CREUTZFELDT-JAKOB DISEASE POLICY Page 1 of 18 Reviewed: March 2015

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1 Page 1 of 18 Policy Applies to: All staff employed by Mercy Hospital, Credentialed Specialists, Allied Health Professionals and contracts will be suppted to meet policy requirements. Related Standard: AS/NZS 4187:2014. Reprocessing of reusable medical devices in health service ganisations Rationale: This policy provides advice on safe wking practices to prevent the transmission of Creutzfeldt-Jakob Disease (CJD) and variant CJD (vcjd). Definitions: Creutzfeldt-Jakob Disease (CJD) is an infectious disease caused by an agent that is resistant to sterilisation and disinfection processes routinely used in healthcare settings. The transmission of spadic 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 hmones prepared f the human pituitary glands and dura mater preparations Objectives: To prevent the transmission of Creutzfeldt-Jakob Disease (CJD) and variant CJD (vcjd). To identify at risk patients To ensure surgical cleaning and disinfection procedures follow recommended CJD guidelines Implementation: Note: Available epidemiological evidence does not suggest that nmal social routine clinical contact with CJD vcjd patients presents a risk to staff, relatives visits. Standard precautions apply. Risk Assessment; When certain invasive procedures are perfmed there is potential f exposure to CJD. In these situations it is essential that control measures are in place to prevent the iatrogenic transmission of CJD. The table in Appendix 1 categises patients by risk. The status f the patient must be determined by the consultant under whose care the patient is. This should be recded in their clinical recd. Creutzfeldt - Jakob disease (CJD) is a notifiable disease to the Ministry of Health. Evaluation: Patient clinical recd

2 Page 2 of 18 Infection Control rept Infection Control Committee Appendices 1. Diagnostic criteria 11. Classification criteria 111. Procedure f Management of Instruments and Equipment used in CJD cases IV. CJD Patient Notification Instrument Fm V. CSSD management of Instruments and Equipment Flowchart Associated Documents External Health Act, Notifiable Diseases List, Ministry of Health New Zealand Sterile Services Association Guidelines: Management of Instrumentation of Creutzfeldt-Jakob Disease, %20Management%20of%20Instrumentation%20and%20CJD.pdf WHO infection control guidelines f transmissible spongifm encephalopathies. Rept of a WHO consultation, Geneva, Switzerland, March Southern District Health Board, Creutzfeldt - Jakob Disease Policy, Midas 21466, v 3, 2011 Internal Standard Precautions Policy Waste Management Policy Linen Management Personal Protective Equipment Policy - staff

3 Process Surgical Invasive Procedures CREUTZFELDT-JAKOB DISEASE POLICY Page 3 of 18 The measures to be taken when perfming invasive surgery depend on: How likely the patient is to be carrying the infectious agent (risk status) and How likely it is that infection could be transmitted by the procedure being carried out F all patients with, at increased risk of CJD vcjd the following precautions should be taken: ACTION Theatre Management Wherever appropriate and possible, the intervention should be perfmed in an operating theatre as opposed to a clinic treatment room. A discussion about the procedure and the surgical instruments required should occur befe booking the case with the appropriate parties (i.e. consultants involved in the patient s care, labaty, public health an infection control). RATIONALE To minimise the risk of transmission and contamination At the time of the procedure all equipment, instruments and other items not required f the actual procedure should be removed from the theatre. All equipment used during the procedure should have a protective impervious covering that can be disposed of immediately after completion of the surgery. Any surfaces that can not have not been protected need to be disinfected using dilute Sodium Hypochlite 1% (1: 10 dilution). Where possible, procedures should be perfmed at the end of the theatre list to allow a terminal clean of the theatre befe the next session. Only the minimum number of healthcare personnel required should be involved. If possible do not use power equipment to avoid the scatter of blood and body fluids. Use the following single use PPE and dispose of as infectious waste; liquid repellent operating gown over a plastic apron, gloves, mask and protective full face vis. Use single use disposable surgical instruments

