|
||||||||||||||||||
From: TSS ()
1 CJD INCIDENTS PANEL Public summary of the 14th meeting 18th January 2005 2 1. Composition of the meeting The twelfth meeting of the CJD Incidents Panel was held in London on 18th January. It was attended by 21 members of the Panel and specialist advisors and observers from the Department of Health (DH), the devolved administrations and the Health Protection Agency (HPA). The meeting was chaired by Professor Don Jeffries. 2. Panel appointments Mr David Pryer had accepted the recent offer of appointment from the Chief Medical Officer (CMO), on behalf of the UK Chief Medical Officers, as Chairman of the Panel, following a selection process undertaken by the NHS Appointments Commission. The Chairman thanked Mr Tullo for his service to the Panel as ophthalmology expert and Professor Roger Buckley who had acted as alternate to Mr Tullo during the past year; he welcomed Mr Ian Pearce as a new member and expert in opthalmology. Dr Douglas Russell, a new member nominated by the Royal College of General Practitioners, was also welcomed. The Chairman reminded those present that members were appointed to contribute as experts in their field rather than as representatives of particular organisations, even when nominated by them. 3. Matters arising from the minutes of the previous meeting 3.i Correspondence with President of Royal College of Ophthalmologists The Panel noted the correspondence with the President of the Royal College of Ophthalmologists. It had been suggested at the previous meeting that he should be informed about an incident involving cataract surgery provided by a private company due to concerns which included the lack of surgical instrument traceability, decontamination standards and the fate of the instruments used. 3.ii TSE transmissions in occupational health settings The issue of TSE transmissions in occupational settings had been referred to the ACDP TSE Working Group following the previous meeting. The TSE Working Group’s considered opinion was that it was highly unlikely that an individual would become infected with CJD following a needlestick injury. There had been no recorded transmissions of TSEs to humans by this route. However, the TSE Working Group recognised the need to maintain centrally a secure database of occupational injuries on a long-term basis . It was agreed that the chairs of the TSE Working Group 3 and the Panel should send a formal request to the DH to commission surveillance of occupational exposure to TSEs. 3.iii Clarification of Panel advice about ‘at risk’ patients At the previous meeting the Panel had agreed that recipients of implicated blood components should be asked for consent to testing by the National CJD Surveillance Unit of tissue removed during tonsillectomy, appendicectomy and splenectomy procedures. It had also been suggested that advice letters from the Panel and the HPA could remind colleagues of the potential value of post mortem investigations. Clarification was now sought by the Secretariat as to whether these actions should also apply to other groups at increased risk of developing vCJD as a result of incidents involving surgical procedures and implicated plasma products. The Panel agreed that a subgroup would meet to discuss this question and allied issues, including the effect of cultural norms on consent and the potential contribution of coroners. 4. Quarterly summary of reported incidents The Panel noted that 12 incidents had been reported to the Panel in the third quarter of 2004, compared with three in the second quarter. 5. Discussion and endorsement of incidents 5.i Endorsement of advice provided (no precedent) PI 287 Advice had been requested concerning a service engineer who might have been exposed to CJD during servicing of an anaesthetic ventilator used on a patient known to have CJD. It had been withdrawn from use on patients and was being used for training purposes. The Panel advised that the ventilator could not have been contaminated and therefore the service engineer had not been exposed to CJD. Two other advice letters were approved (PI 293 and PI 44/109). 5.ii Incidents involving contactable patients There had now been 10 incidents in which the Panel had advised the local team to notify patients that they had been placed in an ‘at risk’ category. Thirty-one patients had been contacted to date (to the Secretariat’s knowledge). PI 256 4 The local team had expressed an initial reluctance to implement Panel advice to notify patients in relation to this incident concerning an individual with confirmed sporadic CJD; a further letter reiterating the advice had been sent following discussion at the previous Panel meeting. The Panel endorsed the letter – advising non-compliance with Panel advice be discussed with the strategic health authority (SHA). It was pointed out that if a foundation trust (not the case here) did not follow Panel advice, the SHA would not be the relevant authority to refer to. PI 259 This incident involved a recipient of implicated blood components found at post mortem to have evidence of abnormal prion protein in the spleen and a cervical lymph node. A second letter had conveyed new advice on contacting patients on whom instruments had subsequently been used following a cataract operation on the