Transmissible Spongiform Encephalopathies ( TSEs ) / Creutzfeldt Jakob Disease ( CJD ) |
| Publication: 01/11/2000 |
| Next review: 08/06/2025 |
| Clinical Guideline |
| CURRENT |
| ID: 682 |
| Approved By: Trust Clinical Guidelines Group |
| Copyright© Leeds Teaching Hospitals NHS Trust 2022 |
This Clinical Guideline is intended for use by healthcare professionals within Leeds unless otherwise stated. |
Transmissible Spongiform Encephalopothies(TSE’s)/ Creutzfeldt Jakob Disease (CJD)
- Appendix 1 - Distribution of TSE infectivity in human tissues and body fluids
- Appendix 2 - Algorithm chart for precautions for reusable intruments for surgical procedures on patients with, or "at increased risk of" CJD, vCJD and other human prion diseases
- Appendix 3 - Summary of precautions advised for the use of Endoscopes - (CJD other than vCJD)
- Appendix 4 - Summary of precautions for the use of endoscopes - (vCJD and CJD type uncertain)
- Appendix 5 - Common flexible endoscopic procedures classified as invasive or non-invasive
- Appendix 6 - Make up and disposal of sets for patients "at increased risk" of CJD/vCJD
- Appendix 7 - Log sheet for disposal of "high risk" equipment
- Appendix 8 - Procedure Manaual
- Appendix 9 - Information for patients undergoing surgery or neuro-endoscopy on high risk tissues
- Appendix 10: Possible risk of CJD/vCJD Quarantine of Flexible Endoscope Form
- Appendix 11: Dental Addendum
Summary of Guideline
- The human Transmissible Spongiform Encephalopathy agents (TSEs) are:
- Creutzfeldt Jakob disease (CJD) including classical sporadic; familial; iatrogenic and variant;
- Variable Protease-Sensitive Prionopathy (VPSPr);
- Gerstmann Sträussler Scheinker (GSS) syndrome;
- Fatal familial insomnia (FFI);
- Kuru
- TSEs are caused by unconventional infectious agents currently thought to be proteins known as prions. TSE agents exhibit unusual resistance to most decontamination methods.
- There is no evidence that TSEs have been, or can be spread from person to person by close contact or through occupational exposure.
- For routine clinical contact: continue to use Standard Precautions.
- For patients having invasive surgical procedures or an endoscopy a risk assessment for risk of CJD must be conducted and documented as part of admission procedures for both routine and emergency admissions or at pre-admission screening.
- For patients undergoing surgery/invasive or endoscopic procedures who have a differential diagnosis that includes CJD (or significant exposure to a TSE agent) Infection Prevention and Control must be involved in the decision taken with regard to instrument/endoscope use and decontamination.
Aims
This guideline covers the specific precautions to be taken for symptomatic patients and patients “at increased risk” of developing CJD or vCJD in the aim of preventing the transmission of the disease.
Any measures to be taken depend on:
- How likely the patient is to be carrying the infectious agent (risk status); (see Table 1) and
- How likely it is that infection could be transmitted by the procedure being carried out.
Background
TSEs are caused by unconventional infectious agents currently thought to be proteins known as prions. TSE agents exhibit unusual resistance to conventional decontamination methods (e.g. autoclaving or chemical disinfection).
The human TSE’s occur in 3 groups:
- Idiopathic diseases: sporadic CJD and sporadic fatal insomnia
- Familial diseases: familial CJD, Gerstmann-Straussler-Scheinker diseases (GSS) and fatal familial insomnia
- Acquired diseases: human agents: Kuru and iatrogenic CJD Bovine agent: Variant CJD (vCJD)
The use of the term CJD in this guideline encompasses sporadic CJD, familial CJD, genetic CJD, Fatal Familial Insomnia (FFI) and Gerstmann-Straussler-Scheinker Disease (GSS). As CJD accounts for 95% of reported cases of human TSE’s, the term “CJD” has been used throughout as a proxy for all human TSE’s to assist readability.
The human TSEs cause a variety of neurological symptoms including dementia and personality disorders as well as neuromuscular symptoms e.g. unsteadiness, involuntary muscular jerking. All human TSEs are extremely rare but all are usually fatal. The worldwide incidence of CJD is about 1 per million people each year. There are no proven specific treatments available.
There is evidence that the distribution of the disease specific prion protein in tissue is more widespread in the body in variant CJD (vCJD) than in patients affected by sporadic CJD. In sporadic CJD, the presence of abnormal prion protein in patients with clinical disease appears to be restricted to the central nervous system (CNS) However, abnormal prion protein has been detected in various lymphoid tissues, including tonsils, spleen, gastrointestinal lymphoid tissue (appendix and rectum), lymph nodes, thymus and adrenal glands of patients with clinical vCJD. This information is used to generate specific Infection Prevention and Control precautions. (See Appendix 1)
In this guideline, the term ‘patients with, or “at increased risk” of, CJD or vCJD’ is used as a proxy for all patients groups in Table 1. Where this term is used, the guidance is applicable to all patient groups in this Table
Diagnosis
Whilst the evidence to date does not suggest that CJD or vCJD are spread from person to person by close contact, it is known that transmission of sporadic CJD can occur in specific situations associated with medical interventions (known as iatrogenic infections). A number of cases of iatrogenic CJD have been associated with the administration of hormones prepared from human pituitary glands and dura mater preparations and one case has been reported associated with a corneal graft. Iatrogenic transmission has also been identified following neurosurgical procedures with inadequately decontaminated instruments or EEG needles. There has been no known transmission of vCJD via surgery or use of tissue or organs. Since 2003, four cases of presumed person to person transmission of vCJD infection via blood transfusion of non-leucodepleted red blood cells have been reported in the UK. Consequently there are particular groups of patients who present a greater risk of potential exposure to the CJD agent.
When considering measures to prevent transmission to patients or staff in the healthcare setting, it is important to make a distinction between
- symptomatic patients, i.e. those who fulfil the diagnostic criteria for definite, probable or possible CJD or vCJD, and
- patients “at increased risk” i.e. those with no clinical symptoms, but who are “at increased risk” of developing CJD or vCJD, because of their family or medical history, and/or they have been informed they are “at increased risk” for public health purposes.
Table 1 below details the classification of the risk status of symptomatic and patients deemed “at increased risk.”
There are currently no widely available laboratory tests for human TSEs although the diagnosis can be confirmed by examination of brain tissue after death. Therefore diagnosis is dependent on a specific set of criteria based on clinical symptoms as set down by the National CJD Surveillance Unit (NCJDSU)
Table 1 Categorisation of patients by risk
|
|
Patient groups |
|
Symptomatic |
|
|
Patients “at increased risk” |
|
|
Patients identified as “at |
|
| Patients identified as “at increased risk” through iatrogenic exposures
|
|
(Taken from ‘Transmissible Spongiform Encephalopathy Agents: Safe Working and the Prevention of Infection: Part 4’ Department of Health February 2015)
Management
Risk Assessment for Identifying Patients with, or at Increased Risk of CJD or vCJD prior to Surgery or Endoscopy
The CJD Incidents Panel has identified a number of individuals or groups who are at increased risk of CJD or vCJD.
