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News 2001
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RE-INTRODUCTION OF RE-USABLE INSTRUMENTS FOR TONSIL SURGERY
December 15th, 2001
The Department of Health today (14.12.01) announced the reintroduction of re-usable surgical instruments for tonsillectomy and adenoidectomy surgery. This change follows discussions with the British Association of Otorhinolaryngologists (BAO - representing ear, nose and throat surgeons) on adverse events caused by single-use instruments and the balance of risks to patients.
The move to single use instruments was announced on 4 January 2001. This followed advice from the Spongiform Encephalopathy Advisory Committee (SEAC) that there was a theoretical risk of transmission of variant Creutzfeldt-Jacob Disease (vCJD) from re-usable surgical instruments, as the infective prion agent is not completely destroyed by normal sterilisation.
SEAC had endorsed using tonsillectomy as a pilot scheme to see how single-use instruments would work in practice. SEAC has stressed that the key steps in reducing any risk of vCJD transmission is the rigorous implementation of washing, decontamination and general hygiene procedures in the health care setting. The Department of Health published the results of a national survey of decontamination on 11 December 2001, with central decontamination services in all Trusts rated as either good or adequate.
Following the introdution of single use instruments there was an increase in adverse incidents - typically increased bleeding but including one death. These have been urgently investigated by the Department of Health and the Medical Devices Agency, who issued a Hazard Notice on 26 October 2001 giving new advice to surgeons on the use of diathermy. The Department subsequently suspended the routine use of single-use diathermy on 4 December 2001.
The Department has also found that other single-use instruments and their use by surgeons has led to adverse incidents. This represents an actual risk to patients, compared with a theoretical risk of transmission of vCJD. Given this balance of risks, the Department of Health has decided that surgeons can return to using re-usable surgical equipment which should be sterilised in the normal way. Where surgeons do not have immediate access to re-usable instruments, in the interim they can choose to continue using single-use instruments if they are comfortable with their use and they have not had an increase in adverse events.
*. The introduction of single use instruments was announced on 4 January 2001, following advice from the Spongiform Encephalopathy Advisory Committee (SEAC). http://www.doh.gov.uk/newsdesk/archive/jan2001/4-naa-04012001.html
*. SEAC publishes summaries of its meetings and Q&A on its recommendations on its website: http://www.defra.gov.uk/animalh/bse/bse-science/level-4-seac.html
*. The results of the national decontamination survey are published on the NHS Estates website. http://www.decontamination.nhsestates.gov.uk
*. The Department of Health announced the suspension of single-use diathermy forceps on 4 December 2001. Diathermy is a tool used to close the wound and seal tissues using heat rather than stitches. The suspension applied to all forms of diathermy. The Medical Devices Agency issued a Hazard Notice on 24 October 2001 on single-use electrosurgical diathermy. See the MDA Website, Publications, MDA Safety Warning, Hazard Notices, 2001, HN 2001(04). http://www.medical-devices.gov.uk/
*. Around 6,500 tonsillectomies are performed each month. While tonsil surgery is usually a safe procedure, post-operative bleeding can cause complications in a number of patients each year.
DECONTAMINATION SURVEY RESULTS PUBLISHED
December 11th, 2001
National survey leads to big improvement in standards
The Department of Health today published the results of a national survey of decontamination services for surgical instruments in the NHS. The survey follows advice from the Spongiform Encephalopathy Advisory Committee (SEAC) that a key factor in reducing the theoretical risk of person-to-person spread of variant Creutzfeldt-Jakob Disease (vCJD) is a high standard of decontamination of surgical instruments. Effective decontamination is also a key component in high quality surgical care.
There are 182 acute NHS Trusts covering 249 hospitals with central Sterile Services Departments in England. In any one year approximately 6.5 million surgical procedures take place. The surgical instruments from these procedures must be routinely and effectively decontaminated in order to minimise the risk of transmitting infection.
Reviews by NHS Trusts and inspections by NHS Estates decontamination teams across the country found that decontamination services in 109 hospitals did not initially meet acceptable standards. By implementing urgent action plans and improving the management of decontamination services, NHS Estates now rates decontamination in all 249 hospitals with central sterile services as either acceptable or better.
