Midmark M9 - Sterilization Monitoring Guidelines

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003-2707-99

Sterilization Monitoring Guidelines

Physical Monitors

Temperature and pressure measuring devices can help detect sterilizer malfunctions. The sterilizer’s control

system aborts the cycle and displays a message if physical conditions go outside established limits. The

optionalprintercanbeusedtocreatearecordofeachload’sactualcycletime,temperature,andpressure.

Chemical Indicators

Chemical indicators are designed to verify that conditions in the sterilizer chamber were adequate to achieve

sterilization.Theydonotvalidatethataprocesseditemissterile.Ifachemicalindicatorshowsafailure,

itemsinthatloadareconsiderednon-sterile.Potentialcausesforsterilizationfailureinclude:improper

cleaning,packing,loading,orasterilizermalfunction.Determinethecauseofanysterilizationfailure,and

remedythesituationbeforerunningthenextcycle.OnlyFDAclearedchemicalindicatorslabeledforuse

withthenontraditionalsteamsterilizationcycleparameters.e.g.temperatureandexposuretime,ofthe

M9 / M11 Sterilizers should be used for monitoring the cycles. Follow the chemical indicator’s instructions

forproperstorage,use,interpretation,anddisposal.

Biological Indicators

Biological indicators are microbiological devices designed to accompany items being sterilized to monitor

adequacyofthesterilizationprocess.Ifabiologicalindicatorshowsafailure,itemsinthatloadare

considerednon-sterile.Potentialcausesforsterilizationfailureinclude:impropercleaning,packing,loading,

orasterilizermalfunction.Determinethecauseofanysterilizationfailure,andremedythesituationbefore

runningthenextcycle.OnlyFDAclearedbiologicalindicatorslabeledforusewiththenontraditional

steamsterilizationcycleparameters.e.g.temperatureandexposuretime,oftheM9/M11Sterilizers

shouldbeusedformonitoringthecycles.Followthebiologicalindicatorsinstructionsforproperstorage,

use,interpretation,anddisposal.

Note

This information below is provided for reference only. Contact appropriate state/local agencies for

specific sterilization guidelines for your office. Additional information on infection control is available

from the Centers for Disease Control and Prevention (CDC), Organization for Safety and Asepsis

Procedures (OSAP) ), Association for the Advancement of Medical Instrumentation (AAMI), and

Association for Professionals in Infection Control and Epidemiology (APIC).

Note

Use only FDA cleared chemical & biological indicators designed for steam sterilization that are

compatible with the particular sterilization cycle temperature and exposure time being monitored.

Use sterility monitors with each sterilization load. If a sterilizing cycle is terminated prematurely,

reprocess instruments to ensure sterility of the load. Follow manufacturer’s instructions for proper

disposal of used indicators.

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