Specifications

10
TP202 Rev. A © Midmark Corporation 2013
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
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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.