Dear Alex,
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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.
Sincerely,
Ralph J. Basile
Vice President of Marketing
Healthmark Industries Company, Inc.
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Sincerely,
Alex Kirk
Healthmark Industries Company, Inc.
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