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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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