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Inside Washington is a regular feature of Communiqué.
These columns are written by Judith Veale, J.V. Biomedical Consultants, Rehoboth, Massachusetts.
From the January/February 2007 issue of Communiqué
Ethylene Oxide Sterilization
The AAMI Ethylene Oxide Sterilization Hospital Practices Working Group
is continuing work on a new edition of ANSI/AAMI ST41, Ethylene
oxide sterilization in health care facilities: Safety and effectiveness. Much of the discussion thus far has focused on the appropriate use
and practicality of the biological-indicator (BI) challenge test
pack currently recommended for qualification testing. Some of the
materials recommended for inclusion in the challenge test pack are
no longer widely available in healthcare facilities, and others (i.e.,
latex tubing) are prohibited in some facilities. To this point, the
Working Group is inclined toward recommending that healthcare facilities
rely on sterilizer manufacturers or other service providers to conduct
testing that involves use of the challenge test pack, and that healthcare
facilities continue to use the routine BI test pack for regular sterilizer
efficacy testing. However, this issue is still being debated.
A revised draft of the recommended practice will be balloted (for the second time) in advance of the Working Group's April 2007 meeting. If the ballot is successful (i.e., the Working Group establishes a consensus on the provisions of the document), the proposed new edition of the recommended practice will likely be available for public review and comment during the summer of 2007.
Steam Sterilization
The new recommended practice, Comprehensive guide to steam sterilization
and sterility assurance in health care facilities (ANSI/AAMI ST79),
has been published. The document merges and updates five existing
AAMI documents: ANSI/AAMI ST46 (Steam sterilization and sterility
assurance in health care facilities), ANSI/AAMI ST37 (Flash sterilization:
Steam sterilization of patient care items for immediate use), ANSI/AAMI
ST42 (Steam sterilization and sterility assurance using table-top
sterilizers in office-based, ambulatory-care medical, surgical, and
dental facilities), ANSI/AAMI ST35 (Safe handling and biological
decontamination of medical devices in health care facilities and
in nonclinical settings), and ANSI/AAMI ST33 (Guidelines for the
selection and use of reusable rigid sterilization container systems
for ethylene oxide sterilization and steam sterilization in health
care facilities).
AAMI standards and recommended practices are usually reviewed and updated every five years or so; However, ANSI/AAMI ST79 will be on a "continuous maintenance" schedule, meaning it will be reviewed and updated every year. Thus, interested parties will be able to suggest revisions or request clarifications in a timely manner, and any amendments adopted will be published annually.
Already being considered as additions to ST79 are annexes on subjects such as extended cycles and special considerations associated with ophthalmic instruments. At its April 2007 meeting, the Working Group will review any proposed revisions to the recommended practice.
Sterilization Container Systems
The AAMI standard, Containment Devices for Reusable Medical Device
Sterilization, covers design, performance and labeling criteria for
reusable rigid sterilization containers, instrument cases and cassettes,
and organizing trays intended for use in containing reusable medical
devices for sterilization. This document has been approved as both
an AAMI standard and an American National Standard and is currently "in
press." The standard will likely be available in early 2007.
Water Quality for
Processing Medical Devices
The AAMI technical information report (TIR), Water for the Reprocessing
of Medical Devices, covers the importance of water quality and effective
water treatment; categories of water quality suitable for various stages
of medical device reprocessing and various types of medical devices;
the selection of appropriate water quality for particular applications;
water treatment systems; monitoring water quality; strategies for bacterial
control; water distribution and storage; quality control procedures
and continuous quality improvement; and personnel considerations. The
TIR has been completed and will likely be published in the spring of
2007.
Hospital Steam Sterilizers
Work is underway on a new edition of ANSI/AAMI ST8, Hospital Steam
Sterilizers. A second working draft of the revised standard was considered
at the November 2006 meeting of the Hospital Steam Sterilizer Working
Group. A proposal to require sterilizer manufacturers to qualify
extended cycles was tabled, pending the completion of work by other
AAMI Working Groups on this issue.
Protective Apparel
The AAMI recommended practice, Processing of reusable surgical
textile for use in health care facilities (ANSI/AAMI ST65:2000), is under
revision. This document provides guidelines for the proper handling,
processing and preparation of reusable surgical textiles, either
on- or off-site. The revision project was organized at a November
2006 meeting, with a view to preparing a first working draft of the
new edition by early 2007.
User Participation in AAMI Standards-Development Activities
AAMI technical committees typically consist of equal numbers of participants
representing device and equipment manufacturers, professional and
regulatory organizations, and healthcare facilities. For AAMI sterilization-related
activities, in particular, the participation of central service professionals
is always welcomed and actively sought. For information on how to
apply for membership in AAMI technical committees, visit AAMI's web
site at www.aami.org.
Further information on these and other AAMI documents can be obtained at the AAMI web site: www.aami.org