It is essential that any patients who have been notified for public health purposes are identified before invasive procedures/surgery or endoscopy in order to ensure the correct Infection Prevention and Control procedures are followed.
ALL patients about to undergo ANY elective or emergency surgical or endoscopic procedure should be asked the question:
“Have you ever been notified that you are at increased risk of CJD or vCJD for public health purposes?”
The actions to take following the patient’s response to the above question are:
| Patient’s response |
Action |
|
No |
Surgery or endoscopy should proceed using normal infection prevention and control procedures unless the procedure is likely to lead to contact with high risk tissue |
|
Yes |
Please ask the patient to explain further the reason they were notified Special Infection Control precautions should be taken for all surgery or endoscopy involving contact with medium or high infectivity tissues. (See Appendix 1) and the Infection Prevention and Control Team should be consulted for advice. |
|
Unable to respond |
Surgery or endoscopy should proceed using normal Infection Prevention and Control procedures unless the procedure is likely to lead to contact with high-risk tissue. If this is the case further guidance should be sought from Transmissible Spongiform Encephalopathy Agents: Safe Working and the Prevention of Infection: Annex J Jan 2017 |
In the event that a patient is about to have emergency surgery or neuro-endoscopy is physically or otherwise unable 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 2 prior to the surgery or neuro-endoscopy.
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 intradural 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
In addition to 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 in Table 3 to assess possible unrecognised risk of CJD/vCJD.
N.B. If a patient has answered YES in Table 2, there is no need to ask the additional questions as the patient’s risk status has been established.
Tissues assumed or proven to have high level infectivity for CJD or vCJD are:
- Brain
- Spinal cord
- Implanted dura mater grafts prior to 1992
- Cranial nerves, specifically:
- the entire optic nerve
- only the intracranial components of the other cranial nerves
- Cranial nerve ganglia
- Posteria eye, specifically:
- Posteria hyaloid face
- Retina
- Retinal pigment epithelium
- Choroid
- Subretinal fluid
- Optic nerve
- Pituitary gland
Appendix 1 gives further advice on CJD/vCJD tissue infectivity
Appendix 9 is an information sheet for pre-surgical patients undergoing surgery or neuroendoscopy on high risk tissues regarding the questions they will be asked.
|
Question to Patient |
Notes to Clinician |
Patients response |
Action to be taken following patient’s response |
|
|
1 |
Have you a history of CJD or other prion disease in your family? If yes, please specify. |
Patient should be considered to be at risk from genetic forms of CJD if they have or have had:
|
NO |
Surgery or neuro-endoscopy can proceed using normal infection control procedures |
|
YES |
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, special infection control precautions should be taken and the local Infection Prevention Team should be consulted for advice. Further guidance on the management of these patients will be given below. 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 Public Health England Patients who are at increased risk of genetic forms of CJD should be offered the opportunity of referral to the National Hospital for Neurology and Neurosurgery, Queen Square, London: http://www.nationalprionclinic.org/ |
|||
|
Question to Patient |
Notes to Clinician |
Patients response |
Action to be taken following patient’s response |
|
|
2 |
Have you ever received growth hormone or gonadotrophin treatment? If yes, please specify
|
Recipients of hormone derived from human pituitary glands, e.g. growth hormone or gonadotrophin, have been identified as at increased risk of 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 |
NO/Not certain |
Surgery or neuro-endoscopy can proceed using normal infection prevention and control procedures |
|
YES |
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, special infection control precautions should be taken and the local Infection Prevention Team should be consulted for advice. Further guidance on the management of these patients will be given below. 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 Public Health England Patients should also be offered a referral to the Patients who are at increased risk of CJD due to receipt of human derived growth hormone or gonadotrophin should be offered the opportunity of |
|||
|
Question to Patient |
Notes to Clinician |
Patients response |
Action to be taken following patient’s response |
|
|
3 |
Have you ever had surgery on your brain or spinal cord?
|
(a) Individuals who underwent intradural brain or intradural spinal surgery before August 1992 who received (or might have received) a graft of human-derived dura mater are “at increased risk” of transmission of sporadic CJD (unless evidence can be provided that human-derived dura mater was not used) |
NO |
Surgery or neuro-endoscopy can proceed using normal infection prevention and control procedures |
|
YES |
Further investigation should be undertaken, to establish the details needed to assess the patient’s CJD risk. 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 prevention and control precautions should be taken and the local Infection Prevention Team should be consulted for advice. Further guidance on the management of these patients will be given below. 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 PHE website |
Health services should ensure that healthcare staff conducting pre-surgery assessments receive instruction and/or training necessary to understand the reasons for asking these questions. It is important that these questions are asked in a manner that does not cause undue anxiety, and therefore the questioner should be prepared and able to reassure the patient, and provide further information if needed. Information for patients is available from the GOV.uk website.
Hospital Care of Patients with, or ‘at increased risk’ of CJD
General Ward contact
There is no evidence that normal social or routine clinical contact of CJD patients presents a risk to healthcare workers, relatives or others. Isolation of patients with CJD is not necessary; they can be nursed in an open ward using Standard Infection Prevention and Control Precautions
However, when certain invasive interventions are performed, there is the potential for exposure to the agents of TSE’s. In these situations it is essential that control measures are in place to prevent iatrogenic transmission.
Sample taking and other Invasive Medical Procedures
When performing any procedures or taking any samples, the possible infectivity of the tissues must be considered and any necessary precautions taken. Information on tissue infectivity is in Appendix 1. It is important to ensure that only trained staff, who are aware of the hazards, carry out invasive procedures that may lead to contact with medium or high-risk tissue.
Body secretions and body fluids (including saliva, blood and cerebrospinal fluid (CSF) and excreta) are all low risk for CJD. It is therefore likely that the majority of samples taken or procedures performed will be low risk.
Blood and body fluid samples from patients with, or “at increased risk” of CJD, should be treated as potentially infectious for blood borne viruses and handled using standard precautions as for any other patient, i.e.
- Use of personal protective equipment (PPE) as required
- Avoidance of sharps injuries
- Safe disposal of sharps and contaminated waste
- Single-use disposable equipment wherever possible
Samples from patients with, or ‘at increased risk’ of CJD should be marked with a ‘Biohazard’ label. It is advisable to contact the laboratory for advice before submitting specimens.
Spillages
Standard Precautions should be followed for ANY spillages, which should be cleared up as quickly as possible, keeping contamination to a minimum. Disposable gloves and an apron should be worn.
For spillages of large volumes of liquid, absorbent granules should be used to absorb the spillage.
The surface should be disinfected with 10,000 ppm chlorine-releasing agent after the spillage has been removed.
Any waste (including cleaning tools such as mop heads and PPE worn) should be disposed of as clinical waste.