4 Page 4 of 18 ACTION and equipment where possible. Dispose of single use items in the infectious waste. RATIONALE Reprocessing instruments that are not designated as single use Where single use instruments are not available, the handling of reusable instruments depends on a combination of the risk status of the patient, the tissue(s) involved in the procedure and the type of CJD refer to Appendix III Matrices f Management of Reusable Instruments f specific instructions. Complex Instruments Some expensive items of equipment, such as drills, may be prevented from being contaminated by using shields, guards coverings. The drill bit, other parts in contact with high risk tissue(s), and the protective coverings would then need to be incinerated. Advice should be sought from the manufacturer to determine practicality. To minimise the risk of transmission and contamination Prevent all items from being destroyed To minimise the risk of transmission and contamination Use of Laser f tonsillectomy: smoke plume Some ENT surgeons may use laser techniques as an alternative to conventional surgery f tonsillectomy. Quarantining of any surgical instruments of suspected CJD cases Reusable instruments in procedure involving tissues designated as high- medium infectivity, on a possible CJD vcjd patient are to be quarantined pending a confirmed diagnosis. Infm CSSD about the instruments befe they go to CSSD. On completion of the procedure, the nurse is to separate and dispose of single use items. The nurse is to take instruments in a specifically There is no evidence of the transmission of CJD by the respiraty route. Any risk to surgeons from smoke plume is thought to be very low, but there is no data on vcjd. To minimise the risk of transmission and contamination To ensure safe transptation of equipment to CSSD.

5 Page 5 of 18 ACTION designated airtight container to CSSD decontamination area. Instruments should be processed as Procedures f Management of Instruments and Equipment used in CJD Cases (Appendix IV). Once processed (as per appendix 111), the instruments are to be placed in an impervious rigid plastic container and the lid sealed with heavy duty tape and labelled with the patient s identification details (name, date of birth and NHI number). The label is to also state the surgical procedure in which the instruments were used and the name of the CSSD manager. The sealed box must be sted in a secure designated place under the control of the responsible person until the outcome of any further investigations in known. If the patient is confirmed as suffering from CJD vcjd, the sealed box must be placed in the infectious waste stream f incineration. If an alternative diagnosis is confirmed, the instruments may be removed from the box by the person responsible ( designated) and reprocessed accding to best practice and returned f use. Additional decontamination procedures are not required. RATIONALE To enable crect identification and processing of instruments that have been used in CJD cases.

6 Page 6 of 18 Appendix I DIAGNOSTIC CRITERIA Spadic CJD Definite Spadic CJD requires neuropathological/ immunocytochemcial confirmation. Probable Spadic CJD patients have rapidly progressive dementia and at least two of the following four symptoms: 1. Myoclonus 2. Visual cerebellar problems 3. Pyramidal extrapyramidal features 4. Akinetic mutism plus typical electroencephalogram (EEG) with generalised triphasic periodic complexes at approximately 1 second, clinical criteria f possible spadic CJD (see below) and positive assay f protein in the cerebrospinal fluid. Possible Spadic CJD patients will have rapidly progressive dementia. Two of the symptoms listed under probable spadic CJD above and a duration of less than 2 years. Iatrogenic (accidentally transmitted) CJD Definite Iatrogenic CJD requires a neuropathological diagnosis of CJD in a patient with a recognised risk fact f iatrogenic CJD (See below). Probable Iatrogenic CJD is defined as either a progressive predominately cerebella syndrome in a human pituitary growth hmone recipient, a clinical diagnosis of probable CJD in a patient with a recognised risk fact f CJD (see below). Relevant Exposure Risks f the Classification as Iatrogenic CJD The relevance of any exposure to disease must take into account the timing of the exposure in relation to the disease onset. Treatment with human pituitary growth hmone, human pituitary gonadotrophin human dura mater graft Cneal graft in which the cneal don has been classified as definite probable human prion disease Exposure to neurosurgical instruments used in a case of definite probable human prion disease Treatment of blood f a don subsequently diagnosed with vcjd Note: This list is provisional as previously unrecognised mechanism of human prion diseases may occur