Health Minister Lord Philip Hunt said:
"We are determined to build on this momentum to raise standards of decontamination throughout the NHS. The Department of Health has announced that £200million will be spent improving decontamination services by 2003. This will be invested in new equipment and facilities that will decontaminate surgical equipment to the highest standards."
The Decontamination Survey used a traffic light system to classify individual hospital decontamination services as either red, amber or green. The Survey results and appendices, including preliminary snapshot survey, are available on the NHS Estates website: www.decontamination.nhsestates.gov.uk
The national survey started with the publication of Health Service Circular HSC 2000/032 "Decontamination of medical devices" October 2000, which required NHS organisations to review their management arrangements urgently and to carry out a health and safety audit of their decontamination procedures. Health Service Circulars are published on the Department of Health Website. Visit www.doh.gov.uk/publications/coinh.html and use 'Click on here to enter COIN'.
The Spongiform Encephalopathy Advisory Committee (SEAC) publishes summaries of its meetings and its recommendations. See their website: www.defra.gov.uk/animalh/bse/bse-science/level-4-seac.html
SUSPENSION OF DIATHERMY IN TONSIL AND ADENOID SURGERY
December 4th, 2001
Precaution pending outcome of inquiry into patient death
The Department of Health today has instructed surgeons to suspend the use of all single-use electrosurgical diathermy forceps in tonsil and adenoid surgery with immediate effect. The only exception is when a surgeon is unable to control bleeding by other means. In a move to protect patient safety, this suspension is pending the outcome of investigations into a number of adverse events, including the death of a patient following tonsil surgery.
The announcement was made to surgeons via an urgent message sent overnight. It follows urgent discussions with the British Association of Otorhinolaryngologists (Ear, Nose and Throat surgeons) and the Medical Devices Agency.
The investigation into the fatal incident is ongoing, but a causal factor could be the use of single-use diathermy of either the monopolar or bipolar type. The Department of Health introduced single-use instruments for tonsillectomy and adenoidectomy earlier this year to remove the risk of transmission of variant CJD through surgical instruments. Surgeons had reported a number of problems with the instruments and these led to adjustments to their manufacture. In response to reports of a number of adverse incidents - mainly haemorrhaging - the Medical Devices Agency issued a Hazard notice on single-use diathermy forceps on 24 October 2001. This led to a fall in the number of adverse incidents, but the reports have continued and now include a death following tonsil surgery.
Deputy Chief Medical Officer Dr Pat Troop said:
"While the investigation into this tragic death is ongoing, we cannot take risks with patient safety. The suspension on using diathermy is a sensible precaution. We need to establish why diathermy is causing problems before we let these routine operations proceed using these devices."
The Medical Devices Agency, the NHS Purchasing and Supply Agency and the Department of Health are working in close co-operation with Ear, Nose and Throat surgeons and their professional association to find a solution that enables diathermy to be safely reintroduced for tonsil and adenoid surgery.
1. The introduction of single use instruments was announced on 4 January 2001, following advice from the Spongiform Encephalopathy Advisory Committee (SEAC). SEAC recommended introducing single use instruments for specific procedures to reduce the risk of transmission of variant CJD via surgical instruments.http://www.doh.gov.uk/newsdesk/archive/jan2001/4-naa-04012001.html
2. The Medical Devices Agency issued a Hazard Notice on 24 October 2001 on single-use electrosurgical diathermy forceps. Diathermy is a tool used to close the wound and seal tissues using heat rather than stitches. The suspension applies to all forms of diathermy. See the MDA Website, Publications, MDA Safety Warning, Hazard Notices, 2001, HN 2001(04). http://www.medical-devices.gov.uk/
3. Around 6,500 tonsillectomies are performed each month. While tonsil surgery is usually a safe procedure, post-operative bleeding can cause complications in a number of patients each year. Many surgeons do not use diathermy routinely during tonsillectomy on children, but have it available as a back-up.