index patient. Identification of sets of ‘two subsequent patients’ for each of the instruments used was advised. The Panel commented on the draft of a third advice letter following the receipt of precise information concerning the identification of contactable patients in relation to other procedures. PI 260 The Panel commented on the draft of a further advice letter in relation to this incident also involving cataract surgery on a patient with possible sporadic CJD. PI 267 In this incident involving a recipient of implicated blood components, a second advice letter had been sent following the Panel decision that recipients of implicated blood components should be regarded by the Panel as ‘presumed infected with vCJD for public health purposes’. This letter advised contacting patients on whom instruments had been used following six medium risk procedures, provided that the first two subsequent patients in relation to each procedure could be identified: four endoscopies with biopsy; one colonoscopy with polypectomy; and an excision of a parotid gland tumour (if the instruments had come into contact with lymph nodes). PI 271 It was reported that, following the Panel advice to contact ‘at risk’ patients on whom instruments had been used following three cataract operations, the local team were in the process of tracing the three sets of ‘two subsequent patients’. 5 5.iii Endorsement of advice provided (based on precedent) PI 272, PI 275, PI 276, PI 278, PI 279, PI 283, PI 289, PI 291, PI 292, PI 295, PI 296 The Panel endorsed the advice based on precedent on incidents issued from the Panel since the previous meeting. It was confirmed that the Panel had decided previously that it was not justified to notify the ‘contacts of contacts’: for example, where a recipient of implicated plasma products had had neurosurgery, it was advised that there was no need to inform patients on whom the surgical instruments had been used subsequently. 5.iv Other advice The Panel noted six other advice letters in response to enquiries concerning matters related to the Panel remit, although not to specific incidents. Two letters gave prospective infection control advice. Two letters advised on clinical interventions not considered to be incidents (past procedures on ‘at risk’ recipients of implicated plasma products). The fifth letter concerned a query from a patient identified as ‘at risk’ of vCJD who reported that a surgical procedure had been delayed as a result of their ‘at risk’ status. Whether or not this was in fact the case, the Panel confirmed the principle in the framework document that there should be no discrimination arising from the identification of patients as being at increased risk of developing CJD. The sixth letter concerned the marking of paper patient records to ensure information about ‘at risk’ status is available as needed. It was noted that marking manual records could never be 100% effective and might give rise to concerns about discrimination: effective pre-surgery assessment was therefore key. 6. DH-funded store for CJD-contaminated instruments A presentation was given on the store for instruments potentially contaminated with CJD located at the HPA Centre for Preparedness and Emergency Response, Porton Down. The DH had provided five years’ funding for the store, until 2007. Its function was to provide secure storage for potentially contaminated instruments which would otherwise be destroyed by trusts in order that they might be used for testing methods for CJD detection and decontamination. Potentially contaminated instruments could be identified to send to the store either immediately following surgery on a patient known to have or to be at risk of CJD, or during investigation of a Panel incident. The store was not for the quarantine of instruments, for example, those kept for patients 6 diagnosed with CJD, or instruments which might be released for normal use following a diagnosis other than CJD in a patient suspected of having CJD. A protocol had been developed for the collection and storage of instruments. The Panel supported the need for a second protocol to set out criteria for evaluation of requests to release instruments for research purposes. 7. Dentistry 7.i Scottish survey of decontamination in general dental practice A presentation was given on the main findings of the Scottish Survey of Decontamination in General Dental Practice undertaken by the Glennie Group in collaboration with Health Protection Scotland. The main objective of the survey had been to look at the decontamination cycle rather than infection control per se and provide an evidence base for implementing measures to improve decontamination practice. The findings showed that the cleaning of instruments often did not meet acceptable standards and was poorly controlled. Cleaning instructions for some instruments had either not been supplied by manufacturers and suppliers or had not been adjusted for the UK. It was agreed that the findings were probably representative of primary dental care settings throughout the UK. The Scottish Executive had used the survey findings to develop a list of 10 ‘priorities for immediate action’ included in a joint letter from the Chief Medical Officer and Chief Dental Officer in Scotland. In England and Wales