Advice on CJD and Instrument Reprocessing

By Nancy Chobin, RN, AAS, ACSP, CSPM

Q: I was recently informed we will be performing surgery on a patient with suspect Creutzfeldt-Jakob Disease (CJD). We were informed that all the instruments should be soaked in bleach or discarded after the surgery. Can you provide some current recommendations on this?

A: There has been much attention to CJD over the years. CJD is a rare, fatal neurological disease cause by an infectious protein, hence the term “prion.” The prions are very resistant to all forms of inactivation including regular steam cycles, ETO, gas and vapor phase peroxide, etc. To add to the confusion, there are recommendations from the World Health Organization (WHO), Centers for Disease Control and Prevention (CDC) and the Association for the Advancement of Medical Instrumentation (AAMI) ST-79, Annex C. Some of the recommendations from these different organizations conflict with one another.   

In the United States, AAMI standards are considered national standards and reflect practices for the U.S. Therefore, the recommendations in ST-79 should direct your practice.

A major issue with CJD is the long incubation period, which can be as long as 60 years for the conventional form. The variant form vCJD initiated in the United Kingdom and was spread by eating meat from cows infected with bovine spongiform encephalitis (cow form of CJD).  The incubation period for the variant form is not known.

Some of the major recommendations from AAMI ST-79 Annex C include:
• All known instances of iatrogenic CJD have resulted from exposure to infectious brain, pituitary, or eye tissue.   Tissue infectivity studies in experimental animals have determined the infectiousness of different body tissues (Brown, 1996). Tissues that have the highest prion concentration are brain and dura mater. Transmissibility is directly related to the concentration of prions in tissues.
• To minimize the possibility of use of neurosurgical instruments that have been potentially contaminated during procedures performed on patients in whom CJD is later diagnosed, health care facilities should consider using the sterilization guidelines outlined below for neurosurgical instruments used during brain biopsy done on patients in whom a specific lesion has not been demonstrated (e.g., by magnetic resonance imaging or computerized tomography scans). Alternatively, neurosurgical instruments used in such patients could be disposable or the instruments could be quarantined until the pathology of the brain biopsy is reviewed and CJD excluded (Rutala and Weber, 2001). 
• Devices that are constructed so that cleaning procedures result in effective tissue removal (e.g., surgical instruments) can be cleaned and then steam sterilized at 134 degrees C for greater than or equal to 18 minutes in a prevacuum sterilizer or at 121 degrees C to 132 degrees C for one hour in a gravity-displacement sterilizer.
• Devices that are impossible or difficult to clean can be discarded.
• To minimize drying of tissues and body fluids on the object, devices should be kept moist until cleaned and decontaminated.
•  Immediate-use steam sterilization (formerly known as flash sterilization) should not be used for reprocessing these devices.
• Contaminated items that have been in contact with high-risk tissue and have not been processed according to these recommendations (e.g., medical devices used for brain biopsy before diagnosis) should be recalled and appropriately reprocessed.
• A tracking system should be in place that permits recall of devices used on high-risk tissue and high-risk patients.
Understand that instruments subjected to bleach or sodium hydroxide (as recommended by the WHO) will corrode and destroy surgical instruments.  In addition, you should not subject surgical instruments to extended cycles unless the manufacturer has validated for these exposure times.  Many spine  and ophthalmic instrument companies have done so.

Your facility should develop a comprehensive CJD Policy based on AAMI ST-79, Annex C.  You need to be prepared for CJD cases, not wait until you have a patient with a known or suspected case.

Nancy Chobin, RN, AAS, ACSP, CSPM, is vice president of sterile processing services for Barnabas Health in West Orange, N.J.