NEW GUIDANCE ON PATIENT NOTIFICATION EXERCISES WHEN A HEALTH CARE WORKER IS FOUND TO BE INFECTED WITH HIV
November 28th, 2001
The Department of Health today announced a new policy on the action to be taken whenever a healthcare worker is found to be infected with HIV. This new policy is based on advice from the Expert Advisory Group on AIDS and the UK Advisory Panel on Health Care Workers Infected with Blood Borne Viruses.
From now on the risk of HIV transmission to patients will be assessed on a case by case basis using a criteria based framework. The extent of the patient notification exercise will depend on the level of risk of exposure. This may mean that in some instances there is no patient notification exercise, or it is limited in scope. Until now all patients have been notified regardless of their level of risk.
The decision to review our policy was reached at the end of last year. Work reviewing all the relevant facts and consideration of the future options has been ongoing since the beginning of this year.
The decision to change the policy was reached in the light of the fact that we have never detected a transmission of HIV from an infected health care worker to a patient in this country, even though we have undertaken 22 extensive look back exercises involving thousands of patients. This policy change has been taken in an effort to avoid unnecessary anxiety to patients and means that our policy is now more in line with that of the rest of the world.
The Department is currently working with health professionals and patients to draw up specific guidance to quantify the level of risk associated with clinical procedures that are classified as exposure prone. The guidance will be designed to give Directors of Public Health clear criteria to guide them when considering whether a patient notification exercise is warranted, and its extent. Under the new guidance, all patients that are notified will be offered pre-test discussion and an HIV antibody test.
Previous guidance 'AIDS/HIV infected Health Care Workers: Guidance on the management of Infected Health Care Workers and Patient Notification' was published in December 1998.
Exposure prone procedures are those invasive procedures where there is a risk that injury to the worker may result in the exposure of the patients open tissues to the blood of their health care worker. These include procedures where the workers gloved hands may be in contact with sharp instruments, needle tips or sharp tissues (e.g. spicules of bone or teeth) inside a patients open body cavity, wound or confined anatomical space where the hands or finger tips may not be completely visible at all times.
Some countries have carried out patient notification exercises in the past (mainly the USA) but most now feel that the risk of transmission of HIV from health care worker to patient is so small that these are no longer justified because of the unnecessary anxiety they cause patients.
No case of HIV transmission from an infected health care worker to a patient has ever been recorded in the UK. There have only been two reported incidents world wide In a well publicised case of a dentist in Florida HIV was transmitted to six patients, however the exact route of transmission has never been established. More recently transmission of HIV from an infected orthopaedic surgeon to a patient was reported in France.
NEW NATIONAL GUIDANCE FOR PATIENT CONSENT
November 22nd, 2001
The Reference guide to consent for examination or treatment and 12 key points on consent: the law in England were published in March 2001.
Consent - what you have a right to expect, a set of leaflets for patients, were published in July 2001.
Today we are publishing the Good practice in consent implementation guide, containing a model consent policy and model consent forms. There are four new model consent forms to meet the needs of different groups of patients:
for patients able to consent for themselves; for those with parental responsibility, consenting on behalf of a child or a young person; for patients able to consent for themselves and for those with parental responsibility consenting on behalf of a child/ young person where the procedure does not involve any impairment ofconsciousness; and for adults who lack capacity to consent.
There are also three new guidance documents:
Seeking consent: working with children; working with older people; and working with people with learning disabilities.
All these documents can be downloaded from www.doh.gov.uk/consent or ordered from 08701 555 455.
Interim guidance on post-mortem examination for the NHS was published in March 2000, available from www.doh.gov.uk/publications/pointh.html or ordered from 08701 555 455. The Government is currently reviewing the law governing the use of human organs and tissues as part of the follow-up to the Liverpool and Bristol Inquiry reports.
It has accepted the Chief Medical Officer's recommendation - The removal, retention and use of human organs and tissue from post-mortem examination: advice from the Chief Medical Office, January 2001
www.doh.gov.uk/orgretentionadvice consent forms for
obtaining consent to hospital post-mortems and any subsequent retention of tissue and organs should be provided for use throughout the NHS. The Department of Health, in association with stakeholders, is in the process of developing these model forms which will be published for consultation shortly. There will also be a parallel pilot phase.
