sterile processing
By Julie E. Williamson
Current Standards Vital
to Sterile Processing
Success: Does Your SPD
Have the Latest?
S
terile Processing departments (SPDs) functioning in the
absence of the latest industry standards, guidelines and
recommended practices are at risk of a multitude of negative
outcomes, not the least of which can include increased risks
to patients and healthcare workers; survey deficiencies,
citations and fines; and potentially devastating damage to
the facility’s reputation.
Sometimes, SP professionals don’t have any version of
certain standards; others may only have outdated versions –
such as an older version of ANSI/AAMI ST79, Comprehensive
guide to steam sterilization and sterility assurance in health care
facilities, instead of the most current 2017 version. ST79 is a
comprehensive document with valuable information for the
SPD, operating room, infection prevention, safety, risk man-
agement, and engineering/facilities management. ANSI/AAMI
ST79: 2017 is the go-to reference for steam sterilization in all
healthcare facilities and is applicable regardless of sterilizer size
or facility size. 1 Developed by sterilization and manufacturing
professionals ST79:2017 can help SP professionals:
• Support safety at every step for processing medical devices;
• Follow proper sterilization practices of processed items
across multiple facility departments
• Understand the complete life cycle of sterilization
processing - from managing temperature and humidity to
processes for the decontamination area
• Substantiate the need for equipment upgrades to meet
federal guidelines that reduce potential citations
• Support the delivery of properly processed medical devices
critical to optimizing patients’ health
• Guide personnel toward desirable performance objectives 1
Its availability and use will also help facilities stay in com-
pliance with accrediting bodies such as the Joint Commission
and the Centers for Medicare and Medicaid Services. AAMI
notes that it is the document by which surveyors are being
trained; therefore, surveyors will be looking to ensure the
facilities they inspect are well versed on that document and
have it readily available to staff members.
To help SP professionals petition their facilities for the most
current standards, guidelines and recommended practices
needed for quality customer service and patient safety, the
International Association of Healthcare Central Service Materiel
Management (IAHCSMM) drafted a Standards Value Letter, a
free, customizable template that SP managers can share with
administrators and other executives. 2
The Standards Value Letter lists the most current standards,
Technical Information Reports (TIRs) and guidelines facilities
should have available to all individuals responsible for SP
functions. These include the following from the Association
www.healthcarehygienemagazine.com • february 2020
for the Advancement of Medical Instrumentation (AAMI),
the Association of periOperative Registered Nurses (AORN)
and the Centers for Disease Control and Prevention (CDC):
1. ANSI/AAMI ST79: 2017, Comprehensive guide to steam
sterilization and sterility assurance in health care facilities
2. AORN Guidelines for Perioperative Practices, 2020
3. ANSI/AAMI ST58:2013, Chemical sterilization and
high-level disinfection in health care facilities (Note: This
document is currently under review)
4. ANSI/AAMI ST41: 2008/(R) 2018, Ethylene oxide steriliza-
tion in health care facilities (for facilities using ethylene oxide)
5. ANSI/AAMI ST91:2015, Flexible and semi-rigid endo-
scope processing in health care facilities
6. ANSI/AAMI ST90:2017, Processing of health care
products - Quality management systems for processing in
health care facilities
7. AAMI TIR 68:2018, Low and intermediate-level disin-
fection in healthcare settings for medical devices and patient
care equipment and sterile processing environmental surfaces
8. AAMI TIR 67:2018, Promoting safe practices pertaining
to the use of sterilant and disinfectant chemical in health
care facilities
9. AAMI TIR 34:2014, Water for the reprocessing of
medical device
10. AAMI TIR 63:2014, Management of loaned critical
and semi-critical medical devices that require sterilization or
high-level disinfection
11. CDC Guideline for Decontamination and Sterilization
in Healthcare Facilities, 2008
The CDC Guideline for Decontamination and Sterilization
in Healthcare Facilities, 2008, is available free of charge on the
agency’s website (https://www.cdc.gov/infectioncontrol/pdf/
guidelines/disinfection-guidelines-H.pdf). Note: This version was
updated in May 2019 and all SPDs should have that version on
file for their SP professionals. There is a charge for the other
documents, however, budgeting for these documents is essential
given healthcare organizations’ desire to provide the very best
patient care and quality customer service. Failing to have current
standards on file in one’s department could prove costly for
facilities if adverse events occur, such preventable infections or
injuries to patients or staff, or subsequent litigation.
Diligent adherence to the latest standards and best practices
will help drive patient and employee safety, advance infection
prevention efforts, and keep exemplary customer service a
top priority.
To access the IAHCSMM Standards Value Letter, visit:
https://www.iahcsmm.org/resource-documents/iahcsmm-
standards-value-letter.html
Julie E. Williamson, BA, is IAHCSMM’s communications
director/editor.
References:
1. ANSI/AAMI ST79:2017. https://www.aami.org/productspublications/
ProductDetail.aspx?ItemNumber=1383
2. IAHCSMM Standards Value Letter. https://www.iahcsmm.org/
resource-documents/iahcsmm-standards-value-letter.html
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