Clinical Waste
General guidance on the safe management of clinical waste is given in the Department of Health’s guidance document ‘Health Technical Memorandum 07- 01: Safe Management of Healthcare Waste’, available at: Link
The ACDP TSE risk Management Sub Group have agreed that tissues, and contaminated materials such as dressings and sharps, from patients with, or “at increased risk” of, CJD, should be disposed of as in the following table:
Table 4: Disposal of clinical waste from patients with, or “at increased risk” of, CJD
|
Diagnosis of CJD |
High or medium risk tissue* |
Low risk tissue and body fluids** |
|
Definite |
Incinerate |
Normal clinical waste disposal |
|
Probable |
Incinerate |
Normal clinical waste disposal |
|
“At increased risk” |
Incinerate |
Normal clinical waste disposal |
* See Appendix 1
** Tissues and materials deemed to be low risk include body fluids such as urine, saliva, sputum, blood and faeces. Blood from vCJD patients is considered to be low risk except when transfused in large volumes
Childbirth
In the event that a patient with or “at increased risk” of CJD becomes pregnant it is important to ensure patient confidentiality is properly maintained. Childbirth should be managed using Standard Precautions. (LTHT Standard Infection Prevention and Control Precautions). The placenta and other associated material and fluids are designated as low risk tissues, and should be disposed of as clinical waste
Bed linen
Used or fouled bed linen (contaminated with body fluids or excreta), should be washed and dried in accordance with current standard practice. No further handling or processing is necessary.
Occupational exposure
Although cases of CJD have been reported in healthcare workers, there have been no confirmed cases linked to occupational exposure. However it is prudent to take a precautionary approach. The highest potential risk is from exposure to high infectivity tissues through inoculation injury. For any accident involving sharps or contamination of abrasions with blood or body fluids or splashes into the eyes or mouth the LTHT Inoculation Incident - Prevention and Management of and Inoculation Incident Policy should be followed.
Healthcare workers who work with patients with definite, probable or possible CJD/vCJD should be appropriately informed about the nature of the risk and relevant safety procedures.
Surgical procedures and instrument management
The measures to be taken when performing invasive surgery depend on:
- How likely the patient is to be carrying the infectious agent (risk status) (see appendix 1); and
- How likely it is that infection could be transmitted by the procedure being carried out.
- For patients with or “at increased risk” of CJD where the instruments come into contact with high or medium risk tissue the instruments will either need to be single-use or destroyed. (This is outwith national guidance as neither the Trust nor the decontamination provider BBraun have facilities for pre-cleaning and quarantining instruments
- Where the instruments come into contact with low risk tissue there are no special precautions.
(see Appendix 2)
Pre- invasive/surgical procedure measures
For all patients with, or “at increased risk” of CJD, the following precautions should be taken for those patients undergoing medium/high risk surgical procedures:
- The nurse in charge of the relevant theatre/department must inform the Infection Prevention and Control department
- Theatre must put together a set of instruments for the individual use of the patient or utilise single use instrumentation where available. .
- Because instrumentation used in a medium/high risk procedure will need to be destroyed after use, the nurse in charge of the relevant theatre/department will need to inform B Braun of any reusable instrument stock to be used. This will ensure accurate records for traceability.
- BBraun must be informed of new or amended instrument sets/supplementary stock at least 72 hours in advance using aa PD4 form(See Appendix 6).
- For endoscopy see below and Appendix 5.
Theatre management
- The procedure should be performed by experienced staff who understand the nature of the risk
- Wherever appropriate and possible the intervention should be performed in an operating theatre
- Where possible, procedures should be performed at the end of the list, to allow normal cleaning of theatre surfaces before the next session;
- Only the minimum number of health care personnel required should be involved;
- Protective clothing should be worn, i.e. liquid-repellent operating gown, over a plastic apron, gloves, mask and goggles or full-face visor.
- For symptomatic patients, this protective clothing should be single-use and disposed of. All waste should be destroyed by incineration in the yellow and purple striped bag waste stream.
- for patients “at increased risk” of CJD, this protective clothing need not be single use and may be reprocessed
- Maintain a one way flow of instruments
- Single-use disposable surgical instruments and equipment should be used where possible.
- Some expensive re-usable equipment (e.g. drills) may be protected from contamination by using shields, guards or covering, so that the entire items do not need to be destroyed. In this case, the drill bit, other parts in contact with high or medium risk tissues, and the protective coverings used would then need to be incinerated. However, in practice, it may be difficult to ensure effective protective covering and advice should be sought from neurosurgical staff and the manufacturer to determine practicality.
- A list of any workers exposed (those involved in a medium/nigh risk surgical procedure) as should be made and records kept for 40 years.
Post operative instrument decontamination/disposal
Following use all equipment used in the procedure must be placed into an incineration bin and sealed. Form G1.5F1 must be completed and sent to the Decontamination Team so a record can be made of the equipment destruction. (See Appendix 7) If the instrumentation would normally be reprocessed through Sterile Services, as above Bbraun are to be informed in order that the unique ID which is linked to the instrument tracking and traceability system can be updated to evidence that the instrumentation is no longer available for use.
N.B. LTHT is currently unable to quarantine surgical instruments
Endoscopy procedures and endoscope management
For all patients with, or “at increased risk” of CJD the following precautions should be taken for endoscopy procedures:
- The nurse in charge must inform the Infection Prevention and Control department and agree the appropriate precautions to be taken as per the guidance set out in HTM 01-06 and ACDP TSE Annex F.
- The nurse in charge must inform the Endoscope Decontamination Hub Manager in advance of the procedure of any endoscope that will destroyed after use or returned to the Hub for reprocessing prior to quarantine/storage. This will ensure accurate records for traceability, appropriate handling and that the correct endoscope/equipment decontamination process is followed.
National guidance includes other general precautions to decrease the risk of transmission of TSEs through endoscopic procedures
- Channel cleaning brushes and, if biopsy forceps or other accessories have been passed, the rubber valve on the endoscope biopsy/instrument channel port should be disposed of as clinical waste after each use. Single use (i.e. disposable) biopsy forceps should be used routinely in all patients. This guideline endorses the advice that endoscope accessories should be single use wherever possible. There MUST be systems in place that enable endoscopes, together with all their detachable components and any reused accessories, to be traced to the patients on whom they have been used.
- Endoscopes used for certain procedures in the CNS and nasal cavity in individuals with possible sporadic CJD, or in whom the diagnosis is unclear should be removed from use or quarantined pending diagnosis or exclusion of CJD (See Appendices 3/4 )
- Endoscopes other than those used in the CNS and nasal cavity, which have been used for invasive procedures in individuals designated as at risk of vCJD, should be removed from use or quarantined to be re-used exclusively on the same individual patient if required (See Appendix 5)
If it is appropriate to quarantine an endoscope after use, as above, the nurse in charge must liaise with the Endoscope Decontamination Hub Manager with regard to collection of the endoscope after use, decontamination and quarantine/storage. After use the endoscope for quarantine should undergo the normal bedside pre-clean. Within the Endoscope Decontamination Hub the endoscope should be processed separately through the manual cleaning and endoscope washer disinfector (EWD). Any staff handling the endoscope should wear appropriate personal protective equipment i.e. liquid-repellent operating gown, a plastic apron, gloves, mask and goggles or full-face visor.
