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  1. 1. Page 1 of 3 PALMS OF PASADENA HOSPITAL Standard Operating Policy Effective Date: 12/00 Department No.S.O.P. No: SUR SUBJECT: CREUTZFELDT-JAKOB DISEASE PRECAUTIONS IN SURGERY PURPOSE: To define the procedure for disinfection/sterilization of surgical instrumentation and to provide guidelines for special precautions necessary for disinfection of equipment used on patients with a potential diagnosis of Creutzfeldt- Jakob Disease. Creutzfeldt-Jakob Disease (CJD) is a rare, transmissible, progressive, degenerative neurological disorder which is invariably fatal. It emerged from relative obscurity in 1996 with the report of a new variant of the disease and speculation about its relationship to Mad Cow Disease. The need for special precautions is due to an extremely resistant prion which resists normal inactivation methods, such as steam sterilization or Ethylene Oxide (ETO) sterilization. Despite fears to the contrary, Creutzfeldt-Jocob Disease is not contagious through casual contact with a CJD patient. However, it can be transmitted by exposure to brain or nervous system tissue, usually through certain medical/surgical procedures. The prion, which is the infectious agent, is almost never found in blood or urine and blood transfusions do not appear to be a major risk factor for the acquisition of CJD. POLICY: Whenever a neurosurgical procedure involving brain tissue is scheduled for a person sustected of having Creutzfeldt-Jacob disease, the following precautions and procedure will be initiated for protecting patients and personnel: 1. All aspects of Standard Precautions apply, but no other special precautions are needed for contact with urine, stool, sweat, tears or for transporting patients. 2. Traffic in the operating room will be restricted to those individuals required for the procedure. SOURCE: Standards & Recommended Practices, AORN 2000, APIC, National Institute of Neurological Disorders 11/00, American Journal of Infection Control 2/98, “Prion Disease of the CNS” Major Clinical Syndromes DATE OF REVIEW: NEW
  2. 2. REVISION NO. AREAS AFFECTED: SURGICAL SERVICES APPROVED BY: TITLE: Director of Surgical Services CJD PRECAUTIONS IN SURGERY: Page 2 of 3 3. Use of personal protective equipment will be strictly enforced: A. Double-gloving by sterile personnel recommended. B. Use of protective eyewear is essential due to potential splashing or spraying of CSF or brain tissue. C. Use of impervious gowns by sterile personnel will be required. D. Masks will be worn as usual during surgical procedure. 4. Handling of laboratory specimens: A. Tissue considered to have high risk of CJD prion are brain, duramater, and corneal tissues. B. Notify Laboratory/Histology before transporting specimens to lab C. Specimen is be placed a specimen container with “Suspected CJD” clearly written on label. D. Specimen container is then placed into a zip-lock plastic bag and transported to the histology lab by personnel wearing gloves. 5. Decontamination/disinfection of Operating Room: A. Before routine cleaning of the OR Room, disinfect surfaces contaminated with infectious material (OR table, neuro headrest) by wiping with a 1-2N concentrated solution of Sodium Hydroxide (Stored in flammable cabinet), allowing the solution to remain in contact with the contaminated surfaces for at least one hour. Then rinse well with water. NOTE**SODIUM HYDROXIDE IS VERY CAUSTIC. HANDLE CAREFULLY. RESPIRATOR MUST BE WORN BECAUSE OF RESPIRATORY HAZARDS (Obtain from Environmental Services) Review MSDS before handling. Excess solution may be disposed of by flushing down hopper. B. Procede with routine cleaning, wearing Personal Protective Equipment (gown, gloves, mask, eyewear protection).Environmental surfaces (Floors, walls, counter tops, or other surfaces) would not be expected to be associated with transmission of CJD to health care workers or patients and can be cleaned in the conventional fashion. C. Liquids should be sucked into suction liners, “ISOLIZED”, and then discarded in the biomedical waste that will be sent for incineration. 6. Decontamination/sterilization of Non-disposable instruments:Two major factors significantly affect the sterilization strategy for CJD-contaminated instruments.
  3. 3. One is the type of tissue to which the instrument has been exposed, and the other is the ability to clean the device. A. Disposable intems/instruments should be used whenever possible. B. If the instrument is exposed to high-risk tissue that contains a high prion burden (brain tissue or CSF), and CANNOT BE CLEANED effectively, it will be discarded (frazier suction tips, Rhoton suction tips, and ventriculostomy needles). CJD PRECAUTIONS IN SURGERY Page 3 of 3 C. Instruments that are exposed to high-risk tissue, but that CAN BE CLEANED effectively: 1). Will be sent to the Decontamination Room in a hard, closed container (Use Soak Pan that is kept up sterile). 2). Clearly communicate to SPD personnel that the instruments have to be treated using the Creutzfeldt- Jacob procedure. 3). These exposed instruments must then be soaked in a 1-2N concentrated solution of Sodium Hydroxide for one(1) hour before terminal sterilization. 4). Sterilization must be done at 132 degrees C (269 degrees F) for one(1) hour in a Gravity Displacement sterilizer. ***NOTE: Gravity Ddisplacement sterilizers are the flash sterilizers--except the one between Rms 6 & 7, which is a pre-vacuum sterilizer. These are set for 270 degrees F The SPD sterilizers are also pre-vacuum. We cannot use our pre-vacuum sterilizers because they cannot achieve the recommended temperature pre-vacuum sterilization of CJD instruments. D. Instruments that are NOT in contact with high-risk tissue and can be cleaned effectively, can be cleaned by conventional processing and the usual sterilization/disinfection protocols can be used. E. Current guidelines for cleaning and disinfection of flexible endoscopes after use on a patient with CJD need not be changed.