dentistry was included in the NHS strategy for improving decontamination services and in the current development by NICE of guidance on managing the risk of transmission of CJD during surgery. Education and collaborative working between dental practice inspectors and community infection control nurses were identified as important ways of helping improve decontamination standards in dentistry. Discussion of the findings concluded that they did not necessarily affect the results of the dental risk assessment undertaken by the DH. The assumptions used in the analysis of the potential risk of vCJD transmission through re-use of instruments in dental surgery had taken into account a certain amount of material adhering to dental instruments following decontamination: now there was evidence that this was the case. 7.ii Chief Dental Officer’s letter to dentists 7 Further comments were invited from Panel members on a draft letter for dentists in England concerning patients with CJD or at increased risk of developing vCJD prepared by the HPA CJD Section at the request of the Chief Dental Officer. 8. Update on decontamination programmes 8.i England The National Team had discussed with strategic health authorities (SHAs) how they would take forward their strategies for improving decontamination, including the use of funds allocated to improve decontamination in primary care. Some SHAs had held roadshows to explain their strategy to primary care trusts. A conference would take place in February for professional bodies with an interest in improving decontamination services. The specification for tracking and tracing systems drawn up by NHS Estates to help hospitals purchase systems to meet their needs was out for consultation with the NHS and potential suppliers. The NHS-funded centre in NE London was expected to open soon and the redevelopment of the Sterile Services Department at Scarborough was complete. The Healthcare Commission would include decontamination in their inspections from April 2005. Dental schools had received funding to improve their decontamination services. The e-learning package developed by NHS Estates for hospital staff with an interest in good decontamination practice had been launched at a series of roadshows in the autumn and NHS Estates was hoping to extend this training to primary care staff. 8.ii Northern Ireland At the request of the Permanent Secretary, the Department for Health and Personal Social Services (DHPSS) was considering specific actions regarding the decontamination of re-usable medical devices. This might include an assessment of decontamination policies, procedures and practices for all re-usable medical devices. The DHPSS was currently considering the Independent Review Group’s Report into the Systems and Processes of Flexible Endoscope Decontamination in N Ireland. Following the report by a trust in May 2004 that a gastroscope had been used for over three years without full compliance with the manufacturer’s instructions on decontamination, the DHPSS had immediately initiated a wider review to provide complete assurance with respect to the effective cleaning and decontamination of all endoscopes in use across the HPSS. In July an independent external review had been commissioned of the systems and processes used within N Ireland to 8 achieve the cleaning and high-level disinfection of flexible endoscopes following their use in the investigation and treatment of patients. 8.iii Scotland It was hoped that 2006 would see the completion of a project whereby Glasgow Hospital had been funded to build a new central sterilised services department for the whole of the Glasgow area. The current focus for improvement of decontamination services was on primary care and endoscopy. 8.iv Wales Of the 17 hospital sterilisation and disinfection units in Wales, the last was expected to achieve accreditation to the EU Medical Device Directive in March 2005. The Decontamination Project Board would continue to oversee the accreditation process and planned to issue their final report to the Health and Social Services Committee of the National Assembly for Wales in March. Funding for electronic tracking systems for all departments had been included in the programme to improve decontamination services and these were factored into management systems. Local health boards were beginning to discuss provision for general medical practices from accredited departments. One exemplar trust providing decontamination services for GPs in a large part of Wales using the local ambulance service was now also running a pilot with local dental practices. The initial cost of providing additional instruments for general practices had been shown to be £500 per practice and the cost of replacing instruments would be included in the contract. The Decontamination Project Board had recommended the e-learning package for decontamination commissioned by NHS Estates, involving the Institute of Sterile Services Managers, for use in Wales. This would be included in the overall work in relation to healthcare associated infections (HCAIs) which had an educational component for all aspects of HCAIs. 