AAMI ST90 has just been released. It’s titled Processing of health care products – Quality management systems for processing in health care facilities. The new 50 page standard was developed by a group that included industry, practitioners (including nursing representatives), academia, government, affiliated organizations, and other interested parties. It is focused on guidelines for hospitals and other healthcare facilities. You’ll use it to set up procedures and guidelines supporting quality management systems (QMS) for processing medical devices (sterilization).
The hospital and health care facilities industry is fast adopting processes used by quality professions for many years. These protocols are helping this industry improve outcomes, with an increased focus on systematic process improvement using a range of quality tools. The AAMI ST90 is based on ANSI/AAMI/ISO 13485 and follows its format. However, you can use this document even if you are not implementing the 13485.
The standard is to be used for the sterilization processing of medical devices. With the knowledge that many adverse effects are in fact caused by human error, creating a QMS for effective and consistent processing during sterilization is a reasonable goal. So you’ll find information in this standard for setting your objectives, creating a document trail, management responsibilities, resource management, and of course, measurement, analysis, and improvement.
The AAMI ST90 is then arranged to support this. It begins with the usual scope, referenced documents, and definitions sections. Next follow sections on QMS, management, resources, product realization, and the measurement, analysis and improvement process. Four Annexes cover document and record retention, risk management, product QA testing for steam sterilization, and the six major steps in creating a QMS. A 30-item bibliography completes the text.
Now you’ll want to get a copy of this new standard. Choose Document Center Inc., an authorized distributor of the AAMI standards. You can order them on our website at www.document-center.com in paper format or for pdf download. Here is a direct link to the order page for AAMI ST90 for your convenience.
It’s also possible to purchase AAMI standards as part of our Standards Online company-wide cloud access service. For more information about this, please get in touch by phone (650-591-7600) or email (info@document-center.com). We’ve been working with standards since 1982. We’re your “one-stop shop” for all your standards needs. Make us your Standards Experts!