AAMI News August 2018

AAMI Standards Board Approves Development of Six Items

The AAMI Standards Board approved six new work item proposals—three for standards and three for technical information reports (TIRs)—during a meeting in early July.

Standards are consensus documents that follow a detailed and prescribed development path, including a public comment period. TIRs do not require the same level of consensus development, do not require a public comment period, and are usually developed much faster than a standard.

The approved projects are:

  • AAMI TIR99, which will focus on the sterile processing of dilators and transesophageal and ultrasound probes in healthcare facilities. It will outline the proper steps for processing dilators and probes, providing much-needed guidance to healthcare personnel.
  • AAMI ST100, a new standard for end-to-end sterility assurance that will provide a comprehensive framework that connects the sterility assurance activities at each point in the supply chain, from the definition of the product needs during research and development to the manufacture and distribution of the product to the customer, consumer, and/or patients.
  • AAMI TIR101, which will address fluid delivery performance testing for infusion pumps. This will be the first U.S. guidance to define fluid delivery performance test methods to accurately and efficiently align with the intended use of an infusion pump to provide clinically relevant presentation of test results.
  • AAMI TIR102, which will map the Food and Drug Administration’s Quality System Regulation (21 CFR Part 820) to the regulatory requirement references found in ANSI/AAMI/ISO 13485:2016. This tool is intended to help medical device manufacturers transition to a 13485-based quality management system ahead of a proposed U.S. regulatory change.
  • AAMI EQ103, a new standard that will offer guidance on developing an alternative equipment maintenance (AEM) program, addressing maintenance strategies and activities, as well as their frequency, to help ensure the use of a consistent, quantitative, risk-based methodology in AEM development.
  • A revision of AAMI EQ56, Recommended practice for a medical equipment management program, that will identify standardized quality management principles across the patient care continuum and align with the concepts found in ISO 20000, Information technology—Service management.

For more information about the AAMI standards program or to learn how to join a committee, visit www.aami.org/standards.