HIV-positive NHS worker fights for right to privacy
November 20th, 2001
An HIV-positive worker in the NHS is fighting a landmark legal action that could prevent those he has treated knowing that they could have been in contact with the virus. The worker is reportedly claiming that his right to privacy should supersede the rights of patients he has treated to know of his condition. If his claim is upheld in law, the case could have "serious implications" for the way in which the NHS handles such cases. The worker won an injunction on Saturday (17/11/01) to prevent a newspaper publishing his name or the branch of medicine he works in, although the newspaper said he worked in a field that involved the routine wearing of rubber gloves to prevent the transmission of infection. (The Guardian 19/11/01; p.8) http://www.guardian.co.uk © Health Media Ltd 2001 http://www.health-secure.net
NEW REGULATORY BODIES FOR HEALTH WORKERS
November 17th, 2001
Legislation to introduce two new regulatory watchdogs to oversee the work of nurses, midwives and allied health professions, was introduced today by Health Minister, John Hutton.
1. The legislation in is the form of Orders made under section 60 of the Health Act 1999. Copies are available on the DOH website at:
www.doh.gov.uk/nursingandmidwiferyorder
www.doh.gov.uk/healthprofessionsorder
2. The Nursing and Midwifery Order provides for the Nursing and Midwifery Council to come into effect from April 2002. The Council has existed in shadow form since May 2001. Its President is Jonathan Asbridge. The Nursing and Midwifery Council (NMC) will replace the United Kingdom Central Council for Nursing and Midwifery (UKCC) and its four national boards.
3. The Health Professions Order provides for the Health Professions Council to come into effect from April 2002. The Council has existed in shadow form since May 2001. Its President is Professor Norma Brook. The Health Professions Council (HPC) will replace the Council for Professions Supplementary to Medicine (CPSM) and its twelve boards.
The professions initially covered by HPC will be arts therapists; chiropodists; clinical scientists; dietitians; medical laboratory technicians; occupational therapists; orthoptists; paramedics; physiotherapists; prosthetists and orthotists; radiographers; and speech and language therapists. There will be scope to add other groups as they become ready for regulation.
REFORM OF THE SYSTEM FOR DEALING WITH CLINICAL NEGLIGENCE CLAIMS
August 29th, 2001
CMO issues document inviting views on clinical negligence reforms
The next steps in improving the system of clinical negligence claims for patients were taken today as Chief Medical Officer, (CMO) Professor Liam Donaldson, published proposals for reform.Professor Donaldson today issued a document, inviting views from the public and NHS staff on how to reform the current, often bureaucratic, clinical negligence system. Comments received will inform the CMO's advisory committee on options for reform and the development of a White Paper for early next year.
Following the Bristol Inquiry the document is part of a broader reform programme to make the NHS better and safer for patients. A recent National Audit Office report found that, on average, legal costs were more than damages actually paid out in 44 per cent of cases and the average case took five and a half years to settle.
Call for Ideas can be found on our website www.doh.gov.uk/clinicalnegligencereform or hard copies can be obtained by phoning 0113 254 6376. Comments should be sent by 10 October to Carolyn Heaney, Head of Complaints and Clinical Negligence Policy Team, Rm 3E45,Quarry House, Quarry Hill, Leeds, LS2 7UE.
Risk Assessment on Variant CJD Transmission Published
March 17th, 2001
The Department of Health published on the 16th March 2001 the report " Risk Assessment for the transmission of vCJD via surgical instruments" It is published in both a summary (33 pages) and full length version (144 pages, including annexes)
The report can be located at: www.doh.gov.uk/cjd/riskassessmentsi.htm
Medical Technical Officer - PTB Staffs B Whitley Council - New Pay Rates
March 17th, 2001
*Increases to National Salary Scales 2001/2. *Increases in Emergency Duty Payments *Increases to London Allowances
Full details of the arrangements available at: www.doh.gov.uk/coinh.htm Look for reference: Advance Letter (PTB) 1/2001.