9. Issues concerning risk from blood products 9.i Report on notification of recipients of plasma products The Panel received a report on the September 2004 notification of recipients of implicated plasma products coordinated by the HPA. Preparation for the patient notification exercise had included working from the Det Norsk Veritas blood risk assessment and manufacturing data to calculate the risk of implicated plasma products and developing a communication strategy and documentation tailored to the different groups of health professionals and patients to be involved. During the period 9 from September until the end of December 2004, the HPA CJD Section had carried out approximately 1,800 individual patient risk assessments for patients who had received certain implicated plasma product batches for the treatment of conditions other than bleeding disorders or primary immunodeficiency. Twelve of these individuals had received sufficient doses to be considered ‘at risk’ for public health purposes. Further risk assessments would be undertaken as trusts completed their tracing of recipients of implicated plasma products. 10. Framework document The Panel commented on a draft revision of the framework document. This revision incorporates updates in the light of the two recent notifications of implicated blood product recipients; the agreement of the CMO for England to the establishment of a database of contactable patients; and other minor updates of fact and wording. It was agreed that a further draft of the revised framework document would be circulated to Panel members for their detailed comments. 11. Risk assessments: progress report from Department of Health 11.i Endoscopy A revised version of Annex F to the ACDP TSE Working Group guidance had been posted on the DH website in September. Enquiries had been received by the Panel Secretariat and the DH concerning the implementation of this guidance for relatively common endoscopy procedures in haemophilia patients, eg the treatment of varices associated with hepatitis C. A group had met in January to discuss this issue. Work continues on defining the invasive procedures performed using endoscopes , which carry a risk of contamination of the endoscope channel with the CJD agent with a view to supplementing the guidance in Annex F. 11.ii Revised surgical risk assessment Since the risk assessment undertaken in 1998/1999, new evidence had been found concerning the amount of material which remains on surgical instruments following cleaning, but there was still limited knowledge about the amount of this material attributable to the last patient on whom the instrument had been used, ie the rate of tissue exchange between instruments and patients. Varying levels of risk had been estimated in relation to different categories of lymphoid tissue. A revision of the surgical risk assessment had already been presented to SEAC and NICE and was requested for the agenda of the next Panel meeting. 10 11.iii Blood component recipients: ‘reverse’ risk assessment This risk assessment addressed the question of risk attributable to donors if recipients of their blood developed vCJD. The probability calculations suggested that, under certain assumptions, in a one donor to one recipient scenario, donors to vCJD cases could be seen to have a 50% chance of vCJD infection. It might therefore be consistent with Panel recommendations to consider them ‘at risk’ for public health purposes. Single transfusions are uncommon: therefore there is usually more than one donor per recipient. Whilst there was certainty about the fact that blood components from identified donors had been received by patients who later developed vCJD, there would always be uncertainty about which donor, if any, was the source of the recipient’s infection, if there were more than one. To notify large numbers of patients and ask them to take special public health precautions would run counter to the Panel’s avoidance of informing ‘diluted cohorts’ following surgical incidents. It was agreed that a small meeting needed to consider the issue and relevant data in more detail, following consideration by MSBT later in January. 11.iv Breastmilk There was as yet no evidence of vertical transmission of vCJD via breastmilk and milk banks excluded donors at increased risk of developing CJD. However, the Panel were asked to consider whether sufficient precautions were in place to prevent ‘at risk’ patients from donating breastmilk for other people’s babies, since the standard request to ‘at risk’ patients not to donate ‘tissue and organs’ did not specifically warn them not to donate breastmilk. It was agreed that the standard wording in Panel advice letters concerning the public health precautions to be taken by ‘at risk’ patients would not be changed but that the background information developed by the HPA to support clinicians when informing these patients of their ‘at risk’ status would be amended to include a reference to breastmilk as well as sperm (already included) in relation to tissue. 12. Items for information The Panel noted the items included for information. 13. Date of next meeting 11th May 2005 in London. 