Importance of Following Standards and Guidelines

In healthcare, standards provide healthcare providers with a set of requirements, specifications and guidelines established and agreed upon by industry experts as the gold standard of care. In the US, American National Standards Institute Inc. (ANSI) and the Association for the Advancement of Medical Instrument (AAMI) are recognized authorities and sources of consensus standards for the medical device industry.

ANSI/AAMI Standards for Sterilization

There are two primary ANSI/AAMI guidance document for sterilization.

ANSI/AAMI ST79:20171 Comprehensive guide to steam sterilization and sterility assurance in healthcare facilities that provides guidance specific to steam sterilization.

ANSI/AAMI ST58:2013/(R)20182 was developed by AAMI and approved by the ANSI in 2013 provides standards and recommended practices for the use of low temperature chemical sterilization and high-level disinfection in a healthcare facility. Standard 58 or ST58 covers a broad range of topics including work area design considerations (Section 3), decontamination and preparation of instruments (Section 6), using chemical sterilant safely and effectively (Section 7).

ST58, Section 9: Quality Control

ST58 Section 9 covers product identification and traceability, documentation, and record-keeping, monitoring of chemical sterilization, product testing, product recalls, and quality process improvement. ASP can help you meet AAMI recommendations for the following topics in ST58 Section 9.

ST58 Section 9.2.2: Cycle documentation and record-keeping

AAMI Recommendation2

For each chemical sterilization, the following information should be recorded and maintained:

  • a) the assigned lot number, processor and cycle number
  • b) the specific contents of the lot or load, including quantity, department, and a description of the items
  • c) the patient’s name and medical record number, if available
  • d) the procedure, physician, and—if applicable—serial number or other identification of the item
  • e) the shelf-life date
  • f) the exposure time and temperature, if not provided on the physical monitors
  • g) the date and time of cycle
  • h) the time, temperature
  • i) the name or initials of the operator
  • j) the results of BI

How ASP Can Help Meet This Guideline

Together, STERRAD® Systems and STERRAD VELOCITY® System’s built-in scanner and touch-screen interface facilitate seamless input of BI, sterilizer and load information and thereby reduces the need of manual record keeping.

ST58 Section 9.5.4.2: Using biological indicators and process challenge devices

AAMI Recommendation2

Health care personnel should use the BIs and PCDs recommended by the manufacturer of the selected gaseous chemical sterilization system and cleared by the FDA for use with that sterilization system or BIs and PCDs cleared by the FDA as substantially equivalent.

How ASP Can Help Meet This Guideline

As the manufacturer of STERRAD® Systems, ASP only recommends the use of the STERRAD VELOCITY® System with its sterilizers. STERRAD VELOCITY® BI/PCDs were developed by ASP using exclusive proprietary data and technology which results in accurate results and minimizes false positives.

ST58 Section 9.5.4.3: Frequency of use of biological indicators and process challenge devices

AAMI Recommendation2

A PCD with the appropriate BI should also be used at least daily, but preferably in every sterilization cycle.

Rationale: The condition of the sterilizer equipment, the expertise of the sterilizer operator, and other factors determining the success or failure of a sterilization cycle could vary from one cycle to another.

How ASP Can Help Meet This Guideline

STERRAD VELOCITY® BI/PCD is the only all-in-one Process Challenge Device for STERRAD® Systems that meets AAMI recommended guidelines.

This means that when you run a STERRAD VELOCITY® BI/PCD in a sterilization cycle, the load is automatically challenged to a level equal to or greater than your most difficult device to sterilize.

ST58 Section 9.5.4.4.2: Qualification test procedure with BIs

AAMI Recommendation2

The test procedure is as follows:

  • a) Before being exposed to the sterilization cycle, the PCD should be labeled with appropriate sterilizer lot and load information.
  • b) The PCD should be positioned in the load or chamber according to the sterilizer manufacturer’s written IFU, and a normal cycle should be run.
  • c) Upon completion of the sterilization cycle, the manufacturer’s written IFU for removing the PCD from the load or chamber and the BI from the PCD should be followed. The BI should be identified and then incubated according to the IFU of the BI manufacturer.
  • d) Each day that test BIs are run, at least one BI that is from the same lot and that has not been exposed to the sterilant should be incubated as a control to verify the pre-sterilization viability of the test spores, the ability of the media to promote growth of the test spores, and the proper incubation temperature. Test and control lot numbers should be recorded. Upon completion of the incubation period, the test and control results should be read and recorded. If the control BI from a lot fails to grow, it should be assumed that the test BIs from that lot are not viable or that improper incubation occurred. Therefore, the results from the test BIs should be considered invalid and the test should be repeated.

How ASP Can Help Meet This Guideline

The STERRAD VELOCITY® System guides users through compliant biological indicator (BI) processing and automatically creates audit-ready records and can store up to 22,000 complete records including the information recommended by AAMI (as shown in the section to the left).

Annotated Velocity Report

For more information on how ASP can help you meet AAMI recommended guidelines, request a consultation from a sterilization expert.

References

  1. American National Standard/Association for the Advancement of Medical Instrumentation. ANSI/AAMI ST79:2017 Comprehensive guide to steam sterilization and sterility assurance in healthcare facilities.
  2. American National Standard/Association for the Advancement of Medical Instrumentation. ANSI/AAMI ST58:2013/(R)2018 Chemical sterilization and high-level disinfection in health care facilities.

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