New AAMI Guidelines

AAMI guidelines for medical devices promote safe practices.

The Association for the Advancement of Medical Instrumentation, known as AAMI, develops standards, recommends practices and develops technical reports for medical devices. Although the AAMI updates most standards in a multiyear cycle, it updates the standards for steam sterilization continuously.

Standards for Hospitals

Sterilization Part 1 provides 11 documents, including an amendment to AAMI's guide to steam sterilization, ST79. The amendment includes new guidance on sterilization process failure and a checklist for analyzing the causes of such failure.

Standards for Manufacturers

Sterilization Part 2 provides 23 documents, including two new standards. One of the new standards describes general requirements and tests for washer-disinfectors. The other new standard focuses on understanding biological indicators in the sterilization process.

Effects

AAMI standards represent a national consensus that provides guidelines for the medical industry. The American National Standards Institute often adopts AAMI guidelines as standards.

Significance

The AAMI standards for steam sterilization focus on preventing improper sterilization procedures, including improper temperatures, inappropriate cleaning instruments and contamination by environmental factors.

Further Information

You can purchase the complete text of each AAMI standard online (see Resources) or by calling 877-249-8226.

References

• AAMI: About the Standards Program
• AAMI: ST41 and ST79 Registry
• Infection Control Today: AAMI Updates Sterilization Standards Collections
• Materials Management in Health Care: Adhering to Standards

Resources

• AAMI: The 2010 AAMI Resource Catalog