7 Page 7 of 18 Genetic CJD Definite Genetic CJD requires a neuropathological confirmation of CJD plus either definite CJD in a first degree relative (i.e. parent, child sibling) a pathogenic prion protein gene mutation. Probable Genetic CJD is defined as a progressive neuropsychiatric disder plus either definite probable CJD in a first degree relative (i.e. parent, child sibling) a pathogenic prion protein gene mutation. Variant CJD (vcjd) Definite vcjd patents will have a progressive neuropsychiatric disder and neurological confirmation of the disease, showing spongifm change and extensive PrP deposition with flid plaques through the cerebrum and cerebellum Probable vcjd patients can be classified under two sets of criteria: 1. They will have a progressive neuropsychiatric disder of duration greater than 6 months where routine investigations do not suggest an alternative diagnosis. They will also have at least four of the following five symptoms: a) Early psychiatric symptoms (depression, anxiety, apathy, withdrawal, delusions) b) Persistent painful sensy symptoms (including frank pain and/ unpleasant dysesthesia) c) Ataxia d) Myoclonus chea dystonia dementia and an EEG will not show the typical appearance of spadic CJD no EEG has been done and there is a symmetrical high signal in the posteri thalamus on a MRI brain scan. These patients would have no histy of potential iatrogenic exposure. 2. Alternatively, they will have a progressive neuropsychiatric disder of duration greater than 6 months, where routine investigations do not suppt an alternative diagnosis, and where there is no histy of potential of iatrogenic exposure plus a positive tonsil biopsy which is positive f PrP-res. Possible vcjd patients will have progressive neuropsychiatric disder of duration greater than 6 months where routine investigations do not suggest an alternative diagnosis and no histy of potential iatrogenic exposure. They will have at least four out of the five symptoms listed above and an EEG should not show the typical appearance of spadic CJD no EEG has been perfmed.

8 Page 8 of 18 Patients who do not fulfil the criteria f possible CJD Diagnosis unclear the diagnostic criteria f definite, probable possible are not met, n is there a reasonable alternative diagnosis. CJD therefe remains a possibility. CJD thought likely- infmation indicates that a clinical diagnosis of CJD is very likely because of atypical disease features and / an atypical course atypical clinical investigation results and results and / a reasonable alternative diagnosis is made but not confirmed. Definitely not CJD infmation indicates that CJD is not the diagnosis and there is an alternative diagnosis proven on the basis on clinical examination, clinical investigations pathology.

9 Page 9 of 18 Appendix II Classification Criteria - Patient risk groups Classification Criteria Patient risk groups When considering measures to prevent transmission to patients staff in the healthcare setting, it is useful to make a distinction between; Symptomatic patients, i.e. those who fulfil the diagnostic criteria f definite, probable possible CJD v CJD. Patients as increased risk i.e. those with no clinical symptoms, but who are potentially at risk of developing CJD vcjd because of their medical family histy. The following table details the classification of the risk status of symptomatic and asymptomatic patients.

10 Categisation of Patients by Risk CREUTZFELDT-JAKOB DISEASE POLICY Page 10 of 18 Patients should be categised as follows, in descending der of risk: 1. Symtomatic Patients 2. Patients at increased risk from genetic fms of CJD 3. Patients identified as at increased risk of CJD/vCJD through iatrogenic exposures Patients who fulfil the diagnostic criteria f definite, probable possible CJD vcjd. Patients with neurological disease of unknow aetiology who do not fit the criteria f possible CJD vcjd, but where the diagnosis of CJD is being actively considered. Individuals who have been shown by specific genetic testing to be at significant risk of developing CJD Individuals who have a blood relative known to have a genetic mutation indicative of familial CJD; Individuals who have have had two me blood relatives affected by CJD other prion disease. Recipients of hmone derived from human pituitary glands, e.g. growth hmone gonadotrophin. In NZ use of cadaver derived human growth hmone has been prohibited since However the use of other human-derived products may have occurred in other countries. Individuals who have received a graft of dura mater. (People who underwent neurosurgical procedures operations f tumour cyst of the spine befe August 1992 may have received a graft of dura mater, and should be treated as at risk, unless evidence can be provided that dura mater was not used). Patients who have had surgery using instruments that had been used on someone who went on to develop CJD/vCJD, was at increased risk of CJD/vCJD. Individuals who have received an gan tissue from a don infected with CJD/vCJD was at increased risk of CJD/vCJD. Individuals who have been identified pri to high risk surgery as having received blood blood components from 80 me dons since January Individuals who have received blood from someone who went on to develop vcjd. Individuals who have given blood to someone who has also given blood to a patient who went on to develop vcjd Individuals who have been treated with certain implicated UK sourced plasma products between 1980 and 2001