Following the decontamination of the endoscope, the endoscope washer disinfector and any EWD connectors used should be run through an empty disinfection cycle and then an EWD self-disinfect cycle
The decontaminated endoscope should be placed in a sealed box and a Possible risk of CJD/vCJD Quarantine of Flexible Endoscope form (Appendix 10) completed and attached. The Endoscope Decontamination Hub Manager will arrange storage in a designated quarantine area until the outcome of any further investigations is known or it is required on the same patient. If an alternative diagnosis is confirmed by the IPC Team, the endoscope may be removed from the quarantine area and reprocessed according to best practice and returned to use.
If it is agreed that an endoscope should be destroyed after use it should not be returned to the Endoscope Decontamination Hub, but instead be placed by the clinical team into an incineration bin and sealed. Form G1.5F1 must be completed and sent to the Infection Prevention Team so a record can be made of the endoscope destruction. (See Appendix 7). The Endoscope Decontamination Hub Manager should be informed in order that the unique ID which is linked to the endoscope tracking and traceability system can be updated to evidence that the instrumentation is no longer available for use.
National Resource for CJD
Advice is available from the UK Health Security Agency CJD Section, who can be contacted on 020 8327 6090.
Following Death of a Patient
In the event of the death of a patient in the risk categories as shown in Table 1,follow the procedure outlined in LTHT Standard Infection Prevention and Control Precautions. Removal of the body from the ward should be carried out using normal infection control measures. It is recommended that the deceased patient is placed in a body bag prior to transportation to the mortuary.
If a post mortem is required, only fully trained, competent staff should undertake a post mortem on patients defined in Table 1. At least two people are required to be present - the pathologist assisted by at least one other.
Post mortem examinations on CJD cases can take place in any mortuary subject to local risk assessment.
Disposable protective clothing should be worn during the procedure, including a theatre suit, gown or preferably a full disposable coverall, apron, hat, double gloves, and a full face visor which completely encloses the operator’s head to protect the eyes and mouth.
Disposable mortuary instruments should be used wherever possible and incinerated after use.
| |
Provenance
| Record: | 682 |
| Objective: | The purpose of this guideline is to ensure that all healthcare staff within LTHT are aware of the risks associated with CJD, variant CJD (vCJD) and other human prion diseases and know the safe working practices to prevent their transmission. |
| Clinical condition: | CJD/vCJD |
| Target patient group: | All patients at LTHT |
| Target professional group(s): | Secondary Care Doctors Secondary Care Nurses |
| Adapted from: |
Evidence base
|
Minimise transmission risk of CJD and vCJD in healthcare settings: Prevention of CJD and vCJD by Advisory Committee on Dangerous Pathogens' Transmissible Spongiform Encephalopathy (ACDP TSE) Subgroup. (August 2017) |
Endoscopy and individuals at risk of vCJD for public health purpose
published November 2005: A consensus statement form the BSG
Decontamination Working Group and the ACDP TSE Working Group
Endoscopy sub-group
HSC 1999/178. Variant Creutzfeldt-Jakob Disease (vCJD): Minimising the Risk of Transmission. Department of Health. London
(and http://www.open.gov.uk/doh/coinh.htm)
Creutzfeldt-Jakob Disease: Guidance for Health Care Workers. Department of Health. London (and http://www.doh.gov.uk/cjd/cjdguidance.htm)
The use of Clinical Audit to support the implementation of NICE guidance IPG 666 National Institute for Health and Clinical Excellence (NICE)
Patient Safety and reduction of risk of transmission of Creutzfeldt-Jakob disease (CJD) via interventional procedures. (September 2008)
National Institute for Health and Care Excellence (NICE) 2020 Reducing the risk of transmission or Creutzfeldt-Jakob disease (CJD) from surgical instruments used for interventional procedures on high risk tissues
Decontamination of surgical instruments (HTM 01-01) Health Technical Memorandum (HTM) 01-01: management and decontamination of surgical instruments (medical devices) used in acute care. (July 2016)
Management and decontamination of flexible endoscopes (HTM 01-06) Health Technical Memorandum (HTM) 01-06 offers guidance on the management and decontamination of flexible endoscopes. (June 2016)
Approved By
Trust Clinical Guidelines Group
Document history
LHP version 1.0
Related information
Appendix 1: Distribution of TSE infectivity in human tissues and body fluids
|
Tissue |
Presence of abnormal Prion Protein and assumed level of infectivity |
|||
|
CJD other than vCJD |
vCJD |
|||
|
PrPTSE detected |
Assumed level of infectivity |
PrPTSE detected |
Assumed level of infectivity |
|
|
Brain |
+ve |
High P |
+ve |
High P
|
|
Spinal cord |
+ve |
High P |
+ve |
High P |
|
Cranial nerves, specifically the entire optic nerve and only the intracranial components of the other cranial nerves |
+ve |
High |
+ve |
High |
|
Cranial ganglia |
+ve |
High |
+ve |
High P P |
|
Posterior eye, specifically the posterior hyaloid face, retina, retinal pigment epithelium, choroid, subretinal fluid, optic nerve |
+ve |
High P |
+ve |
High |
|
Pituitary gland |
+ve |
High (?) |
+ve |
High (?) |
|
Spinal ganglia 1 |
+ve |
Medium |
+ve |
Medium P |
|
Olfactory epithelium |
+ve |
Medium |
NT |
Medium |
|
Dura mater2 |
-ve |
Low |
+ve4 |
Low |
|
Tonsil |
-ve |
Low |
+ve |
Medium P P |
|
Lymph nodes and other organised lymphoid tissues containing follicular structures |
-ve |
Low P |
+ve |
Medium P |
|
Gut-associated lymphoid tissue |
-ve |
Low |
+ve |
Medium |
|
Appendix |
-ve |
Low |
+ve |
Medium |
|
Spleen |
+ve |
Low P |
+ve |
Medium P P P |
|
Thymus |
-ve |
Low |
+ve |
Medium |
|
Anterior eye and cornea |
-ve |
Low |
-ve |
Low |
|
Peripheral nerve |
+ve |
Low |
+ve |
Low |
|
Skeletal muscle |
+ve |
Low |
+ve |
Low |
|
Dental Pulp |
-ve |
Low |
-ve |
Low |
|
Gingival Tissue |
NT |
Low |
-ve |
Low |
|
Blood and bone marrow |
NT |
Low |
-ve |
Low |
|
CSF3 |
-ve |
Low P |
-ve |
Low |
|
Placenta |
-ve |
Low |
-ve |
Low |
|
Urine |
-ve |
Low |
-ve |
Low |
|
Other tissues |
-ve |
Low P |
+ve4 |
Low |
Key: +ve = tested positive -ve = tested negative NT = not tested
P =infectivity proven in experimental transmission studies
1 Spinal ganglia have a high assumed level of infectivity in the WHO Guidelines. However, unpublished results on the infectivity of spinal ganglia indicate that this tissue is of medium infectivity.
