should be assured that it is not possible to contract vCJD by giving blood. Blood donors are highly committed to helping others and we greatly value their contribution. The NHS depends on their continued commitment to donating blood which saves lives every day in this country.

The vast majority of the over two million current blood donors will not be involved in this new safety measure and need take no action. However, current and past blood donors who are concerned can contact the National Blood Service helpline on 0845 7711 711.

People who have received blood donations and other members of the public who are concerned should contact NHS Direct on 0845 850 9850.

As with our actions to date on the possible transmission of vCJD, we continue to follow a highly precautionary approach.


Client ref 2005/0256

GNN ref 118433P

http://www.gnn.gov.uk/content/detail.asp?NewsAreaID=2&ReleaseID=164111

TSS




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