11 Page 11 of 18 Handling of Instruments patients with, at increased risk of, CJD (other than vcjd) Tissue Infectivity Status of Patient Definite probable Possible At increased risk High Brain Spinal Cd Dura Mater Cranial nerves, specifically the entire optic nerve and the intracranial components of the other cranial nerves Cranial ganglia Posteria eye, specifically the posteri hyaloids face, retina, retinal pigment epithelium, choid subretinal fluid and optic nerve Destroy Quarantine f re-use exclusively on the same patient Or Quarantine pending diagnosis Or Destroy Or Quarantine f re use exclusively on the same patient Pituitary gland Medium Spinal ganglia Olfacty epithelium Destroy Quarantine pending diagnosis Destroy Quarantine f re use exclusively on the same patient Quarantine f re use exclusively on the same patient Low No special precautions No special precautions No special precautions

12 Page 12 of 18 Handling of Instruments patients with, at increased risk of, vcjd Tissue Infectivity Status of Patient Definite probable Possible At increased risk High Brain Spinal Cd Dura Mater Cranial nerves, specifically the entire optic nerve and the intracranial components of the other cranial nerves Cranial ganglia Posteria eye, specifically the posteri hyaloids face, retina, retinal pigment epithelium, choid subretinal fluid and optic nerve Destroy Quarantine f re-use exclusively on the same patient Or Quarantine pending diagnosis Or Destroy Or Quarantine f re use exclusively on the same patient Pituitary gland Medium Spinal ganglia Olfacty epithelium Tonsil Appendix Thymus Destroy Quarantine pending diagnosis Destroy Adrenal gland Lymph nodes and gutassociated lynmphoid tissues Quarantine f re use exclusively on the same patient Quarantine f re use exclusively on the same patient Low No special precautions No special precautions No special precautions

13 Page 13 of 18 Appendix 111 Procedure f Management of Instruments and Equipment used in CJD cases Applies to: All Mercy Hospital Theatre Nursing and CSSD Technicians, Credentialed Specialists, Allied Health Professionals and contracts will be suppted to meet policy requirements. Equipment Needed: Full PPE which includes; Theatre Scrub Unifm Disposable Hat Disposable Overshoes Full Length Gown Apron Full Face Mask Blue High Level Disinfection Gloves Yellow Infectious Waste Bags Disposable Tin Foil Trays Large Cleaning Splash Bowls (Must be able to fit in closed designated quarantine container) Closed container f quarantine of instrumentation and equipment if required. Cleaning agent f manually wiping items - Sonidet Cleaning Tools (all new and to be discarded after processing) i.e. Flat Cleaning Brush, Lint Free Cloths, Internal Brushes if required etc CJD Notification Fm (F: Clinical/Theatre/CSSD/Fms/CJD Notification Fm) Implementation: Theatre Co-dinat to infm CSSD Team Leader pri to admission that a patient with a suspected case of CJD will be coming to Theatre f a procedure. CSSD are to be infmed as instruments and equipment require different processing techniques f patients with suspected CJD. Two CSSD Technicians will be nominated by CSSD Management to process items used on a suspected confirmed CJD Patient. One Technician will be designated Clean the other Dirty. These details will be handed over to the Theatre Staff by CSSD management pri to the case commencing as these designated staff are the only authised personnel to deal with the reusable instruments and equipment used with this case.