2 Dura mater is designated low infectivity as virtually no detectable abnormal prion protein has been found in cases of CJD; however, as grafts of these tissues are associated with CJD transmission, probably as a result of contamination by brain and because of the lengthy period of implantation in the CNS, procedures conducted on intradural tissues (i.e. brain, spinal cord and intracranial sections of cranial nerves) or procedures in which human dura mater was implanted in a patient prior to 1992, remain high risk.
3 Although PrPTSE has not been detected in the CSF in either sporadic or vCJD, experimental transmission of infectivity has been achieved from CSF in sporadic CJD in 4 of 27 primates by intracerebral inoculation indicating that levels of infectivity are likely to be much lower than in the CNS.
4 PrPTSE has been detected in dura mater, skin, kidney, liver, pancreas, ovary and uterus in a case of vCJD in USA with a lengthy duration of illness. Earlier studies of these tissues in UK vCJD cases gave negative results
Taken from Transmissible Spongiform Encephalopathy Agents: Safe Working and the Prevention of Infection: Annex A1 December 2010
Appendix 2: Algorithm chart for precautions for reusable instruments for surgical procedures on patients with, or “at increased risk” of CJD, vCJD and other human prion diseases
Appendix 3: Summary of Precautions advised for the use of Endoscopes - (CJD other than vCJD)
|
Tissue Infectivity |
Status of Patient |
||
|
Symptomatic |
Asymptomatic |
||
|
Definite/probable |
Possible/diagnosis unclear1 |
At risk2 inherited/iatrogenic |
|
|
High:
|
single use OR destroy after use OR quarantine3 for re-use exclusively on the same index patient
|
single use OR quarantine pending diagnosis |
single use OR destroy after use OR quarantine3 for re-use exclusively on the same index patient |
|
Medium:
|
single use OR destroy after use OR quarantine3 for re-use exclusively on the same index patient
|
single use OR quarantine pending diagnosis |
single use OR destroy after use OR quarantine3 for re-use exclusively on the same index patient |
|
Low/none detectable:
|
no special precautions4 |
no special precautions4 |
no special precautions4 |
* The advice of the consultant carrying out the endoscopic procedure in the nasal cavity should be sought to determine whether a risk of contamination of the endoscope with olfactory epithelium can be excluded with confidence. If such contamination cannot be excluded, take precautions appropriate for medium infectivity tissues
- This includes patients with neurological disease of unknown aetiology who do not fit the criteria for possible CJD but where a diagnosis of CJD is being actively considered
- This advice refers to the use of flexible endoscopes in patients at risk of developing CJD
- Quarantined endoscopes may be re-used exclusively on the same individual patient if required. The endoscope should be fully cleaned and decontaminated immediately after use, before being quarantined. (as per the advice in this guidance)
- The decontamination procedures advised in this guidance, taken together with the MDA Bulletin MDA DB2002 (05) and BSG Guidelines for Decontamination of Equipment for Gastrointestinal Endoscopy 2008 should be followed.
Appendix 4: Summary of Precautions for the use of Endoscopes – (vCJD and CJD type uncertain)
|
Tissue Infectivity |
Status of Patient |
|||
|
Symptomatic |
Asymptomatic |
|||
|
Definite/probable |
Possible vCJD, possible sCJD or diagnosis unclear1 |
At risk (blood*** recipient from a donor who later developed vCJD) |
At risk2 other iatrogenic |
|
|
High:
|
single use OR destroy after use OR quarantine3 for re-use exclusively on the same index patient |
single use OR quarantine pending diagnosis |
single use OR destroy after use OR quarantine3 for re-use exclusively on the same patient |
single use OR destroy after use OR quarantine3 for re-use exclusively on the same patient |
|
Medium:
|
single use OR remove from use OR quarantine3 for re-use exclusively on the same index patient |
single use OR quarantine pending diagnosis |
single use OR destroy after use OR quarantine3 for re-use exclusively on the same index patient |
no special precautions unless contaminated with olfactory epithelium* If contaminated: single use OR destroy after use OR Quarantine3 for re-use exclusively on the same index patient |
|
Medium:
|
single use OR remove from use OR quarantine3 for re-use exclusively on the same index patient |
single use OR quarantine pending diagnosis |
single use OR destroy after use OR quarantine3 for re-use exclusively on the same index patient |
no special precautions4 |
|
Low/none detectable:
|
no special precautions4 |
no special precautions4 |
no special precautions4 |
no special precautions4 |
* The advice of the consultant carrying out the endoscopic procedure in the nasal cavity should be sought to determine whether a risk of contamination of the endoscope with olfactory epithelium can be excluded with confidence. If such contamination cannot be excluded, take precautions appropriate for medium infectivity tissues.
** For the purpose of this table, lymphoid tissue refers to the spleen, thymus, tonsils and adenoids, lymph nodes, the appendix and the gastro-intestinal tract sub-mucosa.
*** A small number of individuals are known to have received labile blood components (whole blood, red cells, white cells or platelets) from a donor who later developed vCJD.
- This includes patients with neurological disease of unknown aetiology who do not fit the criteria for possible CJD but where a diagnosis of CJD is being actively considered
- This advice refers to the use of flexible endoscopes in patients at risk of developing CJD. For guidance on the use of rigid endoscopes
- Quarantined endoscopes may be re-used exclusively on the same individual patient if required. The endoscope should be fully cleaned and decontaminated immediately after use, before being quarantined (as per the advice in this guidance) The endoscope should be decontaminated alone using an AutomaticEndoscope Washer Disinfector (EWD). The EWD should be decontaminated as per paragraph F1(e) of this guidance
- The decontamination procedures advised in this guidance, taken together with the CFPP 01-06 or equivalent national guidance and BSG Guidelines for Decontamination of Equipment for Gastrointestinal Endoscopy (2014) should be followed.
