Sterile Processing

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.   

Life science companies continually evaluate their operations for opportunities to improve throughput, increase compliance, and reduce costs. Medical device manufacturers, laboratories, and R&D facilities can all experience greater flexibility and more control with an in-house ethylene oxide (EO) sterilization program. By reducing what can be a two-week turnaround time with outsourced sterilization, operations managers can expect faster release of finished goods and increased inventory turns for a measurable and sustainable economic benefit. In particular, companies that process small, high-value devices can benefit from the new 3M™ Steri-Vac™ Sterilizer/Aerator GSX Series ethylene oxide (EO) sterilization system, with state-of-the-art mechanical design, real-time cycle information on the high-resolution color touch screen, and the ability to quickly and easily customize sterilization cycles.

Q: On occasion, I will be asked to process a device which does not have instructions for use. Sometimes, the item is not a medical device (e.g., zipper). I am told I must process the device because the surgeon requires it for a case. I usually process the device. I have just learned this is not the correct practice. How do I handle this?