AAMI Introductory American National Standards
Jun 11, 2015
AAMI IntroductoryAmerican National Standards
Delivery of Sterile Item – pg 1 Sterilization process
Facility Design
Staff Training
Quality Improvement Plan from Point of use to the reuse
Documentation and reporting process
Limitations – pg 1
Seen in all aspects discussed previously
Environmental Restrictions Facility Funding
Set difficulties Need to allocate resources
Flash Sterilization – pg 2
Sterilization Preprogrammed The user select the option according
med device manufacture written Instructions
Load Configuration (porous material…) Items usually Unwrapped
Single Wrapper may be used IF: Rigid Containers IF:
Items are assumed to be wet
Flash Sterilization – pg 2 Cont
Items must be transferred immediate to the point of use Respect aseptic tech No storage or half life
Removal of gross soil is essential before any method of sterilization
Decontamination is to protect the worker
Documentation is essential
Flash Sterilization – pg 2 Cont The transfer tech:
Worker Safety: hot wet items Sterilizer once opened: contamination Occur▪ Recommendation: HEPA Filter + Laminar Flow Area
Way to deliver the items:▪ Stop Hand Washing / Scrubbing▪ HEPA Filter Area
If these Not Present: Once Sterilizer Opened, Grap the item By Sterile Cloth and put them in the Rigid Container
Idea: Flash Sterilizer near the Operating Room Important Concept: Longer time opened
Greater Number of Particles Contamination Infection Control Audit is mandatory
Flash Sterilization – pg 2 Cont
Implantables Should not be Flash Sterilized
Risk of failure increase Greater risk of infection
BI Must be used even though should not be used
Decontamination Process
Patient In Surgery
Etiologic Agents
Etiologic Agents - Cont
Infectious Dose Improper Cleaning
Etiologic Agents - Cont
Staff Training … Why
Complexity of items that need to be resterilized
Manufacture written Instruction The Rationale Approach The presence of educational
Speakers (Sterilization Team)