Appendix 5: Common flexible endoscopic procedures classified as invasive or non-invasive
The term “working channel” applies to the endoscope channel that is used for both the passage of accessories and the suction removal of liquids and gases
|
|
Procedure |
Contamination of working channel |
|
Invasive |
Notes/ Exceptions |
|
1 |
ARTHROSCOPY, BRONCHOSCOPY AND CYSTOSCOPY |
||||
|
1a |
All arthroscopy procedures |
These procedures will not involve contact of the endoscope with infectious tissue. |
None |
_ |
|
|
1b |
Diagnostic cystoscopy or *bronchoscopy |
Providing no biopsy is taken it is very unlikely that the endoscope will become contaminated* |
None. Tissue contamination would not result from a straightforward diagnostic procedure. |
_ |
|
|
1c |
Cystoscopy with biopsy to obtain fixed lymphoid tissue |
When a biopsy is taken of lymphoid tissue, there is a risk that the working channel could become contaminated with potentially infectious tissue. |
Lymphoid tissue could come into contact with the lining of the working channel. Tissue may be deposited in the working channel. |
+ |
Biopsy of the bladder can be considered non-invasive (-) if it can be determined with confidence that there has been no contact with, or invasion of, lymphoid tissue. |
|
1d |
Bronchoscopy with biopsy to obtain fixed lymphoid tissue |
When a biopsy is taken of lymphoid tissue, there is a risk that the working channel could become contaminated with potentially infectious tissue. |
Lymphoid tissue could come into contact with the lining of the working channel. Tissue may be deposited in the working channel. |
+ |
Bronchoscopy with biopsy can be considered non-invasive (-) if it can be determined with confidence that there has been no contact with, or invasion of, lymphoid tissue. |
|
1e |
Transbronchial biopsy |
There is a risk that the working channel may become contaminated with lymphoid tissue during transbronchial biopsy. |
Lymphoid tissue could come into contact with the lining of the working channel. Tissue may be deposited in the working channel.
|
+ |
|
|
|
Procedure |
Contamination of working channel |
|
Invasive |
Notes/ Exceptions |
|
2 |
ENDOSCOPIC ULTRASOUND(EUS) |
||||
|
2a |
Diagnostic EUS |
Providing no biopsy is taken it is very unlikely that the endoscope will become contaminated. |
None. Tissue contamination would not result from a straightforward diagnostic ultrasound procedure. |
_ |
|
|
2b |
EUS with biopsy |
Biopsy utilises a needle that may result in contamination of the working channel with lymphoid tissue. |
The needle is sheathed and therefore not in contact with working channel |
_ |
|
|
3 |
UPPER GI ENDOSCOPY |
||||
|
3a |
*Diagnostic gastroscopy |
Providing no biopsy is taken it is very unlikely that the endoscope will become contaminated.* |
None. Tissue contamination would not result from a straightforward diagnostic endoscopy. |
_ |
|
|
3b |
Gastroscopy with biopsy |
Even with efficient single use forceps contamination of the working channel with submucosal lymphoid tissue is likely. |
Contaminated tissue may come into contact with the lining of the endoscope working channel |
+ |
Cytology is of negligible risk provided a sheathed technique is used. Alternatively cytology (using a sheathed cytology device) could be taken at the first gastroscopy if malignancy is strongly suspected. Some larger channel endoscopes allow the passage of a sheath through which biopsy may be done while protecting the endoscope working channel from tissue contamination. Following biopsy, the tip of the biopsy forceps is fully retracted into the sheath, the tip of which is kept protruding from the endoscope tip throughout. The practice of taking a single biopsy and removing the endoscope with the forceps protruding and then severing it with wire cutters, is to be discouraged. |
|
|
Procedure |
Contamination of biopsy channel |
Mechanism |
Invasive (+) or Non-Invasive (-) |
Notes/Exceptions |
|
3c |
Gastroscopy with brush cytology |
The cytology brush is sheathed and therefore there is low risk of the working channel becoming contaminated with lymphoid tissue. Cytology is of negligible risk provided a sheathed technique is used |
No contact of lymphoid tissue with the working channel. |
_ |
|
|
3d |
Gastroscopy and balloon dilatation of stricture (oesophagus or pylorus) |
Balloon dilatation may disrupt submucosal lymphoid tissue, which could be transferred to the working channel as the balloon is retracted back into this channel. |
Contamination would be through ‘contact’ and would be lower than biopsy. Modifying the technique to include removing the endoscope and used balloon as one (without retracting it back into the working channel) would minimise the risk. |
|
This technique should be considered non-invasive ONLY if the endoscope and balloon are withdrawn from the patient as one (i.e. without retracting the balloon into the working channel) and the balloon is cut-off and destroyed. |
|
3e |
Gastroscopy and bougie dilatation of oesophagus |
Bougie dilatation over a guide wire involves disruption of submucosal tissue only when the endoscope has been withdrawn. |
No contamination of the working channel with lymphoid tissue. |
_ |
|
|
3f |
Gastroscopy and polypectomy |
Polypectomy snares use diathermy, which coagulates tissue and this adheres to the snare. Although the snare is sheathed it is possible for lymphoid tissue to contaminate the working channel. |
Polyp tissue fragments are readily sucked into the working channel during and after polypectomy |
+ |
Some endoscopists advocate the use of slow continuous irrigation of the working channel with water during polypectomy in order to minimise the risk of polyp fragments coming into contact with the internal surface of the endoscope working channel. Experience is, however, limited, and if polyp fragments become aspirated into the working channel (as is normally the case) the procedure is immediately deemed invasive. |
|
|
Procedure |
Contamination of biopsy channel |
Mechanism |
Invasive (+) or Non-Invasive (-) |
Notes/Exceptions |
|
3g |
Gastroscopy and endoscopic mucosal resection (EMR) |
The risks are the same as for polypectomy but the disruption of sub mucosal lymphoid tissue will be greater. A diathermy current is used and tissue will adhere to the snare. |
Polyp tissue fragments are readily sucked into the working channel during and after EMR. |
+ |
Some endoscopists advocate the use of slow continuous irrigation of the working channel with water during polypectomy in order to minimise the risk of polyp fragments coming into contact with the internal surface of the endoscope working channel. Experience is, however, limited, and if polyp fragments become aspirated into the working channel (as is normally the case) the procedure is immediately deemed invasive.
|
|
3h |
Gastroscopy or enteroscopy and argon plasma coagulation |
In theory the technique involves no contact with the mucosa. However contact frequently occurs and tissue adheres to the catheter. |
Tissue is likely to enter the working channel. |
+ |
|
|
3i |
Gastroscopy and use of heater probe |
Can be used to arrest bleeding but tissue may adhere to the probe and contaminate the working channel. |
Lymphoid tissue contamination of the working channel is possible. |
+ |
Heater probe should be discarded after use and disposed of by incineration. |
|
3j |
Gastroscopy and injection of ulcer |
This may be a necessary procedure and haemostasis may be achieved through a variety of methods. Injection of adrenaline would not disrupt submucosal lymphoid tissue but there is contact between the needle and sub mucosal tissue. |
Good technique would minimise risk. The needle is sheathed and therefore not in contact with the working channel. Poor technique might result in the unsheathed needle coming into contact with channel, rendering the procedure invasive |
_ |
|
|
|
Procedure |
Contamination of biopsy channel |
Mechanism |
Invasive (+) or Non-Invasive (-) |
Notes/ |
|
3k |
Gastroscopy and injection of varices |
This may be a necessary procedure and haemostasis may be achieved through a variety of methods. Injection of a sclerosing agent would not disrupt submucosal lymphoid tissue but there is contact between the needle and submucosal tissue. |
Good technique minimises the risk. The needle is sheathed and therefore not in contact with the working channel. Poor technique might result in the unsheathed needle coming into contact with channel, rendering the procedure invasive. |
_ |
|
|
3l |
Gastroscopy and banding of varices |
Bands are applied to prominent veins in the oesophagus. Submucosal lymphoid tissue should not be disrupted and in theory the risk should be low. |
Tissue does not come into contact with the working channel during banding |
_ |
|
|
3m |
Gastroscopy and mucosal clipping |
No disruption of lymphoid tissue |
No contamination of the biopsy channel with lymphoid tissue |
_ |
|
|
3n |
Gastroscopy and insertion of a PEG (Percutaneous Endoscopic Gastrostomy)
|
Patients with vCJD may require a PEG feeding tube.
