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1 Validating Sterilization of Medical Devices CDR Martha OLone, RN, BSN Infection Control Devices Branch DAGID / ODE / FDA.

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Presentation on theme: "1 Validating Sterilization of Medical Devices CDR Martha OLone, RN, BSN Infection Control Devices Branch DAGID / ODE / FDA."— Presentation transcript:

1 1 Validating Sterilization of Medical Devices CDR Martha OLone, RN, BSN Infection Control Devices Branch DAGID / ODE / FDA

2 2 ObjectivesObjectives l Provide background information on sterilization validation for medical devices l Obtain panel guidance on how to design and interpret sterilization validation studies for medical devices after exposure to TSE material

3 3 QuestionsQuestions l 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?

4 4 Validating Sterilization of Medical Devices l Spaulding Classification of Medical Devices l Sterilization Methods l Medical Device Reprocessing Steps l Healthcare Sterilization Processes l Medical Device Reprocessing Review l Validation l Available Recommendations/Guidelines

5 5 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 -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, 5 th edition 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 -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, 5 th edition

6 6 Descending Order of Resistance ???? Prions ???? l Bacterial Spores l Mycobacteria l Non-lipid or Small Viruses l Fungi l Vegetative Bacteria l Lipid or Medium-Size Viruses

7 7 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) 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)

8 8 Sterilization Processes Currently Used in Healthcare Settings l Steam (Moist Heat) Sterilization Gravity displacement cycles - 121ºC, min Prevacuum cycles – ºC, 3-5 min l Dry Heat Sterilization l Ethylene Oxide (EtO) Sterilization l Liquid Chemical Sterilization l Gas Plasma Hydrogen Peroxide Sterilization Process

9 9 Review of Reusable Medical Device Reprocessing l 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

10 10 Sterilization Validation l Sterilization of critical medical devices l 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

11 11 Sterilization Validation l 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?

12 12 Virus Validation l For medical devices incorporating animal derived tissue l Objective: final product below one infectious particle per 10 6 devices l Similar to SAL 1 X in traditional medical devices sterilization processes

13 13 Virus Validation Studies l Scaled down (e.g.1/100) manufacturing procedures l Relevant model viruses (DNA, RNA, single and double stranded enveloped and non- enveloped) l Spike virus in different steps in the manufacturing process and determine post- step PFU l Sum the viral clearance values for each manufacturing step

14 14 WHO Recommendations Annex III (For reprocessing CJD contaminated instruments) l Disposable Instruments: Incinerate (and all instruments exposed to high infectivity tissues.) l Heat Resistant Instruments: Immerse in 1N NaOH Heat in a gravity displacement autoclave at 121°C for 30 min, or 132º C for 3-5 min Rinse in water Routine sterilization process

15 15 Draft CDC HICPAC Guidelines for CJD Decontamination l 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 134°C depending on type of sterilizer- gravity displacement or prevac- for 1hr 2. OR immerse instruments in 1N NaOH for 1 hour and heat in a gravity displacement sterilizer at 121°C for 30 minutes, clean; and subject to routine sterilization 3. Clean thoroughly, then autoclave at 134°C for 18 minutes in a prevacuum sterilizer or 132°C for 1 hour in a gravity displacement sterilizer. Discard contaminated medical devices that are impossible or difficult to clean

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