14 Page 14 of 18 A CJD notification fm (appendix 1V) is filled in by the theatre team and sent to CSSD with instruments and equipment but NOT in the bowl. This is to enable the identification of the instruments and that they have been used on a possible CJD case. (F:Clinical/Theatre/CSSD/Fms/CJD Notification Fm At the completion of the case the Scrub Nurse will accompany instruments and ensure they are handed over to the designated Dirty CSSD Technician in der f crect identification of instruments f processing. All sharps and single use items will be removed and discarded by the scrub nurse and point of generation i.e. Theatre Sluice. The sharps container should be locked off and sent f disposal at the completion of surgery. F safe transptation of equipment to CSSD, All instruments and equipment will be transpted to CSSD Main Decontamination Area in a bowl specifically f transpting items used on a suspected confirmed CJD Patient. To ensure that staff are protected from splashes and from coming into contact with potentially contaminated equipment and body fluids on the equipment, CSSD staff member designated as Dirty will wash reusable instruments and equipment in the following manner. NEVER MECHANICALLY PROCESS ANY SUSPECTED CJD INSTRUMENTS AND EQUIPMENT Nominated CSSD Dirty staff will wear full PPE as listed above. Remove bowl from the trolley and place into the dirty sink. Run water into the bowl to allow it to drain out and down the plug hole. DO NOT put the plug into place. Continue running warm water until the cleaning process is complete DO NOT place instruments equipment directly under the flow of the water. Hold items below the surface of the water in the bowl while cleaning Clean all surfaces and lumens of all items Once clean place instruments into tinfoil dishes which are lined with lint free cloths.

15 Page 15 of 18 Wipe surfaces around wash area, taps and sink with lint free cloths. using dilute Sodium Hypochlite 1% (1: 10 dilution). Dry area with fresh lint free cloths. Place all cleaning equipment used eg cloths, brushes etc into yellow infectious waste bag. Remove PPE and discard into the same yellow infectious waste bag as used f the cleaning equipment. Once the instruments and equipment have been manually cleaned, the CSSD Technician who has been designated as clean takes over. Clean Technician will wear full PPE f precaution In der to remove water droplets pat dry the instruments and equipment in the tin foil trays with lint free cloths. Place Instruments and Equipment into designated bowl and place into the quarantine container. Place lid onto quarantine container and seal with heavy duty tape. Discard used tinfoil dishes into the yellow infectious waste bag. Discard PPE into the yellow infectious waste bag Complete the documentation on the CJD Notification fm and hand over to CSSD Management.

16 Page 16 of 18 INSTRUMENT QUARANTINE Items DO NOT need to be incinerated unless a confirmed diagnosis is obtained. The container is to be put into quarantine in a secure area in CSSD until a diagnosis has been determined. If the diagnosis confirms that the patient has CJD, then the container is to be placed into a yellow waste bag f incineration. If the diagnosis is not CJD, then the items are removed from the container and processed through a full CSSD process. This includes decontamination, inspection, packing and sterilising. Items are then put back into circulation f use. Ensure that documentation is complete on the CJD notification fm at each required stage so that we have a recd of the process followed.

17 Page 17 of 18 Appendix IV CJD Patient Notification Instrument Fm Patient Label: affix here Surgery Date Surgeon: Surgery Type: Scrub Nurse: Instruments Used: Type (list) add separate pages if required I verify that the instruments listed have been processed as per policy stands f processing. a) Name: Signature: Processing role: Clean Dirty Date: b) Name: Signature: Processing role: Clean Dirty Date: Results of Diagnosis: Date: Date: Instrument Treatment Plan: (tick) Items destroyed Items reprocessed f circulation Additional comments: Signature: CSSD team leader: Date:

18 Page 18 of 18 Appendix V CSSD Process f Management of Instruments and Equipment Algithm chart f precautions f reusable instruments f surgical procedures on patients with, at increased risk of, CJD, vcjd and other human prion diseases. PATIENT Possible Definite Probable At increased risk Procedure involves high medium risk tissues Procedure involves low risk tissues Procedure involves low risk tissues Procedure involves high medium risk tissues Procedure involves high medium risk tissues Procedure involves low risk tissues Quarantine instruments pending diagnosis Definite probable C JD diagnosis inconclusive Alternative diagnosis confirmed EITHER: Dispose of instruments by incineration OR Quarantine instruments f re-use exclusively on the same patient Dispose of instruments by incineration Reprocess instruments accding to the best practice and return to use Reprocess instrument accding to best practice and return to use