|
The most common ‘pull through’ method does involve a needle penetrating the stomach via the abdominal wall. In theory a small amount of submucosal lymphoid tissue might adhere to the needle and transfer to the wire or thread, which is pulled up via the working channel. |
_ If modified technique is used |
Non-endoscopic (radiological) gastrostomy is recommended if possible. However, if this is not an option, the modified PEG technique must be used. This means that the endoscope and wire or thread are withdrawn with the grasping device in full view (i.e. the wire or thread is NOT withdrawn into the endoscope). If the wire or thread is withdrawn into the endoscope, the procedure must be considered invasive. |
|
|
Procedure |
Contamination of biopsy channel |
Mechanism |
Invasive (+) or Non-Invasive (-) |
Notes/ |
|
3o |
Gastroscopy and stenting |
No contact between working channel and lymphoid tissue. |
Insertion of oesophageal stents does not disrupt lymphoid tissue during placement as the endoscope has been withdrawn and even with rescoping the working channel is unlikely to become contaminated. |
_ |
|
|
3p |
Gastroscopy and drainage of pancreatic pseudocysts |
This is an invasive procedure that is potentially liable to contaminate the biopsy channel. |
Contact between working channel with gastric submucosal lymphoid tissue is possible. |
+ |
|
|
4 |
ENDOSCOPIC RETROGRADE |
||||
|
4a |
ERCP without sphincterotomy |
It is unlikely that the endoscope will become contaminated. |
No contamination of the working channel with lymphoid tissue. |
_ |
|
|
4b |
ERCP with sphincteroplasty |
There is a significant risk that the biopsy channel will become contaminated with lymphoid tissue. |
It is necessary to withdraw the dilatation balloon via the working channel of the endoscope so contamination with lymphoid tissue is possible. Subsequent manoeuvres to remove stones from the bile duct using retrieval balloons or baskets could contaminate the duodenoscope working channel |
+ |
|
|
4c |
ERCP with sphincterotomy |
The diathermy papillotomy knife used in this procedure frequently has adherent tissue and it is likely that the working channel could become contaminated with lymphoid tissue. |
Adherent tissue may be deposited in the working channel as the sphincterotome is withdrawn. Subsequent manoeuvres to remove stones from the bile duct using retrieval balloons or baskets could also contaminate the duodenoscope working channel |
+ |
|
|
|
Procedure |
Contamination of biopsy channel |
Mechanism |
Invasive (+) or Non-Invasive (-) |
Notes/ |
|
5 |
ENTEROSCOPY |
||||
|
5a |
Enteroscopy without biopsy |
Tissue contamination of the working channel is very unlikely. |
No contamination would result from a straightforward diagnostic enteroscopy. |
_ |
|
|
5b |
Enteroscopy with biopsies |
It is likely that the working channel will become contaminated with lymphoid tissue |
Contaminated tissue may be deposited in the working channel |
+ |
It may become feasible to perform biopsy non-invasively if long-sheathed biopsy forceps become available |
|
6 |
COLONOSCOPY |
||||
|
6a |
Colonoscopy without biopsy |
A diagnostic colonoscopy is unlikely to contaminate the working channel with sub mucosal lymphoid tissue. |
No contamination would result from a straightforward diagnostic colonoscopy. |
_ |
|
|
6b |
Colonoscopy and biopsy |
It is likely that the working channel will become contaminated with ileal submucosal tissue or colonic submucosal lymphoid aggregates |
Contamination of the working channel very likely. |
+ |
Sheathed biopsy, where feasible, may allow tissue sampling while avoiding the risk of working channel contamination. Following biopsy, the tip of the biopsy forceps is fully retracted into the sheath, the tip of which is kept protruding from the endoscope tip throughout. The practice of taking a single biopsy and removing the endoscope with forceps protruding, then severing it with wire cutters, is to be discouraged. |
|
6c |
Colonoscopy and balloon dilatation |
Balloon dilatation of an inflammatory stricture would disrupt lymphoid tissue and contaminate the balloon. |
Withdrawing the balloon through the working channel would contaminate the colonoscope. |
_ |
The technique should be considered non-invasive ONLY if the endoscope and balloon are withdrawn from the patient as one (i.e. without retracting the balloon into the working channel) and the balloon is cut-off and destroyed. |
|
|
Procedure |
Contamination of biopsy channel |
Mechanism |
Invasive (+) or Non-Invasive (-) |
Notes/ |
|
6d |
Colonoscopy and polypectomy |
Coagulation of tissue which then adheres to the snare. Sometimes small polyps retrieved using the suction channel and a biopsy “trap” This would increase the risk of contamination with lymphoid tissue. |
Polyp tissue fragments are readily sucked into the working channel during and after polypectomy |
+ |
Some endoscopists advocate the use of slow continuous irrigation of the working channel with water during polypectomy in order to minimise the risk of polyp fragments coming into contact with the internal surface of the endoscope working channel. Experience is, however limited, and if polyp fragments become aspirated into the working channel (as is normally the case) the procedure is immediately deemed invasive. |
|
6e |
Colonoscopy and endoscopic mucosal resection |
As with biopsy, lymphoid tissue may contaminate the biopsy channel. |
Tissue adheres to the snare which would have to be withdrawn through the colonoscope on most occasions. Polyp tissue fragments are readily sucked into the working channel during and after EMR |
+ |
Some endoscopists advocate the use of slow continuous irrigation of the working channel with water during EMR in order to minimise the risk of polyp fragments coming into contact with the internal surface of the endoscope working channel. Experience is, however limited, and if polyp fragments become aspirated into the working channel (as is normally the case) the procedure is immediately deemed invasive. |
|
6f |
Colonoscopy and argon plasma coagulation |
Adherent tissue is likely to contaminate the suction/biopsy channel. |
Contact with lymphoid tissue frequently occurs and tissue adheres to the catheter. Tissue is likely to enter the working channel. |
+ |
|
|
|
Procedure |
Contamination of biopsy channel |
Mechanism |
Invasive (+) or Non-Invasive (-) |
Notes/ |
|
6g |
Colonoscopy and stenting |
No contact between working channel and lymphoid tissue. |
Insertion of colonic stents does not disrupt lymphoid tissue during placement as the endoscope has been withdrawn and even with rescoping the working channel is unlikely to become contaminated. |
_ |
|
|
7 |
FLEXIBLE SIGMOIDOSCOPY |
||||
|
7a |
Flexible sigmoidoscopy |
This diagnostic procedure is unlikely to result in contamination of the working channel. |
No contamination of the channel with lymphoid tissue would occur. |
_ |
For ‘invasive’ procedures the risks are identical to those procedures associated with colonoscopy (see above) |
Notes
* Where intubation is via the nasal cavity the advice of the endoscopist performing the procedure should be sought to determine whether a risk of
contamination of the endoscope with olfactory epithelium can be excluded with confidence. If such contamination cannot be excluded it is advised
to intubate via an oral route or take precautions appropriate for medium infectivity tissues.
