In this blog, I usually review documents that come under the heading “standards.” These are compliance publications that have legal implications, to meet both best practices and, on occasion, regulatory requirements. However, many of our standards developing organizations create other types of publications, intended to improve the practices of the industries they support. The new AAMI SPVVQ, “Basic Concepts in Sterilization Processes Verification, Validation, And Qualification,” is just one of those types of releases.
Donna Swenson’s 132 page “textbook” on the subject is intended to be used by both medical device manufacturers and sterilization processing personnel. This is because medical devices have become much more complex, involving sensitive electronics and emerging technologies. And the dangers of the spread of hard to treat infection from inadequately sterilized equipment are increasing. The goal? Better designed equipment and processes, enabled and executed by personnel aware of the physics, chemistry and microbiology of reprocessing itself.
Ms. Swenson begins her book with a review of the science behind sterilization and quality management. She then moves on to the basics of process validation and verification. Both cleaning validation and steam sterilization validation have chapters devoted to them, with information on selection, validation and verification for each. Process and product design for steam sterilization are also covered.
Chapter 8 discusses product quality assurance testing, using the AAMI ST79 as the basis for the review. The final chapter covers the verification of the steam sterilization process in healthcare facilities, the challenge of ensuring that equipment and personnel continue to perform as expected.
As a manufacturer, you want to be sure that your equipment is designed for successful reprocessing in the healthcare environment. And facility management need to be assured that the processes for safeguarding patients can be trusted. Ms. Swenson’s textbook provides both sides with the information needed to improve and support these efforts.
The AAMI SPVVQ can be purchased from Document Center in both paper format and for pdf download. Use our webstore at www.document-center.com. Or you are welcome to contact our staff by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com). We have over 450,000 unique standards titles for you to choose from. So no matter what industry you’re in, make Document Center your Standards Experts!
