Board C-01

Effects of CJD Decontamination Protocols on Surgical Instruments

D.N.Busick, S.A.Brown, K.Merritt, Office of Science and Technology, CDRH, FDA, Rockville, MD

To prevent patient-to-patient transmission of Creutzfeldt-Jakob Disease, the World Health Organization (WHO) recommends destroying instruments used on tissues possibly contaminated with CJD. Because it is impractical and costly to destroy instruments that are designed to be reusable, an alternative is to thoroughly decontaminate before reusing instruments that have contacted high-infectivity tissues (e.g., brain, spinal cord) of patients with confirmed or suspected CJD. The WHO and the US Centers for Disease Control and Prevention (CDC) have suggested that one of the following CJD-decontamination methods be used prior to routine cleaning and sterilization of surgical instruments:

- Autoclave in 1 N sodium hydroxide at 121°C for 30 minutes; OR

- Soak in either 1 N sodium hydroxide or 5% bleach for 60 minutes, then autoclave (dry or in water) for 60 minutes.

We subjected a variety of surgical instruments to the WHO-recommended decontamination methods to determine the effects on the instruments. Some instruments tolerated the decontamination procedures well; others did not (for example, gold-plated forceps handles corroded after soaking in bleach). We also subjected identical instruments to two standard methods for testing corrosion resistance, to determine whether the methods could predict the instruments’ response to decontamination.


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Last updated on 2003-MAR-20 by frf