Appendix 6 - Make up and disposal of sets for patients “at increased risk” of CJD/vCJD
|
Make up and disposal of sets for patients “at increased risk” of CJD/vCJD |
|
|
|
|
|
Purpose: |
To ensure that equipment that is used in a procedures involving “high risk” tissue on patients “at increased risk” of CJD/vCJD is handled and disposed of in the correct manner and a log made for traceability. |
|
Scope: |
All sets/ trays either existing or made up and processed specifically for a named “at increased risk” patient. |
|
Responsibility: |
Senior theatres staff, Infection Prevention team |
|
Related Documents: |
Braun protocol Introduction or amendments of new sets, Braun form PD4, |
|
Procedure: |
On notification of an “at increased risk” patient the theatre must follow the TSE Trust guideline to identify if the procedure is classed as involving “high risk” tissues. If it is it will be necessary to risk assess the situation and see if it is possible for an individual set to be made up for use on the patient. |
|
Location of further copies: |
Trust Intranet, each theatre |
|
Amendments from previous version: |
|
Appendix 7 - Log sheet for disposal of “high risk” equipment
Appendix 8 - B.Braun Procedure Manual
Appendix 9 - Information for patients undergoing surgery or neuro-endoscopy on high risk tissues
Information for patients undergoing surgery or neuro-endoscopy on high risk tissues
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 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?
What is CJD?
Creutzfeldt-Jakob disease (CJD) is a rare brain disorder that affects about 1 in a million people each year. CJD is thought to be caused by the build up in the brain of an abnormal form of a protein called a ‘prion’. Unfortunately CJDis fatal, and as yet there is no known cure. There are different types of CJD, including variant CJD (vCJD). vCJD is caused by eating meat from cows infected with BSE.
How can CJD spread from person to person?
A person who is infected with CJD may have abnormal prion protein in their body for years before becoming ill. If that person has an operation, or donates blood, tissues or organs, during that time, the abnormal prion protein that causes CJD could spread to other patients.
Why are we asking you about CJD before your operation?
The abnormal prion protein that causes CJD is very hard to remove or destroy. If surgical instruments are used on a patient who is infected with CJD they may still have prion protein on them, even after they have been properly washed and disinfected. They could then spread CJD to other patients. This is particularly important for operations on the brain, spinal cord and the back of the eye as these parts of the body contain the largest amount of abnormal prion
protein.
What have these questions got to do with CJD?
CJD has been spread in several ways and different groups of people may have an increased risk of CJD. We ask whether there is anyone in your family who has had CJD because some types of CJD can be inherited. These types of CJD are caused by faulty genes and may be passed from parent to child.
We ask whether you have had surgery on the brain or spinal cord because some of these operations used to use grafts of ‘dura mater’ (the tough lining round the brain and spinal cord). Some of these grafts have been linked to CJD infection - these grafts are no longer used.
We ask whether you have been treated with growth hormone or gonadotrophin infertility treatment because these used to be prepared from pituitary glands. Some of these hormone treatments have been linked to CJD infection -these hormones are no longer used.
What happens if I answer ‘Yes’ to any of these questions?
If you answer ‘Yes’ to any of these questions, medical staff will now examine your medical records in more detail to determine whether or not you may have an increased risk of CJD.
What will happen then?
If you do have an increased risk of CJD special precautions will be taken with the surgical instruments used in your operation. Your GP will be informed and will ask you to come and discuss what this means in more detail.
Please remember that the overall risk of CJD spreading by these routes is generally very low. These questions are an extra measure to prevent CJD spreading through surgery. This should not affect the medical care you receive now or in the future.
What if I don’t have a GP?
The health protection unit for your area will make sure that another doctor discusses this with you.
Can I have a blood test to see if I am infected with CJD?
Unfortunately there is no blood test available yet which could show if you have CJD.
Where can I find out more?
The following organisations offer further information and support.
- NHS Choices: http://www.nhs.uk/conditions/Creutzfeldt-Jakob disease/Pages/Introduction.aspx
- CJD Support Network website: www.cjdsupport.net
- National CJD Surveillance Unit website: www.cjd.ed.ac.uk
- National Prion Clinic website: www.nationalprionclinic.org/
Appendix 10: Possible risk of CJD/vCJD Quarantine of Flexible Endoscope Form
Appendix 11: Dental Addendum
The following advice has been taken from the Department of Health’s document ‘Transmissible spongiform encephalopathy agents: safe working and the prevention of infection’, ‘Part 4 - Infection control of CJD, vCJD and other human prion diseases in healthcare and community settings’ (10th August 2017); and is relevant to all dentists practicing in the Leeds Dental Institute.
Dentistry
4.70 The risks of transmission of infection from dental instruments are thought to be very low provided satisfactory standards of infection control and decontamination are maintained. There is no reason why any patient with, or “at increased risk” of, CJD or vCJD, should be refused routine dental treatment. Such people can be treated in the same way as any member of the general public.
4.71
Information for dentists about the management of patients with, or “at increased risk” of, CJD/vCJD can be found in Decontamination Health Technical Memorandum 01-05: Decontamination in primary care dental practices (March 2013) at: https://www.gov.uk/government/publications/decontamination-in-primary-care-dental-practices. This also includes advice for dentists on the re-use of endodontic instruments and vCJD.
4.72
Dental instruments used on patients with, or “at increased risk” of, CJD or vCJD can be handled in the same way as those used in any other low risk surgery, i.e. these instruments can be reprocessed according to best practice and returned to use. Dentists are reminded that any instruments labelled by manufacturers as ‘single use’ should not be re-used under any circumstances.
4.73
Advice on the decontamination of dental instruments can be found in the Department of Health guidance HTM01-05 Decontamination Health Technical Memorandum 01-05: Decontamination in primary care dental practices (March 2013). This guidance has been produced to reflect a reasonable and rational response to emerging evidence around the effectiveness of decontamination in primary care dental practices, and as the possibility of prion transmission through protein contamination of dental instruments. It is available at: Link
Equity and Diversity
The Leeds Teaching Hospitals NHS Trust is committed to ensuring that the way that we provide services and the way we recruit and treat staff reflects individual needs, promotes equality and does not discriminate unfairly against any particular individual or group.