Question:
Does a sterile single use/ disposable instrument that will be used as a critical instrument still require sterile storage requirements (T, RH, & P monitoring)? Are the requirements not limited to reusable metal instruments?
Answer:
No, if your organization has purchased a sterile instrument or supply, it will need to be stored per the MIFU and it will need to be prevented from getting dirty or damaged. The sterile supplies and instruments purchased have protective covering supplied by the manufacturer which is designed to keep it sterile until used or until the product expiration date.
These can be kept in clean storage area as they do not fall under the AAMI sterile instrument storage requirements. If they are stored in a clean storage room, they still will have to follow FGI guidelines for temperature, humidity, and pressure and this depends on how the space is classified. For example, is it listed as a critical space subject to EC.02.05.05 EP 15?
Is there a regulatory resource to support the “configuration” comment? One facility was cited for sterile supplies hanging over bottom rack. I’m getting resistance.