11 Annex 1 CJD Incidents Panel Membership (18th January 2005) Name Expertise Chairman Professor Don Jeffries (acting) Mr David Pryer (elect) Deputy Chairman (acting) Dr Mike Painter Virology Lay member Public Health Members Mr Adam Balen Mr John Barker Professor Mike Bramble Dr Gerry Bryant Ms Patricia Cattini Dr Geoff Craig Professor Lesley Fallowfield Dr Calliope (Bobbie) Farsides Ms Jean Gaffin Dr Pat Hewitt Professor James Ironside Ms Diana Kloss Professor John Lumley Mr Henry Marsh Mr Ian Pearce Dr Geoff Ridgway Dr Douglas Russell Dr Roland Salmon Dr John Saunders Dr Peter Simpson Mr Andrew Tullo (retiring) Mrs Gillian Turner Dr Hester Ward Professor Bob Will Ms Kate Woodhead Dr Tim Wyatt Obstetrics and Gynaecology Sterile Service Management Gastroenterology Public Health Medicine Infection Control Nursing Dental Surgery Communication with Patients Ethics Lay Representative Blood Safety TSE Infectivity, Neuropathology Law General Surgery Neurosurgery Ophthalmology Microbiology General Practice Epidemiology Medical Ethics Anaesthesiology Ophthalmology Lay Representative Epidemiology Neurology Theatre Nursing Microbiology Observers Dr Peter Christie Ms Carole Fry Dr Glenda Mock Dr Mike Simmons Scottish Executive Health Department Nursing Officer, Health Protection Division, Department of Health Department of Health, Social Services & Public Safety, Northern Ireland National Assembly of Wales Secretariat Professor Noel Gill Dr Kate Soldan Ms Helen Janecek Ms Katie Oakley Health Protection Agency Centre for Infections: Consultant Epidemiologist Consultant Scientist Senior Administrator CJD Incidents Nurse Investigator 12 Annex 2 List of Papers Paper Number CJDIP 14/ Title 01 Attendee/apology list 02 Draft minutes of 13th meeting on 6th September 2004 03 Draft public summary of 13th meeting on 6th September 2004 04a Correspondence with President of Royal College of Ophthalmologists 04b List of cadre of experts 05 Quarterly summary of reported incidents 06a Advice for endorsement and discussion (without precedent): PI 287, PI 293, PI 44/109 06b Advice for endorsement and discussion (patients to be contacted): PI 256, PI 259, PI 260, PI 267, PI 271 06c Advice for endorsement and discussion (with precedent): PI 272, PI 275, PI 276, PI 278, PI 279, PI 283, PI 289, PI 291, PI 292, PI 295, PI 296 06d Other advice for endorsement and discussion 07 Draft protocol for MRC-funded store for vCJD-contaminated instruments 08a Scottish survey of decontamination in general dental practce 08b Correspondence with Chief Dental Officer’s department 08c Chief Dental Officer’s letter to dentists (draft) 09a Update on decontamination in England 09b Update on decontamination in N Ireland 09d Update on decontamination in Wales 10a Report on notification of recipients of plasma products 10b Future notifications – plans and issues for discussion 10c Follow-up of blood component recipients 10e Correspondence with Mr A Tullo 11 Draft revision for comment 12a Endoscopy: Revised Annex F of ACDP TSE Working Group guidance and correspondence with Mr M Else 12b Blood component recipients: ‘reverse’ risk assessment 12c Organs and tissues: letter to Dr G Thould 13 Draft annual report 2003 to 2004 14 Papers for information http://www.hpa.org.uk/infections/topics_az/cjd/summary_0105.pdf CJD ENDOSCOPY RISK http://www.rense.com/general34/scopes.htm http://www.vegsource.com/talk/madcow/messages/94229.html Variant Creutzfeldt-Jakob disease: update LETTER GUT/ENDOSCOPY http://www.vegsource.com/talk/madcow/messages/93658.html -------- Original Message -------- SEVEN MAJOR SAFETY INCIDENTS/ALERTS IN 12 MONTHS LONDON, November 11 /PRNewswire/ -- The campaign will target decision-makers and influencers such as the Rt. http://www.newratings.com/analyst_news/article_508114.html http://www.vegsource.com/talk/madcow/messages/9911422.html http://www.vegsource.com/talk/madcow/messages/91365.html http://www.rense.com/general34/scopes.htm http://www.vegsource.com/talk/madcow/messages/9910417.html http://www.vegsource.com/talk/madcow/messages/9911694.html some history on the topic of sporadic CJDs and Endoscopy Equipment ??? From: "Terry S. Singeltary Sr." > Date: Sat Nov 30, 2002 11:13 am http://health.groups.yahoo.com/group/cjdvoice/message/22929 From: "Terry S. Singeltary Sr." > Date: Tue Mar 5, 2002 10:37 am http://health.groups.yahoo.com/group/cjdvoice/message/20647 From: "Terry S. Singeltary Sr." > Date: Thu Mar 7, 2002 1:03 pm http://health.groups.yahoo.com/group/cjdvoice/message/20663 From: "Terry S. Singeltary Sr." > Date: Mon Aug 27, 2001 2:51 pm http://health.groups.yahoo.com/group/cjdvoice/message/18796 From: "Terry S. Singeltary Sr." > Date: Sat Aug 25, 2001 11:59 pm http://health.groups.yahoo.com/group/cjdvoice/message/18786 http://health.groups.yahoo.com/group/cjdvoice/message/18777 http://www.vegsource.com/talk/madcow/messages/91365.html TSS ################# BSE-L-subscribe-request@uni-karlsruhe.de ################# Lancet Neurology 2005; 4:805-814 DOI:10.1016/S1474-4422(05)70225-8 Coexistence of multiple PrPSc types in individuals with Creutzfeldt-Jakob disease Magdalini Polymenidou a, Katharina Stoeck a, Markus Glatzel a b, Martin Vey c, Anne Bellon c and Adriano Aguzzi a Summary Methods Findings Interpretation Affiliations a Institute of Neuropathology, University Hospital Zurich, Switzerland Correspondence to: Dr Adriano Aguzzi, Institute of Neuropathology, University Hospital of Zürich, Schmelzbergstrasse 12, CH-8091 Zürich, Switzerland http://www.thelancet.com/journals/laneur/article/PIIS1474442205702258/abstract
|