Validating Sterilization of Medical Devices

Validating Sterilization
of Medical Devices
CDR Martha OLone, RN, BSN
Infection Control Devices Branch
DAGID / ODE / FDA
1
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
10
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?
11
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
12
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
13
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
14
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
16

Validating Sterilization of Medical Devices

Uploaded by

Copyright:

Available Formats

Validating Sterilization of Medical Devices

Uploaded by

Document Information

Original Description:

Original Title

Copyright

Available Formats

Share this document

Share or Embed Document

Sharing Options

Did you find this document useful?

Is this content inappropriate?

Copyright:

Available Formats

Validating Sterilization of Medical Devices

Uploaded by

Copyright:

Available Formats

Validating Sterilization

Provide background information on

Obtain panel guidance on how to

For prion contaminated critical medical devices:

What is the acceptable sterilization process

What endpoint is appropriate?

Spaulding Classification of Medical Devices

Medical Device Reprocessing Steps

Healthcare Sterilization Processes

Medical Device Reprocessing Review

Spaulding Classification of Medical Devices

Semi- critical devices

Non- critical devices

Descending Order of Resistance

Non-lipid or Small Viruses

Lipid or Medium-Size Viruses

Steps for Medical Device Reprocessing

High Level Disinfection-semi critical devices

Sterilization- critical devices

Sterilization Processes Currently

Steam (Moist Heat) Sterilization

Gravity displacement cycles - 121C, 20-30 min

Dry Heat Sterilization

Ethylene Oxide (EtO) Sterilization

Liquid Chemical Sterilization

Gas Plasma Hydrogen Peroxide Sterilization Process

Review of Reusable Medical

FDA Guidance: Labeling Reusable Medical Devices for Reprocessing In

Sterilization of critical medical devices

Objective: sterilization process should

Standards/Guidance available to provide

For prion contaminated critical medical devices:

What is the acceptable sterilization process

What endpoint is appropriate?

For medical devices incorporating

Objective: final product below one

Similar to SAL 1 X 10-6 in traditional

Virus Validation Studies

Scaled down (e.g.1/100) manufacturing procedures

Relevant model viruses (DNA, RNA, single and

Spike virus in different steps in the manufacturing

Sum the viral clearance values for each

WHO Recommendations Annex III

Disposable Instruments: Incinerate

(and all instruments exposed to high infectivity

Heat Resistant Instruments:

Draft CDC HICPAC Guidelines

Critical or Semicritical Devices Exposed to High Risk Tissues

Keep instruments wet or damp until they are decontaminated

You might also like