Validating Sterilization
of Medical Devices
CDR Martha OLone, RN, BSN
Infection Control Devices Branch
DAGID / ODE / FDA
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Objectives
Provide background information on
sterilization validation for medical
devices
Obtain panel guidance on how to
design and interpret sterilization
validation studies for medical devices
after exposure to TSE material
Questions
For prion contaminated critical medical devices:
What is the acceptable sterilization process
for prion removal/ inactivation?
What endpoint is appropriate?
Log reduction of infectivity?
Is there an indicator agent for prions?
Validating Sterilization of
Medical Devices
Spaulding Classification of Medical Devices
Sterilization Methods
Medical Device Reprocessing Steps
Healthcare Sterilization Processes
Medical Device Reprocessing Review
Validation
Available Recommendations/Guidelines
Spaulding Classification of Medical Devices
BASED ON RISK OF INFECTION
Critical devices
Enter normally sterile body tissue: e.g., surgical instruments
-Sterilization
Semi- critical devices
Contact mucous membranes: e.g., flexible endoscopes
-Sterilization, if not feasible- Minimally high level disinfection
Non- critical devices
Contact intact skin: e.g., stethoscopes, electrocardiogram electrodes
-Intermediate or Low level disinfection
- Block, 5th edition
Descending Order of Resistance
???? Prions ????
Bacterial Spores
Mycobacteria
Non-lipid or Small Viruses
Fungi
Vegetative Bacteria
Lipid or Medium-Size Viruses
Steps for Medical Device Reprocessing
Cleaning
Required for effective disinfection or sterilization
Goal: Reduce bioburden
Remove organic / inorganic clinical contaminants
High Level Disinfection-semi critical devices
Endpoint- To kill mycobacteria and some spores
Sterilization- critical devices
Validated process used to render a product free of all forms of
viable microorganisms (AAMI)
Endpoint- To kill spores (as an indicator microorganism)
Sterilization Processes Currently
Used in Healthcare Settings
Steam (Moist Heat) Sterilization
Gravity displacement cycles - 121C, 20-30 min
Prevacuum cycles 132-134 C, 3-5 min
Dry Heat Sterilization
Ethylene Oxide (EtO) Sterilization
Liquid Chemical Sterilization
Gas Plasma Hydrogen Peroxide Sterilization Process
Review of Reusable Medical
Device Reprocessing
FDA Guidance: Labeling Reusable Medical Devices for Reprocessing In
Health Care Facilities: FDA Reviewer Guidance, April, 1996
Labeling for a reusable device that contacts the patient in some manner
must include reprocessing instructions
The instructions must indicate the appropriate microbicidal process for
the device
Critical - Sterilization
Semicritical At least high level disinfection
Noncritical Intermediate or low level disinfection
The reprocessing process must be feasible considering the intended
location of reprocessing (e.g., health care facility or home use)
Reprocessing instructions must be validated
Sterilization Validation
Sterilization of critical medical devices
Objective: sterilization process should
demonstrate a spore (BI) kill to achieve a
sterility assurance level (SAL) of 1x10-6
Standards/Guidance available to provide
validation methods for traditional
sterilization processes utilizing bacterial
spores
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Sterilization Validation
For prion contaminated critical medical devices:
What is the acceptable sterilization process
for prion removal/ inactivation?
What endpoint is appropriate?
Log reduction of infectivity?
Is there an indicator agent for prions?
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Virus Validation
For medical devices incorporating
animal derived tissue
Objective: final product below one
infectious particle per 106 devices
Similar to SAL 1 X 10-6 in traditional
medical devices sterilization processes
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Virus Validation Studies
Scaled down (e.g.1/100) manufacturing procedures
Relevant model viruses (DNA, RNA, single and
double stranded enveloped and non-enveloped)
Spike virus in different steps in the manufacturing
process and determine post-step PFU
Sum the viral clearance values for each
manufacturing step
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WHO Recommendations Annex III
(For reprocessing CJD contaminated instruments)
Disposable Instruments: Incinerate
(and all instruments exposed to high infectivity
tissues.)
Heat Resistant Instruments:
Immerse in 1N NaOH
Heat in a gravity displacement autoclave at
121C for 30 min, or 132 C for 3-5 min
Rinse in water
Routine sterilization process
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Draft CDC HICPAC Guidelines
for CJD Decontamination
Critical or Semicritical Devices Exposed to High Risk Tissues
and/or High Risk patients
Keep instruments wet or damp until they are decontaminated
Options:
1. Clean and sterilize the contaminated devices by immersion in 1N
NaOH, remove, rinse in water and autoclave (sterilizer) in an
open pan as recommended by WHO at 121 C or 134C
depending on type of sterilizer- gravity displacement or prevacfor 1hr
2. OR immerse instruments in 1N NaOH for 1 hour and heat in a
gravity displacement sterilizer at 121C for 30 minutes, clean; and
subject to routine sterilization
3. Clean thoroughly, then autoclave at 134C for 18 minutes in a
prevacuum sterilizer or 132C for 1 hour in a gravity displacement
sterilizer.
Discard contaminated medical devices that are impossible or
15 difficult to clean
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