AAMI PREVIEW – ISSUE NO. 24

AAMI's Steam Sterilization Committee meets next week in Arlington Virginia. This is the group responsible for authoring consensus standards related to the proper reprocessing of surgical instruments. These standards are voluntarily followed by healthcare facilities, medical device manufacturers and often referenced by the FDA, AORN, JCAHO and other regulatory and standards bodies - not just in the U.S. and Canada, but worldwide. There are several meetings going on concurrently. As voting members, we will be attending the following working group meetings: Monday: " Instructions for reprocessing of resterilizable medical devices" - Work Group 12: This committee is completely reviewing the current document with the goal of publishing an updated version in the next couple of years. This is the document manufacturers reference when authoring instructions for use related to device reprocessing by healthcare facilities. Tuesday: "Steam Sterilization Hospital Practices" - WG40: This is the group responsible for authoring the often quoted and referenced ST79. The current iteration of ST79 was first published in 2006 and was updated in 2008 and 2009. There have been enough significant changes to this document that it is the goal of the committee to author a complete, updated version soon. "Washer Disinfectors" - WG13: Primarily spearheaded by our colleagues in Europe, it is the role of this work group to review and accept and reject and/or note national deviations from this ISO (International Standards Organization) so that these documents (ISO15883-x) apply to the unique circumstances and practices in North America. "Packaging" - WG07: Primarily oriented toward setting standards that manufacturers of sterilization packaging and the medical device manufacturers that use that packaging should follow (pouches, sterilization wrap, etc.). This group has reached out to health care facility users as well, to help bridge the gap between industry practice and that at the healthcare facility. Much like the Washer Disinfector work group, this is an international effort which AAMI participates in a supports. Wednesday: "Cleaning Of Reusable Medical Devices" - WG93: The name might imply that this is related to cleaning of reusable medical devices at the healthcare facility, but in fact, this is a compendium (A TIR or Technical Information Resource is AAMI parlance) of methods that medical device manufacturers can use to validate that the instructions they provide to healthcare facilities actually work. This document is a few years old and is being updated with many of the changes in the state of the art of testing in our industry. We are looking forward to AAMI meetings. The process of writing legislation is often compared to "watching sausage get made" and in many ways the AAMI process resembles this. But AAMI 's strength is its open nature to public comment and input - hopefully from the widest population of interested and knowledgeable stakeholders.